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VEROTEC contains betahistine. This medicine is called a histamine analoge. it is used to treat:
□ Dizziness (vertigo)
□ Ringing in the ears (tinnitus)
□ Hearing loss suffered by people with Ménière’s disease
This medicine works by improving blood flow in the inner ear. This lowers the build up of pressure.
Do not take VEROTEC:
□ If you are allergic to Betahistine dihydrochloride or any of the ingredients in the tablets (see section 6 for further details)
□ If you have high blood pressure due to an adrenal tumor (phaeochromocytoma).
If any of the above applies to you, do not take this medicine and talk to your doctor.
Take special care with VEROTEC:
Tell your doctor if you:
□ Have a stomach ulcer □ Have asthma
□ Are pregnant or planning to become pregnant
□ Are breast-feeding
If any of the above applies to you, talk to your doctor before taking this medicine.
Your doctor will tell you whether it is safe for you to start taking this medicine.
Your doctor may also want to monitor your asthma while you take VEROTEC.
Taking other medicines with VEROTEC:
Please tell your doctor or pharmacist if you are taking or have taken any other medicines, including medicines obtained without a prescription. This includes herbal medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
□ Anti-histamines - these may (in theory) lower the effect of VEROTEC. Also, VEROTEC may lower the effect of anti-histamines.
□ Monoamine-oxidase inhibitors (MAOIs) - used to treat depression or Parkinson’s disease. These may increase the exposure of VEROTEC.
Taking VEROTEC with food and drink:
You can take VEROTEC with or without food.
Pregnancy and breastfeeding:
Pregnancy
Do not take VEROTEC if you are pregnant unless your doctor has decided that it is absolutely necessary. Ask your doctor for advice.
Breast-feeding
Do not breast-feed while using VEROTEC unless instructed by your doctor. It is not known if VEROTEC passes into breast milk.
Driving and using machines:
VEROTEC is not likely to affect your ability to drive or use tools or machinery. However, remeber that diseases for which you are being treated with VEROTEC (vertigo, tinnitus and hearing loss associated with Ménière’s syndrome) can make you feel dizzy or be sick, and can affect your ability to drive or use machines.
Swallow the tablets with water.
□ Preferably take the tablet with a meal.
How much VEROTEC to take:
Always follow your doctor’s instructions because your doctor might adjust your dose.
□ VEROTEC is available in three strengths, an 8 mg tablet, 16 mg tablet and 24 mg tablet.
□ The usual starting dose is 16 mg three times a day (48 mg).
□ Your doctor may lower your dose to 8 mg three times a day (24 mg).
Keep taking your tablets. The tablets can take a while to start to work.
VEROTEC is not recommended for those under 18 years old.
How to stop taking VEROTEC:
Keep taking your tablets until your doctor tells you to stop. Even when you start feeling better, your doctor may want you to carry on taking the tablets for some time to make sure that the medicine has worked completely.
If you take more VEROTEC than you should:
If you or someone else takes too much VEROTEC (an overdose), talk to a doctor or go to a hospital straight away. Take the medicine pack with you.
If you forget to take VEROTEC:
If you miss a tablet, wait until the next dose is due. Do not try to make up for the dose you have missed. If you have any further questions on the use of this product, ask your doctor or pharmacist
Like all medicines, VEROTEC can cause side effects, although not everybody gets them. It is important that you are aware of what these side effects may be.
The following serious side effects may occur during treatment with VEROTEC:
Allergic reactions such as:
□ Swelling of your face, lips, tongue or neck. This may cause difficulty breathing.
□ A red skin rash, inflamed itchy skin
If any of these side effects occur you should stop treatment immediately and contact your doctor.
Common side effect (at least 1 in 100 and less than1 in 10 patients):
□ Nausea □ Indigestion □ Headache
Other side effects:
□ Itching □ Rash □ Hives
□ Mild gastric pain and bloating. Taking VEROTEC with food can help reduce any stomach problems.
Keep out of the reach and sight of children.
□ Do not store above 30 °C.
□ Do not use VEROTEC after the expiry date which is stated on the carton and on the blister, after (EXP).
□ 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 Betahistine Dihydrochloride . Each VEROTEC 8, 16 and 24 tablets contains 8 mg, 16 mg and 24 mg respectively of Betahistine Dihydrochloride.
□ The other ingredients are: microcrystalline cellulose 50 micrometer, mannitol, colloidal anhydrous silica, anhydrous citric acid, purified talc.
he Jordanian pharmaceutical manufacturing company.
P.O. BOX 151, Um Al-Amad 16197, Jordan
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
يحتوي ﭭيروتيك على بيتاهستين. هذا الدواء يسمى بنظير الهيستامين. يستخدم هذا الدواء لمعالجة:
□ الدوخة
□ طنين الأذن
□ فقدان السمع الذي يعاني منه الأشخاص المصابين بمرض مينيير
هذا الدواء يعمل عن طريق تحسين جريان الدم في الأذن الداخلية وهذا يساعد على التقليل من تراكم الضغط.
موانع استعمال ﭭيروتيك:
□ إذا كنت تعاني من حساسية لبيتاهستين دايهايدروكلورايد أو لأي من مكونات ﭭيروتيك الأخرى (انظر القسم 6).
□ إذا كنت تعاني ارتفاع ضغط الدم بسبب ورم في الغدة الكظرية (ورم القواتم).
إذا كان أي من المذكورة أعلاه ينطبق عليك، فلا تتناول الدواء وتحدث مع طبيبك.
الاحتياطات عند استعمال ﭭيروتيك:
أخبر طبيبك إذا كنت:
□ تعاني قرحة في المعدة.
□ تعاني من الربو.
□ حاملا أو تخططي للإنجاب.
□ مرضعة.
إذا كان أي من المذكور أعلاه ينطبق عليك، تحدث مع طبيبك قبل تناول الدواء.
سوف يخبرك طبيبك ما إذا كان آمناً بالنسبة لك البدء بتناول هذا الدواء.
قد يحتاج طبيبك أيضاً لمراقبة الربو لديك أثناء تناول ﭭيروتيك.
تناول أدوية أخرى مع ﭭيروتيك:
أخبر طبيبك أو الصيدلاني إذا كنت تستخدم أواستخدمت موخراً أي أدوية أخرى، بما في ذلك الأدوية التي تم الحصول عليها دون وصفة طبية. وهذا يشمل الأدوية العشبية.
أخبر طبيبك إذا كنت تستخدم أي من الأدوية التالية، على وجه الخصوص:
□ مضادات الهستامين وهي تقلل من تأثير ﭭيروتيك (نظرياً). وأيضاً قد يقلل ﭭيروتيك من تأثير مضادات الهيستامين.
□ مثبطات أكسيداز أحادي الأمين - يستخدم لمعالجة الاكتئاب أو داء باركنسون . وهذه قد تزيد من التعرض لڨيروتيك.
تناول ﭭيروتيك مع الطعام والشراب:
من الممكن تناول ﭭيروتيك مع أو بدون الطعام.
الحمل والإرضاع:
الحمل:
لاتتناولي ﭭيروتيك إذا كنتي حاملاً ما لم يقرر طبيبك بأنه من الضروي تماماً استخدامه. اسألي طبيبك للحصول على المشورة.
الرضاعة:
لاينصح باستخدام ﭭيروتيك للأمهات المرضعات ما لم يقرر طبيبك بأنه من الضروي تماماً استخدامه. لم يثبت بعد إذا كان ﭭيروتيك يتم إفرازه مع الحليب أم لا.
تأثير المستحضر على القيادة واستخدام الآلات:
من غير المحتمل أن يؤثر ﭭيروتيك على قدرتك على القيادة أو استخدام الأدوات أو الآلات. ومع ذلك، تذكر أن الأمراض التي يتم علاجك منها باستخدام ﭭيروتيك (الدوار، طنين الأذن وفقدان السمع المرتبط بمتلازمة مينيير) يمكن أن تجعلك تشعر بالدوار أو المرض، ويمكن أن تؤثر على قدرتك على القيادة أو استخدام الآلات.
□ ابتلع الأقراص مع الماء.
□ يفضل تناول القرص مع الوجبة.
كم يجب أن تأخذ من ﭭيروتيك:
اتبع دائماً تعليمات طبيبك، لأن طبيبك قد يضبط لك الجرعة.
□ يتوفر ﭭيروتيك بثلاثة عيارات، أقراص 8 ملغم، أقراص 16 ملغم وأقراص 24 ملغم.
□ جرعة البدء الاعتيادية هي 16 ملغم ثلاث مرات يومياً (48 ملغم).
□ قد يقلل لك طبيبك الجرعة إلى 8 ملغم ثلاث مرات يومياً (24 ملغم).
عليك الاستمرار في تناول دوائك. قد يستغرق الدواء بعض الوقت للبدء في العمل.
لا ينصح باستخدام ﭭيروتيك لمن هم دون 18 عاماً.
كيفية التوقف عن تناول ﭭيروتيك:
استمر بتناول الأقراص إلى حين يخبرك طبيبك بإيقاف تناولها.
حتى لو بدأت تشعر بالتحسن، فقد يرغب طبيبك بالاستمرار بتناول الأقراص لبعض الوقت، للتأكد من أن الدواء يعمل بشكل كامل.
الجرعة الزائدة من ﭭيروتيك:
اذا تناولت أنت أو شخص كمية كبيرة من ﭭيروتيك، عليك التحدث إلى طبيبك أو الذهاب إلى المستشفى مباشرة. عليك أن تأخذ علبة الدواء معك.
نسيان تناول ﭭيروتيك:
إذا نسيت تناول القرص، انتظر حتى الجرعة التالية المقررة. لا تحاول تعويض الجرعة التي نسيتها.
إذا كانت لديك أي أسئلة أخرى حول استخدام هذا المستحضر، اسأل طبيبك أو الصيدلاني.
كغيره من الأدوية، فقد يسبب ﭭيروتيك أعراضاً جانبيةً، بالرغم من أنها لاتحدث للجميع. لذلك من المهم أن تكون على علم بهذه الأعرض الجانبية.
قد تحدث الأعراض الجانبية التالية أثناء المعالجة باستخدام ﭭيروتيك:
تفاعلات الحساسية مثل:
□ تورم الوجه أو الشفاه أو اللسان أو الرقبة. وقد يؤدي ذلك إلى صعوبة في التنفس.
□ طفح جلدي أحمر، جلد ملتهب وحكة.
إذا حدثت لك أياً من هذه الأعراض الجانبية، فإنه يجب وقف المعالجة مباشرةً والاتصال بطبيبك.
الأعراض الجانبية الشائعة (على الأقل مريض واحد من 100 مريض و أقل من مريض واحد من 10مرضى):
□ غثيان □ عسر الهضم □ صداع
الأعراض الجانبية الأخرى تشمل:
□ حكة □ طفح جلدي □ شرى
□ ألم معتدل في المعدة وانتفاخ. تناول ﭭيروتيك مع الطعام قد يساعد في تقليل مشاكل المعدة.
□ يحفظ بعيداً عن متناول الأطفال.
□ لا يحفظ بدرجة حرارة أعلى من 30°م.
□لا ينبغي استعمال ﭭيروتيك 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 الإجراءات على حماية البيئة.
المادة الفعالة هي بيتاهستين دايهايدروكلورايد. كل قرص من أقراص ﭭيروتيك 8، 16 و24 يحتوي على 8، 16 و 24 ملغم على التوالي من بيتاهستين دايهايدروكلورايد.
□ المكونات الأخرى هي: سلولوز بلوري مكروي 50 ميكروميتر، منيتول، سيليكاغروية لامائية، حمض الستريك اللامائي، تلك نقي.
أقراص ﭭيروتيك 8 هي أقراص سكرية دائرية اللون ضحلة ثنائية التحدب منقوش عليها “H1“ من جانب واحد و غير منقوشة من الجانب الآخر.
□ أقراص ﭭيروتيك 16 هي أقراص سكرية دائرية اللون ضحلة ثنائية التحدب منقوش عليها “H2“ من جانب واحد وحز للكسر من الجانب الآخر.
□ أقراص ﭭيروتيك 24 هي أقراص سكرية دائرية اللون ضحلة ثنائية التحدب منقوش عليها “H3“ من جانب واحد و غير منقوشة من الجانب الآخر.
□ علب تحتوي على 60 قرص من أقراص ﭭيروتيك 8 المحفوظة في أشرطة.
□ علب تحتوي على 50 قرص من أقراص ﭭيروتيك 16 المحفوظة في أشرطة.
□ علب تحتوي على 50 قرص من أقراص ﭭيروتيك 24 المحفوظة في أشرطة.
الشركة الأردنية لإنتاج الأدوية.
ص.ب. 151- أم العمد 16197- الأردن.
المملكة العربية السعودية: للإبلاغ عن الأعراض الجانبية: المركزالوطني للتيقظ:
فاكس: 00966112057662، مركز اتصال الهيئة العامة للغذاء والدواء (SFDA):19999، البريد الإلكتروني: npc.drug@sfda.gov.sa، الموقع الإلكتروني: https://ade.sfda.gov.sa
Vertigo, tinnitus and hearing loss associated with Ménière's syndrome
Route of administration: Oral
1-1-1 Usual adult dose (including the elderly):
Initially 16 mg three times daily taken preferably with meals. Maintenance doses are generally in the range 24-48 mg daily.
1-1-2 Paediatric population:
Not recommended for use in children below 18 years due to insufficient data on safety and efficacy.
1-1-3 Geriatric population:
Although there are limited data from clinical studies in this patient group, extensive post-marketing experience suggests that no dose adjustment is necessary in this patient population.
1-1-4 Renal impairment:
There are no specific clinical studies available in this patient group, but according to post-marketing experience no dose adjustment appears to be necessary.
1-1-5 Hepatic impairment:
There are no specific clinical studies available in this patient group, but according to post-marketing experience no dose adjustment appears to be necessary
q Caution is advised in the treatment of patients with a history of peptic ulcer.
q Clinical intolerance to VEROTEC in bronchial asthma patients has been shown in a relatively few patients.
These patients need to be carefully monitored during the therapy.
q No in-vivo interaction studies have been performed. Based on in-vitro data no in-vivo inhibition on Cytochrome P450 enzymes is expected.
q In vitro data indicate an inhibition of Betahistine metabolism by drugs that inhibit monoamino-oxidase (MAO) including MAO subtype B (e.g. selegiline). Caution is recommended when using Betahistine and MAO inhibitors (including MAO-B selective) concomitantly.
q As Betahistine is an analogue of histamine, interaction of Betahistine with antihistamines may in theory affect the efficacy of one of these drugs.
There are no adequate data from the use of Betahistine in pregnant women.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity at clinically relevant therapeutic exposure. As a precautionary measure, it is preferable to avoid the use of betahistine during pregnancy.
1-1-1 Use during lactation
It is not known whether Betahistine is excreted in human milk. Betahistine is excreted in rat milk. Effects seen post-partum in animal studies were limited to very high doses. The importance of the drug to the mother should be weighed against the benefits of nursing and the potential risks for the child.
1-1-2 Fertility
Animal studies did not show effects on fertility in rats.
Vertigo, tinnitus and hearing loss associated with Ménière’s syndrome can negatively affect the ability to drive and use machines. In clinical studies specifically designed to investigate the ability to drive and use machines betahistine had no or negligible effects.
The following undesirable effects have been experienced with the below indicated frequencies in betahistine treated patients in placebo controlled trials [very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10,000)].
q Gastrointestinal disorders
Common: nausea and dyspepsia
q Nervous system disorders
Common: Headache
In addition to those events reported during clinical trials, the following undesirable effects have been reported spontaneously during post-marketing use and in scientific literature. A frequency cannot be estimated from the available data and is therefore classified as “not known”.
q Immune System disorders
Hypersensitivity reactions, e.g. anaphylaxis have been reported.
q Gastrointestinal disorders
Mild gastric complaints (e.g. vomiting, gastrointestinal pain, abdominal distension and bloating) have been observed. These can normally be dealt with by taking the dose during meals or by lowering the dose.
q Skin and subcutaneous tissue disorders
Cutaneous and subcutaneous hypersensitivity reactions have been reported, in particular angioneurotic oedema, urticaria, rash, and pruritus.
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
The following undesirable effects have been experienced with the below indicated frequencies in betahistine treated patients in placebo controlled trials [very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10,000)].
q Gastrointestinal disorders
Common: nausea and dyspepsia
q Nervous system disorders
Common: Headache
In addition to those events reported during clinical trials, the following undesirable effects have been reported spontaneously during post-marketing use and in scientific literature. A frequency cannot be estimated from the available data and is therefore classified as “not known”.
q Immune System disorders
Hypersensitivity reactions, e.g. anaphylaxis have been reported.
q Gastrointestinal disorders
Mild gastric complaints (e.g. vomiting, gastrointestinal pain, abdominal distension and bloating) have been observed. These can normally be dealt with by taking the dose during meals or by lowering the dose.
q Skin and subcutaneous tissue disorders
Cutaneous and subcutaneous hypersensitivity reactions have been reported, in particular angioneurotic oedema, urticaria, rash, and pruritus.
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
Pharmacotherapeutic group: antivertigo preparation
ATC code: N07C A01
The mechanism of action of betahistine is only partly understood. There are several plausible hypotheses that are supported by animal studies and human data:
• Betahistine affects the histaminergic system:
Betahistine acts both as a partial histamine H1-receptor agonist and histamine H3-receptor antagonist also in neuronal tissue, and has negligible H2-receptor activity. Betahistine increases histamine turnover and release by blocking presynaptic H3-receptors and inducing H3-receptor downregulation.
• Betahistine may increase blood flow to the cochlear region as well as to the whole brain:
Pharmacological testing in animals has shown that the blood circulation in the striae vascularis of the inner ear improves, probably by means of a relaxation of the precapillary sphincters of the microcirculation of the inner ear. Betahistine was also shown to increase cerebral blood flow in humans.
• Betahistine facilitates vestibular compensation:
Betahistine accelerates the vestibular recovery after unilateral neurectomy in animals, by promoting and facilitating central vestibular compensation; this effect characterized by an up-regulation of histamine turnover and release, is mediated via the H3 Receptor antagonism. In human subjects, recovery time after vestibular neurectomy was also reduced when treated with betahistine.
• Betahistine alters neuronal firing in the vestibular nuclei:
Betahistine was also found to have a dose dependent inhibiting effect on spike generation of neurons in lateral and medial vestibular nuclei.
The pharmacodynamic properties as demonstrated in animals may contribute to the therapeutic benefit of betahistine in the vestibular system.
The efficacy of betahistine was shown in studies in patients with vestibular vertigo and with Ménière's disease as was demonstrated by improvements in severity and frequency of vertigo attacks.
Absorption:
Orally administered betahistine is readily and almost completely absorbed from all parts of the gastro-intestinal tract. After absorption, the drug is rapidly and almost completely metabolized into 2-pyridylacetic acid. Plasma levels of betahistine are very low. Pharmacokinetic analyses are therefore based on 2-PAA measurements in plasma and urine.
Under fed conditions Cmax is lower compared to fasted conditions. However, total absorption of betahistine is similar under both conditions, indicating that food intake only slows down the absorption of betahistine.
Distribution:
The percentage of betahistine that is bound by blood plasma proteins is less than 5 %.
Biotransformation:
After absorption, betahistine is rapidly and almost completely metabolized into 2-PAA (which has no pharmacological activity).
After oral administration of betahistine the plasma (and urinary) concentration of 2-PAA reaches its maximum 1 hour after intake and declines with a half-life of about 3.5 hours.
Excretion:
2-PAA is readily excreted in the urine. In the dose range between 8 and 48 mg, about 85% of the original dose is recovered in the urine. Renal or faecal excretion of betahistine itself is of minor importance.
Linearity:
Recovery rates are constant over the oral dose range of 8 – 48 mg indicating that the pharmacokinetics of betahistine are linear, and suggesting that the involved metabolic pathway is not saturated.
Chronic toxicity
Adverse effects in the nervous system were seen in dogs and baboons after intravenous doses at and above 120 mg/kg.
Chronic oral toxicity testing for 18 months in rats at a dose of 500 mg/kg and 6 months in dogs at a dose of 25 mg/kg showed betahistine to be well tolerated with no definitive toxicities.
Mutagenic and carcinogenic potential
Betahistine does not have mutagenic potential.
In an 18 months’ chronic toxicity study in rats betahistine up to a dose of 500 mg/kg did not show any evidence for carcinogenic potential.
Reproduction toxicity
Effects in reproductive toxicity studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
q Microcrystalline Cellulose 50 micrometer
q Mannitol
q Colloidal Anhydrous Silica
q Anhydrous Citric Acid
q Purified Talc.
Not applicable.
Do not store above 30°C
VEROTEC 8 Tablets are packed in boxes of 60 Tablets blistered in PVC/PE/PVDC (90)/Aluminium Foil blisters.
No special requirements.
Any unused product or waste material should be disposed of in
accordance with local requirements.
