Betahistina normon 24 mg comprimidos

Leaflet: information for the user

Betahistina Normon 24 mg tablets

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

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

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

2. What you need to know before you start taking 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 additional information

Betahistina Normon 24 mg tablets belong to a group of medicines called antivertiginous: preparations against dizziness and its active ingredient is dihydrochloride of betahistina.

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

The active ingredient of this medication is a histamine analogue that acts by improving blood circulation in the inner ear and thereby reduces pressure. The inner ear is one of the organs responsible for the sense of balance.

Do not take Betahistina Normon 24 mg:

- if you are allergic to the active ingredient betahistina or to any of the other components of this medication (listed in section 6)

- if you have a cancer of the adrenal glands called phaeochromocytoma.

Warnings and precautions

Consult your doctor or pharmacist before starting to take betahistina:

- if you have bronchial asthma,

- if you have or have had a stomach ulcer,

- if you suffer from skin rashes and intense itching (urticaria), skin eruption (exanthema) or hay fever.

Patients should be carefully monitored by the doctor during treatment with this medication.

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 medications and Betahistina Normon 24 mg

Inform your doctor or pharmacist if you are using, have used recently or may have to use any other medication, including those acquired without a prescription.

The administration at the same time of this medication with antiallergic medications such as antihistamines (especially H1 antagonists) may reduce the effectiveness of both medications.

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

The administration at the same time of this medication with monoamine oxidase inhibitors (MAO), (used for the treatment of Parkinson's disease), may increase the effect of betahistina.

Use of Betahistina Normon 24 mg with food and beverages:

It is recommended to take Betahistina Normon 24 mg during or after meals to avoid gastrointestinal discomfort.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, believe you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

The effect of this medication on the fetus is unknown, therefore Betahistina Normon 24 mg should not be taken during pregnancy, unless your doctor considers it necessary.

The effect of this medication on breast milk is unknown, therefore if you are taking Betahistina Normon 24 mg, do not breastfeed your child.

No data is available on the effect of this medication on fertility.

Driving and operating machinery

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

Betahistina Normon 24 mg contains lactose:

This medication contains lactose. If your doctor has indicated that you have a intolerance to certain sugars, consult with him before taking this medication.

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

The dosage varies according to individuals and how they respond to treatment.

The recommended initial dose is 24 mg once a day.

Maximum daily dose: the patient may 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 medication usually does not manifest until two weeks have passed.

Use in children and adolescents

This medication 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 Toxicological Information Service, phone: 91 562 04 20 indicating the medication and the amount ingested.

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

You may also experience, rapid heart rate (tachycardia), low blood pressure (hypotension), difficulty breathing with a sensation of choking (bronchospasm), accumulation of fluid in tissues (edema). Seizures may occur after taking very high doses. It is recommended that you receive symptomatic treatment since there is no specific antidote.

If you forget to take Betahistina Normon 24 mg:

Do not take a double dose to compensate for the missed doses.

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

If you interrupt treatment with Betahistina Normon 24 mg:

You should take Betahistina Normon 24 mg for as long as your doctor recommends. Do not interrupt treatment prematurely, as this may not produce the expected results.

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 will experience them.

During treatment with betahistina, the following severe adverse effects may occur:

Allergic reactions such as: facial swelling, lip, tongue, or neck swelling. This may cause respiratory difficulty.

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

If any of these adverse effects occur, stop treatment immediately and contact your doctor.

Frequent Adverse Effects (may affect up to 1 in 10 people)

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

Taking betahistina with food may help reduce these stomach problems.

Unknown Frequency (frequency cannot be estimated from available data)

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

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 Medicinal Products for Human Use website:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Store below 25°C.

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.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Betahistina Normon 24 mg tablets

- The active ingredient is betahistina in the form of dihydrochloride of betahistina. Each tablet contains 24 mg of betahistina, in the form of dihydrochloride of betahistina

- The other components are: povidone, microcrystalline cellulose, lactose monohydrate, anhydrous colloidal silica, crospovidone and stearic acid.

Appearance of the product and contents of the packaging

Betahistina Normon 24 mg tablets are presented in the form of white, round, biconvex, bisected and marked on one face with a breaking line.

Packaging of 60 tablets, in Aluminio/Aluminio-Poliamida-PVC blister.

Holder of the marketing authorization and responsible for manufacturing:

LABORATORIOS NORMON, S.A.

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

Date of the last review of this leaflet:July 2019

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