Leaflet: information for the user

Betahistina Aurovitas16mg tablets EFG

dihydrochloride of betahistine

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before starting to take Betahistina Aurovitas

3. How to take Betahistina Aurovitas

4. Possible side effects

5. Storage of Betahistina Aurovitas

6. Contents of the pack and additional information

Betahistina is a type of medication called an “histamine analogue”.

Betahistina Aurovitas is used to treat Meniere's Syndrome.

The symptoms include:

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

How this medication works

This medication works by improving circulation in the inner ear and thereby reducing pressure.

Do not take Betahistina Aurovitas

• If you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).
• If you have phaeochromocytoma, 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 a stomach ulcer (peptic ulcer).
• If you have asthma.
• If you suffer from urticaria, skin eruptions or a runny nose caused by an allergy, as these symptoms may be exacerbated.
• If you have low blood pressure.
• The diclorhidrato of betahistina is not the appropriate treatment for the following forms of vertigo:
• • benign positional vertigo,
  • vertigo related to a central nervous system disease.
• If you are pregnant or plan to become pregnant.
• If you are breastfeeding.

If you suffer from any of the symptoms mentioned above, consult your doctor about whether you can take Betahistina Aurovitas tablets. These patient groups must 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

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

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

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

Monamine 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 helps to reduce stomach problems.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

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

Do not take dihidrocloruro 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 dihidrocloruro of betahistina tablets unless your doctor tells you to. It is not known if betahistina passes into breast milk.

Driving and operating machinery

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.

Follow exactly the administration instructions 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 time to start working.

How to take Betahistina Aurovitas

• The tablets should be taken with water.
• Take the tabletduring 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 can adjust your dose.

The usual dose is:

Adults

The usual dose is 24 mg to 48 mgperday(half or one tablet of16mgthree times a day).

Dose

The daily dose should not exceed 48 mg.

In some cases, improvement may not be noticeable until two weeks after starting treatment. The best result is obtained after several months of treatment.

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

Try to take the tablet at the same time every day. This will ensure a constant amount of the medication in the 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 for 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 (phone 91 562 04 20), indicating the medication and theamount 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 choking (bronchospasm), fluid accumulation in tissues (edema). Seizures may occur after taking very high doses.

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

Speak with your doctor or go to the hospital immediately. Bring the Betahistina Aurovitas packaging with you.

If you forgot to take Betahistina Aurovitas

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

If you interrupt treatment with Betahistina Aurovitas

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

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them. Few side effects have been reported with betahistina.

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

Allergic reactions:

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

If you experience any of these adverse reactions, discontinue treatment immediately and consult your doctor.

Other adverse reactions include:

Frequent (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 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, p. anaphylaxis.

Other adverse reactions that have been reported with betahistina use

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

Skin and subcutaneous tissue disorders

Unknown frequency: skin and subcutaneous tissue hypersensitivity reactions, particularly angioneuritic edema, urticaria, exanthema, and pruritus.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly to the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the box, blister pack, and label of the bottle after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Betahistina Aurovitas Composition

• The active ingredient is dihydrochloride of betahistina. Each tablet contains16 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 packaging contents

Tablet.

Uncoated tablets, white to off-white in color, round (diameter8,5mm), marked with “X”and scoredon one face of the tablet andmarkedwith“88” on the other.The tablet can be divided into equal doses.

Betahistina Aurovitas16mg tablets are available in blisters of Polyamide / Aluminum / PVC / Aluminum and high-density polyethylene (PEAD) bottles with polypropylene closure, white opaque in color, filled with cotton.

Packaging sizes:

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

PEAD bottles: 30 and 1,000 tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid,

Spain

Responsible manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

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

Republic of Czechia:Betahistin Aurovitas
Ireland:Vertigon16mg tablets

Italy:Betaistina Aurobindo
Netherlands:Betahistine diHCl Aurobindo16mg, tabletten
Portugal:Beta-histina Aurobindo
Spain: Betahistina Aurovitas16mg tablets EFG

Last review date of this leaflet:December 2021

Detailed information about this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/