Prospecto: information for the user

Betahistina TecniGen 8 mg tablets EFG

Betahistina dihidrocloruro

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

Betahistina is used for:

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

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

How Betahistina TecniGen works

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

Do not take Betahistina TecniGen

• If you are allergic to betahistina dihidrocloruro or any of the other components of this medication (listed in section 6).
• If your doctor has told you that you have a certain type of adrenal gland cancer (called “feocromocitoma”).

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

Other medications and Betahistina TecniGen

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

Particularly, inform 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 the exposure to 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 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

The effect of betahistina on the fetus is unknown:

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

The effect of betahistina on breast milk is unknown:

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

Driving and operating machinery

It is likely that betahistina will not affect your ability to drive or operate machinery. 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 operate machinery.

Betahistina TecniGen contains mannitol

It may produce a mild laxative effect because it contains mannitol

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

• 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 can 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:

One to two tablets, three times a day.

Distribute your tablets uniformly throughout the day. For example, take one tablet in the morning and another at night.

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

Treatment duration

Continue taking your medication until your doctor tells you to stop. The medication may take 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 the 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 Toxicological 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 compensate for the missed doses.

If you interrupt treatment with Betahistina TecniGen

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

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

The following adverse effects may occur with this medication:

Allergic Reactions

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

• Redness or swelling on the skin, skin rash, or itching on inflamed skin
• Swelling of the face, lips, tongue, or neck
• Decreased blood pressure
• Loss of consciousness
• Difficulty breathing

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

Other adverse effects include:

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

• Uncomfortable feeling (nausea)
• Indigestion (dyspepsia)
• Headache

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

• Mild gastrointestinal discomfort such as nausea, gastrointestinal pain, bloating, and abdominal distension.

Taking betahistina with meals 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 can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.Reporting adverse effects can help provide more information about the safety of this medication.

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

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

Store below 30 °C.

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

Composition of Betahistina TecniGen

• The active ingredient is betahistine dihydrochloride.

Each tablet contains 8 mg of betahistine dihydrochloride.

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

Appearance of the product and content of the container

Betahistina TecniGen 8 mg tablets EFG are white, round, flat, non-coated, and smooth on both sides.

Packaging of 50 and 60 tablets in PVC/PVDC/Alu blisters.

Only some package sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3rd floor. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid)

Spain

Responsible for manufacturing

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

Last review date of this leaflet: October 2020

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