PACKAGE LEAFLET: INFORMATION FOR THE USER

Betahistine Dihydrochloride 8 mg Tablets Betahistine Dihydrochloride 16 mg Tablets

Read all of this leaflet carefully before you start taking this medicine.

-    Keep this leaflet. You may need to read it again.

-    If you have any further questions, ask your doctor or pharmacist.

-    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

-    If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

THIS LEAFLET CONTAINS

1.    What Betahistine Dihydrochloride is for

2.    Before you take Betahistine Dihydrochloride Tablets

3.    How to take Betahistine Dihydrochloride Tablets

4.    Possible side effects

5.    How to store Betahistine Dihydrochloride Tablets

6.    Further information

1.    WHAT BETAHISTINE DIHYDROCHLORIDE IS FOR

Betahistine dihydrochloride is a medicine that is used to treat symptoms of Meniere's syndrome, such as dizziness, ringing in the ears, loss of hearing and nausea.

2.    BEFORE YOU TAKE BETAHISTINE DIHYDROCHLORIDE TABLETS Do not take Betahistine Dihydrochloride Tablets

•    If you are allergic (hypersensitive) to BETAHISTINE dihydrochloride or to any of the other components of the tablet (see also section 6 'Further information')

•    If you have a phaeochromocytoma, a rare tumour of the adrenal gland

Take special care with Betahistine Dihydrochloride Tablets

•    If you suffer or if you have suffered from a stomach ulcer (peptic ulcer)

•    If you have asthma

•    If you have low blood pressure

If you suffer from any of the above conditions, consult your doctor about whether you may take Betahistine Dihydrochloride Tablets. These groups of patients should be monitored by a doctor during treatment.

Taking other medicines

An interaction means that the medicines or substances can affect the way each other works or the side effects when both are being taken at the same time. So far no interactions of Betahistine dihydrochloride with other medicines have been observed.

It is possible that Betahistine dihydrochloride may influence the effect of antihistamines. Antihistamines are medicines that are used in particular for the treatment of allergies such as hay fever and for car sickness. Consult your doctor or pharmacist if you are using antihistamines (medicines against allergies) at the same time.

Inform your doctor or your pharmacist if you are using (or have recently used) other medicines. This also applies for other medicines that are available without prescription.

Pregnancy and breast-feeding

There is insufficient data on the use of Betahistine dihydrochloride during pregnancy and breast-feeding. If you are pregnant or breast-feeding, do not use Betahistine dihydrochloride without consulting your doctor first.

Driving and using machines

Betahistine dihydrochloride has no known effect on the ability to drive or use machinery.

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.

3.    HOW TO TAKE BETAHISTINE DIHYDROCHLORIDE TABLETS

Always take Betahistine Dihydrochloride Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual dose is:

Adults:

The usual starting dose is one to two 8 mg tablets or a half to one 16 mg tablet three times a day. The maintenance dose is usually in the range of 24-48 mg daily. It may take a couple of weeks before you notice any improvement.

The duration of treatment required will differ for everyone.

Use of Betahistine dihydrochloride in children and young adults under the age of 18 years is not recommended.

A dosage adjustment in the elderly is not necessary.

Patients with impaired liver function or renal impairment do not require a dosage adjustment.

How to use

Betahistine dihydrochloride can be taken with water or another liquid. Choose a fixed time to take your medicine to give a regular effect and prevent forgetting to take it. You should take Betahistine dihydrochloride in the morning, afternoon and evening. If you experience stomach complaints, then it may be preferable to take Betahistine dihydrochloride with meals.

If you take more Betahistine Dihydrochloride Tablets than you should

If you have taken more than the prescribed dose, consult your doctor. The symptoms of a betahistine overdose are nausea, vomiting, digestion problems, coordination problems and with higher doses - fits.

If you forget to take Betahistine Dihydrochloride Tablets

Wait until you have to take your next dose. Do not take a double dose to make up for a forgotten tablet.

Do not stop treatment without consulting your doctor

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Betahistine dihydrochloride can cause side effects, although not everybody gets them. The following side effects may occur:

Immune system: allergic reactions, shock

Nervous system: headaches (common; affecting more than 1 in 100, but less than 1 in 10 patients)

Gastrointestinal tract: nausea and indigestion (common; affecting more than 1 in 100, but less than 1 in 10 patients)

In some patients, the use of Betahistine dihydrochloride can lead to mild stomach complaints. In this case, Betahistine dihydrochloride should be taken with meals. If this does not help, please contact your doctor. If necessary, the dosage may be reduced.

Skin: hypersensitivity reactions such as swelling of the skin and mucous membranes of the face, hands or feet, rash, itching, hives

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5.    HOWTO STORE BETAHISTINE DIHYDROCHLORIDE TABLETS

Keep out of the reach and sight of children.

Do not use Betahistine Dihydrochloride Tablets after the expiry date which is stated on the box after 'Exp'.

Store Betahistine Dihydrochloride Tablets in the original package and keep the blister in the outer carton in order to protect from light and moisture. Betahistine Dihydrochloride Tablets do not require any special temperature storage conditions.

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.

6.    FURTHER INFORMATION

What Betahistine Dihydrochloride Tablets contain

The active substance is betahistine dihydrochloride.

One tablet contains 8 mg betahistine dihydrochloride or one tablet contains 16 mg betahistine dihydrochloride.

The other ingredients are povidone, microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silica, crospovidone and stearic acid.

What Betahistine Dihydrochloride Tablets look like and contents of the pack

Betahistine Dihydrochloride 8mg Tablets: a round, white tablet with the inscription 'B8' on one side. Tablets in blister strips; 30, 50, 84, 100 or 120 tablets in a cardboard box.

Betahistine Dihydrochloride 16mg Tablets: a round, white tablet with the inscription 'B16' on one side and a break groove on the other. The tablet can be divided into equal halves. Tablets in blister strips; 20, 30,42, 50, 60 or 84 tablets in a cardboard box.

Not all pack sizes may be marketed.

Marketing Authorisation Holder;

Activase Pharmaceuticals Limited, 11 Boumpoulinas Street, 1060 Nicosa, Cyprus Manufacturers:

DDSA Pharmaceuticals Limited, 310 Old Brompton Road, London, SW5 9JQ

For more information about this product, please contact the Marketing Authorisation Holder.

This leaflet was last revised in 08/2012