BETAHISTINE NORMON 8 mg TABLETS

Introduction

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Betahistine dihydrochloride

Read the entire leaflet carefully before starting to take the medicine, as it contains important information for you.

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

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1. What is Betahistina Normon and what is it 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. Package contents and additional information

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

Betahistina Normon belongs to a group of medicines called antivertigo medicines, and its active ingredient is betahistine 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 inside 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 to any of the other components 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 may need to take any other medicine, including those obtained without a prescription.

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

Concomitant administration of Betahistina Normon with monoamine oxidase inhibitors (MAOIs) (used to treat 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 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

It is unknown whether 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 can 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 were insignificant.

3. How to take Betahistina Normon

Follow exactly the administration instructions of this medicine 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 1 tablet of 8 mg three times a day to 2 tablets of 8 mg three times a day (maximum dose). The maintenance dose will be adjusted based on your response, being the minimum effective dose, 1 tablet of 8 mg three times a day.

The tablets should be taken with water.

In some cases, improvement may not begin to be evident 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 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.

Use in children and adolescents

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.

If you take more Betahistina Normon 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 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 feeling of suffocation (bronchospasm), and fluid accumulation in the tissues (edema). Seizures may occur after taking very high doses.

Symptomatic treatment is recommended, as there is no specific antidote.

If you forget to take Betahistina Normon

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

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 other doubts about 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 everyone gets them.

The classification by frequency is as follows:

Very common: may affect more than 1 in 10 patients

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 an unknown frequency:

Immune system disorders

Hypersensitivity reactions, such as anaphylaxis.

Gastrointestinal disorders

Mild stomach problems (such as 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 side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's 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 special storage conditions.

Do not use this medicine after the expiration date stated on the packaging and blister after CAD.

The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Betahistina Normon:

The active ingredient is betahistine dihydrochloride. Each tablet contains 8 mg of betahistine dihydrochloride.

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

Appearance of the product and package contents

Betahistina Normon 8 mg tablets EFG are presented in the form of white or almost white, round, and serigraphed tablets.

Each package contains 60 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

LABORATORIOS NORMON, S.A.

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

Other presentations

Betahistina Normon 16 mg tablets EFG

Date of the last revision of this leaflet:June 2024

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