BETAHISTINE TARBIS 24 mg TABLETS

Introduction

Package Leaflet: Information for the User

Betahistina Tarbis 24 mg Tablets EFG

Betahistina Dihydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Betahistina Tarbis and what is it used for
2. What you need to know before you take Betahistina Tarbis
3. How to take Betahistina Tarbis
4. Possible side effects
5. Storage of Betahistina Tarbis
6. Contents of the pack and other information

1. What is Betahistina Tarbis and what is it used for

Betahistina Tarbis contains betahistina. This medicine is called a “histamine analogue”.

Betahistina is indicated for the treatment of vertigo, tinnitus, and hearing loss associated with Meniere's syndrome.

This medicine works by improving blood flow in the inner ear. This reduces the accumulation of pressure.

2. What you need to know before you take Betahistina Tarbis

Do not take Betahistina Tarbis

• If you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• If you have high blood pressure due to a suprarenal gland tumor (pheochromocytoma).

If you are in any of the above situations, do not take this medicine and consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before taking betahistina:

• If you have a stomach ulcer
• If you have asthma
• If you are pregnant or planning to become pregnant
• If you are breast-feeding

If any of the above applies to you, consult your doctor or pharmacist before taking betahistina.

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

It is also possible that your doctor may want to monitor your asthma while you are taking betahistina.

Other medicines and Betahistina Tarbis

Tell your doctor or pharmacist if you are using, have recently used, or might use other medicines, including those obtained without a prescription. This includes herbal medicines.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• Antihistamines: these may (in theory) reduce the effect of betahistina. Additionally, Betahistina may also reduce the effect of antihistamines.
• Monoamine oxidase inhibitors (MAOIs) - medicines used to treat depression or Parkinson's disease. These may increase exposure to betahistina.

Using Betahistina Tarbis with food, drinks, and alcohol

You can take this medicine with or without food.

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.

Do not take betahistina tablets if you are pregnant unless your doctor decides that it is absolutely necessary. Ask your doctor for advice.

Do not breast-feed when taking betahistina tablets unless your doctor tells you to. It is not known whether betahistina passes into breast milk.

Driving and using machines

Betahistina is unlikely to affect your ability to drive or use tools or machines.

However, remember that the illness for which you are being treated with betahistina (vertigo, tinnitus, and hearing loss associated with Meniere's syndrome) may make you feel dizzy or sick, affecting your ability to drive and use machines.

3. How to take Betahistina Tarbis

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

How to take Betahistina Tarbis

• Swallow your tablet with water.
• Preferably, take the tablet with a meal.

How much Betahistina Tarbis to take

Always follow the instructions of your doctor because your doctor may adjust your dose.

Initially, 8 to 16 mg three times a day, preferably with meals.

Maintenance doses are generally in the range of 24 to 48 mg per day.

Keep taking your tablets. They may take some time to start working.

Betahistina is not recommended for children under 18 years.

If you stop taking Betahistina Tarbis

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

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

If you take more Betahistina Tarbis than you should

If you or someone else takes too much betahistina (overdose), talk to a doctor or go to a hospital straight away. Take the medicine with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount taken.

If you forget to take Betahistina Tarbis

If you forget to take a dose, wait until the next one. Do not try to make up for the missed dose.

If you have any further questions on the use of this medicine, 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 Betahistina Tarbis:

Allergic reactions such as:

• Swelling of the face, lips, tongue, or throat. This can cause difficulty breathing.
• A red skin rash, itchy inflamed skin

If you get any of these side effects, stop taking the treatment immediately and talk to your doctor.

Common(may affect up to 1 in 10 people):

• Nausea
• Indigestion
• Headache

Other side effects that have been reported with the use of betahistina

Itching, skin rash, hives, mild stomach upset such as vomiting, stomach pain, and swelling. Taking betahistina with food may help reduce stomach problems.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency website: www.notificaRAM.es.

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

5. Storage of Betahistina Tarbis

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the blister and on the carton after “EXP”. The expiry date is the last day of the month shown.

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 protect the environment.

6. Contents of the pack and other information

Composition of Betahistina Tarbis

The active substance is betahistina dihydrochloride.

Each tablet contains 24 mg betahistina dihydrochloride equivalent to 15.63 mg betahistina.

The other ingredients are:

Microcrystalline cellulose (E460), mannitol (E421), colloidal anhydrous silica (E551), citric acid (E330), talc (E553b).

Appearance and packaging

Tablet.

Betahistina Tarbis 24 mg Tablets EFG

White to off-white, scored, round, biconvex tablets, engraved with "24 / B" on one face and smooth on the other (diameter of 10 mm and thickness of 4.40 mm).

The score line is only to facilitate breaking and swallowing, but not to divide into equal doses.

Betahistina Tarbis tablets are available in blister packs of 30, 60, 84, 90, and 120 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

Netherlands

This medicine is authorised in the Member States of the European Economic Area under the following names:

Netherlands: Betahistine Amarox 24 mg tabletten

Spain: Betahistina Tarbis 24 mg comprimidos EFG

Date of last revision of this leaflet: January 2022

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/