Betahistine Normon 8 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Betahistina Normon 8 mg tablets EFG

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 questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if the adverse reactions are not listed in this leaflet. See section 4.

Package leaflet contents

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 other information

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

Betahistina Normon belongs to a group of medicines known as anti-vertigo agents, and its active ingredient is betahistine dihydrochloride.

Betahistina is used in the treatment of Ménière's syndrome, a disorder characterized by the following symptoms: vertigo (with nausea and vomiting), hearing loss, and the sensation of ringing or noise in the ear (tinnitus).

The active substance in this medicine is an analogue of histamine that acts by improving circulation in the inner ear, thereby reducing pressure. The inner ear is one of the organs responsible for balance.

2. What you need to know before taking Betahistina Normon

Do not take Betahistina Normon

• If you are allergic to the active substance 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 phaeochromocytoma.

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 ulcer.
• If you suffer from skin hives and intense itching (urticaria), skin rash (exanthema), or hay fever.

Other medicines and Betahistina Normon

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

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

Concomitant administration of Betahistina Normon with monoamine oxidase inhibitors (MAOIs) (used in the treatment of Parkinson's disease) may increase the effect of Betahistina Normon.

Use of Betahistina Normon with food, beverages, and alcohol

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

Children and adolescents

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

Pregnancy, lactation and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

It is unknown whether this medicine affects the fetus; therefore, Betahistina Normon should not be taken during pregnancy unless considered necessary by your doctor.

It is unknown whether this medicine passes into breast milk; therefore, if you are taking Betahistina Normon, you should not breastfeed your baby.

Driving and Operating Machinery

Betahistine is indicated for Ménière'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, betahistine had no effects or the effects were negligible.

3. How to take Betahistina Normon

Follow exactly the instructions given by your doctor or pharmacist for administering this medicine. If in doubt, consult your doctor or pharmacist again.

Your doctor will adjust your dose according to your response to treatment, starting from an initial dose of one 8 mg tablet three times a day up to two 8 mg tablets three times a day (maximum dose). The maintenance dose will be adjusted according to your response, with the minimum effective dose being one 8 mg tablet three times a day.

The tablets should be taken with water.

In some cases, improvement may not become evident until two weeks after starting treatment. Optimal results are achieved after several months of treatment.

The tablets may 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 discomfort.

Use in children and adolescents

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

If you take more Betahistina Normon than you should

In case of overdose or accidental ingestion, immediately consult your doctor or pharmacist, or call the Toxicology Information Service at telephone number: 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 develop rapid heartbeat (tachycardia), low blood pressure (hypotension), difficulty breathing with a feeling of suffocation (bronchospasm), and fluid accumulation in 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 missed doses. If you forget to take a dose, wait until the next scheduled dose and continue your normal treatment.

If you interrupt treatment with Betahistina Normon

You should take betahistine for as long as your doctor recommends. Do not stop treatment earlier, as the expected results would not be achieved.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

The frequency classification is as follows:

Very common: may affect more than 1 in 10 people

Gastrointestinal disorders

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

Nervous system disorders

Common: headache.

Following marketing and reported in the scientific literature, the following adverse reactions have been reported with unknown frequency:

Immune system disorders

Hypersensitivity reactions, for example anaphylaxis.

Gastrointestinal disorders

Mild gastric discomfort (e.g. vomiting, gastrointestinal pain, distension and abdominal swelling). These effects can usually be managed by taking the medicine during meals or by reducing the dose.

Skin and subcutaneous tissue disorders

Cutaneous and subcutaneous hypersensitivity reactions, particularly angioneurotic edema (swelling of the skin and mucous membranes, especially of the face, mouth, tongue, and hands), urticaria, skin rash, and itching (pruritus).

Reporting of adverse reactions:

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it involves possible adverse reactions not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse reactions, 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 stated on the packaging and on the blister after EXP.

The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE point located at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Betahistina Normon:

The active substance is betahistina dihydrochloride. Each tablet contains 8 mg of betahistina dihydrochloride.

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

Appearance of the product and contents of the container

Betahistina Normon 8 mg tablets EFG are presented as white or almost white, round, film-coated tablets, printed with a marking.

Each pack contains 60 tablets.

Marketing Authorization Holder and Manufacturing Responsible

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 latest revision of this leaflet: June 2024

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