Betahistamine Normon 24 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Betahistina Normon 24 mg tablets

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask 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, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Betahistina Normon 24 mg is and what it is used for
2. What you need to know before taking Betahistina Normon 24 mg
3. How to take Betahistina Normon 24 mg
4. Possible adverse effects
5. How to store Betahistina Normon 24 mg
6. Contents of the pack and other information

1. What Betahistina Normon 24 mg is and what it is used for

Betahistina Normon 24 mg tablets belong to a group of medicines called antivertigo agents: preparations for the treatment of vertigo. The active substance is betahistine dihydrochloride.

Betahistina Normon 24 mg tablets are used for the treatment of Ménière's syndrome, a disorder characterized by the following symptoms: vertigo (with nausea and vomiting), hearing loss, and sensation of 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 the sense of balance.

2. What you need to know before starting Betahistina Normon 24 mg

Do not take Betahistina Normon 24 mg:

• if you are allergic to the active substance betahistidine or to any of the other ingredients of this medicine (listed in section 6),
• if you have a tumor of the adrenal glands 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 ulcers,
• if you suffer from skin rashes with intense itching (urticaria), skin eruptions (exanthema), or hay fever.

Patients should be carefully monitored by their doctor during treatment with this medicine.

Children and adolescents

Betahistina Normon 24 mg is not recommended for use in children and adolescents under 18 years of age due to lack of experience in these age groups.

Other medicines and Betahistina Normon 24 mg

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 this medicine with antiallergic drugs such as antihistamines (especially H1 antagonists) may reduce the effectiveness of both medicines.

Caution is recommended when using betahistine together with MAO inhibitors (including selective MAO-B inhibitors such as selegiline), as this may lead to inhibition of betahistine metabolism.

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

Use of Betahistina Normon 24 mg with food and beverages:

It is recommended to take Betahistina Normon 24 mg during or after meals to avoid gastric discomfort.

Pregnancy, breastfeeding 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 24 mg 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 24 mg, you should not breastfeed.

There are no data available on the effect of this medicine on fertility.

Driving and use of machines

Betahistina Normon 24 mg 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 driving or machine use, betahistine had no effects or effects were negligible.

Betahistina Normon 24 mg contains lactose:

This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Betahistina Normon 24 mg

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

The dose varies depending on the individual and how they respond to treatment.

The recommended initial dose is 24 mg once daily.

Maximum daily dose: the patient may increase the dose to 24 mg taken twice daily (48 mg divided into two doses).

Maintenance dose: this will be established according to the response to treatment, aiming to achieve the lowest effective dose.

It is best to take the tablets with food.

The effect of the medicine usually does not become apparent until after about two weeks.

Use in children and adolescents

This medicine should not be used in children and adolescents, as its safety and efficacy have not been established.

If you take more Betahistina Normon 24 mg than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 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.

Also possible are increased heart rate (tachycardia), low blood pressure (hypotension), difficulty breathing with a feeling of suffocation (bronchospasm), and fluid accumulation in 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 24 mg:

Do not take a double dose to make up for missed doses.

If you forget to take a dose, wait until your next scheduled dose and continue your treatment as normal.

If you stop taking Betahistina Normon 24 mg:

You should take Betahistina Normon 24 mg for as long as your doctor recommends. Do not stop treatment prematurely, as the expected results will not be achieved.

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

4. Possible adverse effects

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

The following serious adverse effects may occur during treatment with betahistine:

Allergic reactions such as: swelling of the face, lips, tongue or neck. This may cause difficulty breathing.

Red rash on the skin, skin inflammation and itching.

If you experience any of these adverse effects, you must stop treatment immediately and contact your doctor.

Frequent adverse effects (may affect up to 1 in 10 people)

Headache, occasional drowsiness, nausea, indigestion, mild stomach problems such as vomiting, stomach pain and bloating.

Taking betahistine with food may help reduce these stomach problems.

Frequency not known (frequency cannot be estimated from available data)

Itching, rash, hives, abnormal heartbeats (palpitations).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Betahistine Normon 24 mg

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

Store below 25°C.

Do not use this medicine after the expiry date stated on the packaging 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 at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Betahistina Normon 24 mg Tablets

• The active substance is betahistine in the form of betahistine dihydrochloride. Each tablet contains 24 mg of betahistine as betahistine dihydrochloride.
• The other components are: povidone, microcrystalline cellulose, monohydrate lactose, anhydrous colloidal silica, crospovidone, and stearic acid.

Appearance of the medicinal product and contents of the pack

Betahistina Normon 24 mg tablets are presented as white, round, biconvex, bevelled tablets, marked on one side with a break line.

Packaging: 60 tablets in aluminum/aluminum-polyamide-PVC blisters.

Marketing Authorization Holder and Manufacturer:

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the most recent revision of this leaflet: July 2019

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.