Betahistine Aurovitas 8 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Betahistina Aurovitas 8 mg tablets EFG

betahistine dihydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. 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, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these effects are not listed in this leaflet. See section 4.

Contents of the leaflet:

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

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

Betahistina is a type of medicine known as a "histamine analogue".

Betahistina Aurovitas is used to treat Ménière's syndrome.

The symptoms include:

• Sensation of dizziness (vertigo).
• Ringing in the ears (tinnitus).
• Hearing loss or difficulty hearing.

How this medicine works

This medicine works by improving circulation in the inner ear and thereby reduces pressure.

2. What you need to know before taking Betahistina Aurovitas

Do not take Betahistina Aurovitas

• If you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• If you have phaeochromocytoma, a rare tumour of the adrenal glands.

Warnings and precautions

Talk to your doctor or pharmacist before taking Betahistina Aurovitas:

• If you have or have had a stomach ulcer (peptic ulcer).
• If you have asthma.
• If you suffer from urticaria, skin rashes, or allergic rhinitis, as these conditions may be exacerbated.
• If you have low blood pressure.
• Betahistine dihydrochloride is not the appropriate treatment for the following types of vertigo:
  • benign paroxysmal positional vertigo,
  • dizziness related to a central nervous system disorder.
• If you are pregnant or planning to become pregnant.
• If you are breastfeeding.

If you experience any of the symptoms listed above, consult your doctor to determine whether you can take Betahistina Aurovitas tablets. These patient groups should be monitored by a doctor during treatment.

Use in children and adolescents

Betahistina Aurovitas is not recommended for use in children and adolescents (under 18 years of age).

Other medicines and Betahistina Aurovitas

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

Antihistamines, because betahistine may theoretically not work properly. Betahistine may reduce the effect of antihistamines.

Monoamine-oxidase inhibitors (MAOIs) – used to treat depression or Parkinson’s disease. These may increase the effect of betahistine.

Taking Betahistina with food, drinks and alcohol

Betahistina Aurovitas can be taken with or without food. However, Betahistina Aurovitas may cause mild stomach problems (see section 4). Taking betahistine with food helps reduce stomach-related side effects.

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 not known whether betahistine dihydrochloride affects the fetus.

Do not take betahistine dihydrochloride tablets during pregnancy unless your doctor decides it is absolutely necessary. Consult your doctor for advice. Do not breastfeed while taking betahistine dihydrochloride tablets unless instructed to do so by your doctor. It is unknown whether betahistine passes into breast milk.

Driving and using machines

It is unlikely that Betahistina Aurovitas will affect your ability to drive or operate machinery or tools.

However, bear in mind that the condition for which you are being treated with Betahistina Aurovitas (Menière’s syndrome) may cause dizziness or nausea, which could affect your ability to drive and use machines.

3. How to take Betahistina Aurovitas

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

• Your doctor will adjust the dose according to your response.
• Continue taking your medicine. The medicine may take some time to start working.

How to take Betahistina Aurovitas

• The tablets should be taken with water.
• Take the tablet during or after a meal. Betahistina Aurovitas may cause mild stomach problems (see Section 4). Taking Betahistina Aurovitas with food may help reduce stomach problems.

How much Betahistina Aurovitas to take

Always follow your doctor's instructions, as they are the ones who can adjust your dose.

The usual dose is:

Adults

The usual dose is 24 mg to 48 mg per day (one or two 8 mg tablets three times daily).

Dose

The daily dose should not exceed 48 mg.

In some cases, improvement may not begin to be noticeable until two weeks after starting treatment. The optimal result is achieved after several months of treatment.

If you take more than one tablet per day, divide your doses evenly throughout the day. For example, take one tablet in the morning, one at midday, and one at night.

Try to take the tablet at the same time each day. This will ensure a constant amount of the medicine in your body. Taking the tablets at the same time every day will also help you remember to take them. The use of Betahistina Aurovitas is not recommended in children.

If you take more Betahistina Aurovitas than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service (telephone number 91 562 04 20), indicating the medicine and the amount ingested.

If you or others take too many Betahistina Aurovitas tablets (overdose), symptoms such as nausea, drowsiness, and abdominal pain may occur. 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 taking very high doses.

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

Talk to your doctor or go immediately to a hospital. Take the Betahistina Aurovitas packaging with you.

If you forget to take Betahistina Aurovitas

Wait until the next scheduled dose. Do not take a double dose to make up for forgotten doses.

If you stop taking Betahistina Aurovitas

Keep taking the tablets as directed by your doctor. Even when you start feeling better, your doctor may want you to continue taking the tablets for some time to ensure the medicine has fully worked.

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 experiences them. Very few adverse effects have been reported with betahistina.

The following serious adverse reactions may occur during treatment with betahistina:

Allergic reactions:

• Redness or lumps on the skin, skin rash or itching of inflamed skin.
• Swelling of the face, lips, tongue or throat.
• Decreased blood pressure.
• Loss of consciousness.
• Difficulty breathing.

If you experience any of these adverse reactions, you must stop treatment immediately and speak with your doctor.

Other adverse reactions include:

Common (may affect up to 1 in 10 patients):

• Discomfort (nausea).
• Indigestion (dyspepsia).
• Headache.

The following adverse effects have been reported spontaneously during post-marketing use and in scientific literature. The frequency cannot be estimated from the available data and is therefore classified as "not known":

Blood and lymphatic system disorders

Frequency not known: thrombocytopenia.

Immune system disorders

Frequency not known: hypersensitivity reactions, e.g. anaphylaxis.

Other adverse reactions reported with betahistina intake

Mild stomach problems such as discomfort (vomiting), stomach pain, dry mouth, diarrhea, and stomach swelling (abdominal distension) and swelling. Taking betahistina with food may help reduce stomach problems.

Skin and subcutaneous tissue disorders

Frequency not known: cutaneous and subcutaneous hypersensitivity reactions, particularly angioneurotic edema, urticaria, exanthema, and pruritus.

Reporting of adverse effects

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

5. Storage of Betahistina Aurovitas

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 carton, blister pack, and label of the bottle after EXP. The expiry date refers to the last day of the month indicated.

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

6. Contents of the container and other information

Composition of Betahistina Aurovitas

• The active substance is betahistine dihydrochloride. Each tablet contains 8 mg of betahistine dihydrochloride.
• The other components (excipients) are: microcrystalline cellulose, mannitol, povidone, crospovidone, citric acid, colloidal anhydrous silica, talc and stearic acid.

Appearance of the product and contents of the container

Tablet.

Uncoated tablets, white to off-white, flat, round (diameter 7.0 mm), marked with an “X” on one side of the tablet and “87” on the other.

Betahistina Aurovitas 8 mg tablets are available in blisters made of Polyamide / Aluminium / PVC / Aluminium.

Pack sizes: Blister packs: 10, 20, 30, 50, 60, 84, 90, 100 and 120 tablets.

Only some pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid,

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

or

Generis Farmacêutica, S.A.

Rua João de Deus, n. 19

Venda Nova,

2700-487 Amadora

Portugal

This medicinal product is authorized in the EEA Member States under the following names:

Cyprus: Betahistine Aurobindo 8 mg δισκ?α

France: BETAHISTINE ARROW GÉNÉRIQUES 8 mg, comprimé

Ireland: Vertigon 8 mg tablets

Italy: Betaistina Aurobindo

Malta: Betahistine 8 mg tablets

Netherlands: Betahistine diHCl Aurobindo 8 mg, tabletten

Portugal: Beta-histina Aurobindo

Spain: Betahistina Aurovitas 8 mg tablets EFG

Date of the most recent review of this leaflet: December 2021

Detailed 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/).