BETASERC 16 MG 60 TAB; betahistine, antivertigo agents agents .
ACTIVE-INGREDIENT OF BETASERC 16 MG 60 TAB
Each tablet contains: 16 mg betahistine dihydrochloride.
INDICATION OF BETASERC 16 MG 60 TAB
Meniere’s Syndrome as defined by the following core symptoms: – vertigo (dizziness with nausea/vomiting). – hardness of hearing or hearing loss. – tinnitus (perseption of sound in the ear in the absence of corresponding external sound (e.g.ringing)).
DOSAGE OF BETASERC 16 MG 60 TAB
Follow all directions given to you by your pharmacist or doctor carefully . They may differ from the information contained in this leaflet
Ask your pharmacist or doctor for help if you do not understand the instructions on the box .
The recommended dose is : –
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 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. 1/2 – 1 tablet 3 times daily. – pediatric population : betaserc is not recommended for use in children under the age of 18 years due to insufficient data on safety and efficiacy . – geriatric population : although there are limited data from clinical studies in this patients group , extensive postmarketing experience suggests that no dose adjustment in necessary in this patient population . renal and or hepatic impairement : there are no speecific clinical trials available in this patient groups , but according to postmarketing experience no dose adjustment appears to be nessary .
OVER-DOSAGE OF BETASERC 16 MG 60 TAB
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.
CONTRA-INDICATION OF BETASERC 16 MG 60 TAB
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.
STORAGE OF BETASERC 16 MG 60 TAB
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 OF BETASERC 16 MG 60 TAB
Packages containing 60 tablets (16 mg) Per pack ( not all pack sizes may be marketed). The blisters (bubble packs) are made of PVC/PVDC and aluminum lidding foil.
BETASERC 16 MG 60 TAB MANUFACTURED BY
Abbott Healthcare SAS for ABBOTT HEALTHCARE PRODUCTS B.V., THE NETHERLANDS