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GABANET belongs to a group of medicines used to treat epilepsy and peripheral neuropathic pain (long lasting pain caused by damage to the nerves).
The active ingredient in GABANET is Gabapentin.
GABANET is used to treat:
□ Various forms of epilepsy (seizures that are initially limited to certain parts of the brain, whether the seizure spreads to other parts of the brain or not). The doctor treating you or your child 6 years of age and older will prescribe GABANET to help treat epilepsy when the current treatment is not fully controlling the condition. You or your child 6 years of age and older should take GABANET in addition to the current treatment unless told otherwise. GABANET can also be used on its own to treat adults and children over 12 years of age.
GABANET can also be used on its own to treat adults and children over 12 years of age.
□ Peripheral neuropathic pain (long lasting pain caused by damage to the nerves).
A variety of different diseases can cause peripheral neuropathic pain (primarily occurring in the legs and/or arms), such as diabetes or shingles.
Pain sensations may be described as hot, burning, throbbing, shooting, stabbing, sharp, cramping, aching, tingling, numbness, pins and needles, etc.
If you are allergic (hypersensitive) to Gabapentin or any of the other ingredients of GABANET (listed in section 6).
Take special care with GABANET:
□ If you suffer from kidney problems your doctor may prescribe a different dosing schedule.
□ If you are on haemodialysis (to remove waste products because of kidney failure), tell your doctor if you develop muscle pain and/or weakness.
□ If you develop signs such as persistent stomach pain, feeling sick and being sick contact your doctor immediately as these may be symptoms of acute pancreatitis (an inflamed pancreas).
□ If you have nervous system disorders, respiratory disorders, or you are more than 65 years old, your doctor may prescribe you a different dosing regimen.
□ Before taking this medicine, tell your doctor if you have ever abused or been dependent on
alcohol, prescription medicines or illegal drugs; it may mean you have a greater risk of becoming dependent on GABANET.
Dependence
Some people may become dependent on GABANET (a need to keep taking the medicine). They may have withdrawal effects when they stop using GABANET (see section 3, “How to take GABANET” and
“If you stop taking GABANET”). If you have concerns that you may become dependent on GABANET, it is important that you consult your doctor.
If you notice any of the following signs whilst taking GABANET, it could be a sign that you have become dependent.
□ You feel you need to take the medicine for longer than advised by your prescriber
□ You feel you need to take more than the recommended dose
□ You are using the medicine for reasons other than prescribed
□ You have made repeated, unsuccessful attempts to quit or control the use of the medicine
□ When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again
If you notice any of these, speak to your doctor to discuss the best treatment pathway for you,
including when it is appropriate to stop and how to do this safely.
A small number of people being treated with anti-epileptics such as Gabapentin have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.
Important information about potentially serious reactions
Serious skin rashes including Stevens-Johnson syndrome, toxic epidermal necrolysis and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with gabapentin. Stop using gabapentin and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
Read the description of these symptoms in section 4 of this leaflet under ‘Contact your doctor immediately if you experience any of the following symptoms after taking this medicine as they can be serious’
Muscle weakness, tenderness or pain and particularly, if at the same time, you feel unwell or have a high temperature it may be caused by an abnormal muscle breakdown which can be life-threatening and lead to kidney problems. You may also experience discoloration of your urine, and a change in blood test results (notably blood creatine phosphokinase increased). If you experience any of these signs or symptoms, please contact your doctor immediately.
Taking other medicines with GABANET:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, tell your doctor (or pharmacist) if you are taking or have been recently taking any medicines for convulsions, sleeping disorders, depression, anxiety, or any other neurological or psychiatric problems.
□ Medicines containing opioids such as morphine
If you are taking any medicines containing opioids (such as morphine), please tell your doctor or pharmacist as opioids may increase the effect of
GABANET.
In addition, combination of GABANET with opioids may cause symptoms like sleepiness, sedation, decrease in breathing, or death.
□ Antacids for indigestion
If GABANET and antacids containing aluminium and magnesium are taken at the same time, absorption of Gabapentin from the stomach may be reduced. It is therefore recommended that GABANET is taken at the earliest two hours after taking an antacid.
Gabapentin:
□ Is not expected to interact with other antiepileptic drugs or the oral contraceptive pill.
□ May interfere with some laboratory tests, if you require a urine test tell your doctor or hospital what you are taking.
GABANET with food:
GABANET can be taken with or without food.
Pregnancy, breastfeeding and fertility:
□ If you are pregnant or think you may be pregnant, you must tell your doctor straight away and discuss possible risks the medicine you are taking might pose to your unborn baby.
□ You should not stop your treatment without discussing this with your doctor.
□ If you are planning to become pregnant you should discuss your treatment with your doctor or pharmacist as early as possible before you become pregnant.
□ If you are breastfeeding or planning to breastfeed, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy:
GABANET can be used during the first trimester of pregnancy if needed.
If you plan to become pregnant or if you are pregnant or think you may be pregnant, talk to your doctor straight away.
If you have become pregnant and you have epilepsy, it is important that you do not stop taking your medicine without first consulting your doctor, as this may worsen your illness. Worsening of your epilepsy may put you and your unborn child at risk.
In a study reviewing data from women in Nordic countries who took gabapentin in the first 3 months of pregnancy, there was no increased risk of birth defects or problems with the development of brain function (neurodevelopment disorders). However, babies of women who took gabapentin during pregnancy had an increased risk of low birth weight and preterm birth.
If used during pregnancy, gabapentin may lead to withdrawal symptoms in newborn infants. This risk might be increased when gabapentin is taken together with opioid analgesics (drugs for treatment of severe pain).
Contact your doctor immediately if you become pregnant, think you might be pregnant or are planning to become pregnant while taking GABANET. Do not suddenly discontinue taking this medicine as this may lead to a breakthrough seizure, which could have serious consequences for you and your baby.
Breastfeeding:
Gabapentin, the active substance of GABANET, is passed on through human milk. Because the effect on the baby is unknown, it is not recommended to breast-feed while using GABANET.
Fertility:
There is no effect on fertility in animal studies.
Driving and using machines:
GABANET may produce dizziness,
drowsiness and tiredness. You should not drive, operate complex machinery or take part in other potentially hazardous activities until you know whether this medication affects your ability to perform these activities.
Important information about some of the ingredients of GABANET:
GABANET hard capsules contain lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Always take GABANET exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure. Do not take more medicine than prescriped.
Your doctor will determine what dose is appropriate for you.
Epilepsy, the recommended dose is
Adults and adolescents:
Take the number of capsules as instructed. Your doctor will usually build up your dose gradually. The starting dose will generally be between 300 mg and 900 mg each day. Thereafter, the dose may be increased as instructed by your doctor, up to a maximum of 3600 mg each day and your doctor will tell you to take this in 3 separate doses, i.e. once in the morning, once in the afternoon and once in the evening.
Children aged 6 years and above:
The dose to be given to your child will be decided by your doctor as it is calculated against your child’s weight. The treatment is started with a low initial dose which is gradually increased over a period of approximately 3 days. The usual dose to control epilepsy is 25-35 mg per kg of body weight per day. It is usually given in 3 separate doses, by taking the capsule(s) each day, usually once in the morning, once in the afternoon and once in the evening.
GABANET is not recommended for use in children below 6 years of age.
Peripheral Neuropathic Pain, the
recommended dose is
Adults:
Take the number of capsules as instructed by your doctor. Your doctor will usually build up your dose gradually. The starting dose will generally be between 300 mg and 900 mg each day. Thereafter, the dose may be increased as instructed by your doctor, up to a maximum of 3600 mg each day and your doctor will tell you to take this in 3 separate doses, i.e. once in the morning, once in the afternoon and once in the evening.
If you have kidney problems or are receiving haemodialysis:
Your doctor may prescribe a different dosing schedule and/or dose if you have problems with your kidneys or are undergoing
haemodialysis.
If you are an elderly patient (over 65 years of age):
you should take the normal dose of GABANET unless you have problems with your kidneys. Your doctor may prescribe a different dosing schedule and/or dose if you have problems with your kidneys.
If you have the impression that the effect of GABANET is too strong or too weak, talk to your doctor or pharmacist as soon as possible.
Method of administration
GABANET is for oral use. Always swallow the capsules with plenty of water.
Continue taking GABANET until your doctor tells you to stop.
If you take more GABANET than you should:
Higher than recommended doses may result in an increase in side effects including loss of consciousness, dizziness, double vision, slurred speech, drowsiness and diarrhoea. Call your doctor or go to the nearest hospital emergency unit immediately if you take more GABANET than your doctor prescribed. Take along any capsules that you have not taken, together with the container and the label so that the hospital can easily tell what medicine you have taken.
If you forget to take GABANET:
If you forget to take a dose, take it as soon as you remember unless it is time for your next dose. Do not take a double dose to make up for a forgotten dose.
If you stop taking GABANET:
Do not suddenly stop taking GABANET. If you want to stop taking GABANET, discuss this with your doctor first. They will tell you how to do this. If your treatment is stopped it should be done gradually over a minimum of 1 week. After stopping a short or long-term treatment with GABANET, you need to know that you may experience certain side effects, so-called withdrawal effects. These effects can
include seizures, anxiety, difficulty sleeping, feeling sick (nausea), pain, sweating, shaking, headache, depression, feeling abnormal, dizziness, and feeling generally unwell. These effects usually occur within 48 hours after stopping GABANET. If you experience withdrawal effects, you should contact your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, GABANET can cause side effects, although not everybody gets them.
Stop using GABANET and seek medical attention immediately if you notice any of the following symptoms:
□ Reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
□ Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or
drug hypersensitivity syndrome).
Contact your doctor immediately if you experience any of the following symptoms after taking this medicine as they can be serious:
□ Persistent stomach pain, feeling sick and being sick as these may be symptoms of acute pancreatitis (an inflamed pancreas)
□ Breathing problems, which if severe you may need emergency and intensive care to continue breathing normally
□ GABANET may cause a serious or life-threatening allergic reaction that may affect your skin or other parts of your body such as your liver or blood cells.You may or may not have rash when you get this type of reaction. It may cause you to be hospitalized or to stop GABANET Call your doctor right away if you have any of the following symptoms:
- Skin rash and redness and/or hair loss
- Hives - Fever
- Swollen glands that do not go away
- Swelling of your lip, face and tongue
- Yellowing of your skin or of the whites of the eyes
- Unusual bruising or bleeding
- Severe fatigue or weakness
- Unexpected muscle pain
- Frequent infections
These symptoms may be the first signs of a serious reaction. A doctor should examine you to decide if you should continue taking GABANET.
If you are on haemodialysis, tell your doctor if you develop muscle pain and/or weakness.
Other side effects include:
Very common side-effects (may affect more than 1 in 10 people):
□ Viral infection
□ Feeling drowsy, dizziness, lack of coordination
□ Feeling tired, fever
Common side-effects (may affect up to 1 in 10 people):
□ Pneumonia, respiratory infections, urinary tract infection, inflammation of the ear or other infections
□ Low white blood cell counts
□ Anorexia, increased appetite
□ Anger towards others, confusion, mood changes, depression, anxiety, nervousness, difficulty with thinking
□ Convulsions, jerky movements, difficulty with speaking, loss of memory, tremor, difficulty sleeping, headache, sensitive skin, decreased sensation (numbness), difficulty with
coordination, unusual eye movement, increased, decreased or absent reflexes
□ Blurred vision, double vision □ Vertigo
□ High blood pressure, flushing or dilation of blood vessels
□ Difficulty breathing, bronchitis, sore throat, cough, dry nose
□ Vomiting (being sick), nausea (feeling sick), problems with teeth, inflamed gums, diarrhoea, stomach pain, indigestion, constipation, dry mouth or throat, flatulence
□ Facial swelling, bruises, rash, itch, acne
□ Joint pain, muscle pain, back pain, twitching
□ Difficulties with erection (impotence)
□ Swelling in the legs and arms, difficulty with walking, weakness, pain, feeling unwell, flu-like symptoms
□ Decrease in white blood cells, increase in weight
□ Accidental injury, fracture, abrasion
Additionally in clinical studies in children, aggressive behaviour and jerky movements were reported commonly.
Uncommon side effects (may affect up to 1 in 100 people):
□ Agitation (a state of chronic restlessness and unintentional and purposeless motions)
□ Allergic reactions such as hives
□ Decreased movement
□ Racing heartbeat □ Diffculty swallowing
□ Swelling that may involve the face, trunk and limbs
□ Abnormal blood test results suggesting problems with the liver
□ Mental impairment □ Fall
□ Increase in blood glucose levels (most often observed in patients with diabetes)
Rare: (may affect up to 1 in 1,000 people):
□ Decrease in blood glucose levels (most often observed in patients with diabetes)
□ Loss of consciousness
□ Trouble breathing, shallow breaths
(respiratory depression)
After marketing Gabapentin the following side-effects have been reported:
□ Decreased platelets (blood clotting cells)
□ Suicidal thoughts, hallucinations
□ Problems with abnormal movements such as writhing, jerking movements and stiffness
□ Ringing in the ears
□ Yellowing of the skin and eyes (jaundice), inflammation of the liver
□ Acute kidney failure, incontinence
□ Increased breast tissue, breast enlargement
□ Adverse events following the abrupt discontinuation of gabapentin (anxiety, difficulty sleeping, feeling sick, pain, sweating), chest pain
□ Breakdown of muscle fibers
(rhabdomyolysis)
□ Change in blood test results (creatine phosphokinase increased)
□ Problems with sexual functioning including inability to achieve a sexual climax, delayed ejaculation
□ Low blood sodium level
□ Anaphylaxis (serious, potentially life threatening allergic reaction including difficulty breathing, swelling of the lips, throat, and tongue, and hypotension requiring emergency treatment)
□ Becoming dependent on GABANET (drug dependence).
After stopping a short or long-term treatment with GABANET you need to know that you may
experience certain side effects, so-called withdrawal effects (see “If you stop taking GABANET”)
□ Keep out of the reach and sight of children.
□ Do not store above 30°C, protected from humidity
□ Do not use GABANET after the expiry date which is stated on the carton and on the blister, after (EXP).Date.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
The active substance is Gabapentin. Each hard capsule of GABANET 300 and GABANET 400 contains 300 and 400 mg of Gabapentin, respectively.
□ The other ingredients:
GABANET 300: Lactose anhydrous, maize starch, purified talc, empty hard gelatin capsules size (1) buff and buff.
GABANET 400: Lactose anhydrous, maize starch, purified talc, empty hard gelatin capsules size (0) orange and orange.
The Jordanian pharmaceutical manufacturing company.
P.O. BOX 151, Um Al-Amad 16197, Jordan
Saudi Arabia: To report any side effect(s): The
National Pharmacovigilance Center (NPC):
Fax: +966-11-205-7662,
SFDA Call Center: 19999,
E-mail: npc.drug@sfda.gov.sa,
Website: http://ade.sfda.gov.sa
ينتمي جابانت إلى مجموعة من الأدوية التي تستخدم لعلاج الصرع وآلام الاعتلال العصبي الطرفي (آلام طويلة الأمد ناجمة عن تلف الأعصاب).
المادة الفعالة الموجودة في جابانت هي جابابنتين.
يستخدم جابانت لمعالجة:
□ أشكال الصرع المختلفة (نوبات تقتصر في البداية على أجزاء معينة من الدماغ، سواء كانت تنتشر هذه النوبات إلى أجزاء الدماغ الأخرى أم لا). سوف يصف لك الطبيب الذي يعالجك أو يعالج ابنك الذي يبلغ من العمر 6 سنوات أو أكبر جابانت للمساعدة في علاج الصرع عندما تكون المعالجة الحالية لا تسيطر بالكامل على الحالة. يجب أن تأخذ انت أو ابنك البالغ من العمر 6 سنوات أو أكبر جابانت بالإضافة إلى علاجك الحالي ما لم يتم إخبارك بغير ذلك.
يمكن استخدام جابانت بمفرده لمعالجة البالغين والأطفال فوق 12 سنة من العمر.
□ آلام الاعتلال العصبي الطرفي (آلام طويلة الأمد ناجمة عن تلف الأعصاب). قد تسبب العديد من الأمراض آلام الاعتلال العصبي الطرفي (تحدث بشكل أساسي في الساقين والذراعين)، مثل مرض السكري والحزام الناري.
يمكن وصف الإحساس بالألم على شكل سخونة، حرقة، خفقان، آلام بارقة، طعن وخز، ألم حاد، تشنج، وجع، نخز، خدران، تنميل، إلخ.
إذا كنت تعاني من حساسية لجابابنتين أو لأي من مكونات جابانت الأخرى.( المذكورة في قسم 6).
الاحتياطات عند استعمال جابانت:
□ إذا كنت تعاني من مشاكل في الكلى، فقد يصف لك طبيبك جدول جرعات مختلف.
□ إذا كنت تقوم بغسيل للكلى (لإزالة الفضلات المنتجة بسبب فشل الكلى) عليك إخبار طبيبك إذا حدث لك ألم في و/ أو ضعف في العضلات.
□ إذا حدث لك أعراض مثل ألم مستمر في المعدة والشعور بالغثيان و القيء، فإن عليك الاتصال بطبيبك مباشرة، لأنها قد تكون أعراض لالتهاب حاد في البنكرياس.
□ إذا كنت تعاني من اضطرابات في الجهاز العصبي أو اضطرابات تنفسية أو إذا كان عمرك يزيد عن 65 عاماً ، قد يصف لك طبيبك نظاماً مختلفًا للجرعات.
□ قبل تناول هذا الدواء، أخبر طبيبك إذا كنت قد أساءت استخدامه أو كنت معتاد على تناول الكحول أو الأدوية الموصوفة أو المخدرات غير المشروعة؛ قد يعني ذلك أن لديك خطرًا أكبر في أن تصبح مدمن على جابانت.
الاعتماد (الإدمان)
قد يصبح بعض الأشخاص معتمدين على جابانت (الحاجة إلى الاستمرار في تناول الدواء). حيث انهم قد يعانون من آثار انسحاب عند التوقف عن استخدام جابانت (انظر القسم
"إذا توقفت عن تناول جابانت"). إذا كانت لديك مخاوف من أن تصبح معتمدًا على جابانت، من المهم أن تستشير طبيبك.
إذا لاحظت أيًا من العلامات التالية أثناء تناول جابانت، فمن الممكن أن تكون علامة على أنك تعاني من ذلك.
□ كنت تشعر أنك بحاجة إلى تناول الدواء لفترة أطول مما نصحك به الطبيب
□ تشعر أنك بحاجة إلى تناول أكثر من الجرعة الموصى بها
□ كنت تستخدم الدواء لأسباب غير موصوفة لك
□ قمت بمحاولات متكررة وغير ناجحة للتوقف عن تناول الدواء أو التحكم في استخدامه
□ عند التوقف عن تناول الدواء تشعر بالتوعك، وتشعر بالتحسن بعد تناول الدواء مرة أخرى.
إذا لاحظت أيًا من هذه الأمور، تحدث مع طبيبك لمناقشة أفضل مسار علاجي لك، بما في ذلك متى يكون من المناسب التوقف عن تناوله وكيفية القيام بذلك بأمان.
عدد قليل من الأشخاص الذين يتعالجون بمضادات الصرع مثل جابابنتين، كان لديهم أفكار لإيذاء أو قتل أنفسهم. إذا كان لديك في أي وقت مثل هذه الأفكار، فإن عليك الاتصال بطبيبك مباشرة.
معلومات هامة حول تفاعلات قد تكون خطيرة
تم الإبلاغ عن طفح جلدي خطير بما في ذلك متلازمة ستيفنز جونسون وانحلال البشرة السمي والتفاعل الدوائي مع كثرة اليوزينيات والأعراض الجهازية (DRESS) يترافق مع استخدام جابابنتين. توقف عن استخدام جابابنتين واطلب الرعاية الطبية على الفور إذا لاحظت أيًا من الأعراض المتعلقة بهذه التفاعلات الجلدية الخطيرة الموصوفة في القسم 4.
اقرأ وصف هذه الأعراض الموجود في قسم 4 داخل النشرة تحت عنوان " اتصل بطبيبك مباشرة إذا حدثت لك أي من هذه الأعراض التالية بعد تناول هذا الدواء لأن هذه الأعراض قد تكون خطيرة"
إذا حدث لك ضعف أو ألم في العضلات وخاصة إذا شعرت في نفس الوقت بتوعك أو ارتفاع في درجة الحرارة فإن ذلك قد يكون ناجم عن تحطم العضلات غير الطبيعي والذي قد يكون خطيراً ويؤدي إلى مشاكل في الكلى. وقد تواجه أيضاً تغير في لون البول وحدوث تغير في نتائج فحص الدم (زيادة ملحوظة في فسفوكيناز الكرياتين في الدم). يرجى الاتصال بطبيبك مباشرة إذا واجهت أي من هذه العلامات أو الأعراض.
تناول أدوية أخرى مع جابانت:
يرجى إخبار طبيبك أو الصيدلي إذا كنت تتناول أو تناولت مؤخراً أو قد تتناول أي أدوية أخرى. على وجه الخصوص، أخبر طبيبك (أو الصيدلي) إذا كنت تتناول أو كنت تتناول أي أدوية مؤخرا لعلاج التشنجات، اضطرابات النوم، الاكتئاب، القلق أو أي مشاكل عصبية أو نفسية أخرى.
□ الأدوية التي تحتوي على مواد أفيونية مثل مورفين
إذا كنت تتناول أي أدوية أفيونية (مثل مورفين)، يرجى إخبار طبيبك أو الصيدلي لأن الأدوية الأفيونية قد تزيد من تأثير جابانت. بالإضافة إلى أن استخدام الأدوية الأفيونية مع جابانت قد يؤدي إلى أعراض مثل النعاس، الخدر إنخفاض التنفس، أو الموت.
□ مضادات الحموضة لمعالجة عسر الهضم
إذا تم تناول جابانت و مضادات الحموضة التي تحتوي على ألمنيوم أو مغنيزيوم في نفس الوقت، فإن امتصاص جابابنتين من المعدة قد ينخفض. لذلك فإنه ينصح بتناول جابانت بعد ساعتين من تناول مضادات الحموضة.
جابابنتين:
□ من غير المتوقع أن يتداخل جابابنتين مع أدوية الصرع الأخرى أو مع حبوب منع الحمل الفموية.
□ قد يتداخل جابابنتين مع بعض الفحوصات المخبرية، فإذا أردت أن تعمل فحص للبول، فإن عليك إخبار طبيبك أو المستشفى بالأدوية التي تتناولها.
تناول جابانت مع الطعام:
يمكن تناول جابانت مع الطعام أو بدونه.
الحمل، الرضاعة والخصوبة:
□ إذا كنت حاملاً أو تعتقدين أنك حامل، فيجب عليك إخبار طبيبك على الفور، ناقشي المخاطر المحتملة التي قد يشكلها الدواء الذي تتناولينه على طفلك الذي لم يولد بعد.
□ يجب ألا تتوقف عن علاجك دون مناقشة ذلك مع طبيبك.
□ إذا كنت تخططين للحمل عليك مناقشة علاجك مع طبيبك أوالصيدلي في أقرب وقت ممكن قبل أن تصبحي حاملاً.
□ إذا كنت مرضعة أو تخططين للرضاعة الطبيعية، اسألي طبيبك أو الصيدلي للحصول على المشورة
قبل تناول هذا الدواء.
الحمل:
يمكن استخدام جابانت خلال الأشهر الثلاثة الأولى من الحمل إذا لزم الأمر.
إذا كنت تخططين للحمل أو إذا كنت حاملاً أو تعتقدين أنك قد تكونين حاملاً، فتحدثي إلى طبيبك على الفور.
إذا أصبحت حاملاً و تعانين من الصرع، فمن المهم ألا تتوقفي عن تناول الدواء دون استشارة طبيبك أولا، لأن ذلك قد يؤدي إلى تفاقم مرضك. تفاقم حالتك قد يعرضك أنت وطفلك الذي لم يولد بعد للخطر.
في دراسة تستعرض بيانات النساء في دول الشمال اللاتي تناولن جابابنتين في الأشهر الثلاثة الأولى خلال فترة الحمل، لم يكن هناك خطر متزايد للعيوب الخلقية أو مشاكل في وظائف نمو الدماغ (اضطرابات النمو العصبي). ومع ذلك، فإن أطفال النساء اللاتي تناولن جابابنتين خلال فترة الحمل كان الحمل أكثر عرضة لخطر انخفاض الوزن عند الولادة والولادة المبكرة.
إذا تم استخدامه أثناء الحمل، فقد يؤدي جابابنتين إلى أعراض الانسحاب عند الأطفال حديثي الولادة. هذا الخطريمكن أن يزيد عند تناول جابابنتين بالتزامن مع المسكنات الأفيونية (أدوية لعلاج ألم حاد).
يجب الاتصال بالطبيب مباشرة إذا كنت حاملاً، أو إذا كنت تعتقدي بأنك حاملاً أو تخططين للإنجاب أثناء تناولك جابانت. لا تتوقف بشكل مفاجئ عن تناول الدواء لأن ذلك قد يؤدي إلى حدوث النوبة، والتي يمكن أن يكون لها عواقب وخيمة لك ولطفلك.
الرضاعة:
يمر جابابنتين المادة الفعالة لجابانت في حليب الأم. لا ينصح بالإرضاع أثناء تناول جابانت بسبب عدم معرفة تأثيره على الطفل.
اسأل طبيبك أو الصيدلي للحصول على المشورة قبل تناول أي دواء.
الخصوبة:
لا يوجد أي تأثير على الخصوبة في الدراسات على الحيوانات.
تأثير المستحضر على القيادة واستخدام الآلات:
قد يسبب جابانت دوخة ونعاس وتعب. يجب أن لاتقود السيارة أو تشغل الآلات المعقدة أو تقوم بأنشطة أخرى محتملة الخطورة، حتى تتعرف ما إذا كان هذا الدواء يؤثر على قدرتك لإنجاز هذه الأنشطة أم لا.
معلومات هامة حول بعض مكونات جابانت:
تحتوي كبسولات جابانت على لاكتوز (نوع من السكريات). إذا أخبرك طبيبك بأن لديك عدم القدرة على تحمل بعض السكريات، فإن عليك الاتصال بطبيبك قبل تناول هذا الدواء.
3. طريقة استخدام جابانت
دائماً تناول جابانت تماماً كما أخبرك طبيبك. يجب عليك مراجعة طبيبك أو الصيدلي إذا كنت غير متأكد.
سيحدد لك الطبيب الجرعة المناسبة لك.
الصرع، الجرعة الموصى بها
البالغين والمراهقين:
تناول الكبسولات وفقاً للتعليمات. سيزيد لك طبيبك الجرعة بشكل تدريجي. ستتراوح جرعة البدء ما بين 300 ملغم و 900 ملغم كل يوم. فيما بعد، يمكن زيادة الجرعة وفقاً لتعليمات طبيبك كحد أقصى إلى 3600 ملغم كل يوم، وسوف يخبرك طبيبك بتناولها على 3 جرعات منفصلة، بمعنى مرة في الصباح ومرة بعد الظهر ومرة في المساء.
الأطفال الذين تتراوح أعمارهم من 6 سنوات فما فوق:
سيتم تحديد الجرعة التي سوف تعطى لطفلك من قبل طبيبك، كما تم حسابها بناءً على وزن طفلك. تتم المعالجة بجرعة بدء منخفضة والتي تزداد تدريجياً خلال فترة 3 أيام تقربياً. الجرعة المعتادة للسيطرة على الصرع هي 25-35 ملغم لكل كغم من وزن الجسم يومياً. وعادة ما تعطى على 3 جرعات منفصلة، عن طريق تناول كبسولة يومياً مرة صباحاً ومرة ظهراَ ومرة مساءً.
لا ينصح باستخدام جابانت للأطفال ما دون 6 سنوات.
ألم الاعتلال العصبي الطرفي، الجرعة الموصى بها:
البالغين:
تناول الكبسولات وفقاً لتعليمات طبيبك. سوف يزيد لك طبيبك الجرعة بشكل تدريجي. ستتراوح جرعة البدء مابين 300 ملغم و900 ملغم كل يوم. فيما بعد، يمكن زيادة الجرعة بناءً على تعليمات طبيبك كحد أقصى إلى 3600 ملغم كل يوم، وسوف يخبرك طبيبك تناولها على 3 جرعات منفصلة، بمعنى مرة في الصباح ومرة بعد الظهر ومرة في المساء.
إذا كنت تعاني من مشاكل في الكلى أو تخضع لغسيل كلوي:
قد يصف لك طبيبك جدول جرعات مختلف و/ أو جرعة مختلفة إذا كان لديك مشاكل في الكلى أو إذا كنت تخضع لغسيل الكلى.
إذا كنت من المرضى المسنين ( أكثر من 56 سنة):
يجب أن تأخذ الجرعة المعتادة من جابانت إلا إذا كان لديك مشاكل مع الكلى. قد يصف لك طبيبك جدول جرعات مختلف و/ أو جرعة مختلفة إذا كنت تعاني من مشاكل في الكليتين.
إذا كان لديك شعور بأن تأثير جابانت قوي جداً أو ضعيف جداً، فإن عليك التحدث إلى طبيبك أو الصيدلي بأسرع ما يمكن.
طريقة الإستعمال:
يستخدم جابانت عن طريق الفم. دائما تناول الكبسولات مع الكثير من الماء.
استمر في أخذ جابانت حتى يخبرك طبيبك بالتوقف.
الجرعة الزائدة من جابانت:
قد تؤدي الجرعات التي تكون أعلى من الموصى بها إلى زياده في الأعراض الجانبية والتي تشمل فقدان الوعي، دوخة ، رؤية مزدوجة، كلام متداخل، نعاس وإسهال. اتصل بطبيبك أو اذهب إلى أقرب وحدة طوارئ إذا تناولت جابانت أكثر مما وصف لك طبيبك. عليك أن تأخذ معك كبسولة مع العلبة واللصاقة، حيث يسهل على المستشفى التعرف على الدواء الذي تناولته.
نسيان تناول جابانت:
إذا نسيت تناول الجرعة، عليك تناولها في أقرب وقت ممكن من تذكرها ما لم يكن موعد الجرعة التالية. لا تتناول جرعة مضاعفة لتعويض الجرعة المنسية.
التوقف عن تناول جابانت:
لا تتوقف فجأة عن تناول جابانت. إذا كنت ترغب في التوقف عن تناول جابانت، فناقش هذا الأمر مع طبيبك أولا. سيخبرونك بكيفية القيام بذلك. حيث أن وقف العلاج الخاص بك ينبغي أن يكون تدريجيا على مدى 1 أسبوع على الأقل. بعد التوقف عن العلاج القصير أو الطويل الأمد بـجابانت، عليك أن تعلم أنك قد تواجه آثارًا جانبية معينة، تسمى آثار الانسحاب. يمكن لهذه التأثيرات أن تشمل النوبات، القلق، صعوبة النوم، الشعور بالمرض (الغثيان)،الألم، التعرق، الاهتزاز، الصداع، الاكتئاب، الشعور غير الطبيعي، الدوخة، و الشعور بالإعياء بشكل عام. تحدث هذه التأثيرات عادةً خلال 48 ساعة بعد إيقاف جابانت. إذا واجهت آثار الانسحاب، يجب عليك الاتصال طبيبك.
عة أو تشبه الهدف أو دائرية على الجذع، وغالبًا ما تكون مصحوبة ببثور مركزية، تقشير الجلد وتقرحات الفم والحلق والأنف والأعضاء التناسلية والعينين.
كغيره من الأدوية، فإن جابانت قد يسبب آعراضاً جانبية، بالرغم من أنها لاتحدث للجميع.
توقف عن استخدام جابانت واطلب العناية الطبية على الفورإذا لاحظت أيًا من الأعراض التالية:
□ بقع حمراء غير مرتفعة أو تشبه الهدف أو دائرية على الجذع، وغالبًا ما تكون مصحوبة ببثور مركزية، تقشير الجلد وتقرحات الفم والحلق والأنف والأعضاء التناسلية والعينين. يمكن لهذه الطفح الجلدي الخطير أن يسبقها حمى وأعراض تشبه أعراض الأنفلونزا (متلازمة ستيفنز جونسون، انحلال الأنسجة الميتة).
□ طفح جلدي منتشر وارتفاع درجة حرارة الجسم وتضخم الغدد الليمفاوية (متلازمة SSERD أو متلازمة فرط الحساسية للأدوية).
اتصل بطبيبك مباشرة إذا حدثت لك أي من هذه الأعراض التالية بعد تناول هذا الدواء لأن هذه الأعراض قد تكون خطيرة:
□ آلام مستمرة في المعدة ،غثيان وقيء، قد تكون هذه أعراض التهاب حاد في البنكرياس.
□ مشاكل في التنفس، والتي قد تحتاج إلى رعاية الطوارئ والعناية المركزة لمواصلة التنفس بشكل طبيعي إذا كانت شديدة.
□ قد يسبب جابانت تفاعل تحسسي وخيم أو مهدد للحياة و الذي قد يؤثر على الجلد أو على أجزاء أخرى في جسمك مثل الكبد أو خلايا الدم. قد تعاني أو لا تعاني من طفح عند حدوث هذا النوع من التفاعل. قد يسبب لك هذا الدخول إلى المستشفى أو التوقف عن استخدام جابانت. اتصل مع طبيبك فوراً إذا كان لديك أي من الأعراض التالية:
- طفح جلدي و احمرار و/أو تساقط الشعر
- شرى
- حمى
- تورم الغدد الذي لا يزول
- تورم في الشفاه، الوجه واللسان، اصفرار في الجلد أو في بياض العيون
- تكدم أو نزف غير اعتيادي
- تعب أو ضعف وخيم، ألم عضلي غير متوقع
- عدوى متكرره.
قد تكون هذه الأعراض علامات أولية على تفاعل وخيم. يجب أن يقوم طبيبك بفحصك ليقرر إذا كان من الممكن الاستمرار بتناول جابانت أم لا.
إذا كنت تقوم بغسيل للكلى، فإن عليك إخبار طبيبك إذا حدث لك ألم و/ أو ضعف عضلي.
تشمل الأعراض الجانبية الأخرى:
أعراض جانبية شائعة جداً (قد تؤثر على أكثر من مريض واحد من كل 10 مرضى):
□ عدوى فيروسية
□ الشعور بنعاس، دوخة، فقدان التناسق
□ الشعور بالتعب، الحمى
أعراض جانبية شائعة (قد تؤثر على مريض واحد من كل 10 مرضى):
□ التهاب رئوي، عدوى الجهاز التنفسي، عدوى السبيل البولي، التهاب الأذن أو عدوى أخرى
□ انخفاض عدد خلايا الدم البيضاء
□ الشعور بنعاس، دوخة، فقدان التناسق
□ الغضب اتجاه الأخرين، ارتباك، تغيرات في المزاج، اكتئاب، قلق، عصبية، صعوبة في التفكير
□ اختلاجات، حركات نفضية، صعوبة في الكلام، فقدان في الذاكرة، رعاش، صعوبة في النوم، صداع، حساسية جلد، قلة الاحساس (خدران) ، صعوبة في التناسق، حركة غير اعتيادية في العين، زيادة أو انخفاض أو غياب ردود الفعل
□ تغيم الرؤية، رؤية مزدوجة
□ دوخة
□ ارتفاع ضغط الدم، احمرار أو تمدد الأوعية الدموية
□ صعوبة في التنفس، التهاب الشعب الهوائية، التهاب الحلق، سعال، جفاف الأنف
□ قيء، غثيان، مشاكل في الأسنان، التهاب اللثة، إسهال، ألم في البطن، عسر الهضم، إمساك، جفاف في الفم أو الحلق، تطبل البطن
□ تورم الوجه، كدمات، طفح، حكة، حب شباب
□ ألم في المفاصل، ألم في العضلات، ألم في الظهر، نفضان
□ صعوبة في الإنتصاب (ضعف جنسي)
□ تورم في الساقين والذراعين، صعوبة في المشي، ضعف، ألم، شعور بالتعب، أعراض شبيهة بالإنفلونزا
□ انخفاض خلايا الدم البيضاء، زيادة في الوزن
□ إصابة عرضية، كسر، كشط
بالإضافة إلى ذلك، تم الإبلاغ بشكل شائع عن سلوك عدواني و حركات نفضية في الدراسات السريرية للأطفال.
أعراض جانبية غير شائعة (قد تؤثر على مريض واحد من كل 100 مريض):
□ هياج (حالة من التململ المزمن والحركات غير المقصودة والعديمة الغرض)
□ تفاعلات تحسسية مثل الشرى
□ انخفاض في الحركة
□ نبضات قلب متسارعة
□ صعوبة في البلع
□ التورم والذي قد يشمل الوجة والجذع والأطراف
□ نتائج غير طبيعية لفحص الدم، تشير إلى مشاكل في الكبد
□ الإختلال العقلي
□ السقوط
□ زيادة مستويات الجلوكوز في الدم (غالبًا ما تلاحظ في مرضى السكري)
أعراض جانبية نادرة ( قد تؤثر على مريض واحد من كل 1000 مريض):
□ زيادة مستويات الجلوكوز في الدم (غالبًا ما تلاحظ في مرضى السكري)
□ فقدان الوعي
□ صعوبة التنفس، التنفس الضحل (توقف الجهاز التنفسي)
تم الإبلاغ عن الأعراض الجانبية التالية خلال تجربة التسويق للجابابنتين:
□ انخفاض الصفائح الدموية
□ أفكار في الإنتحار، هلوسة
□ مشاكل مع حركات غير طبيعية مثل التلوي، وحركات رجيح وتصلب
□ رنين في الأذن
□ اصفرار في الجلد والعيون (يرقان)، التهاب في الكبد
□ فشل كلوي حاد، سلس
□ زيادة أنسجة الثدي، تضخم الثدي
□ أعراض جانبية تحدث بعد التوقف المفاجئ عن استخدام جابابنتين ( قلق، صعوبة في النوم، غثيان، ألم، تعرق)، ألم في الصدر
□ تغير في نتائج فحوصات الدم (زيادة فسفوكيناز الكرياتين في الدم)
□ مشاكل في الأداء الجنسي بما في ذلك عدم القدرة على الوصول إلى الذروة الجنسية، تأخر القذف
□ انخفاض مستوى الصوديوم في الدم
□ تفاعل تحسسي شديد (خطير يحتمل أن يهدد الحياة بما في ذلك صعوبة في التنفس، تورم في الشفتين، الحنجرة واللسان، وانخفاض ضغط الدم حيث يتطلب العلاج في الطوارئ)
□ الاعتماد على جابانت (الادمان على المخدرات)
بعد التوقف عن العلاج قصير أو طويل الأمد بـ جابانت، عليك أن تعرف أنك قد تعاني من آثار جانبية معينة، تسمى آثار الانسحاب (أنظر “إذا توقفت عن تناول جابانت”).
يحفظ بعيداً عن متناول الأطفال.
□ لا يحفظ بدرجة حرارة أعلى من 30°م، يحفظ بعيداً عن الرطوبة.
□ لا ينبغي استعمال جابانت بعد تاريخ انتهاء الصلاحية الموجود على العلبة وعلى شريط الدواء.
لا ينبغي التخلص من الأدوية من خلال مياه الصرف الصحي أو المنزلي. اسأل الصيدلاني عن كيفية التخلص من الأدوية التي لم تعد مطلوبة. سوف تساعد هذه الاجراءات على حماية البيئة.
المادة الفعالة هي جابابنتين. كل كبسولة صلبة من كبسولات جابانت 300 و جابانت 400 تحتوي على 300 و400 ملغم من جابابنتين على التوالي.
□ المكونات الأخرى هي:
جابانت 300: لاكتوز لامائي، نشا الذرة، تالك منقى، كبسولة جيلاتينية صلبة مفرغة حجم (1) تتكون من جسم و غطاء لونه أصفر مائل إلى البني .
جابانت 400: لاكتوز لامائي، نشا الذرة، تالك منقى، كبسولة جيلاتينية صلبة مفرغة حجم (0) تتكون من جسم و غطاء برتقالي اللون.
□ كبسولات جابانت 300 هي كبسولات جيلاتينية صلبة أسطوانية الشكل (حجم 1) تتكون من جسم لونه أصفر مائل إلى البني مطبوع عليه ®Gab 300’ وغطاء لونه أصفر مائل إلى البني مملوءة بمسحوق أبيض مائل إلى سكري.
□ كبسولات جابانت 400 هي كبسولات جيلاتينية صلبة أسطوانية الشكل (حجم 0) تتكون من جسم برتقالي اللون مطبوع عليه ‘®Gab 400’ وغطاء برتقالي اللون مملوءة بمسحوق أبيض مائل إلى سكري.
□ علب تحتوي على 48 كبسولة من كبسولات جابانت 300 المحفوظة في أشرطة.
□ علب تحتوي على 768 كبسولة من كبسولات جابانت 300 المحفوظة في أشرطة.
□ علب تحتوي على 48 كبسولة من كبسولات جابانت 400 المحفوظة في أشرطة.
□ علب تحتوي على 504 كبسولة من كبسولات جابانت 400 المحفوظة في أشرطة.
لشركة الأردنية لإنتاج الأدوية. ص.ب. 151 -أم العمد 16197 - الأردن.
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فاكس: 966112057662 +،
مركز الاتصال بالهيئة العامة للغذاء و الدواء في السعودية: 19999، البريد الإلكتروني: Npc.drug@sfda.gov.sa
الموقع الإلكتروني:
https://ade.sfda.gov.sa
Epilepsy
Gabapentin is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults and children aged 6 years and above (see section 5.1).
Gabapentin is indicated as monotherapy in the treatment of partial seizures with and without secondary generalization in adults and adolescents aged 12 years and above.
Treatment of peripheral neuropathic pain
Gabapentin is indicated for the treatment of peripheral neuropathic pain such as painful diabetic neuropathy and post-herpetic neuralgia in adults.
Posology
For all indications a titration scheme for the initiation of therapy is described in Table 1, which is recommended for adults and adolescents aged 12 years and above. Dosing instructions for children under 12 years of age are provided under a separate sub-heading later in this section.
Table 1 | ||
DOSING CHART – INITIAL TITRATION | ||
Day 1 | Day 2 | Day 3 |
300 mg once a day | 300 mg two times a day | 300 mg three times a day |
Discontinuation of Gabapentin
In accordance with current clinical practice, if Gabapentin has to be discontinued it is recommended this should be done gradually over a minimum of 1 week independent of the indication.
Epilepsy
Epilepsy typically requires long-term therapy. Dosage is determined by the treating physician according to individual tolerance and efficacy.
Adults and adolescents:
In clinical trials, the effective dosing range was 900 to 3600 mg/day. Therapy may be initiated by titrating the dose as described in Table 1 or by administering 300 mg three times a day (TID) on Day 1. Thereafter, based on individual patient response and tolerability, the dose can be further increased in 300 mg/day increments every 2-3 days up to a maximum dose of 3600 mg/day. Slower titration of Gabapentin dosage may be appropriate for individual patients. The minimum time to reach a dose of 1800 mg/day is one week, to reach 2400 mg/day is a total of 2 weeks, and to reach 3600 mg/day is a total of 3 weeks. Dosages up to 4800 mg/day have been well tolerated in long-term open-label clinical studies. The total daily dose should be divided in three single doses, the maximum time interval between the doses should not exceed 12 hours to prevent breakthrough convulsions.
Children aged 6 years and above:
The starting dose should range from 10 to 15 mg/kg/day and the effective dose is reached by upward titration over a period of approximately three days. The effective dose of Gabapentin in children aged 6 years and older is 25 to 35 mg/kg/day. Dosages up to 50 mg/kg/day have been well tolerated in a long-term clinical study. The total daily dose should be divided in three single doses, the maximum time interval between doses should not exceed 12 hours.
It is not necessary to monitor Gabapentin plasma concentrations to optimize Gabapentin therapy. Further, Gabapentin may be used in combination with other antiepileptic medicinal products without concern for alteration of the plasma concentrations of Gabapentin or serum concentrations of other antiepileptic medicinal products.
Peripheral neuropathic pain
Adults
The therapy may be initiated by titrating the dose as described in Table 1. Alternatively, the starting dose is 900 mg/day given as three equally divided doses. Thereafter, based on individual patient response and tolerability, the dose can be further increased in 300 mg/day increments every 2-3 days up to a maximum dose of 3600 mg/day. Slower titration of Gabapentin dosage may be appropriate for individual patients. The minimum time to reach a dose of 1800 mg/day is one week, to reach 2400 mg/day is a total of 2 weeks, and to reach 3600 mg/day is a total of 3 weeks.
In the treatment of peripheral neuropathic pain such as painful diabetic neuropathy and post-herpetic neuralgia, efficacy and safety have not been examined in clinical studies for treatment periods longer than 5 months. If a patient requires dosing longer than 5 months for the treatment of peripheral neuropathic pain, the treating physician should assess the patient's clinical status and determine the need for additional therapy.
Instruction for all areas of indication
In patients with poor general health, i.e., low body weight, after organ transplantation etc., the dose should be titrated more slowly, either by using smaller dosage strengths or longer intervals between dosage increases.
Elderly (over 65 years of age)
Elderly patients may require dosage adjustment because of declining renal function with age (see Table 2). Somnolence, peripheral oedema and asthenia may be more frequent in elderly patients.
Renal impairment
Dosage adjustment is recommended in patients with compromised renal function as described in Table 2 and/or those undergoing haemodialysis. Gabapentin 100 mg capsules can be used to follow dosing recommendations for patients with renal insufficiency.
Table 2 | |
DOSAGE OF GABAPENTIN IN ADULTS BASED ON RENAL FUNCTION | |
Creatinine Clearance (ml/min) | Total Daily Dosea (mg/day) |
≥80 | 900-3600 |
50-79 | 600-1800 |
30-49 | 300-900 |
15-29 | 150b-600 |
<15c | 150b-300 |
a Total daily dose should be administered as three divided doses. Reduced dosages are for patients with renal impairment (creatinine clearance < 79 mL/min).
b The 150 mg daily dose to be administered as 300 mg every other day.
c For patients with creatinine clearance <15 mL/min, the daily dose should be reduced in proportion to creatinine clearance (e.g., patients with a creatinine clearance of 7.5 mL/min should receive one-half the daily dose that patients with a creatinine clearance of 15 mL/min receive).
Use in patients undergoing haemodialysis
For anuric patients undergoing haemodialysis who have never received Gabapentin, a loading dose of 300 to 400 mg, then 200 to 300 mg of Gabapentin following each 4 hours of haemodialysis, is recommended. On dialysis-free days, there should be no treatment with Gabapentin.
For renally impaired patients undergoing haemodialysis, the maintenance dose of Gabapentin should be based on the dosing recommendations found in Table 2. In addition to the maintenance dose, an additional 200 to 300 mg dose following each 4-hour haemodialysis treatment is recommended.
Method of administration
For oral use.
Gabapentin can be given with or without food and should be swallowed whole with sufficient fluid-intake (e.g. a glass of water).
Drug Rash with Eosinophilia and Systemic Symptoms (DRESS)
Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and Drug rash with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, have been reported in association with gabapentin treatment. At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs and symptoms suggestive of these reactions appear, gabapentin should be withdrawn immediately and an alternative treatment considered (as appropriate).
If the patient has developed a serious reaction such as SJS, TEN or DRESS with the use of gabapentin, treatment with gabapentin must not be restarted in this patient at any time.
Anaphylaxis
Gabapentin can cause anaphylaxis. Signs and symptoms in reported cases have included difficulty breathing, swelling of the lips, throat, and tongue, and hypotension requiring emergency treatment. Patients should be instructed to discontinue gabapentin and seek immediate medical care should they experience signs or symptoms of anaphylaxis (see section 4.8).
Suicidal ideation and behaviour
Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents in several indications. A meta-analysis of randomised placebo-controlled trials of anti-epileptic drugs has also shown a small increased risk of suicidal ideation and behaviour. The mechanism of this risk is not known. Cases of suicidal ideation and behaviour have been observed in patients treated with gabapentin in the post-marketing experience (see section 4.8).
Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge. Patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. Discontinuation of gabapentin treatment should be considered in case of suicidal ideation and behaviour.
Acute pancreatitis
If a patient develops acute pancreatitis under treatment with Gabapentin, discontinuation of Gabapentin should be considered (see section 4.8).
Seizures
Although there is no evidence of rebound seizures with Gabapentin, abrupt withdrawal of anticonvulsants in epileptic patients may precipitate status epilepticus (see section 4.2).
As with other antiepileptic medicinal products, some patients may experience an increase in seizure frequency or the onset of new types of seizures with Gabapentin.
As with other anti-epileptics, attempts to withdraw concomitant anti-epileptics in treatment refractive patients on more than one anti-epileptic, in order to reach Gabapentin monotherapy have a low success rate.
Gabapentin is not considered effective against primary generalized seizures such as absences and may aggravate these seizures in some patients. Therefore, Gabapentin should be used with caution in patients with mixed seizures including absences.
Gabapentin treatment has been associated with dizziness and somnolence, which could increase the occurrence of accidental injury (fall). There have also been post-marketing reports of confusion, loss of consciousness and mental impairment. Therefore, patients should be advised to exercise caution until they are familiar with the potential effects of the medication.
Concomitant use with opioids and other CNS depressants
Patients who require concomitant treatment with central nervous system (CNS) depressants, including opioids, should be carefully observed for signs of CNS depression, such as somnolence, sedation, and respiratory depression. Patients who use gabapentin and morphine concomitantly may experience increases in gabapentin concentrations. The dose of gabapentin, or concomitant treatment with CNS depressants including opioids, should be reduced appropriately (see section 4.5).
Caution is advised when prescribing gabapentin concomitantly with opioids due to risk of CNS depression. In a population-based, observational, nested case-control study of opioid users, co-prescription of opioids and gabapentin was associated with an increased risk for opioid-related death compared to opioid prescription use alone (adjusted odds ratio [aOR], 1.49 [95% CI, 1.18 to 1.88, p<0.001]).
Respiratory depression
Gabapentin has been associated with severe respiratory depression. Patients with compromised respiratory function, respiratory or neurological disease, renal impairment, concomitant use of CNS depressants and the elderly might be at higher risk of experiencing this severe adverse reaction. Dose adjustments might be necessary in these patients.
Elderly (over 65 years of age)
No systematic studies in patients 65 years or older have been conducted with Gabapentin. In one double blind study in patients with neuropathic pain, somnolence, peripheral oedema and asthenia occurred in a somewhat higher percentage in patients aged 65 years or above, than in younger patients. Apart from these findings, clinical investigations in this age group do not indicate an adverse event profile different from that observed in younger patients.
Paediatric population
The effects of long-term (greater than 36 weeks) Gabapentin therapy on learning, intelligence, and development in children and adolescents have not been adequately studied. The benefits of prolonged therapy must therefore be weighed against the potential risks of such therapy.
Misuse, abuse potential and dependence
Gabapentin can cause drug dependence, which may occur at therapeutic doses. Cases of abuse and misuse have been reported. Patients with a history of substance abuse may be at higher risk for gabapentin misuse, abuse and dependence, and gabapentin should be used with caution in such patients. Before prescribing gabapentin, the patient's risk of misuse, abuse or dependence should be carefully evaluated.
Patients treated with gabapentin should be monitored for symptoms of gabapentin misuse, abuse or dependence, such as development of tolerance, dose escalation and drug-seeking behaviour.
Withdrawal symptoms
After discontinuation of short-term and long-term treatment with gabapentin, withdrawal symptoms have been observed. Withdrawal symptoms may occur shortly after discontinuation, usually within 48 hours. Most frequently reported symptoms include anxiety, insomnia, nausea, pains, sweating, tremor, headache, depression, feeling abnormal, dizziness, and malaise. The occurrence of withdrawal symptoms following discontinuation of gabapentin may indicate drug dependence (see section 4.8). The patient should be informed about this at the start of the treatment. If gabapentin should be discontinued, it is recommended this should be done gradually over a minimum of 1 week independent of the indication (see section 4.2).
Laboratory tests
False positive readings may be obtained in the semi-quantitative determination of total urine protein by dipstick tests. It is therefore recommended to verify such a positive dipstick test result by methods based on a different analytical principle such as the Biuret method, turbidimetric or dye-binding methods, or to use these alternative methods from the beginning.
Excipients with known effect
GABANET hard capsules contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine
There are spontaneous and literature case reports of respiratory depression, sedation, and death associated with gabapentin when co-administered with CNS depressants, including opioids. In some of these reports, the authors considered the combination of gabapentin with opioids to be a particular concern in frail patients, in the elderly, in patients with serious underlying respiratory disease, with polypharmacy, and in those with substance abuse disorders.
In a study involving healthy volunteers (N=12), when a 60 mg controlled-release morphine capsule was administered 2 hours prior to a 600 mg gabapentin capsule, mean gabapentin AUC increased by 44% compared to gabapentin administered without morphine. Therefore, patients who require concomitant treatment with opioids should be carefully observed for signs of CNS depression, such as somnolence, sedation and respiratory depression and the dose of gabapentin or opioid should be reduced appropriately.
No interaction between gabapentin and phenobarbital, phenytoin, valproic acid or carbamazepine has been observed.
Gabapentin steady-state pharmacokinetics are similar for healthy subjects and patients with epilepsy receiving these antiepileptic agents.
Co-administration of gabapentin with oral contraceptives containing norethindrone and/or ethinyl estradiol, does not influence the steady-state pharmacokinetics of either component.
Co-administration of gabapentin with antacids containing aluminium and magnesium, reduces gabapentin bioavailability up to 24%. It is recommended that gabapentin be taken at the earliest two hours following antacid administration.
Renal excretion of gabapentin is unaltered by probenecid.
A slight decrease in renal excretion of gabapentin that is observed when it is co-administered with cimetidine is not expected to be of clinical importance.
Pregnancy
Risk related to epilepsy and antiepileptic drugs (AEDs) in general
Specialist advice regarding the potential risk to a foetus caused by both seizures and antiepileptic treatment should be given to women of childbearing potential, and especially to women planning for pregnancy and women who are pregnant. The need for antiepileptic treatment should be reviewed when a woman is planning to become pregnant. In women being treated for epilepsy, no sudden discontinuation of antiepileptic therapy should be undertaken as this may lead to breakthrough seizures, which could have serious consequences for both mother and child. Monotherapy should be preferred whenever possible because therapy with multiple AEDs could be associated with a higher risk of congenital malformations than monotherapy, depending on the antiepileptics used.
Risk related to gabapentin
Gabapentin crosses the human placenta.
Data from a Nordic observational study of more than 1700 pregnancies exposed to gabapentin in the first trimester showed no higher risk of major congenital malformations among the children exposed to gabapentin compared to the unexposed children and compared to the children exposed to pregabalin, lamotrigine and pregabalin or lamotrigine. Likewise, no increased risk of neurodevelopmental disorders was observed in children exposed to gabapentin during pregnancy.
There was limited evidence of a higher risk of low birth weight and preterm birth but not of stillbirth, small for gestational age, low Apgar score at 5 minutes and microcephaly in newborns of women exposed to gabapentin.
Studies in animals have shown reproductive toxicity (see section 5.3).
Gabapentin can be used during the first trimester of pregnancy if clinically needed.
Neonatal withdrawal syndrome has been reported in newborns exposed in utero to gabapentin. Co-exposure to gabapentin and opioids during pregnancy may increase the risk of neonatal withdrawal syndrome. Newborns should be monitored carefully.
Breast-feeding
Gabapentin is excreted in human milk. Because the effect on the breast-fed infant is unknown, caution should be exercised when Gabapentin is administered to a breast-feeding mother. Gabapentin should be used in breast-feeding mothers only if the benefits clearly outweigh the risks.
Fertility
There is no effect on fertility in animal studies (see section 5.3).
Gabapentin may have minor or moderate influence on the ability to drive and use machines. Gabapentin acts on the central nervous system and may cause drowsiness, dizziness or other related symptoms. Even, if they were only of mild or moderate degree, these undesirable effects could be potentially dangerous in patients driving or operating machinery. This is especially true at the beginning of the treatment and after increase in dose
The adverse reactions observed during clinical studies conducted in epilepsy (adjunctive and monotherapy) and neuropathic pain have been provided in a single list below by class and frequency (very common (≥ 1/10); common (≥ 1/100 to< 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10000 to < 1/1000); very rare (< 1/10000). Where an adverse reaction was seen at different frequencies in clinical studies, it was assigned to the highest frequency reported.
Additional reactions reported from post-marketing experience are included as frequency Not known (cannot be estimated from the available data) in italics in the list below.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
System organ class | Adverse drug reactions | ||
Infections and infestations | |||
Very Common | viral infection | ||
Common | pneumonia, respiratory infection, urinary tract infection, infection, otitis media | ||
Blood and the lymphatic system disorders | |||
Common | leucopenia | ||
Not known | Thrombocytopenia | ||
Immune system disorders | |||
Uncommon | allergic reactions (e.g. urticaria) | ||
Not known | hypersensitivity syndrome( a systemic reaction with a variable presentation that can include fever, rash, hepatitis, lymphadenopathy, eosinophilia, and sometimes other signs and symptoms), anaphylaxis (see section 4.4) | ||
Metabolism and nutrition disorders | |||
Common | anorexia, increased appetite | ||
Uncommon | hyperglycaemia (most often observed in patients with diabetes) | ||
Rare | hypoglycaemia (most often observed in patients with diabetes) | ||
Not known | hyponatraemia | ||
Psychiatric disorders | |||
Common | hostility, confusion and emotional lability, depression, anxiety, nervousness, thinking abnormal | ||
Uncommon | agitation | ||
Not known | Suicidal ideation, hallucinations , drug dependence | ||
Nervous system disorders | |||
Very Common | somnolence, dizziness, ataxia | ||
Common | convulsions, hyperkinesias, dysarthria, amnesia, tremor, insomnia, headache, sensations such as paresthesia, hypaesthesia, coordination abnormal, nystagmus, increased, decreased, or absent reflexes | ||
Uncommon | hypokinesia, mental impairment | ||
Rare | loss of consciousness | ||
Not known | other movement disorders (e.g. choreoathetosis, dyskinesia, dystonia) | ||
Eye disorders | |||
Common | visual disturbances such as amblyopia, diplopia | ||
Ear and labyrinth disorders | |||
Common | vertigo | ||
Not known | tinnitus | ||
Cardiac disorders | |||
Uncommon | palpitations | ||
Vascular disorders | |||
Common | hypertension, vasodilatation | ||
Respiratory, thoracic and mediastinal disorders | |||
Common | dyspnoea, bronchitis, pharyngitis, cough, rhinitis | ||
Rare | respiratory depression | ||
Gastrointestinal disorders | |||
Common | vomiting, nausea, dental abnormalities, gingivitis, diarrhoea, abdominal pain, dyspepsia, constipation, dry mouth or throat, flatulence | ||
Uncommon | dyspagia | ||
Not known | pancreatitis | ||
Hepatobiliary disorders | |||
Not known | hepatitis, jaundice | ||
Skin and subcutaneous tissue disorders | |||
Common | facial oedema, purpura most often described as bruises resulting from physical trauma, rash, pruritus, acne | ||
Not known | Stevens-Johnson syndrome, angioedema, erythema multiforme, alopecia, drug rash with eosinophilia and systemic symptoms (see section 4.4) | ||
Musculoskeletal and connective tissue disorders | |||
Common | arthralgia, myalgia, back pain, twitching | ||
Not known | rhabdomyolysis, myoclonus | ||
Renal and urinary disorder | |||
Not known | acute renal failure, incontinence | ||
Reproductive system and breast disorders | |||
Common | impotence | ||
Not known | breast hypertrophy, gynaecomastia, sexual dysfunction (including changes in libido, ejaculation disorders and anorgasmia) | ||
General disorders and administration site conditions | |||
Very Common | fatigue, fever | ||
Common | peripheral oedema, abnormal gait, asthenia, pain, malaise, flu syndrome | ||
Uncommon | generalized oedema | ||
Not known | withdrawal reactions*, chest pain. Sudden unexplained deaths have been reported where a causal relationship to treatment with gabapentin has not been established. | ||
Investigations | |||
Common | WBC (white blood cell count) decreased, weight gain | ||
Uncommon | elevated liver function tests SGOT (AST), SGPT (ALT) and bilirubin | ||
Not known | blood creatine phosphokinase increased | ||
Injury, poisoning and procedural complications | |||
Common | accidental injury, fracture, abrasion | ||
Uncommon | fall | ||
*After discontinuation of short-term and long-term treatment with gabapentin, withdrawal symptoms have been observed. Withdrawal symptoms may occur shortly after discontinuation, usually within 48 hours. Most frequently reported symptoms include anxiety, insomnia, nausea, pains, sweating, tremor, headache, depression, feeling abnormal, dizziness, and malaise (see section 4.4). The occurrence of withdrawal symptoms following discontinuation of gabapentin may indicate drug dependence (see section 4.8). The patient should be informed about this at the start of the treatment. If gabapentin should be discontinued, it is recommended this should be done gradually over a minimum of 1 week independent of the indication (see section 4.2).
Under treatment with Gabapentin cases of acute pancreatitis were reported. Causality with Gabapentin is unclear (see section 4.4).
In patients on haemodialysis due to end-stage renal failure, myopathy with elevated creatine kinase levels has been reported.
Respiratory tract infections, otitis media, convulsions and bronchitis were reported only in clinical studies in children. Additionally, in clinical studies in children, aggressive behaviour and hyperkinesias were reported commonly.
To report any side effect (s):
Saudi Arabia: To report any side effect(s): National Pharmacovigilance Center (NPC): Fax: +966-11-205-7662, SFDA Call center: 19999, E-mail: npc.drug@sfda.gov.sa, Website: https://ade.sfda.gov.sa
Acute, life-threatening toxicity has not been observed with Gabapentin overdoses of up to 49g. Symptoms of the overdoses included dizziness, double vision, slurred speech, drowsiness, lethargy and mild diarrhoea. All patients recovered fully with supportive care. Reduced absorption of Gabapentin at higher doses may limit drug absorption at the time of overdosing and, hence, minimise toxicity from overdoses.
Overdoses of Gabapentin, particularly in combination with other CNS depressant medications, may result in coma.
Although Gabapentin can be removed by haemodialysis, based on prior experience it is not usually required. However, in patients with severe renal impairment, haemodialysis may be indicated.
An oral lethal dose of Gabapentin was not identified in mice and rats given doses as high as 8000 mg/kg. Signs of acute toxicity in animals included ataxia, laboured breathing, ptosis, hypoactivity, or excitation.
Pharmacotherapeutic group: Other antiepileptics.
ATC Code: N03AX12
Mechanism of action
Gabapentin readily enters the brain and prevents seizures in a number of animal models of epilepsy. Gabapentin does not possess affinity for either GABAA or GABAB receptor nor does it alter the metabolism of GABA. It does not bind to other neurotransmitter receptors of the brain and does not interact with sodium channels. Gabapentin binds with high affinity to the α2δ (alpha-2-delta) subunit of voltage-gated calcium channels and it is proposed that binding to the α2δ subunit may be involved in gabapentin's anti-seizure effects in animals. Broad panel screening does not suggest any other drug targets other than α2δ.
Evidence from several pre-clinical models inform that the pharmacological activity of gabapentin may be mediated via binding to α2δ through a reduction in release of excitatory neurotransmitters in regions of the central nervous system. Such activity may underlie gabapentin's anti-seizure activity. The relevance of these actions of gabapentin to the anticonvulsant effects in humans remains to be established.
Gabapentin also displays efficacy in several pre-clinical animal pain models. Specific binding of gabapentin to the α2δ subunit is proposed to result in several different actions that may be responsible for analgesic activity in animal models. The analgesic activities of gabapentin may occur in the spinal cord as well as at higher brain centers through interactions with descending pain inhibitory pathways. The relevance of these pre-clinical properties to clinical action in humans is unknown.
Clinical efficacy and safety
A clinical trial of adjunctive treatment of partial seizures in paediatric subjects ranging in age from 3 to 12 years, showed a numerical but not statistically significant difference in the 50% responder rate in favour of the Gabapentin group compared to placebo. Additional post-hoc analyses of the responder rates by age did not reveal a statistically significant effect of age, either as a continuous or dichotomous variable (age groups 3-5 and 6-12 years).
The data from this additional post-hoc analysis are summarised in the table below:
Response (≥ 50% Improved) by Treatment and Age MITT* Population | |||
Age Category | Placebo | Gabapentin | P-Value |
< 6 Years Old | 4/21 (19.0%) | 4/17 (23.5%) | 0.7362 |
6 to 12 Years Old | 17/99 (17.2%) | 20/96 (20.8%) | 0.5144 |
**The modified intent to treat population was defined as all patients randomised to study medication who also had evaluable seizure diaries available for 28 days during both the baseline and double-blind phases.
Absorption
Following oral administration, peak plasma Gabapentin concentrations are observed within 2 to 3 hours. Gabapentin bioavailability (fraction of dose absorbed) tends to decrease with increasing dose. Absolute bioavailability of a 300 mg capsule is approximately 60%. Food, including a high-fat diet, has no clinically significant effect on Gabapentin pharmacokinetics.
Gabapentin pharmacokinetics are not affected by repeated administration. Although plasma Gabapentin concentrations were generally between 2 μg/ml and 20 μg/ml in clinical studies, such concentrations were not predictive of safety or efficacy. Pharmacokinetic parameters are given in Table 3.
Table 3
Summary of Gabapentin mean (%CV) steady-state pharmacokinetic parameters following every eight hours’ administration
Pharmacokinetic parameter | 300 mg (N = 7) | 400 mg (N = 14) | 800 mg (N=14) | |||
Mean | %CV | Mean | %CV | Mean | %CV | |
Cmax (μg/ml) | 4.02 | (24) | 5.74 | (38) | 8.71 | (29) |
tmax (hr) | 2.7 | (18) | 2.1 | (54) | 1.6 | (76) |
T1/2 (hr) | 5.2 | (12) | 10.8 | (89) | 10.6 | (41) |
AUC (0-8) μg•hr/ml) | 24.8 | (24) | 34.5 | (34) | 51.4 | (27) |
Ae% (%) | NA | NA | 47.2 | (25) | 34.4 | (37) |
Cmax = Maximum steady state plasma concentration tmax = Time for Cmax T1/2 = Elimination half-life AUC (0-8) = Steady state area under plasma concentration-time curve from time 0 to 8 hours postdose Ae% = Percent of dose excreted unchanged into the urine from time 0 to 8 hours postdose NA = Not available | ||||||
Distribution
Gabapentin is not bound to plasma proteins and has a volume of distribution equal to 57.7 litres. In patients with epilepsy, Gabapentin concentrations in cerebrospinal fluid (CSF) are approximately 20% of corresponding steady-state trough plasma concentrations. Gabapentin is present in the breast milk of breast-feeding women.
Biotransformation
There is no evidence of Gabapentin metabolism in humans. Gabapentin does not induce hepatic mixed function oxidase enzymes responsible for drug metabolism.
Elimination
Gabapentin is eliminated unchanged solely by renal excretion. The elimination half-life of Gabapentin is independent of dose and averages 5 to 7 hours.
In elderly patients, and in patients with impaired renal function, Gabapentin plasma clearance is reduced. Gabapentin elimination-rate constant, plasma clearance, and renal clearance are directly proportional to creatinine clearance.
Gabapentin is removed from plasma by haemodialysis. Dosage adjustment in patients with compromised renal function or undergoing haemodialysis is recommended (see section 4.2).
Gabapentin pharmacokinetics in children were determined in 50 healthy subjects between the ages of 1 month and 12 years. In general, plasma Gabapentin concentrations in children > 5 years of age are similar to those in adults when dosed on a mg/kg basis.
In a pharmacokinetic study in 24 healthy paediatric subjects aged between 1 month and 48 months, an approximately 30% lower exposure (AUC), lower Cmax and higher clearance per body weight have been observed in comparison to available reported data in children older than 5 years.
Linearity/Non-linearity
Gabapentin bioavailability (fraction of dose absorbed) decreases with increasing dose which imparts non-linearity to pharmacokinetic parameters which include the bioavailability parameter (F) e.g. Ae%, CL/F, Vd/F. Elimination pharmacokinetics (pharmacokinetic parameters which do not include F such as CLr and T1/2), are best described by linear pharmacokinetics. Steady state plasma Gabapentin concentrations are predictable from single-dose data.
Carcinogenesis
Gabapentin was given in the diet to mice at 200, 600, and 2000 mg/kg/day and to rats at 250, 1000, and 2000 mg/kg/day for two years. A statistically significant increase in the incidence of pancreatic acinar cell tumours was found only in male rats at the highest dose. Peak plasma drug concentrations in rats at 2000 mg/kg are 10 times higher than plasma concentrations in humans given 3600 mg/day. The pancreatic acinar cell tumours in male rats are low-grade malignancies, did not affect survival, did not metastasise or invade surrounding tissue, and were similar to those seen in concurrent controls. The relevance of these pancreatic acinar cell tumours in male rats to carcinogenic risk in humans is unclear.
Mutagenesis
Gabapentin demonstrated no genotoxic potential. It was not mutagenic in vitro in standard assays using bacterial or mammalian cells. Gabapentin did not induce structural chromosome aberrations in mammalian cells in vitro or in vivo, and did not induce micronucleus formation in the bone marrow of hamsters.
Impairment of Fertility
No adverse effects on fertility or reproduction were observed in rats at doses up to 2000 mg/kg (approximately five times the maximum daily human dose on a mg/m2 of body surface area basis).
Teratogenesis
Gabapentin did not increase the incidence of malformations, compared to controls, in the offspring of mice, rats, or rabbits at doses up to 50, 30 and 25 times respectively, the daily human dose of 3600 mg, (four, five or eight times, respectively, the human daily dose on a mg/m2 basis).
Gabapentin induced delayed ossification in the skull, vertebrae, forelimbs, and hindlimbs in rodents, indicative of fetal growth retardation. These effects occurred when pregnant mice received oral doses of 1000 or 3000 mg/kg/day during organogenesis and in rats given 500, 1000, or 2000 mg/kg prior to and during mating and throughout gestation. These doses are approximately 1 to 5 times the human dose of 3600 mg on a mg/m2 basis.
No effects were observed in pregnant mice given 500 mg/kg/day (approximately 1/2 of the daily human dose on a mg/m2 basis).
An increased incidence of hydroureter and/or hydronephrosis was observed in rats given 2000 mg/kg/day in a fertility and general reproduction study, 1500 mg/kg/day in a teratology study, and 500, 1000, and 2000 mg/kg/day in a perinatal and postnatal study. The significance of these findings is unknown, but they have been associated with delayed development. These doses are also approximately 1 to 5 times the human dose of 3600 mg on a mg/m2 basis.
In a teratology study in rabbits, an increased incidence of post-implantation fetal loss, occurred in doses given 60, 300, and 1500 mg/kg/day during organogenesis. These doses are approximately 1/4 to 8 times the daily human dose of 3600 mg on a mg/m2 basis. The margins of safety are insufficient to rule out the risk of these effects in humans.
q Lactose Anhydrous
q Maize Starch
q Purified Talc
q Empty hard gelatin capsule
Not applicable.
Store away from children, do not store above 30ºC, protected from humidity.
q GABANET 300 Capsules are packed in boxes of 48 Capsules blistered in PVC/ PVDC / Aluminium Foil Blister.
q GABANET 300 Capsules are packed in boxes of 768 Capsules blistered in PVC/ PVDC / Aluminium Foil Blister.
No special requirements.
Any unused product or waste material should be disposed of in accordance with local requirements.
