BETAHISTINA 24 mg Tablets

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

Betahistina TecniGen contains betahistina (dihydrochloride). Betahistina is a type of medicine called a “histamine analogue”.

Betahistina is used for:

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

• dizziness (vertigo) and feeling sick (nausea or vomiting)
• hearing loss or difficulty hearing
• ringing in the ears (tinnitus)

How Betahistina TecniGen works

Betahistina works by improving blood flow in the inner ear. This reduces the pressure.

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

Do not take Betahistina TecniGen

• If you are allergic to betahistina dihydrochloride or any of the other ingredients of this medicine (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 medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking betahistina.

Warnings and precautions

Talk to your doctor or pharmacist before taking betahistina.

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

If any of the above applies to you (or you are not sure), talk to your doctor or pharmacist before taking betahistina. Your doctor may want to keep a closer eye on you while you are taking betahistina.

Children and adolescents

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

Other medicines and Betahistina TecniGen

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those bought without a prescription.

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

• monoamine oxidase inhibitors (MAOIs) - used to treat depression or Parkinson's disease. These may increase the exposure of betahistina
• 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 not sure), talk to your doctor or pharmacist before taking betahistina.

Taking Betahistina TecniGen with food and drink

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 not known if betahistina affects the fetus:

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

It is not known if betahistina passes into breast milk:

• Do not breastfeed your child if you are taking betahistina unless your doctor tells you to.

Driving and using machines

Betahistina is unlikely to 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 have a mild laxative effect because it contains mannitol.

3. How to take Betahistina TecniGen

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, talk to your doctor or pharmacist.

• Swallow your 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 doctor's 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, twice a day.

The tablet can be divided into equal doses.

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

Try to take the tablet at the same time each day. This will ensure that there is a constant amount of the medicine in your body. Taking the tablets at the same time each 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 yet been established.

Duration of treatment

Keep taking your medicine until your doctor tells you to stop. The medicine 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 straight away. Take the medicine with you. The following effects may happen:

• Feeling sick (nausea)
• Drowsiness
• Stomach pain.

In case of overdose or accidental ingestion, talk to your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Betahistina TecniGen

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

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

If you stop taking Betahistina TecniGen

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

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 side effects may happen with this medicine:

Allergic reactions

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

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

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

Other side effects include:

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

• feeling sick (nausea)
• indigestion (dyspepsia)
• headache

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

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

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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Betahistina TecniGen

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

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

Store below 30°C.

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 further information

Composition of Betahistina TecniGen

• The active substance is betahistina dihydrochloride.

Each tablet contains 24 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 pack contents

Betahistina TecniGen 24 mg tablets EFG are white, round, biconvex and uncoated tablets, scored on one side and marked with “II” in relief on both sides of the score, and smooth on the other side.

Packs of 20 and 60 tablets in PVC/PVDC/Alu blisters.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation 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 last revision of this leaflet: October 2020

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