Betahistine Dihydrochloride 8mg Tablets
Betahistine Dihydrochloride 8mg and 16mg Tablets
• Please read this leaflet carefully before you start to take your medicine.
• It gives you important information about your medicine.
• If you want to know more, or you are not sure about anything, ask your pharmacist or doctor.
• Keep the leaflet until you have finished the medicine.
WHAT'S IN YOUR MEDICINE
Betahistine dihydrochloride tablets come in two strengths. Each tablet contains either 8mg or 16mg of the active ingredient Betahistine dihydrochloride.
The tablets also contain: povidone, microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silica, crospovidone and stearic acid.
Betahistine dihydrochloride tablets are available in pack sizes of:
60, 84, 168*
only marketed pack size will appear
Your tablets are manufactured by Cardinel Health Germany 405 GmbH, Steinbeisstrasse 2, 73614 Schorndorf, Germany.
The Marketing Authorisation holder is Actavis, Barnstaple, EX32 8NS, UK.
ABOUT YOUR MEDICINE
Betahistine is one of a class of medicines known as ‘antivertigo preparations’. It works by improving blood flow to the inner ear, which reduces the build up of pressure. It is this pressure within the ear which is thought to cause the vertigo (dizziness), tinnitus (ringing in the ears) and hearing loss suffered by people with Meniere’s disease.
BEFORE TAKING YOUR MEDICINE
Do not take Betahistine dihydrochloride tablets if:
• you know, or have been told that you are hypersensative (allergic) to betahistine dihydrochloride or any of the ingredients of betahistine dihydrochloride tablets
• your doctor has told you that you have phaeochromocytoma (high blood pressure caused by an adrenal tumour)
• you are breast-feeding
Take special care with Betahistine dihydrochloride tablets if:
• you have a stomach ulcer (peptic ulcer), or have suffered from one in the past
• you have, or used to have, asthma
• you suffer from skin rashes
• you suffer from severe low blood pressure (fainting on standing/ light headedness/dizziness)
Please consult your doctor, even if these statements were applicable to you at any time in the past.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially:
• antihistamines (to relieve allergy symptoms)
Important information about some of the ingredients of Betahistine dihydrochloride tablets
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Pregnancy & Breast-feeding
Ask your doctor or pharmacist for advice before taking Betahistine dihydrochloride tablets.
Driving and using machines
Betahistine tablets may make you feel drowsy. Make sure you are not affected before you drive or operate machinery.
TAKING YOUR MEDICINE
Follow your doctor’s instructions.
Initial dosage: 16mg (one 16mg tablet or two 8mg tablets), 3 times daily.
Maintenance dose: The dose may be adjusted according to response to a maintenance dose of between 24 and 48mg daily, taken in three divided doses.
Children: Betahistine dihydrochloride tablets are not recommended for use in children aged under 18 years. Elderly: No adjustment in dosage is necessary.
Betahistine dihydrochloride tablets should be taken with a glass of water, preferably with food.
If you have the impression that the effect of the Betahistine dihydrochloride tablets is too strong or too weak, talk to your doctor or pharmacist.
Your doctor will tell you how long your treatment with Betahistine dihydrochloride tablets will last. Do not stop taking the tablets without consulting your doctor, even if you feel better.
If you take more Betahistine dihydrochloride tablets than you should:
Talk to a doctor or pharmacist immediately.
If you forget to take Betahistine dihydrochloride tablets:
If you forget to take a tablet, take it when you remember. If the next dose is almost due, do not take the missed tablet but carry on as normal with the next dose. Do not take a double dose to make up for individual doses.
POSSIBLE SIDE EFFECTS
Like all medicines, Betahistine dihydrochloride tablets can have side effects:
Contact your doctor immediately if you develop:
• An allergic reaction: swelling of the face, lips, tongue or throat, itchy skin rash, narrowing of the airways causing difficulty breathing or swallowing.
Tell your doctor as soon as possible if you notice any of the following:
Very common (occurring in more than 1 in 10 users):
• being sick, dry mouth, diarrhoea
Rare (occurring in less than 1 in 1,000 users):
• sleepiness, muscle weakness
• stomach upsets, feeling sick, indigestion
• quick or irregular heartbeat (palpitations)
Very rare (occurring in less than 1 in 10,000 users):
• skin rashes
• itching (pruritus)
• altered numbers of certain types of blood cells, you may notice that you bruise easily or have nose bleeds, increased numbers of enzymes seen in liver function tests.
Frequency not known (cannot be estimated by the data):
• headaches, drowsiness
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
STORING BETAHISTINE DIHYDROCHLORIDE TABLETS
Do not use the tablets after the expiry (use by) date shown on the product packaging. Keep the tablets stored below 25°C in a dry place and in the original packaging. KEEP THEM IN A SECURE PLACE WHERE CHILDREN CANNOT GET AT OR SEE THEM. REMEMBER, this medicine is for YOU only. NEVER give it to anyone else. It may harm them, even if their symptoms are the same as yours. Unless your doctor tells you to, do not keep medicines that you no longer need - give them back to your pharmacist for safe disposal.
Date of last revision: October 2012