BETAHISTINE TARBIS 8 mg TABLETS

Introduction

Package Leaflet: Information for the User

Betahistina Tarbis 8 mg Tablets EFG

Betahistina Dihydrochloride

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

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

Contents of the Package Leaflet

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

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

Betahistina Tarbis contains betahistina. This medication is referred to as a "histamine analogue".

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

This medication works by improving blood flow in the inner ear. This reduces the accumulation 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 any of the other ingredients of this medication (listed in section 6).
• If you have high blood pressure due to a suprarenal tumor (pheochromocytoma).

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take betahistina:

• 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 applies to you, consult your doctor or pharmacist before starting to take betahistina.

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

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

Other medications and Betahistina Tarbis

Tell your doctor or pharmacist if you are using, have recently used, or might use other medications, 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 medications:

• Antihistamines: these may (in theory) reduce the effect of betahistina. Additionally, Betahistina may also reduce the effect of antihistamines.
• Monoamine oxidase inhibitors (MAOIs) - medications 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 medication with or without food.

Pregnancy, breastfeeding, and fertility

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

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

Do not breastfeed while taking betahistina tablets without consulting your doctor. 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 machines or tools.

However, remember that the disease 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 medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

How to take Betahistina Tarbis

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

How much Betahistina Tarbis to take

Always follow the instructions of your doctor, as 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.

Continue taking your tablets. They may take some time to start having an effect.

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

If you stop treatment with Betahistina Tarbis

Continue taking the 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 medication 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 immediately. Take the medication 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 medication 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 other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone 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 experience any of these side effects, stop treatment immediately and talk to your doctor.

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

• 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 side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Medicines Agency's website: www.notificaRAM.es.

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

5. Storage of Betahistina Tarbis

Keep this medication out of sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date stated on the blister pack and carton after "EXP". The expiration date is the last day of the month indicated.

Medications should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the pack and further information

Composition of Betahistina Tarbis

The active substance is betahistina dihydrochloride.

Each tablet contains 8 mg betahistina dihydrochloride, equivalent to 5.21 mg betahistina.

The other ingredients are:

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

Appearance and packaging of the product

Tablet.

Betahistina Tarbis 8 mg Tablets EFG

White to off-white, round, flat tablets with a beveled edge, engraved with "8" on one side and "B" on the other (diameter 7 mm and thickness 2.50 mm).

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

Not all 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

Netherlands

This medication is authorized in the Member States of the European Economic Area under the following names:

Netherlands: Betahistine Amarox 8 mg tablets

Spain: Betahistina Tarbis 8 mg Tablets EFG

Date of the last revision of this package leaflet: January 2022

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/