Leaflet: information for the user

Betahistina Tarbis 24 mg tablets EFG

Betahistina dihidrochloride

Read 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, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

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

3. How to take Betahistina Tarbis

4. Possible side effects

5. Storage of Betahistina Tarbis

6. Contents of the pack and additional information

Betahistina Tarbis contains betahistina. This medication is referred to as an “histamine analogue”.

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

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

Do not take Betahistina Tarbis

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

If you find yourself 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 plan to become pregnant
• If you are breastfeeding

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

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

Your doctor may also want to monitor your asthma while you are taking betahistina.

Other medications and Betahistina Tarbis

Inform your doctor or pharmacist if you are using, have used recently, or may need to use other medications, including those purchased without a prescription. This includes herbal medications.

Particularly, inform 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.
• Monamine oxidase inhibitors (MAO inhibitors) - medications used to treat depression or Parkinson's disease. These may increase exposure to betahistina.

Use of 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 unless your doctor advises you to do so. It is unknown if betahistina passes into breast milk.

Driving and operating machinery

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.

Follow exactly the administration instructions for 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 your tablet with water.
• Preferably, take the tablet with a meal.

How Much Betahistina Tarbis to Take

Always follow your doctor's instructions 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.

Continue taking your tablets. These may take time to start working.

Betahistina is not recommended for individuals under 18 years old.

If You Stop Taking Betahistina Tarbis

Continue taking the tablets until your doctor tells you to.

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

If You Take More Betahistina Tarbis Than You Should

If you or someone else takes too much betahistina (overdose), speak with a doctor or go to the hospital immediately. Bring the medication with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service (phone 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 using this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

Allergic reactions such as:

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

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

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

• Nausea
• Indigestion
• Headache.

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

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

Reporting 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 prospectus. You may also report directly through the Spanish System for Pharmacovigilance of Medicines for Human Use website:www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the blister and on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Betahistina Tarbis

The active ingredient is betahistina dihidrocloruro.

Each tablet contains 24 mg betahistina dihidrocloruro equivalent to 15.63 mg of betahistina.

The other components are:

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

Appearance of the product and contents of the packaging

Tablet.

Betahistina Tarbis 24 mg tablets EFG

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

The score is only for breaking and facilitating swallowing, but not for dividing into equal doses.

Betahistina Tarbis tablets are available in packaging with blisters of 30, 60, 84, 90, and 120 tablets.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Responsible for manufacturing

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

Netherlands

This medicine is authorized in the member states of the European Economic Area with the following names:

Netherlands:Betahistine Amarox 24 mg tablets

Spain:Betahistina Tarbis 24 mg tablets EFG

Last review date of this leaflet: January 2022

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