BETAHISTINE NORMON 24 mg TABLETS

Introduction

Package Leaflet: Information for the User

Betahistina Normon 24 mg Tablets

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Betahistina Normon 24 mg is and what it is used for
2. What you need to know before you take Betahistina Normon 24 mg
3. How to take Betahistina Normon 24 mg
4. Possible side effects
5. Storage of Betahistina Normon 24 mg
6. Contents of the pack and other information

1. What Betahistina Normon 24 mg is and what it is used for

Betahistina Normon 24 mg tablets belong to a group of medicines called antivertigo preparations: anti-vertigo and its active ingredient is betahistine dihydrochloride.

Betahistina Normon 24 mg tablets are used for the treatment of Meniere's Syndrome, a disorder characterized by the following symptoms: vertigo (with nausea and vomiting), hearing loss, and a sensation of noise in the ear (tinnitus).

The active ingredient of this medicine is a histamine analogue that acts by improving circulation in the inner ear and thus reducing pressure. The inner ear is one of the organs responsible for the sense of balance.

2. What you need to know before you take Betahistina Normon 24 mg

Do not take Betahistina Normon 24 mg:

• if you are allergic to the active ingredient betahistine or to any of the other ingredients of this medicine (listed in section 6)
• if you have a cancer of the adrenal glands called pheochromocytoma.

Warnings and precautions

Consult your doctor or pharmacist before starting to take betahistine:

• if you have bronchial asthma,
• if you have or have had stomach ulcers,
• if you suffer from skin rashes and intense itching (urticaria), skin rash (exanthema), or hay fever.

Patient should be carefully monitored by the doctor during treatment with this medicine.

Children and adolescents

Betahistina Normon 24 mg is not recommended for use in children and adolescents under 18 years of age due to lack of experience in these age groups.

Other medicines and Betahistina Normon 24 mg

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

Concomitant administration of this medicine with antiallergic medicines such as antihistamines (especially H1 antagonists) may reduce the efficacy of both medicines.

Caution is recommended when using betahistine and MAO inhibitors (including selective MAO-B inhibitors, such as selegiline) at the same time, as it may cause inhibition of betahistine metabolism.

Concomitant administration of this medicine with monoamine oxidase inhibitors (MAOIs) (used for the treatment of Parkinson's disease) may increase the effect of betahistine.

Using Betahistina Normon 24 mg with food and drinks:

It is recommended to take Betahistina Normon 24 mg during or after meals to avoid stomach upset.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

It is not known whether this medicine affects the fetus, so Betahistina Normon 24 mg should not be taken during pregnancy, unless your doctor considers it necessary.

It is not known whether this medicine passes into breast milk, so if you are taking Betahistina Normon 24 mg, you should not breastfeed your child.

No data are available on the effect of this medicine on fertility.

Driving and using machines

Betahistina Normon 24 mg is indicated in Meniere's syndrome. This disease may negatively affect the ability to drive and use machines. In clinical trials specifically designed to investigate the ability to drive or use machines, betahistine had no effects or were insignificant.

Betahistina Normon 24 mg contains lactose:

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Betahistina Normon 24 mg

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

The dose varies depending on the person and how they respond to treatment.

The recommended initial dose is 24 mg once a day.

Maximum daily dose: the patient can increase the dose to 24 mg taken twice a day (48 mg divided into two doses).

Maintenance dose: it will be established based on the response to treatment until the minimum effective dose is reached.

It is best to take the tablets with food.

The effect of the medicine usually does not manifest until after a few weeks.

Use in children and adolescents

This medicine should not be used in children and adolescents since its safety and efficacy have not been established.

If you take more Betahistina Normon 24 mg than you should

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 medicine and the amount taken.

You may experience the following symptoms due to an overdose: nausea, drowsiness, abdominal pain.

It may also appear, accelerated heartbeats (tachycardia), low blood pressure (hypotension), difficulty breathing with a feeling of suffocation (bronchospasm), fluid accumulation in the tissues (edema). Convulsions may occur after taking very high doses. Symptomatic treatment is recommended since there is no specific antidote.

If you forget to take Betahistina Normon 24 mg:

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

If you forget to take a dose, wait until the next dose and continue with the normal treatment.

If you stop taking Betahistina Normon 24 mg:

You should take Betahistina Normon 24 mg for as long as your doctor recommends. Do not stop treatment before, as the expected results will not be achieved.

If you have any other questions about 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.

During treatment with betahistine, the following serious side effects may occur:

Allergic reactions such as: swelling of the face, lips, tongue, or throat. This can cause difficulty breathing.

Red rash on the skin, inflammation, and itching on the skin.

If any of these side effects occur, you should stop treatment immediately and contact your doctor.

Common side effects (may affect up to 1 in 10 people)

Headache, occasional drowsiness, nausea, indigestion, mild stomach problems such as vomiting, stomach pain, and bloating.

Taking betahistine with food may help reduce these stomach problems.

Frequency not known (frequency cannot be estimated from the available data)

Itching, rash, urticaria, abnormal heartbeats (palpitations).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Betahistina Normon 24 mg

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

Store below 25°C.

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 stated.

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 other information

Composition of Betahistina Normon 24 mg tablets

• The active ingredient is betahistine in the form of betahistine dihydrochloride. Each tablet contains 24 mg of betahistine, in the form of betahistine dihydrochloride
• The other ingredients are: povidone, microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silica, crospovidone, and stearic acid.

Appearance and packaging of the product

Betahistina Normon 24 mg tablets are presented in the form of white, round, biconvex, and scored tablets.

Packaging of 60 tablets, in aluminum/aluminum-polyamide-PVC blisters.

Marketing authorization holder and manufacturer:

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of last revision of this leaflet:July 2019

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