BETAHISTINE TECNIGEN 16 mg TABLETS

Introduction

Package Leaflet: Information for the User

Betahistina TecniGen 16 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 or pharmacist.
• 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 not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Betahistina TecniGen and what is it used for
2. What you need to know before taking Betahistina TecniGen
3. How to take Betahistina TecniGen
4. Possible side effects
5. Storage of Betahistina TecniGen
6. Package contents and additional information

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

Betahistina TecniGen contains betahistina (dihydrochloride). Betahistina is a type of medication called a "histamine analogue".

Betahistina is used for:

Treatment of Meniere's Syndrome, the symptoms of which include:

• dizziness (vertigo) and feeling of discomfort (nausea or vomiting)
• hearing loss or difficulty hearing
• feeling of noise inside the ear (tinnitus)

How Betahistina TecniGen works

Betahistina acts by improving blood circulation in the inner ear. This reduces pressure.

2. What you need to know before taking Betahistina TecniGen

Do not take Betahistina TecniGen

• If you are allergic to betahistina dihydrochloride or any of the other ingredients of this medication (listed in section 6).
• If your doctor has told you that you have a certain type of adrenal gland cancer (called "pheochromocytoma").

Do not take this medication if any of the above applies to you. If you are unsure, consult your doctor or pharmacist before starting to take betahistina.

Warnings and precautions

Consult your doctor or pharmacist before starting to take betahistina.

• If you have ever had a stomach ulcer
• If you have asthma

If any of the above applies to you (or you are unsure), consult your doctor or pharmacist before starting to take betahistina. Your doctor may want to monitor you more closely while you are taking betahistina.

Children and adolescents

Betahistina is not recommended for use in children and adolescents under 18 years of age.

Other medications and Betahistina TecniGen

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medication, including those purchased without a prescription.

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

• monoamine oxidase inhibitors (MAOIs) - used to treat depression or Parkinson's disease. These may increase betahistina exposure
• antihistamines - these may decrease (in theory) the effect of betahistina. Betahistina may also decrease the effect of antihistamines.

If any of the above applies to you (or you are unsure), consult your doctor or pharmacist before starting to take betahistina.

Taking Betahistina TecniGen with food and drinks

You can take betahistina with or without food. However, betahistina may cause mild stomach problems (see section 4). Taking betahistina with food may help reduce stomach problems.

Pregnancy and breastfeeding

It is unknown if betahistina affects the fetus:

• Stop taking betahistina and inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant.
• Do not take betahistina if you are pregnant unless your doctor considers it absolutely necessary.

It is unknown if betahistina passes into breast milk:

• Do not breastfeed your child if you are taking betahistina unless your doctor advises you to do so.

Driving and using machines

It is likely that betahistina will not affect your ability to drive or use machines. However, remember that the disease for which you are being treated with betahistina (Meniere's Syndrome) may make you feel dizzy or sick, and this may affect your ability to drive or use machines.

Betahistina TecniGen contains mannitol

It may produce a mild laxative effect because it contains mannitol.

3. How to take Betahistina TecniGen

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

• Swallow the tablet with water.
• The tablets can be taken with or without food. However, betahistina may cause mild stomach problems (listed in section 4). Taking betahistina with food may help reduce stomach problems.

Dosage

The recommended daily dose is 24 mg of betahistina per day in 2 or 3 single doses and may be increased with a medical prescription to 48 mg per day. Betahistina 24 mg has been specifically developed for the highest daily dose of 48 mg per day.

The recommended starting dose is:

Half to one tablet, three times a day.

The tablet can be divided into equal doses.

Distribute your tablets evenly throughout the day. For example, take one tablet in the morning and another in the evening.

Try to take the tablet at the same time every day. This will ensure that there is a constant amount of medication in your body. Taking the tablets at the same time every day will help you remember to take them.

Use in children and adolescents

The safety and efficacy of betahistina in children and adolescents have not been established yet.

Duration of treatment

Continue taking your medication until your doctor tells you to stop. The medication may take some time to start working.

Your doctor will adjust the dose based on your progress.

If you take more Betahistina TecniGen than you should

If you or someone else takes too much betahistina (overdose), talk to a doctor or go to a hospital immediately. Bring the medication with you. The following effects may occur:

• Discomfort (nausea)
• Drowsiness
• Stomach pain.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Betahistina TecniGen

If you forget a dose, skip the missed dose. Take your next dose at the usual time.

Do not take a double dose to make up for missed doses.

If you stop taking Betahistina TecniGen

Do not stop taking betahistina without telling your doctor, even if you start to feel better.

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 side effects may occur with this medication:

Allergic reactions

If you have an allergic reaction, stop taking betahistina and consult a doctor or go to a hospital immediately. The effects may include:

• redness or bumps on the skin, rash, or itching on inflamed skin
• swelling of the face, lips, tongue, or throat
• decrease in blood pressure
• loss of consciousness
• difficulty breathing

Stop taking betahistina and see a doctor or go to a hospital immediately if you notice any of the above effects.

Other side effects include:

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

• discomfort (nausea)
• indigestion (dyspepsia)
• headache

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

• Mild stomach problems such as discomfort (vomiting), gastrointestinal pain, abdominal distension, and bloating.

Taking betahistina during meals may help reduce stomach problems.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Betahistina TecniGen

Keep this medication out of sight and reach of children.

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

Store below 30°C.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Betahistina TecniGen

• The active ingredient is betahistina dihydrochloride.

Each tablet contains 16 mg of betahistina dihydrochloride.

• The other ingredients are: anhydrous citric acid, microcrystalline cellulose, mannitol (E-421), colloidal anhydrous silica, talc.

Appearance of the product and package contents

Betahistina TecniGen 16 mg tablets EFG are white, round, biconvex, and uncoated tablets, scored on one side and marked with "I" in relief on both sides of the score, and smooth on the other side.

Packaging of 20 and 30 tablets in PVC/PVDC/Alu blisters.

Only certain package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid)

Spain

Manufacturer

S.C. SANTA S.A.

Str. Carpatilor nr. 60, objectiv nr. 47, 48, 58, 133, 156

Brasov, jud. Brasov

Cod 500269

Romania

S.C. POLISANO PHARMACEUTICALS S.A.

So?. Alba Iulia nr. 156,

Cod 550052.

Sibiu Jud.

Sibiu

Romania

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande, n.º 2 Abrunheira,

2710-089 Sintra

Portugal

Iberfar, Indústria Farmacêutica S.A.

Estrada Consiglieri Pedroso, 123, Queluz de Baixo

2734-501 Barcarena. Portugal

Date of the last revision of this package leaflet: October 2020

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/