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FevadolPlus tablets can be used in patients over 12 years of agefor the short term treatment of acute moderate pain which is not relieved by other painkillers such as paracetamol, ibuprofen or aspirin alone. They can be used for migraine, headache, dental pain, period pain, strains & sprains, backache, rheumatic pain and sciatica.
The tablets contain three active ingredients. Paracetamol and codeine are painkillers.
Codeine belongs to a group of medicines called opioid analgesics which act to relieve pain. It can be used on its own or in combination with other painkillers. Caffeine acts to further help the effectiveness of paracetamol.
· This medicine contains codeine which can cause addiction if you take it continuously for more than 3 days. This can give you withdrawal symptoms from the medicine when you stop taking it.
· If you take a painkiller for headaches for more than 3 days it can make them worse.
Do not take FevadolPlus tablets:
· If you have ever had an allergic reaction to paracetamol, caffeine, codeine, other opioid painkillers or to any of the other ingredients (listed in Section 6).
· If you are taking other medicines containing paracetamol orcodeine.
· If you are under 12 years.
· For pain relief in children and adolescents (0-18 years of age) after removal of their tonsils or adenoids due to obstructive sleep apnoea syndrome
· If you know that you metabolise very rapidly codeine into morphine
· If you are breastfeeding
Ask your doctor before you take this medicine:
· If you have liver or kidney disease, including alcoholic liver disease.
· If you have bowel problems including blockage of your bowel.
· If you have had an operation to remove your gall bladder.
Warnings and precautions:
Codeine is transformed to morphine in the liver by an enzyme. Morphine is the substance that produces pain relief. Some people have a variation of this enzyme and this can affect people in different ways. In some people, morphine is not produced or produced in very small quantities, and it will not provide enough pain relief. Other people are more likely to get serious side effects because a very high amount of morphine is produced. If you notice any of the following side effects, you must stop taking this medicine and seek immediate medical advice:
Slow or shallow breathing, confusion, sleepiness, small pupils, feeling or being sick, constipation, lack of appetite.
RISKS FROM CONCOMITANT USE WITH OPIOIDS
Concomitant use of benzodiazepines, including Fevadol Plus, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of benzodiazepines and opioids for use in patients for whom alternative treatment options are inadequate.
Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. If a decision is made to prescribe Fevadol Plus concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation.
Drug Interactions
Talk to your doctor or pharmacist before taking these tablets if you are taking any prescribed medicines; particularly metoclopramide or domperidone (for nausea [feeling sick] or vomiting); colestyramine (to lower blood cholesterol); monoamine oxidase inhibitors (MAOIs) prescribed for depression in the last 2 weeks or substances that make you drowsy (e.g. sedatives, antidepressants or alcohol).
If you take blood thinning drugs (anticoagulants e.g. warfarin) and you need to take a pain reliever on a daily basis, talk to your doctor because of the risk of bleeding. But you can still take occasional doses of Fevadol Plus tablets at the same time as anticoagulants.
The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions on a different receptor sites in the CNS that control respiration. Benzodiazepines interact at GABAA sites and opioids interact primarily at mu receptors. When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists. Limit dosage and duration of concomitant use of benzodiazepines and opioids, and monitor patients closely for respiratory depression and sedation.
Please inform your doctor or pharmacist if you are taking:
-flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (high anion gap metabolic acidosis) that must have urgent treatment and which may occur particularly in case of severe renal impairment, sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), malnutrition, chronic alcoholism, and if the maximum daily doses of paracetamol are used.
Phenytoin may reduce the analgesic and antipyretic effects of paracetamol and may increase risk of hepatotoxicity.
Children and adolescents:
Use in children and adolescents after surgery:
Codeine should not be used for pain relief in children and adolescents after removal of their tonsils or adenoids due to Obstructive Sleep Apnoea Syndrome.
Use in children with breathing problems:
Codeine is not recommended in children with breathing problems, since the symptoms of morphine toxicity may be worse in these children.
Pregnancy and breast feeding:
Talk to your doctor before taking Fevadol Plus Tablets if you are pregnant. Do not take Fevadol Plus Tablets while you are breast-feeding. Codeine and morphine passes into breast milk.
Driving and using machines:
This medicine can affect your ability to drive as it may make you sleepy or dizzy.
Do not drive while taking this medicine until you know how it affects you. It is an offence to drive if this medicine affects your ability to drive.
However, you would not be committing an offence if:
The medicine has been taken to treat a medical or dental problem.
You have taken it according to the information provided with the medicine and
It was not affecting your ability to drive safely.
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
Adults aged 18 years and over:
Swallow 2 tablets every 4-6 hours as needed.
Do not take more frequently than every 4 hours.
Do not take more than 8 tablets in 24 hours.
Children aged 16 – 18 years:
Swallow 1-2 tablets every 6 hours as needed.
Do not take more frequently than every 6 hours.
Do not take more than 8 tablets in 24 hours.
Children aged 12 – 15 years:
Swallow 1 tablet every 6 hours as needed.
Do not take more frequently than every 6 hours.
Do not take more than 4 tablets in 24 hours.
· Do not take more than the recommended dose.
· Avoid too much caffeine in drinks like coffee and tea. High caffeine intake can cause difficulty sleeping, shaking and an uncomfortable feeling in the chest.
· Fevadol Plus Tablets should not be taken by children below the age of 12 years, due to the risk of severe breathing problems
· Do not take for more than 3 days. If you need to use this medicine for more than 3 days you must speak to your doctor or pharmacist.
Possible withdrawal effect
This medicine contains codeine and can cause addiction if you take it continuously for more than 3 days. When you stop taking it you may get withdrawal symptoms. You should talk to your doctor or pharmacist if you think you are suffering from withdrawal symptoms.
If you take too many tablets
Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.
If your symptoms continue or your headache becomes persistent, see your doctor.
Information should be given to parents and caregivers on how to recognize the signs and symptoms of morphine toxicity, and advice should be given to stop giving the child codeine and to seek medical attention immediately if the child shows these signs or symptoms, which include: reduced levels of consciousness, somnolence, respiratory depression, “pin-point” pupils, lack of appetite, constipation, or nausea and vomiting.
Some people may have side effects when using this medicine. If you have any unwanted side effects you should seek advice from your doctor, pharmacist or other healthcare professional.
Also you can help make sure that medicines remain as safe as possible by reporting any unwanted side effects.
When using this product you may experience:
· Constipation.
Stop taking this medicine and tell your doctor immediately if you experience:
· Severe abdominal pain, dry mouth, nausea and vomiting if you have recently had your gall bladder removed.
· Nervousness, dizziness, irritability, drowsiness or restlessness.
· Allergic reactions which may be severe such as skin rash and itchingsometimes with swelling of the mouth or face or shortness of breath.
· Skin rash or peeling or mouth ulcers; itching or sweating.
· Breathing problems. These are more likely if you have experienced them before when taking other painkillers such as ibuprofen and aspirin.
· Unexplained bruising or bleeding.
· Nausea, upset stomach, sudden weight loss, loss of appetite and yellowing of the eyes and skin.
· Difficulty in urinating.
If you do get any side effects, even those not mentioned in this leaflet, tell your doctor or pharmacist.
How do I know if I am addicted?
If you take this medicine according to the instructions on the pack, it is unlikely you will become addicted to the medicine. However, if the following apply to you it is important that you talk to your doctor:
· You need to take the medicine for longer periods of time.
· You need to take more than the recommended dose.
· When you stop taking the medicine you feel very unwell but you feel better if you start taking the medicine again.
Keep out of the reach and sight of children.
Do not use this medicine after the ´EXP’ date shown on the pack.
store below 30°C
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.
Active ingredients:
Each tablet contains Paracetamol 500 mg,Codeine Phosphate 8 mg and Caffeine anhydrous30 mg.
Other ingredients areMaize Starch, Maize Starch Pregelatinised, Kollidon CL BASF, Colloidal Silicon Dioxide and Stearic Acid B.P.C
Manufacturer:
DAMMAM PHARMA
Dammam Pharmaceutical Plant
Saudi Arabia
Marketing Authorization Holder and Manufacturer:
SPIMACO
Al-Qassim Pharmaceutical Plant
Saudi Arabia
تستخدم أقراص فيفادول بلص في المرضى فوق سن 12 سنة كعلاج قصير المدى للحد من حدة الألم المعتدل والذى لا يمكن التخلص منه بواسطة مسكنات الألم الأخرى مثل الباراسيتامول أو الإيبوبروفين أو الأسبرين كل على حدة. ويمكن استخدام أقراص فيفادولبلص أيضاً لعلاج الصداع النصفى والصداع وألم الأسنان وألم الدورة الشهرية والإجهادات والالتواءات وآلام الظهر وآلام الروماتيزم وعرق النسا.
الأقراص تحتوى على ثلاث مواد فعالة. الباراسيتامول و الكودايين وهى مواد مسكنة للألم. ينتمي كواديين لمجموعة من الأدوية تسمى المسكنات الأفيونية التي تعمل على تخفيف الألم. يمكن استخدامه وحده أو بالاشتراك مع مسكنات الألم الأخرى. يعمل كافيين على زيادة فعالية الباراسيتامول.
- هذا الدواء يحتوى على الكودايين والذي قد يسبب الإدمان إذا تناولته باستمرار لأكثر من 3 أيام. مما قد يعرضك لأعراض انسحاب الدواء عند توقفك عن تناوله.
- فى حالة تناولك لدواء مسكن للألم لعلاج الصداع لأكثر من 3 أيام قد يتسبب ذلك فى ازدياد سوء الحالة لديك.
لا تقم بتناول أقراص فيفادول بلص في الحالات الآتية:
- إذا تعرضت في أي وقت لتفاعل تحسسي تجاه الباراسيتامول أو الكافيين أو الكودايين أو أي مسكن آخر للألم من مجموعة المسكنات الأفيونية أو أي من المكونات الأخرى لهذا الدواء (والمذكورة في الفقرة 6).
- إذا كنت تتناول أدوية أخرى تحتوى على باراسيتامول أو كودايين.
- إذا كنت أصغر فى العمر من 12 سنة.
- لتخفيف الألم عند الأطفال والمراهقين (0-18 سنة من العمر) بعد إزالة اللوزتين أو الغدة الأنفية بسبب متلازمة انقطاع التنفس ألانسدادي أثناء النوم
- إذا كنت تعرف أنك تقوم بتحويل كودايين إلى مورفين بسرعة كبيرة
- إذا كنت ترضعين طفلك رضاعة طبيعية
اسأل طبيبك المعالج قبل تناول هذا الدواء فى الحالات الآتية:
- إذا كنت مصاباً بأمراض بالكبد أو الكلى, بما في ذلك أمراض الكبد الكحولية.
- إذا كانت لديك مشاكل بالأمعاء بما في ذلك انسداد الأمعاء.
- إذا كنت قد خضعت مسبقاً لعملية جراحية لاستئصال المرارة.
التحذيرات و الاحتياطات:
يتحول كودايين إلى مورفين في الكبد بواسطة إنزيم. المورفين هو المادة التي تنتج تخفيف الألم. بعض الناس لديهم اختلاف في هذا الإنزيم وهذا يمكن أن يؤثرعلى الناس بطرق مختلفة. في بعض الناس،لا يتم إنتاج المورفين أو إنتاجه بكميات صغيرة جدًا، ولن يوفر ما يكفي لتخفيف الألم. من المحتمل أن يتعرض الأشخاص الآخرون لأعراض جانبية خطيرة لأن كمية كبيرة جدًا من المورفين يتم إنتاجها. إذا لاحظت أيًا من الأعراض الجانبية التالية، يجب التوقف عن تناول هذا الدواء وطلب المشورة الطبية الفورية:
التنفس البطيء أو الضحل، الارتباك ، النعاس ،صغر بؤبؤ العين ،الشعور بالمرض ،الإمساك ،نقص الشهية.
مخاطر من الاستخدام المتزامن مع المواد الأفيونية
قد يؤدي الاستخدام المتزامن للبنزوديازيبينات بما في ذلك فيفادول بلص والمواد الأفيونية إلى التخدير العميق، وهبوط التنفس، والغيبوبة، والموت. نظرا لهذه المخاطر اجعل الوصف المتزامن للبنزوديازيبينات والمواد الأفيونية في المرضى الذين خيارات علاجهم البديلة غير كافية.
وقد أثبتت الدراسات الرصدية أن الاستخدام المتزامن للمسكنات الأفيونية والبنزوديازيبينات يزيد من خطر الوفيات المرتبطة بالأدوية مقارنة باستخدام المواد الأفيونية وحدها. إذا تم اتخاذ قرار لوصف فيفادول بلص بالتزامن مع المواد الأفيونية ،أوصف أقل جرعة فعالة والحد الأدنى من فترات الاستخدام المتزامن، وتابع المرضى عن كثب بحثًا عن علامات و أعراض هبوط التنفس والتخدير.
التفاعلات الدوائية
تواصل مع طبيبك المعالج أو الصيدلي قبل تناول هذه الأقراص إذا كنت تتناول أى أدوية موصوفة لك من قبل الطبيب, خصوصاً ميتوكلوبراميد أو دومبيريدون (لعلاج الغثيان (الشعور بالإعياء) أو التقيؤ), كوليستيرامين (لخفض الكوليستيرول بالدم), مثبطات أوكسيديزأحادي الأمين (MAOIs) الموصوفة لعلاج الاكتئاب في الأسبوعين الماضيين أو المواد التي تشعرك بالدوار (مثل المهدئات, مضادات الاكتئاب أو الكحول).
إذا كنت تتناول أدوية لمنع تجلط الدم (مضادات التخثر مثل الوارفارين), وكنت بحاجة لاستخدام مسكن للآلام بشكل يومي,تواصل مع طبيبك المعالج وذلك بسبب خطورة احتمال حدوث نزيف. ومع ذلك, فإنه مازال بإمكانك تناول جرعات من أقراص فيفادول بلص من حين لآخر فى نفس الوقت مع مضادات التخثر.
يزيد الاستخدام المصاحب للبنزوديازيبينات والمواد الأفيونية من خطر هبوط التنفس بسبب العمل على مستقبلات مختلفة في الجهاز العصبي المركزي التي تتحكم في التنفس. تتفاعل البنزوديازيبينات على مواقع GABAaوتتفاعل المواد الأفيونية في المقام الأول مع المستقبلات ميو. عندما يتم الجمع بين البنزوديازيبينات و الموادالأفيونية ،فإنه يوجد احتمال لتفاقم هبوط التنفس المرتبط بالأفيونيات بشكل ملحوظ. حد من الجرعة ومدة الاستخدام المتزامن للبنزوديازيبينات والمواد الأفيونية، وتابع المرضى عن كثب لأعراض هبوط التنفس والتخدير.
يرجى إبلاغ طبيبك أو الصيدلي إذا كنت تتناول:
- فلوكلوكساسيللين (مضاد حيوي) ، وذلك بسبب خطورة حدوث خلل في الدم والسوائل (الحماض الأيضي ذو الفجوة العالية في الأنيون) الذي يجب أن يخضع لعلاج عاجل والذي قد يحدث بشكل خاص في حالة القصور الكلوي الشديد ، والإنتان (عندما تنتشر البكتيريا وسمومها في الدم الذي يؤدي إلى تلف الأعضاء) ، وسوء التغذية ، وإدمان الكحول المزمن ، وفي حالة استخدام الجرعات اليومية القصوى من الباراسيتامول.
قد يقلل الفينيتوين من التأثيرات المسكنة والخافضة للحرارة للباراسيتامول وقد يزيد من خطر السمية الكبدية.
الأطفال والمراهقين:
الاستخدام في الأطفال والمراهقين بعد الجراحة:
لا ينبغي أن تستخدم كودايين لتخفيف الألم عند الأطفال والمراهقين بعد إزالة اللوزتين أو الغدة الأنفية بسبب متلازمة انقطاع النفس الانسدادي أثناء النوم.
الاستخدام في الأطفال الذين يعانون من مشاكل في التنفس:
لا ينصح كودايين في الأطفال الذين يعانون من مشاكل في التنفس،لأن أعراض سمية المورفين قد تكون أسوأ في هؤلاء الأطفال.
الحمل والرضاعة:
تواصلي مع طبيبك المعالج قبل تناول أقراص فيفادول بلص إذا كنتِ حاملاً. لا ينبغي أن يتم استخدام أقراص فيفادول بلص أثناء الرضاعة الطبيعية. يمر كودايين و مورفين من خلال حليب الثدي.
القيادة واستخدام الآلات:
يمكن أن يؤثر هذا الدواء على قدرتك على القيادة لأنه قد يجعلك تشعر بالنعاس أو الدوار.
لا تقوم بالقيادة أثناء تناول هذا الدواء حتى تعرف كيف يؤثر عليك. من الخطأ أن تقود إذا كان هذا الدواء يؤثر على قدرتك على القيادة.
ومع ذلك، فإنك لن ترتكب خطأ إذا:
تناولت الدواء لعلاج مشكلة طبية متعلقة بالأسنان
كنت قد تناولته وفقا للمعلومات المقدمة مع الدواء و لم يؤثر على قدرتك على القيادة بأمان.
تحدث إلى طبيبك أ والصيدلي إذا لم تكن متأكدًا مما إذا كان من الآمن بالنسبة لك قيادة السيارة أثناء تناول هذا الدواء.
البالغين الذين يبلغون 18 عامًا وأكثر:
تناول قرصين كل 4-6 ساعات حسب الحاجة.
لا تأخذ أكثر من كل 4 ساعات.
لا تأخذ أكثر من 8 أقراص في 24 ساعة.
الأطفال الذين تتراوح أعمارهم بين 16 و 18 عامًا:
تناول قرص أو قرصين كل 6 ساعات حسب الحاجة.
لا تأخذ أكثر من كل 6 ساعات.
لا تأخذ أكثر من 8 أقراص في 24 ساعة.
الأطفال الذين تتراوح أعمارهم بين 12 و 15 عامًا:
تناول قرص كل 6 ساعات حسب الحاجة.
لا تأخذ أكثر من كل 6 ساعات.
لا تأخذ أكثر من 4 أقراص في 24 ساعة.
- لا تقم بتناول أكثر من الجرعة الموصى بها.
- تجنب شرب الكثير من الكافيين في المشروبات مثل الشاي والقهوة. حيث أن تناول الكثير من الكافيين قد يسبب صعوبة في النوم, رعشات وشعور بعدم الارتياح في الصدر.
- لا ينبغي للأطفال الذين تقل أعمارهم عن 12 عامًا تناول أقراص فيفادول بلص،وذلك بسبب خطر حدوث مشاكل شديدة في التنفس.
- ينبغي عدم تناول هذا الدواء لفترة تزيد عن 3 أيام. عند حاجتك لاستخدام هذا الدواء لأكثر من 3 أيام يجب عليك استشارة طبيبك المعالج أو الصيدلي.
تأثير الانسحاب المحتمل
هذا الدواء يحتوى على الكودايين والذي قد يسبب الإدمان إذا تناولته باستمرار لأكثر من 3 أيام. مما قد يعرضك لأعراض انسحاب الدواء عند توقفك عن تناوله. ينبغي عليك التواصل مع طبيبك المعالج أو الصيدلي عند اعتقادك بأنك تعانى من أعراض انسحاب الدواء.
فى حالة تناولك العديد من الأقراص:
يجب الحصول على المشورة الطبية الفورية في حالة تناولك جرعة زائدة, حتى إذا كنت تشعر بحالة جيدة, وذلك بسبب خطورة حدوث تلف متأخر وخطير بالكبد.
إذا استمرت لديك الأعراض أو إذا أصبح لديك صداعاً مستمراً, راجع طبيبك المعالج.
وينبغي إبلاغ المعلومات إلى الآباء والأمهات ومقدمي الرعاية حول كيفية التعرف على علامات وأعراض تسمم المورفين ، ويجب أن تعطى المشورة لوقف إعطاء الكوديين الخاص بالأطفال والتماس العناية الطبية على الفور إذا ظهرت علي الطفل هذه العلامات أو الأعراض ، والتي تشمل: انخفاض مستويات وعيه ،النعاس ،ضعف الجهاز التنفسي ،وصغر بؤبؤ العين "عرض نقطة الدبوس" ،انعدام الشهية ،الإمساك ،أو الغثيان والقيء.
قد يتعرض بعض الناس إلى أعراض جانبية عند استخدام هذا الدواء. إذا تعرضت لأي أعراض جانبية غير مرغوبة ينبغي عليك استشارة طبيبك المعالج أو الصيدلي أو غيرهما من متخصصي الرعاية الصحية.
يمكنك أيضاً المساعدة في التأكد من أن الأدوية لا تزال آمنة قدر الإمكان من خلال الإبلاغ عن أي أعراض جانبية غير مرغوب فيها.
عند استخدامك لهذا الدواء قد تتعرض إلى:
· إمساك.
توقف عن تناول هذا الدواء وأخبر طبيبك المعالج فوراً إذا تعرضت لأي من الأعراض الآتية:
· ألم شديد بالبطن, جفاف الفم, غثيان وتقيؤ إذا ما قمت مؤخرا بعملية لاستئصال المرارة.
· عصبية, دوخة, تهيج, نعاس أو أرق.
· تفاعلات تحسسيه والتي قد تكون شديدة مثل الطفح الجلدي والحكة مصحوبة في بعض الأحيان بتورم في الفم أو الوجه أو ضيق في التنفس.
· طفح جلدي أو تقشير أو تقرحات بالفم أو حكة أو تعرق.
· مشاكل في التنفس. وهي أكثر احتمالاً إذا كنت قد تعرضت لها مسبقاً عند استخدام مسكنات الألم الأخرى مثل الإيبوبروفين والأسبرين.
· ظهور كدمات بدون مبرر أو حدوث نزيف.
· غثيان واضطرابات في المعدة, وفقدان مفاجئ للوزن, وفقدان الشهية واصفرار في العينين والجلد.
· صعوبة في التبول.
في حالة تعرضك لأي أعراض جانبية, حتى ولو لم يتم ذكرها في هذه النشرة, أخبر طبيبك المعالج أو الصيدلي.
كيف لي أن أعرف إذا كنت مدمناً؟
إذا تناولت هذا الدواء طبقاً للتعليمات المدونة على العبوة, فمن غير المحتمل أن تتعرض لإدمان هذا الدواء. ومع ذلك, في حالة انطباق الحالات الآتية عليك تواصل مع طبيبك المعالج:
- إذا كنت تحتاج إلى تناول هذا الدواء لفترات زمنية طويلة.
- إذا كنت تحتاج إلى تناول أكثر من الجرعة الموصى بها.
- إذا كنت تصاب بشعور شديد بالتوعك عند التوقف عن تناول هذا الدواء والشعور بتحسن عند البدء فى تناوله مرة أخرى.
يحفظ الدواء بعيداً عن متناول ونظر الأطفال.
لا تستخدم هذا الدواء بعد انتهاء تاريخ الصلاحية المدون على العبوة بعد كلمة "EXP".
يحفظ فى درجة حرارة اقل من 30 درجة مئوية.
يجب عدم التخلص من الأدوية عبر مياه الصرف الصحي أو النفايات المنزلية. اسأل الصيدلي عن كيفية التخلص من الأدوية التي لم تعد بحاجة إليها. سوف تساعد هذه التدابير فى حماية البيئة.
المواد الفعالة:
يحتوى كل قرص على باراسيتامول 500 ملجم, كواديين فوسفات 8 ملجم وكافيين لامائى 30 ملجم.
مكونات أخرى وهى: نشا الذرة, نشا الذرة قبل الهيلمة, ثاني أكسيد السيليكون الغرواني وحمض دهني BPC.
قرص أبيض إلى أبيض تقريبا ،مستطيل ،محدب الوجهين ،محفور بحروف "SP " و رقم "139" على جانب واحد وخط للكسر على الجانب الأخر.
تحتوي عبوة فيفادول بلص على 20 قرصاً.
المصنع:
الدمام فارما
مصنع الأدوية بالدمام
المملكة العربية السعودية
مالك الحقوق التسويقية والمصنع:
الدوائية
مصنع الأدوية بالقصيم
المملكة العربية السعودية
Codeine is indicated in patients older than 12 years of age for the treatment of acute moderate pain which is not considered to be relieved by other analgesics such as paracetamol or ibuprofen alone.
Fevadol Plus Tablets are recommended for the relief of migraine, headache, backache, rheumatic pain, period pains and dental pain.
Adults (including the elderly)
2 tablets up to 3 or 4 times a day if necessary. The dose should not be repeated more frequently than every four hours, and not more than 4 doses (8 tablets) should be given in any 24 hour period.
Paediatric population:
Children aged 16-18 years:
1-2 tablets every 6 hours when necessary up to a maximum of 8 tablets in 24 hours.
Children aged 12 – 15 years:
1 tablet every 6 hours when necessary up to a maximum of 4 tablets in 24 hours.
Children aged less than 12 years:
Codeine should not be used in children below the age of 12 years because of the risk of opioid toxicity due to the variable and unpredictable metabolism of codeine to morphine (see sections 4.3 and 4.4).
For oral administration only.
The duration of treatment should be limited to 3 days and if no effective pain relief is achieved the patients/carers should be advised to seek the views of a physician.
Care is advised in the administration of paracetamol to patients with renal or hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.
Do not exceed the stated dose.
Patients should be advised to consult their doctor if their headaches become persistent.
Patients should be advised not to take other paracetamol or codeine-containing products concurrently.
If symptoms persist consult your doctor.
Keep out of the reach and sight of children.
Patients with obstructive bowel disorders or acute abdominal conditions should consult a doctor before using this product.
Patients with a history of cholecystectomy should consult a doctor before using this product as it may cause acute pancreatitis in some patients.
Excessive intake of caffeine (e.g. coffee, tea and some canned drinks) should be avoided while taking this product.
CYP2D6 metabolism
Codeine is metabolised by the liver enzyme CYP2D6 into morphine, its active metabolite. If a patient has a deficiency or is completely lacking this enzyme an adequate analgesic effect will not be obtained. Estimates indicate that up to 7% of the Caucasian population may have this deficiency. However, if the patient is an extensive or ultra-rapid metaboliser there is an increased risk of developing side effects of opioid toxicity even at commonly prescribed doses. These patients convert codeine into morphine rapidly resulting in higher than expected serum morphine levels. General symptoms of opioid toxicity include confusion, somnolence, shallow breathing, small pupils, nausea, vomiting, constipation and lack of appetite. In severe cases this may include symptoms of circulatory and respiratory depression, which may be life-threatening and very rarely fatal. Estimates of prevalence of ultra-rapid metabolisers in different populations are summarized below:
Population | Prevalence % |
African/Ethiopian | 29% |
African American | 3.4% to 6.5% |
Asian | 1.2% to 2% |
Caucasian | 3.6% to 6.5% |
Greek | 6.0% |
Hungarian | 1.9% |
Northern European | 1%-2% |
Post-operative use in children
There have been reports in the published literature that codeine given post-operatively in children after tonsillectomy and/or adenoidectomy for obstructive sleep apnoea, led to rare, but life threatening adverse events including death (see also section 4.3). All children received doses of codeine that were within the appropriate dose range; however there was evidence that these children were either ultra-rapid or extensive metabolisers in their ability to metabolise codeine to morphine.
Children with compromised respiratory function
Codeine is not recommended for use in children in whom respiratory function might be compromised including neuromuscular disorders, severe cardiac or respiratory conditions, upper respiratory or lung infections, multiple trauma or extensive surgical procedures. These factors may worsen symptoms of morphine toxicity.
The leaflet will state:
Headlines section (to be prominently displayed)
• This medicine is for the short term treatment of acute moderate pain when other painkillers have not worked.
• You should only take this product for a maximum of 3 days at a time. If you need to take it for longer than 3 days you should see your doctor or pharmacist for advice
• This medicine contains codeine which can cause addiction if you take it continuously for more than 3 days. This can give you withdrawal symptoms from the medicine when you stop taking it
• If you take this medicine for headaches for more than 3 days it can make them worse.
Section 1: What the medicine is for:
• Fevadol Plus Tablets can be used in patients over the age of 12 years for the short term relief of moderate pain that is not relieved by other painkillers such as paracetamol or ibuprofen alone. They can be used for migraine, headache, dental pain, backache and rheumatic pain
Section 2: Before taking
• This medicine contains codeine which can cause addiction if you take it continuously for more than 3 days. This can give you withdrawal symptoms from the medicine when you stop taking it
• If you take a painkiller for headaches for more than 3 days it can make them worse.
Section 3: Dosage
• This medicine should not be taken for more than 3 days. If the pain does not improve after 3 days, talk to your doctor for advice.
• Possible withdrawal effects
This medicine contains codeine and can cause addiction if you take it continuously for more than 3 days. When you stop taking it you may get withdrawal symptoms. You should talk to your doctor or pharmacist if you think you are suffering from withdrawal symptoms.
• How do I know if I am addicted?
If you take the medicine according to the instructions on the pack it is unlikely that you will become addicted to the medicine. However, if the following apply to you it is important that you talk to your doctor:
• You need to take the medicine for longer periods of time • You need to take more than the recommended dose • When you stop taking the medicine you feel very unwell but you feel better if you start taking the medicine again |
The label will state:
Front of pack
• Can cause addiction
• Use for 3 days only
Back of pack
• Fevadol Plus Tablets are for the short term treatment of acute moderate pain when other painkillers have not worked. Wait at least four hours after taking any other painkiller before you take this medicine. For: migraine, headache, dental pain, period pain, backache and rheumatic pain
• If you need to take this medicine continuously for more than 3 days you should see your doctor or pharmacist
• This medicine contains codeine which can cause addiction if you take continuously for more than 3 days. If you take this medicine for headaches for more than 3 days it can make them worse
Caution is advised if paracetamol is administered concomitantly with flucloxacillin due to increased risk of high anion gap metabolic acidosis (HAGMA), particularly in patients with severe renal impairment, sepsis, malnutrition and other sources of glutathione deficiency (e.g. chronic alcoholism), as well as those using maximum daily doses of paracetamol. Close monitoring, including measurement of urinary 5-oxoproline, is recommended.
Phenytoin may reduce the analgesic and antipyretic effects of paracetamol and may increase the formation of the toxic N-acetyl-p-benzoquinone imine (NAPQI) metabolite of paracetamol leading to increased risk of hepatotoxicity.
RISKS FROM CONCOMITANT USE WITH OPIOIDS
Concomitant use of benzodiazepines, including Fevadol Plus, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of benzodiazepines and opioids for use in patients for whom alternative treatment options are inadequate.
Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. If a decision is made to prescribe Fevadol Plus concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation.
Paracetamol
The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.
Codeine
Codeine may antagonize the effects of metoclopramide and domperidone on gastrointestinal motility.
Codeine potentiates the central depressive effects of central nervous system depressants including alcohol, anaesthetics, hypnotics, sedatives, tricyclic antidepressants and phenothiazines.
MAOIs taken with pethidine have been associated with severe CNS excitation or depression (including hypertension or hypotension). Although this has not been documented with codeine, it is possible that a similar interaction may occur and therefore the use of codeine should be avoided while the patient is taking MAOIs and for 2 weeks after MAOI discontinuation.
Opiate analgesics may interact with monoamine oxidase inhibitors (MAOI) and result in serotonin syndrome.
The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions on a different receptor sites in the CNS that control respiration. Benzodiazepines interact at GABAA sites and opioids interact primarily at mu receptors. When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists. Limit dosage and duration of concomitant use of benzodiazepines and opioids, and monitor patients closely for respiratory depression and sedation.
Caution should be taken when paracetamol is used concomitantly with flucloxacillin as concurrent intake has been associated with high anion gap metabolic acidosis, especially in patients with risks factors (see section 4.4)
Pregnancy
Use during pregnancy should be avoided, unless advised by a physician. This includes maternal use during labour because of the potential for respiratory depression in the neonate.
The safety of paracetamol-caffeine-codeine during pregnancy has not been established relative to the possible adverse effects of foetal development and should be avoided during pregnancy due to the possible increased risk of lower birth weight and spontaneous abortion associated with caffeine consumption.
Lactation
Codeine should not be used during breastfeeding (see section 4.3).
At normal therapeutic doses codeine and its active metabolite may be present in breast milk at very low doses and is unlikely to adversely affect the breast fed infant.
However, if the patient is an ultra-rapid metaboliser of CYP2D6, higher levels of the active metabolite, morphine, may be present in breast milk and on very rare occasions may result in symptoms of opioid toxicity in the infant, which may be fatal.
Although significant caffeine toxicity has not been observed in breastfed infants, caffeine may have a stimulating effect on the infant.
Due to the caffeine content of this product it should not be used if you are pregnant or breastfeeding.
Patients should be advised not to drive or operate machinery if affected by dizziness or sedation.
This medicine can impair cognitive function and can affect a patient's ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. When taking this medicine, patients should be told:
• The medicine is likely to affect your ability to drive
• Do not drive until you know how the medicine affects you
• It is an offence to drive while under the influence of this medicine
• However, you would not be committing an offence (called 'statutory defence') if:
o The medicine has been taken to treat a medical or dental problem and
o You have taken it according to the information provided with the medicine and
o It was not affecting your ability to drive safely
Adverse events from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by system.
The frequency of these adverse events is not known (cannot be estimated from available data).
Paracetamol
Body System | Undesirable effect |
Blood and lymphatic system disorders | Thrombocytopenia Agranulocytosis |
Immune system disorders | Anaphylaxis Cutaneous hypersensitivity reactions including skin rashes, angiodema and Stevens Johnson syndrome/toxic epidermal necrolysis |
Respiratory, thoracic and mediastinal disorders | Bronchospasm* |
Hepatobiliary disorders | Hepatic dysfunction |
* There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.
Caffeine
Body System | Undesirable effect |
Central nervous system | Nervousness Dizziness |
When the recommended paracetamol-caffeine-codeine dosing regimen is combined with dietary caffeine intake, the resulting higher dose of caffeine may increase the potential for caffeine-related adverse effects such as insomnia, restlessness, anxiety, irritability, headaches, gastrointestinal disturbances and palpitations.
Codeine
Adverse reactions identified during post-marketing use are listed below by MedDRA system organ class. The frequency of these reactions is not known.
Body System | Undesirable effect |
Psychiatric disorders | Drug dependency can occur after prolonged use of codeine at higher doses |
Gastrointestinal disorder | Constipation, nausea, vomiting, dyspepsia, dry mouth, acute pancreatitis in patients with a history of cholecystectomy |
Nervous system disorder | Dizziness, worsening of headache with prolonged use, drowsiness. |
Renal and urinary disorders | Difficulty with micturition |
Skin and subcutaneous tissue disorder | Pruritus, sweating |
|
Overuse of this product, defined as consumption of quantites in excess of the recommended dose, or consumption for a prolonged period of time may lead to physical or psychological dependency. Symptoms of restlessness and irritability may result when treatment is stopped.
Codeine
The effects in overdosage will be potentiated by simultaneous ingestion of alcohol and psychotropic drugs.
Symptoms
An overdose of codeine is characterised, in the first phase, by nausea and vomiting. An acute depression of the respiratory centre can cause cyanosis, slower breathing, drowsiness, ataxia and, more rarely, pulmonary oedema. Respiratory pauses, miosis, convulsion, collapse and urine retention. Signs of histamine release have been observed as well.
Management
This should include general symptomatic and supportive measures including a clear airway and monitoring of vital signs until stable. Consider activated charcoal if an adult presents within one hour of ingestion of more than 350 mg or a child more than 5 mg/kg.
Give naloxone if coma or respiratory depression is present. Naloxone is a competitive antagonist and has a short half-life, so large and repeated doses may be required in a seriously poisoned patient. Observe for at least four hours after ingestion, or eight hours if a sustained release preparation has been taken.
Paracetamol
Liver damage is possible in adults who have taken 10 g or more of paracetamol. Ingestion of 5 g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).
Risk Factors:
If the patient
Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.
Or
Regularly consumes ethanol in excess of recommended amounts.
Or
Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.
Symptoms
Symptoms of paracetamol overdose in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.
Management
Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.
Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or a liver unit.
Caffeine
Symptoms and signs
Overdose of caffeine may result in epigastric pain, vomiting, diuresis, tachycardia or cardiac arrhythmia, CNS stimulation (insomnia, restlessness, excitement, agitation, jitteriness, tremors and convulsions).
It must be noted that for clinically significant symptoms of caffeine overdose to occur with this product, the amount ingested would be associated with serious paracetamol-related liver toxicity.
Management
Patients should receive general supportive care (e.g. hydration and maintenance of vital signs). The administration of activated charcoal may be beneficial when performed within one hour of the overdose, but can be considered for up to four hours after the overdose. The CNS effects of overdose may be treated with intravenous sedatives.
Summary
Treatment of overdose with Fevadol Plus Tablets requires assessment of plasma paracetamol levels for antidote treatment, with signs and symptoms of codeine and caffeine toxicity being managed symptomatically.
Paracetamol is a well-established analgesic, caffeine has a stimulating effect on the central nervous system and possesses a weak diuretic action.
Codeine is a centrally acting weak analgesic. Codeine exerts its effect through µ opioid receptors, although codeine has low affinity for these receptors, and its analgesic effect is due to its conversion to morphine. Codeine, particularly in combination with other analgesics such as paracetamol, has been shown to be effective in acute nociceptive pain.
Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Concentration of paracetamol in plasma reaches a peak in 30-60 minutes and the plasma half-life is 1-4 hours. Paracetamol is relatively uniformly distributed throughout most body fluids and exhibits variable protein binding. Excretion is almost exclusively renal, in the form of conjugated metabolites.
Codeine phosphate is well absorbed after administration and distributes widely throughout the body. 85% of an oral dose is excreted in the urine within 24 hours, 40-70% of this being free or conjugated codeine, 5-15% free or conjugated morphine, 10-20% free or conjugated norcodeine, and trace amounts may be free or conjugated normorphine.
Caffeine is rapidly but irregularly absorbed after oral administration, absorption is pH-related. After an oral dose of 100 mg, peak plasma concentrations of 1.5-2 μg/ml are attained within 1-2 hours. Plasma half-life = 4-10 hours. Caffeine rapidly distributes throughout the body water, and is approximately 15% bound to plasma proteins. In 48 hours, 45% of a dose is excreted in the urine as l-methylxanthine and l-methyluric acid.
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
Maize Starch, Maize Starch Pregelatinised, Kollidon CL BASF, Colloidal Silicon Dioxide and Stearic Acid B.P.C
Not applicable.
Store below 30°C. Store in the original package.
White Opaque PVC/PVDC Blister Strip and Aluminium Foil
Packs of Fevadol Plus tablets contain 20 tablets.
Not applicable.
صورة المنتج على الرف
الصورة الاساسية
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