Prospecto: information for the user

Betahistina Normon 16 mg tabletsEFG

Betahistina dihidrocloruro

Read the entire prospect carefully before starting to takethemedicine, because it contains important information for you.

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

Content of the prospect:

1. What is Betahistina Normon and for what it is used
2. What you need to know before starting to take Betahistina Normon
3. How to take Betahistina Normon
4. Possible adverse effects
5. Storage of Betahistina Normon
6. Contents of the package and additional information

Betahistina Normon belongs to a group of medications known as antivertiginous medications and its active ingredient is dihydrochloride of betahistina.

Betahistina is used for the treatment of Meniere's Syndrome, which is a disorder characterized by the following symptoms: vertigo (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 circulation in the inner ear and thereby reducing pressure. The inner ear is one of the organs responsible for the sense of balance.

Do not take Betahistina Normon

Warnings and Precautions

Consult your doctor or pharmacist before starting to take betahistina:

Other Medications and Betahistina Normon

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

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

The administration at the same time as Betahistina Normon with monoamine oxidase inhibitors (MAOIs), (used for the treatment of Parkinson's disease), may increase the effect of Betahistina Normon.

Use of Betahistina Normon with Food, Drinks, and Alcohol

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

Children and Adolescents

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

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

The effects of this medication on the fetus are unknown, so Betahistina Normon should not be taken during pregnancy, unless your doctor considers it necessary.

The effects of this medication on breast milk are unknown, so if you are taking Betahistina Normon, you should not breastfeed your child.

Driving and Operating Machines

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

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

Your doctor will adjust the dose, based on your response to treatment from an initial dose of half a tablet of 16 mg three times a day to a tablet of 16 mg three times a day (maximum dose). The maintenance dose will be adjusted based on your response, with the minimum effective dose being half a tablet of 16 mg three times a day.

The tablets should be taken with water. The 16 mg tablets are scored to allow them to be divided into two equal halves and facilitate the taking of half a dose (8 mg) when necessary.

Improvement may not become apparent until two weeks after starting treatment. The optimal result is obtained after several months of treatment.

The tablets can be taken with or without food. However, if taken without food, they may cause mild stomach problems (listed in section 4). Taking the tablets with food may help reduce stomach problems.

Use in children and adolescents

Betahistina is not recommended for use in children and adolescents under 18 years due to the scarcity of data on safety and efficacy.

Taking more Betahistina Normon 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 heartbeat (tachycardia), low blood pressure (hypotension), difficulty breathing with a sensation of choking (bronchospasm), fluid accumulation 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.

Missing a dose of Betahistina Normon

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.

Stopping treatment with Betahistina Normon

You should take betahistina for as long as your doctor recommends. Do not interrupt treatment prematurely, as you will not achieve the expected results.

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

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

The classification by frequencies is as follows:

Very frequent: may affect more than 1 in 10 patients

Frequent: may affect up to 1 in 10 patients

Infrequent: may affect up to 1 in 100 patients

Rare: may affect up to 1 in 1,000 patients

Very rare: may affect up to 1 in 10,000 patients

Unknown frequency: the frequency cannot be estimated from the available data

In clinical trials, the adverse effects found were:

Gastrointestinal disorders

Frequent: nausea and dyspepsia (upper abdominal discomfort with a feeling of bloating).

Nervous system disorders

Frequent: headache.

After its commercialization and in scientific literature, the following adverse effects with an unknown frequency have been reported:

Immune system disorders

Hypersensitivity reactions, for example anaphylaxis.

Gastrointestinal disorders

Mild gastric discomfort (for example vomiting, gastrointestinal pain, distension, and abdominal bloating). These effects can usually be treated by taking the medication with meals or reducing the dose.

Skin and subcutaneous tissue disorders

Hypersensitivity skin and subcutaneous reactions, particularly angioneurotic edema (skin and mucous membrane swelling, especially on the face, mouth, tongue, and hands), urticaria, skin rash, and pruritus.

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.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging and in the blister pack 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 the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

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Composition of Betahistina Normon

The active principle is betahistine dihydrochloride. Each tablet contains 16 mg of betahistine dihydrochloride.

The other components (excipients) are: mannitol (E-421), microcrystalline cellulose, citric acid, low-substitution hydroxypropylcellulose, colloidal silica, talc, and macrogol 6000.

Apect to the product and content of the packaging

Betahistina Normon 16 mg tablets EFG are presented in the form of white or almost white, round, scored, and printed tablets.

Each package contains 30 tablets.

Title of the marketing authorization and responsible manufacturer

Title of the marketing authorization

Laboratorios Normon, S.A.

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

Other presentations

Betahistina Normon 8 mg tablets EFG

Last review date of this leaflet:June2024

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