Betahistine Tarbis 16 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Betahistina Tarbis 16 mg tablets EFG

Betahistine dihydrochloride

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these effects are not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Betahistina Tarbis contains betahistine. This medicine is known as a "histamine analogue".

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

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

2. What you need to know before taking Betahistina Tarbis

Do not take Betahistina Tarbis

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

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

Warnings and precautions

Talk to your doctor or pharmacist before starting betahistine:

• If you have a stomach ulcer
• If you have asthma
• If you are pregnant or planning to become pregnant
• If you are breastfeeding

If any of the above apply to you, consult your doctor or pharmacist before starting betahistine.

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 are taking betahistine.

Other medicines and Betahistina Tarbis:

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines, including herbal medicines and those obtained without a prescription.

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

• Antihistamines: these may (in theory) reduce the effect of betahistine. In addition, betahistine may also reduce the effect of antihistamines.
• Monoamine oxidase inhibitors (MAO inhibitors) – medicines used to treat depression or Parkinson’s disease. These may increase exposure to betahistine.

Use of Betahistina Tarbis with food, drinks and alcohol

You may take this medicine with or without food.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not take betahistine tablets during pregnancy unless your doctor decides it is absolutely necessary. Ask your doctor for advice.

Do not breastfeed while taking betahistine tablets unless instructed to do so by your doctor. It is unknown whether betahistine passes into breast milk.

Driving and using machines

Betahistine is unlikely to affect your ability to drive or operate machinery.

However, remember that the condition for which you are being treated with betahistine (vertigo, tinnitus, and hearing loss associated with Ménière’s syndrome) may cause dizziness or nausea, thereby affecting your ability to drive or use machines.

3. How to take Betahistina Tarbis

Follow exactly the instructions for administration of this medicine as given by your doctor or pharmacist. If 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 your doctor's instructions, as your doctor may adjust your dose.

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

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

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

Betahistina is not recommended for patients under 18 years of age.

If you stop treatment with Betahistina Tarbis

Continue taking the tablets until your doctor tells you otherwise.

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

If you take more Betahistina Tarbis than you should

If you or someone else takes too much betahistine (overdose), speak to a doctor or go to a hospital immediately. Take the medicine with you.

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

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 about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The following serious adverse effects may occur during treatment with Betahistina Tarbis:

Allergic reactions such as:

• Swelling of the face, lips, tongue or throat. This may cause difficulty breathing.
• Red rash, inflamed itchy skin.

If you experience any of these adverse reactions, you must stop treatment immediately and speak to your doctor.

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

• Nausea
• Indigestion
• Headache

Other adverse effects reported with the use of betahistine:

Itching, skin rash, urticaria, mild gastric discomfort such as vomiting, stomach pain and bloating. Taking betahistine with food may help reduce stomach problems.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines website: www.notificaRAM.es.

By reporting adverse 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 stated on the blister and on the outer packaging following “EXP”. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be taken to the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Betahistina Tarbis

The active substance is betahistine dihydrochloride.

Each tablet contains 16 mg of betahistine dihydrochloride, equivalent to 10.42 mg of betahistine.

The other components are:

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

Appearance of the product and contents of the pack

Tablet.

Betahistina Tarbis 16 mg tablets EFG

White to almost white, scored, round, biconvex tablets, engraved with "16 / B" on one side and smooth on the other (diameter 8.5 mm, thickness 4.20 mm).

The tablet can be divided into equal doses.

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

However, only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

The Netherlands

This medicinal product is authorized in the European Economic Area member states under the following names:

The Netherlands: Betahistine Amarox 16 mg tabletten

Spain: Betahistina Tarbis 16 mg comprimidos EFG

Date of the most recent revision of this leaflet: January 2022

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