Patient leaflet - Betahistine Dihydrochloride 16 mg tablets

1. What Betahistine dihydrochloride tablets is and what it is used for

The name of your medicine is Betahistine Dihydrochloride Tablets. It is called Betahistine tablets in the rest of the leaflet. This medicine is a histamine analogue.

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 the build-up of pressure.

2. What you need to know before you take Betahistine tablets

Do not take Betahistine tablets:

If you are allergic to betahistine tablets or any of the other ingredients of this medicine (listed in section 6).
If you have an abnormal growth of the adrenal medulla which can cause severe high blood pressure (pheochromocytoma).

Do not take Betahistine tablets if any of the above applies to you. If in doubt, it is essential to seek the advice of your doctor, nurse, or pharmacist before taking Betahistine tablets.

Warnings and precautions

Talk to your doctor, nurse, or pharmacist before taking Betahistine tablets if you have asthma. In this case, treatment with Betahistine tablets requires special monitoring because of the risk of bronchial contraction.

In patients with a history of peptic ulcer, the administration of betahistine requires special monitoring during the course of treatment.

Betahistine tablets are not the appropriate treatment for the following forms of vertigo:

Attacks of benign positional vertigo. Dizziness related to a disorder of the central nervous system.

Precautions for use

Take the tablets halfway through meals to avoid stomach pain. Talk to your doctor, nurse, or pharmacist before taking Betahistine dihydrochloride tablets.

Talk to your doctor, nurse, or pharmacist straight away if you have the impression that the effect of Betahistine tablets is too strong or too weak.

Children

The use of Betahistine dihydrochloride tablets are not recommended for use in children and adolescents below the age of 18.

Other medicines and Betahistine tablets

Tell your doctor, nurse, or pharmacist if you are taking, have recently taken or might take any other medicines.

Betahistine tablets with food and drink

You can take Betahistine tablets with or without food. However, Betahistine tablets may cause mild stomach complaints (see section 4). Taking it with food may help reduce stomach complaints

Pregnancy, breast-feeding and fertility

It is best not to use this medicine during pregnancy or while breastfeeding.

If you discover that you are pregnant during treatment, consult your doctor as only they can judge the need for continued treatment. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, nurse, or pharmacist for advice before taking this medicine.

Driving and using machines

Betahistine tablets do not or are unlikely to affect your ability to drive and use machines.

3. How to take Betahistine tablets

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

Your doctor will tell you how many tablets to take and how long to take them for.
The recommended doses are given below.

Use in adults aged 18 and above

Initial oral treatment is 8 mg to 16 mg three times daily, taken with food. Maintenance doses are generally in the range 24 - 48 mg daily. Dosage can be adjusted to suit individual patient needs.

Use in children and adolescents

Betahistine tablets should not be administered to children and adolescents under 18 years of age.

Method of administration

Oral use.

Take the tablets halfway through meals to avoid stomach pain. Swallow the tablets without chewing with a glass of water. Talk to your doctor, nurse, or pharmacist straight away if you have the impression that the effect of Betahistine tablets is too strong or too weak.

If you take more dose of betahistine tablets than you should Immediately consult your doctor, nurse, or pharmacist.

If you forgot to take Betahistine tablets

Do not take a double dose to make up for the dose you forgot to take.

If you stop taking Betahistine tablets

Do not stop using Betahistine tablets without telling your doctor, even if you feel better.

If you have any further questions on the use of this medicine, ask your doctor, nurse, or pharmacist for more information.

4. Possible side effect

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

Frequent:

Intestinal disorder: nausea, dyspepsia.
Nervous system: headache.

Frequency not estimated:

Haematological and Lymphatic System: Significant decrease in platelet levels.
Immune system disorders: allergic reaction, signs may include swelling of the face, lips, tongue or throat with difficulty breathing (angioedema).
Disorders: Benign gastric disorders have been reported (e.g., gastric pain, vomiting, dry mouth, diarrhoea, abdominal pain, abdominal distension and bloating). These effects can be avoided by taking the tablet with a meal or by reducing the dose.
Skin disorders: allergic skin reactions were observed, particularly angioedema, rash, redness, itching.

Reporting of side effects

If you get any side effects, talk to your doctor, nurse, or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side affects you can help provide more information on the safety of this medicine. Yellow Card Scheme website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

5. How to store Betahistine tablets

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP. The expiry date refers to the last day of that month.
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 to protect the environment.

6. Content of the pack and other information

The active substance is betahistine dihydrochloride. Betahistine tablets come in three strengths containing 8 mg, 16 mg and 24 mg of betahistine dihydrochloride.
The other ingredients are mannitol, cellulose microcrystalline, silico colloidal anhydrous, povidone K-30, Citric acid, crospovidone, talc and stearic acid.

What Betahistine tablets looks like and content of the pack

Betahistine dihydrochloride 8 mg tablets are presented as white to off white, round, flat tablets debossed with “JI” on one side and plain on other side with diameter of tablet 7.10 mm.
Betahistine dihydrochloride 16 mg tablets are presented as white to off white, round, biconvex tablets debossed with “J2” on one side and scoreline on other side with diameter of tablet 8.70 mm. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Betahistine dihydrochloride 24 mg tablets are presented as white to off white, round, biconvex tablets debossed with “J4” on one side and scoreline on other side with diameter of tablet 10.20 mm
The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Your tablets will come in a blister pack in carton containing 8 mg, 16 mg 24 mg: Blister packs in pack size of 84 and 120 tablets.

Marketing Authorisation Holder:

Biovantic Pharma Limited

Kemp House, 160 City Road,

London, EC1V 2NX

United Kingdom

Manufacturer

Cubic Pharmaceuticals Limited

Unit 3, Sextant Park, Neptune Close,

Medway City Estate, Rochester,

ME2 4LU,