Betahistine Tecnigen 16 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package Leaflet: Information for the User

Betahistina TecniGen 16 mg Tablets EFG

Betahistine dihydrochloride

Read the entire leaflet carefully before you start taking this medicine, as 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 or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Betahistina TecniGen contains betahistine (dihydrochloride). Betahistine is a type of medicine known as a "histamine analogue".

Betahistina is used for:

The treatment of Ménière's syndrome, the symptoms of which include:

• dizziness (vertigo) and feeling unwell (nausea or vomiting)
• hearing loss or difficulty hearing
• sensation of noise in the ear (tinnitus)

How Betahistina TecniGen works

Betahistina works 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 betahistine dihydrochloride or to 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 either of the above applies to you. If you are unsure, consult your doctor or pharmacist before starting to take betahistine.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take betahistine if:

• You have ever had a stomach ulcer
• You have asthma

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

Children and adolescents

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

Other medicines and Betahistina TecniGen

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

In particular, inform 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 exposure to betahistine.
• Antihistamines – these may (in theory) reduce the effect of betahistine. Betahistine may also reduce the effect of antihistamines.

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

Taking Betahistina TecniGen with food and drink

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

Pregnancy and breastfeeding

It is unknown whether betahistine affects the fetus:

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

It is unknown whether betahistine passes into breast milk:

• Do not breastfeed while taking betahistine unless your doctor instructs you to do so.

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 (Meniere's syndrome) may cause dizziness or nausea, which could affect your ability to drive or operate machinery.

Betahistina TecniGen contains mannitol

May produce a mild laxative effect because it contains mannitol.

3. How to take Betahistina TecniGen

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• Swallow your tablet with water.
• Tablets may 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 divided doses and may be increased by 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 at night.

Try to take the tablet at the same time each day. This will ensure a constant amount of the medicine 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 has 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 according to your progress.

If you take more Betahistina TecniGen than you should

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

• Discomfort (nausea)
• Drowsiness
• Stomach pain.

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

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 telling your doctor, even if you start to feel better.

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 will experience them.

The following adverse effects may occur with this medicine:

Allergic reactions

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

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

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

Other adverse effects include:

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

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

Other adverse effects reported with the use of betahistine:

• Mild gastric discomfort such as discomfort (vomiting), gastrointestinal pain, bloating and abdominal swelling.

Taking betahistine with meals 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Betahistine TecniGen

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

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Store below 30 °C.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Betahistina TecniGen

• The active substance is betahistina dihydrochloride.

Each tablet contains 16 mg of betahistina dihydrochloride.

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

Appearance of the product and contents of the pack

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

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

Only some pack 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 most recent revision of this leaflet: October 2020

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