Betahistine Normon 16 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Betahistina Normon 16 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 you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects 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 antivertigo agents, and its active substance 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 noise in the ear (tinnitus).

The active ingredient in 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 substance or to 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 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 rashes and intense itching (urticaria), skin eruption (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 Betahistine Normon with food, drinks, and alcohol

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

Children and adolescents

Betahistine 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, 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 Betahistin 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 Betahistin Normon, you should not breastfeed.

Driving and use of machines

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 for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

The tablets should be taken with water. The 16 mg tablets are scored so they can be divided into two equal halves, facilitating administration of a half dose (8 mg) when necessary.

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-related issues.

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 an increased heart rate (tachycardia), low blood pressure (hypotension), breathing difficulty with a sensation of suffocation (bronchospasm), and fluid accumulation in the tissues (edema). Seizures may occur after ingestion of 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 treatment as normal.

If you interrupt treatment with Betahistina Normon

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

If you have any further questions about the use of this medicine, consult 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
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 adverse effects observed were:

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

Central nervous system disorders
Common: headache.

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

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 managed by taking the medicine with food or by reducing the dose.

Skin and subcutaneous tissue disorders
Cutaneous and subcutaneous hypersensitivity reactions, particularly angioneurotic oedema (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 is a possible adverse reaction 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 Betahistine 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 a SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the container and other information

Composition of Betahistina Normon

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

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

Appearance of the product and contents of the pack

Betahistina Normon 16 mg tablets EFG are presented as white or almost white, round, scored, and printed tablets.

Each pack contains 30 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 8 mg tablets EFG

Date of the most recent review 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/