Patient leaflet - Betahistine Dihydrochloride 8 mg tablets

1. WHAT BETAHISTINE TABLETS ARE AND WHAT THEY ARE USED FOR

The name of your medicine is Betahistine Dihydrochloride Tablets. It is called Betahistine Tablets in the rest of the leaflet. Betahistine belongs to a group of medicines known as histamine analogues. It is used to treat:

Dizziness (vertigo)

Ringing in the ears (tinnitus)

Hearing loss suffered by people with Ménière’s disease

This medicine works by improving blood flow in the inner ear. This lowers build up of pressure.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BETAHISTINE TABLETS

Do not take this medicine and tell your doctor if:

You are allergic to betahistine or any of the other ingredients of this medicine (listed in section 6)

You have high blood pressure due to an adrenal tumour (phaeochromocytoma).

lf any of the above applies to you, do not take this medicine and talk to your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Betahistine Tablets if:

you have a stomach ulcer

you have asthma

you are pregnant or planning to become pregnant

you are breast-feeding

Your doctor will tell you whether it is safe for you to start taking this medicine.

Your doctor may also want to monitor your asthma while you take Betahistine Tablets.

Taking other medicines

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes herbal medicines. In particular, tell your doctor or pharmacist if you are taking any of the following medicines: Anti-histamines - these may (in theory) lower the effect of betahistine dihydrochloride. Also, betahistine may lower the effect of anti-histamines.

Monoamine-oxidase inhibitors (MAOls)

used to treat depression or Parkinson’s disease. These may increase the exposure of betahistine.

Taking Betahistine Tablets with food and drink

You can take Betahistine Tablets with or without food. However, betahistine can cause mild stomach problems (listed in section 4). Taking betahistine with food can help reduce stomach problems. Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Betahistine is not likely to affect your ability to drive or use tools or machinery. However, remember that diseases for which you are being treated with Betahistine (vertigo, tinnitus and hearing loss associated with Meniere’s syndrome) can make you feel dizzy or be sick, and can affect your ability to drive or use machines.

3. HOW TO TAKE BETAHISTINE TABLETS

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

Betahistine Tablets are available in 3 strengths, 8 mg, 16 mg and 24 mg tablets.

The usual starting dose is 16 mg three times a day (48 mg).

Your doctor may lower your dose to 8 mg three times a day (24 mg).

Keep taking your tablets. The tablets can take a while to start to work.

Betahistine Tablets are not recommended for children under 18 years old.

Method of administration

Swallow the tablets with water.

Preferably take the tablet with a meal. If you take more Betahistine Tablets than you should

lf you or someone else takes too much betahistine (an overdose), talk to a doctor or go to a hospital straight away. Take the medicine pack with you. If you forget to take Betahistine Tablets

If you miss a tablet, wait until the next dose is due. Do not try to make up for the dose you have missed.

(Continued overleaf)

As stated in design

Package leaflet

TBA

TW254688 (rel)

[All]

TBA

9 points (Reg text)

TW249875 02/04/2026

Black C

If you stop taking Betahistine Tablets

Keep taking your tablets until your doctor tells you to stop.

Even when you start feeling better, your doctor may want you to carry on taking the tablets for some time to make sure that the medicine has worked completely.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following serious side effects may occur during treatment with Betahistine Tablets:

Allergic reactions such as:

swelling of your face, lips, tongue or neck. This may cause difficulty breathing.

a red skin rash, inflamed itchy skin

If any of these side effects occur you should stop the treatment immediately and contact your doctor. Common side effects (may affect up to 1 in 10 people):

Nausea, indigestion, headaches.

Other side effects

Itching, rash, hives, mild gastric complaints such as vomiting, stomach pain and bloating. Taking the tablets with food can help reduce any stomach problems.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE BETAHISTINE TABLETS

Keep this medicine out of the sight and reach of children.

This medicine should preferably be locked in a cupboard or medicine cabinet.

Do not use the tablets after the expiry date which is printed on the carton after EXP. The expiry date refers to the last day of that month. If your doctor stops your treatment, return any unused tablets to a pharmacist.

Store in the original package in order to protect from moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Betahistine Tablets contains

Each tablet contains 8,16 or 24 mg of betahistine dihydrochloride.

The tablets also contain microcrystalline cellulose, mannitol (E421), talc, citric acid, stearic acid, colloidal anhydrous silica, crospovidone and povidone K-30.

What Betahistine Tablets looks like and contents of the pack

Betahistine 8 mg Tablets are presented as white to off white, round, flat tablets debossed with “JI” on one side and plain on other side. The diameter is about 7.10 mm.

Betahistine 16 mg Tablets are presented as white to off white, round, biconvex tablets debossed with “J2” on one side and score line on other side. The diameter is about 8.70 mm.

Betahistine 24 mg Tablets are presented as white to off white, round, biconvex tablets debossed with “J4” on one side and score line on other side. The diameter is about 10.20 mm.

Betahistine Tablets 8 mg, 16 mg and 24 mg are packed in clear PVC/PVDC-Aluminum blister packs. Betahistine Tablets 8 mg are available in packs containing 84 or 120 tablets.

Betahistine Tablets 16 mg are available in packs containing 64 or 84 tablets.

Betahistine Tablets 24 mg are available in packs containing 24, 60 and 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Tillomed Laboratories Limited

220 Butterfield, Great Marlings

Luton, LU2 8DL, United Kingdom

Manufacturer