Pharmacy
/ Betaserc
Read this entire leaflet carefully before you start taking this medicine.
Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or pharmacist. This medicine has been prescribed for 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 and the insignia engraved on one side. The other side is engraved with the number 256.This tablet is for oral administration (to be taken by mouth) and contains 8 mg of betahistine dihydrochloride.
Betaserc 16 mg is a round, biconvex, scored, white tablet with beveled edges and the insignia engraved on one side. On the other side, 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 16 mg of betahistine dihydrochloride. The tablet can be divided into equal halves.
Betaserc 24 mg is a round, biconvex, scored, white tablet with beveled edges and the insignia engraved on one side. On the other side, 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 24 mg of betahistine dihydrochloride. The tablet can be divided into equal halves.
Excipients (non-medicinal ingredients): Microcrystalline
cellulose, mannitol (E421), citric acid monohydrate, colloidal anhydrous silica and talc.
Indications
Ménière's Syndrome as defined by the following core symptoms:
• vertigo (with nausea/vomiting)
• hearing loss (hardness of hearing)
• tinnitus (ringing in the ears)
Symptomatic treatment of vestibular vertigo.
Dosage and administration
Always take Betaserc exactly as your doctor has prescribed. If you have any questions, you should check with 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.
The dosage for adults is 24-48 mg divided over the day.
Your doctor will adjust the dosage according to your response to the medication. Improvement of symptoms may take up to two weeks and the 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 of hearing in later phases of the disease.
Pediatric population:
Betaserc is not recommended for use in children under the age of 18 years due to insufficient data on safety and efficacy.
Contraindications
Do not take Betaserc if you are hypersensitive to the active substance or to any of the excipients.
Warnings and special precautions for use
If you suffer from a phaeochromocytoma or bronchial asthma, your doctor will need to monitor you carefully while you are taking this medication. Furthermore, please inform your doctor or pharmacist if you have a history of peptic ulcer before taking this medication.
Interactions with other medications
No in vivo interaction studies have been performed. Based on in vitro data, no in vivo inhibition on Cytochrome P450 enzymes is expected.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without a prescription.
Pregnancy and lactation
Ask your doctor or pharmacist for advice before taking any medicine during pregnancy.
Pregnancy:
There is no adequate data for the use of betahistine in pregnant women. Animal studies are insufficient with respect to effects on pregnancy, embryonal/foetal development, parturition (giving birth) and postnatal development. The potential risk for humans in this regard is unknown. Betahistine should not be used during pregnancy unless is it deemed 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. It is recommended not to take any medication while nursing. However if you are nursing, 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
Betahistine is regarded to have no or negligible effects on the ability to drive and use machines as no effects potentially influencing this ability were found to be related to betahistine in clinical studies.
Important information about the ingredients
This product contains mannitol, which may have a mild laxative effect.
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.
Undesirable Effects by System Organ Class:
Immune System disorders
Hypersensitivity (allergic) reactions (such as anaphylaxis) have been reported.
Gastrointestinal disorders
In some cases mild gastric complaints have been observed. These can normally be dealt with by taking the dose during meals or by lowering the dose.
Skin and subcutaneous tissue disorders
In very rare cases cutaneous (skin) hypersensitivity reactions have been reported, in particular angioneurotic oedema (sudden onset of face, neck or limb swelling), urticaria (hives), rash and pruritus (itchiness).
Overdose
Symptoms of overdose
A few overdose cases have been reported. Some patients experienced mild to moderate symptoms such as nausea, somnolence (sleepiness) and abdominal pain with doses up to 640 mg.
More serious complications including convulsions, and pulmonary and cardiac 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 mechanism of action of betahistine is partly known. In biochemical studies, betahistine was found to have weak H1 receptor agonistic and potent H3 antagonistic properties in both the central and
autonomic nervous systems. 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 found to have a dose dependent inhibiting effect on spike generation of neurons in lateral and media 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 Ménière's disease and vestibular vertigo.
Betahistine increases histamine turnover and release by blocking presynaptic H3-receptors and inducing H3-receptor downregulation. This effect provides explanation for the efficacy of betahistine in the treatment of vertigo and vestibular diseases.
Pharmacokinetics
Orally administered betahistine is readily and almost completely absorbed from all parts of the gastrointestinal tract. After absorption, the drug is rapidly and almost completely metabolized into 2-PAA (which has no pharmacological activity). Plasma levels of betahistine are very low (i.e., below the detection limit of 100 pg/ml). All pharmacokinetic analyses are therefore based on 2-PAA measurements in plasma and urine.
The plasma concentration of 2-PAA reaches a 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 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.
Incompatibilities
Not applicable
Shelf life and storage conditions
5 years, do not store above 25°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 tablets are supplied in packages containing 10, 20, 30, 50, 60, 90, 100, 120, 500 or 1000 tablets (8 mg), 10, 14, 15, 20, 28, 30, 40, 50, 56, 60, 100, 200, 300, 400 or 500 tablets (16 mg) or 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.
Date of information
July 20, 2007
Manufactured by
SOLVAY PHARMACEUTICALS
01400 Châtillon-sur-Chalaronne
FRANCE
for
SOLVAY PHARMACEUTICALS B.V.
THE NETHERLANDS
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