Betaserc”
betahistine dihydrochloride
Read this entire leaflet carefully before you start taking this medicine.
Keep this leaflet. You may need to read it again. If you have questions not answered by this pamphlet, please ask your doctor
or pharmacist. This medicine has been prescribed to you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
Betaserc 8 mg:
is a round, flat, white tablet with beveled edges. The tablet is engraved with the number 256 on one side. This tablet is for oral
administration (to be taken by mouth) and contains 8mg of betahistine dihydrochloride
Betaserc 16 mg:
is a round, biconvex, scored, white tablet with beveled edges. The tablet is scored and the number 267 is engraved on either side of the
score line. This tablet is for oral administration (to be taken by mouth) and contains 16mg of betahistine dihydrochloride . The tablet can be divided into equal halves to create two doses of 8 mg each.
Betasere 24 mg:
is a round, biconvex, scored, white tablet with beveled edges. The tablet is scored and the number 289 is engraved on either side of the
score line. This tablet is for oral administration (to be taken by mouth) and contains 24mg of betahistine dihydrochloride
The 24 mg tablet can be divided into equal halves.
However, the purpose of the score line is only to facilitate breaking for ease of swallowing and does not divide the tablet into equal doses.
Excipients (non-medicinal ingredients):
Microcrystalline cellulose, mannitol (E421), citric acid monohydrate, colloidal anhydrous silica and talc.
Indications :
Meniere’s syndrome as defined by the following core symptoms:
⦁ vertigo (dizziness with nausea/vomiting) hardness of hearing or hearing loss
⦁ tinnitus (perception of sound in the ear in the absence of corresponding external sound (e.g. ringing)
Symptomatic treatment of vestibular vertigo
(feeling of dizziness, often with nausea and/or
vomiting, even when standing still).
Dosage and administration :
Always take Betaserc exactly as your doctor has prescribed. If you have any questions, contact your doctor or pharmacist.
If you forget to take your tablet(s), do not take a double dose to compensate for it. If you require further information, please ask your doctor or pharmacist for advice.
Betaserc 8 mg/16 mg/ 24mg :
The dosage for adults is 24-48 mg divided over the day.
8 mg tablets
1- 2 tablets 3 times daily
16 ma tablets 1/2 – 1 tablet 3 times daily
Betaserc 24mg :
The dosage for adults is 48mg divided over the day (one tablet twice daily). Your doctor will adjust the dosage according to your response to the medication. Be advised that improvement of symptoms may
take up to two weeks and that best results are sometimes obtained only after a few months. There are indications that treatment from the onset of the disease prevents its progression and/or the loss or
hearing in later phases of the disease.
Petfiafrlc populatron:
Betaserc is not recommended for use in children under the age of 18 years due to insufficient data on safety and efficacy.
Geriatric population:
Although there are limited data from clinical studies in this patient group, extensive postmarketing experience suggests that no do e adjustment is necessary in this patient population.
Renal and/or hepatic impairment:
There are no specific clinical trials available in these patient groups, but according to postmarketing experience no dose adjustment appears to be
Contraindications :
Do not take Betaserc if you are allergic (hypersensitive) to the active substance or to any of the excipients or if you suffer from an adrenal
gland tumor known as a phaeochromocytoma, Warnings and special precautions for use If you suffer from bronchial asthma or have a history of stomach (peptic) ulcer, your doctor will need to monitor you carefully while you are taking this medication.
Interactions with other medications :
Please tell your doctor or pharmacist if you are lacking or have recently taken any other medicines including medicines obtained without a prescription. No interaction studies on living subjects (in vivo) have been performed. Based on laboratory (in vitro) data, no inhibition of Cytochrome P450 enzymes is expected in living subject.
As betahistinc is similar in structure to Histamine, interaction of beta his tine with antihistamines may affect the efficacy of one of these drugs. Tell your doctor if you are taking an antihistamine before taking Betaserc.
Pregnancy and lactation :
Ask your doctor or pharmacist for advice before taking any medicine during pregnancy.
Pregnancy:
No enough information is available with regards to the use of Betaserc in pregnant women. Animal studies arc also insufficient with respect to effects on pregnancy, embryonal/foetal development, giving birth and postnatal development. The potential risk for human foetuses and newborns in this regard is unknown. Do not take Betaserc during pregnancy unless is it deemed absolutely necessary by your doctor.
Lactation:
It is not known whether betahistine is excreted in human milk. There are no animal studies on the excretion of betahistine in milk. You should not take Beiaserc if you are nursing. For further information, talk to your doctor regarding the importance of this
medicine to you, the benefits of nursing and the potential risks to your child.
Effects on ability to drive and use machines:
A shown in clinical studies, Betaserc is regarded to have no or negligible influence on the ability to drive and u e machines.
Undesirable effects :
Like all medicines, Betaserc may have side effects. If you notice any side effects not mentioned in this leaflet, or if any of the side effects get serious, please inform your doctor or pharmacist.
The following undesirable effects have been experienced with the below indicated frequencies in Betaserc-treated patients in placebo-controlled clinical trials: common (between 1 and 10 cases in 100 treated patients)
Gastrointestinal disorders :
Common: nausea and indigestion (dyspepsia)
Nervous system disorders :
Common: headache”
• The frequency of headache in placebo- treated patients (5.9% in a pool of 457 patients) was similar in comparison to Betaserc-treated patients (5.1 % in a pool of 468 patients).In addition to those events reported during clinical trials, the following undesirable effects have been reported spontaneously during posrmarketing use and in scientific literature. A frequency cannot be estimated from the available data and is therefore classified as “not known”.
Immune System disorders :
Allergic (hypersensitivity) reactions, including a serious allergic reaction (anaphylaxis) which can cause difficulty breathing, face and neck swelling and dizziness.
Gastrointestinal disorders :
Mild gastric complaints (e.g. vomiting, gastrointestinal pain, abdominal distension and bloating). These can normally be dealt with by taking the dose during meals or by lowering the dose.
Skin and subcutaneous tissue disorders :
Allergic reactions of the skin or tissues under the skin, in particular a sudden onset of face, neck or limb swelling (angioneurotic oedema), hives (urticaria), rash and itchiness (pruritus).
Overdose :
Symptoms of overdose :
A few overdose cases have been reported. Some patients experienced mild to moderate symptoms such as nausea, sleepiness and abdominal pain with doses up to 640 mg. More serious
complications including convulsions, and lung and heart complications were observed in cases of intentional overdose of Betaserc especially when taken in combination with other overdosed
drugs.
Treatment of overdose :
No specific antidote is known. Treatment of overdose should include standard supportive measures.
Pharmacodynamics :
Pharmacotherapeutic group: Anti-vertigo preparations.
The following is a detailed description of how the active ingredients of Betaserc work. For further explanations please consult your doctor.
The mechanism of action of betahistine is partly known. In biochemical studies, betahistine was found to have weak H1receptor agonistic and potent H3 antagonistic properties in both the central and autonomic nervous systems. Pharmacological testing in animals has shown that 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 found to have a dose dependent inhibitingeffect on spike generation of neurons in lateral and medial vestibular nuclei.
Betahistine accelerates the vestibular recovery after unilateral neurectomy, by promoting and facilitating central vestibular compensation; this effect, characterized by an up-regulation of histamine turnover and release, is mediated through H3 Receptor antagonism.
Taken together these properties contribute to the beneficial therapeutic effects seen with regard to Meniere’s disease and vestibular vertigo.
Betahistine increases histamine turnover and release by blocking presynaptic H3-receptors and inducing Hs-receptordownregulation. This effect provides explanation for the efficacy of betahistine in the treatment of vertigo and vestibular diseases.
Pharmacokinetics :
The following is a detailed description of how the active ingredients of Betaserc are metabolized by the body. For further explanations please consult your doctor.
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-PAA (which has no pharmacological
pharrnacokinetic analyses are therefore based on 2-PAA measurements in plasma and urine. The plasma concentration of 2-PAA reaches its maximum 1 hour after intake. The half-life is
approximately 3.5 hours. 2-PAA is readily excreted in the urine. In the dose range of 8 to 48 mg. about 85% of the original dose is excreted in the urine.
Renal or fecal excretion of betahistine itself is of minor importance.
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. Under fed conditions Cm3x 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.
Incompatibilities :
Not applicable.
Shelf life and storage conditions :
3 years, do not store above 30°C.
Store in the original package in order to protect from light.
Do not use the medicine after the expiry date stated on carton.
Keep this medicine out of the reach and sight of children.
Pack sizes:
Betaserc Bmg tablets are supplied in packages containing: 10,20,30,50,60,90, 100, 120,500 or 1 tablets).
Betaserc 16mg tablets are supplied in packages:containing 10. 14. 15, 20, 28, 30, 40, 50. 56, 60, 100,200. 300. 400 or 500 tablets.
Betaserc 24mg tablets are supplied in packages: 10, 20. 30. 40, 50, 60 or 100 tablets (24 mg) per pack (Not all pack sizes may be marketed).
The blisters (bubble packs) are made of PVC/PVDC and aluminum lidding foil.
Further information
Any unused product or waste material should be disposed of in accordance with local requirements.
The information in this leaflet is limited. For further information, please contact your doctor or pharmacist.
Manufactured by :
Mylan laboratories sas chalaronne france
