BETAHISTINE AUROVITAS 8 mg TABLETS

Introduction

Package Leaflet: Information for the User

Betahistina Aurovitas8 mg tablets EFG

dihydrochloride of betahistine

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication 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 or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Betahistina Aurovitas and what is it used for
2. What you need to know before taking Betahistina Aurovitas
3. How to take Betahistina Aurovitas
4. Possible side effects
5. Storage of Betahistina Aurovitas
6. Package contents and additional information

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

Betahistina is a type of medication called a "histamine analog".

Betahistina Aurovitas is used to treat Meniere's Syndrome.

The symptoms include:

• Dizziness (vertigo).
• Ringing in the ears (tinnitus).
• Hearing loss or difficulty hearing.

How this medication works

This medication works by improving circulation in the inner ear and thereby reducing 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 any of the other components of this medication (listed in section 6).
• If you have pheochromocytoma, a rare tumor of the adrenal glands.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Betahistina Aurovitas:

• If you have or have had stomach ulcers (peptic ulcers).
• If you have asthma.
• If you suffer from hives, skin rashes, or a runny nose caused by an allergy, as these symptoms may be exacerbated.
• If you have low blood pressure.
• Dihydrochloride of betahistina is not the appropriate treatment for the following forms of vertigo:
• • benign positional vertigo attacks,
  • dizziness related to a central nervous system disorder.
• If you are pregnant or plan to become pregnant.
• If you are breastfeeding.

If you experience any of the above symptoms, consult your doctor about 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 children and adolescents (under 18 years of age).

Other medications and Betahistina Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medication.

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

Antihistamines, as betahistina may not work properly. Betahistina may decrease the effect of antihistamines.

Monoamine oxidase inhibitors (MAOIs) - used to treat depression or Parkinson's disease. They may increase the effect of betahistina.

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 betahistina with food can help reduce stomach problems.

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 medication.

It is not known if dihydrochloride of betahistina affects the fetus.

Do not take dihydrochloride of betahistina tablets if you are pregnant unless your doctor decides it is absolutely necessary. Ask your doctor for advice. Do not breastfeed while taking dihydrochloride of betahistina tablets without consulting your doctor. It is not known if betahistina passes into breast milk.

Driving and using machines

Betahistina Aurovitas is unlikely to affect your ability to drive or use machines or tools.

However, remember that the disease for which you are being treated with Betahistina Aurovitas (Meniere's Syndrome) may make you feel dizzy or sick, affecting your ability to drive and use machines.

3. How to take Betahistina Aurovitas

Follow the instructions for administration of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

• Your doctor will adjust the dose, depending on your progress.
• Continue taking your medication. The medication 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 can help reduce stomach problems.

How much Betahistina Aurovitas to take

Always follow the instructions of your doctor, as they 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 a day).

Dose

The daily dose should not exceed 48 mg.

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

If you take more than one tablet a day, space your tablets evenly throughout the day. For example, take one tablet in the morning, one at noon, and one in the evening.

Try to take the tablet at the same time every day. This will ensure that there is a constant amount of the medication in your body. Taking the tablets at the same time every day will 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medication and the amount ingested.

If you or others take too many Betahistina Aurovitas tablets (overdose), you may experience nausea, drowsiness, abdominal pain. You may also experience rapid heartbeat (tachycardia), low blood pressure (hypotension), difficulty breathing with a feeling of suffocation (bronchospasm), fluid accumulation in the 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 to the hospital immediately. Bring the Betahistina Aurovitas package with you.

If you forget to take Betahistina Aurovitas

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

If you stop taking Betahistina Aurovitas

Continue taking the tablets until your doctor tells you to stop. Even when you start to feel better, your doctor may want you to continue taking the tablets for some time to make sure the medication has worked completely.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them. Very few side effects have been reported with betahistina.

The following serious side effects may occur during treatment with betahistina:

Allergic reactions:

• Redness or bumps 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 side effects, you should stop treatment immediately and talk to your doctor.

Other side effects include:

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

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

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

Blood and lymphatic system disorders

Unknown frequency: thrombocytopenia.

Immune system disorders

Unknown frequency: hypersensitivity reactions, e.g. anaphylaxis.

Other side effects reported with betahistina

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

Skin and subcutaneous tissue disorders

Unknown frequency: cutaneous and subcutaneous hypersensitivity reactions, in particular angioedema, urticaria, exanthema, and pruritus.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Betahistina Aurovitas

Keep this medication out of sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date shown on the carton, blister, and label of the bottle after EXP. The expiration date is the last day of the month indicated.

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

6. Package contents and additional information

Composition of Betahistina Aurovitas

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

Appearance of the product and package contents

Tablet.

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

Betahistina Aurovitas 8 mg tablets are available in polyamide/aluminum/PVC/aluminum blisters and high-density polyethylene (HDPE) bottles with a polypropylene cap, white opaque, cotton-filled.

Package sizes:Blisters: 10, 20, 30, 50, 60, 84, 90, 100, and 120 tablets.

HDPE bottles: 30 and 1,000 tablets.

Not all package sizes may be marketed.

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 medication is authorized in the EEA Member States with the following names:

Cyprus: Betahistine Aurobindo 8 mg δισκ?αFrance: 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, tablettenPortugal: Beta-histina Aurobindo

Spain: Betahistina Aurovitas 8 mg tablets EFG

Date of the last revision of this package leaflet:December 2021

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