Betahistine Aurovitas 16 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Betahistina Aurovitas 16mg 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; do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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 adverse 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

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

Betahistina Aurovitas is used to treat Ménière's syndrome.

The symptoms include:

• Feeling 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, 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 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

Consult your doctor or pharmacist before starting to take 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.
• Dihydrochloride betahistine 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 about whether you can take Betahistina Aurovitas tablets. These patient groups should be monitored by a physician 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 betahistina may theoretically not work properly. Betahistina may reduce the effect of antihistamines.

Monoamine oxidase inhibitors (MAOIs) – used to treat depression or Parkinson's disease. These 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 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. Ask your doctor for advice. Do not breastfeed while taking betahistine dihydrochloride tablets unless instructed otherwise by your doctor. It is unknown whether betahistina passes into breast milk.

Driving and using machines

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

However, remember that the condition for which you are being treated with Betahistina Aurovitas (Menière's syndrome) may cause dizziness or nausea, thereby affecting your ability to drive and use machines.

3. How to take Betahistina Aurovitas

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

• Your doctor will adjust the dose depending on your condition.
• 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 (half or one 16 mg tablet 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 effect 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 in the evening.

Try to take the tablet at the same time each day. This will ensure a constant level 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 Poison Information Service (telephone 91 562 04 20), indicating the medicine 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 develop rapid heartbeat (tachycardia), low blood pressure (hypotension), breathing difficulty with a feeling of suffocation (bronchospasm), or 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. Bring the Betahistina Aurovitas packaging with you.

If you forget to take Betahistina Aurovitas

Wait until your 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 until your doctor tells you otherwise. Even when you start to feel 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 can cause adverse effects, although not everyone experiences them. Very few adverse effects have been reported with betahistamine.

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

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 to your doctor.

Other adverse reactions include:

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

• Malaise (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 betahistamine intake

Mild stomach problems such as malaise (vomiting), stomach pain, dry mouth, diarrhea, and stomach swelling (abdominal distension) and swelling. Taking betahistamine 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 through 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 Betahistine 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 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 are unsure, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Betahistina Aurovitas

• The active substance is betahistine dihydrochloride. Each tablet contains 16 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, round (diameter 8.5 mm), marked with an “X” and scored on one side of the tablet and marked with “88” on the other. The tablet can be divided into equal doses.

Betahistina Aurovitas 16 mg tablets are available in blisters made of Polyamide / Aluminium / PVC / Aluminium.

Pack sizes:

Blister packs: 10, 20, 30, 60, 84 and 90 tablets.

Only some pack 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 medicinal product is authorized in the Member States of the EEA under the following names:

Ireland: Vertigon 16 mg tablets

Italy: Betaistina Aurobindo
Malta: Betahistine 16 mg tablets
Netherlands: Betahistine diHCl Aurobindo 16 mg, tabletten
Portugal: Beta-histina Aurobindo
Spain: Betahistina Aurovitas 16 mg comprimidos 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 (Agencia Española de Medicamentos y Productos Sanitarios, AEMPS) (http://www.aemps.gob.es/).