Document: leaflet MAH GENERIC_PL 00289-0574 change

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PAGE 1: FRONT FACE (INSIDE OF REEL)

BETAHISTINE DIHYDROCHLORIDE 8 mg AND 16 mg TABLETS

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

•    Betahistine Dihydrochloride will be referred to as Betahistine in this leaflet.

IN THIS LEAFLET:

1.    What Betahistine is and what it is used for

2.    Before you take Betahistine

3.    How to take Betahistine

4.    Possible side effects

5.    How to store Betahistine

6.    Further information

OWHAT BETAHISTINE IS AND WHAT IT IS USED FOR

Betahistine belongs to a group of drugs called histamine agonists. It improves blood flow in the inner ear therefore reducing the build up of pressure.

Betahistine is used to treat vertigo (a sensation that your surroundings are spinning either up and down or from side to side), tinnitus (ringing in the ear) and hearing loss caused by Meniere's syndrome, a condition that is thought to be caused by the pressure of excess fluid in the ear.

BEFORE YOU TAKE BETAHISTINE

Do NOT take Betahistine if you:

•    are allergic (hypersensitive) to betahistine hydrochloride or any of the other ingredients of this medicine (see section 6 for further details)

•    have a phaeochromocytoma (an adrenal gland tumour resulting in high blood pressure).

Take special care with Betahistine

Tell your doctor before you start to take this medicine if you:

•    have a history of stomach ulcers. Your doctor will monitor you closely during your treatment.

•    have asthma. Your doctor will monitor you closely during your treatment.

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.

Talk to your doctor if you are taking any of the following:

•    Anti-histamines (e.g. cetirizine) - these may (in theory) lower the effect of Betahistine. Also, Betahistine Tablets may lower the effect of anti-histamines.

•    Monoamine-oxidase inhibitors (MAOIs) - used to treat depression or Parkinson's disease. These may increase the level of Betahistine in the blood.

Pregnancy and breast-feeding

If you are pregnant, planning to become pregnant or breast-feeding, ask your doctor or pharmacist for advice before taking this medicine.

Do not breast-feed while using Betahistine unless instructed by your doctor. It is not known if Betahistine passes into breast milk.

Driving and using machines

Betahistine is not likely to affect your ability to drive or operate machinery, although the vertigo, tinnitus and hearing loss associated with Meniere's syndrome (for which you are, taking betahistine) can make you feel dizzy or be sick, and may affect your ability to drive or use machines. Make sure you know how this medicine affects you before you drive or operate machines. Important information about some of the ingredients of Betahistine Patients who are intolerant to lactose should note that Betahistine Tablets contain a small amount of lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

^ HOW TO TAKE BETAHISTINE

Always take Betahistine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The tablets should be swallowed preferably with a glass of water.

The usual dose is:

Adults (including the elderly):

The starting dose is 16 mg three times daily taken preferably with a meal. The usual maintenance dose is between 24 mg and 48 mg daily.

Children:

Betahistine is not recommended for use in children below 18 years.

If you take more Betahistine than you should

If you (or someone else) swallow a lot _B of the tablets all together or if you think a child has swallowed any of the tablets, contact your nearest hospital

_ casualty department or your doctor

immediately. Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.

If you forget to take Betahistine If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten dose. Take the remaining doses at the correct time.

If you stop taking Betahistine

Do not stop taking Betahistine without talking to your doctor first, even if you feel better.

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

POSSIBLE SIDE EFFECTS

Like all medicines, Betahistine can cause side effects, although not everybody gets them.

If the following happens, stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest hospital:

•    an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or hives).

This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.

Common side effects (at least 1 in 100 and less than 1 in 10 patients):

•    Nausea

•    Indigestion

•    Headache.

Other side effects

• Itching, skin rash, or hives (red and sometimes itchy bumps on your skin)

• Mild gastric complaints such as vomiting, stomach pain and bloating. Taking Betahistine with food can help reduce stomach problems.

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

HOW TO STORE BETAHISTINE

Keep out of the reach and sight of children.

Do not store above 25°C. Store in the original package. Do not transfer to another container. Do not use after the expiry date that is stated on the outer packaging. The expiry date refers to the last day of that month.

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.

^ FURTHER INFORMATION

What Betahistine Tablets contain:

•    The active ingredient is betahistine dihydrochloride

•    The other ingredients are povidone, microcrystalline cellulose (E460), lactose monohydrate, colloidal anhydrous silica, crospovidone and stearic acid (E570).

What Betahistine Tablets look like and

contents of the pack:

•    The Betahistine Tablets 8 mg are white to almost white, cylindrical, bi-plane tablets. They are imprinted with 'B8' on one side.

•    The Betahistine Tablets 16 mg are white to almost white, cylindrical, bi-plane tablets. They are imprinted with 'B16' on one side and scored on the reverse.

•    The Betahistine Tablets 8 mg are available in pack sizes of 84 and 120 tablets

•    The Betahistine Tablets 16 mg are available in pack sizes of 60 and 84 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation holder and company responsible for manufacture: TEVA UK Limited, Eastbourne, BN22 9AG.

This leaflet was last revised: January 2013

PL 00289/0573-0574    380823

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