BETAHISTINE NORMON 16 mg TABLETS

Introduction

Package Leaflet: Information for the User

Betahistina Normon 16 mg TabletsEFG

Betahistina Dihydrochloride

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• Keep this leaflet, as 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

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

Betahistina Normon belongs to a group of medicines called antivertigo medicines, and its active ingredient is betahistina dihydrochloride.

Betahistina is used to treat Meniere's Syndrome, which is 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, thereby reducing pressure. The inner ear is one of the organs responsible for the sense of balance.

2. What you need to know before taking Betahistina Normon

Do not take Betahistina Normon

• If you are allergic to the active ingredient or 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.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take betahistina:

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

Other Medicines and Betahistina Normon

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

Taking Betahistina Normon at the same time as antiallergic medicines such as antihistamines (especially H1 antagonists) may reduce the efficacy of both medicines.

Taking Betahistina Normon at the same time as monoamine oxidase inhibitors (MAOIs) (used to treat Parkinson's disease) may increase the effect of Betahistina Normon.

Using Betahistina Normon with Food, Drinks, and Alcohol

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

Children and Adolescents

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

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 if this medicine affects the fetus, so Betahistina Normon should not be taken during pregnancy, unless your doctor considers it necessary.

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

Driving and Using Machines

Betahistina is indicated for 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, betahistina had no effects or they were insignificant.

3. How to Take Betahistina Normon

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If in 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 16 mg tablet three times a day to a 16 mg tablet three times a day (maximum dose). The maintenance dose will be adjusted based on your response, being the minimum effective dose, half a 16 mg tablet 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 administration of half the dose (8 mg) when necessary.

In some cases, the improvement may not begin to become apparent until two weeks after the start of treatment. The optimal result is obtained after several months of treatment.

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

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

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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. You may also experience rapid heart rate (tachycardia), low blood pressure (hypotension), difficulty breathing with a feeling of suffocation (bronchospasm), and fluid accumulation in the tissues (edema). Convulsions may occur after taking very high doses.

Symptomatic treatment is recommended since there is no specific antidote.

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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.

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

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The frequency classification is as follows:

Very common: may affect more than 1 in 10 people

Common: may affect up to 1 in 10 people

Uncommon: may affect up to 1 in 100 people

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

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

Frequency not known: frequency cannot be estimated from the available data

In clinical trials, the following side effects were found:

Gastrointestinal Disorders

Common: nausea and dyspepsia (discomfort in the upper abdomen with a feeling of bloating).

Nervous System Disorders

Common: headache.

After marketing and in the scientific literature, the following side effects have been reported with a frequency not known:

Immune System Disorders

Hypersensitivity reactions, for example, anaphylaxis.

Gastrointestinal Disorders

Mild stomach problems (e.g., vomiting, gastrointestinal pain, abdominal distension, and bloating). These effects can usually be treated by taking the medicine during meals or reducing the dose.

Skin and Subcutaneous Tissue Disorders

Hypersensitivity reactions of the skin and subcutaneous tissue, in particular, angioneurotic edema (swelling of the skin and mucous membranes, especially of the face, mouth, tongue, and hands), urticaria, skin eruptions, and itching (pruritus).

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 side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Betahistina Normon

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the packaging and on the blister 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.

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6. Contents of the Pack and Further Information

Composition of Betahistina Normon

The active ingredient is betahistina dihydrochloride. Each tablet contains 16 mg of betahistina dihydrochloride.

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

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

Each pack contains 30 tablets.

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LABORATORIOS NORMON, S.A.

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

Other Presentations

Betahistina Normon 8 mg Tablets EFG

Date of Last Revision of this Leaflet:June 2024

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