Betahistine Qualigen 8 mg tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Betahistina Qualigen 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, 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, because it could harm them.

If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.Contents of the leaflet:

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

2. What you need to know before taking Betahistina Qualigen

3. How to take Betahistina Qualigen

4. Possible side effects

5. How to store Betahistina Qualigen

6. Contents of the pack and other information

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

Betahistina Qualigen belongs to a group of medicines called anti-vertigo preparations.

Betahistina Qualigen is used for the treatment of Ménière's syndrome, a disorder characterized by the following symptoms: vertigo (with nausea and vomiting), hearing loss, and tinnitus (sensation of noise in the ear).

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

Do not take Betahistina Qualigen:

• if you are allergic to betahistine or to any of the other ingredients of this medicine (listed in section 6).
• if you have a disease called phaeochromocytoma.

Warnings and precautions

• Consult your doctor or pharmacist before starting to take Betahistina Qualigen:
  • if you have bronchial asthma,
  • if you have or have had a stomach ulcer.

Other medicines and Betahistina Qualigen
Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

No interactions between betahistine and other medicines are known to date.

Taking Betahistina Qualigen with food and drinks:

Food does not affect the action of Betahistina Qualigen, so it can be taken before, during, or after meals.

If any stomach discomfort occurs, it is recommended to take Betahistina Qualigen during meals.

Children and adolescents
Use in individuals under 18 years of age is not recommended.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Betahistina Qualigen must not be taken during pregnancy unless your doctor considers it necessary.

Betahistina Qualigen must not be taken during breastfeeding.

Driving and using machines

Betahistina Qualigen does not affect your ability to drive or operate machinery.

Betahistina Qualigen contains lactose: This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Betahistina Qualigen

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

Remember to take your medicine.

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

The dosage varies depending on the individual and their response to treatment. However, the recommended initial dose is generally 16 mg (2 tablets) three times a day, meaning a maximum daily dose of 48 mg (6 tablets) divided into three doses.

Depending on your response, your doctor will indicate the maintenance dose.

The tablets may be taken with meals.

You should take Betahistina Qualigen for as long as your doctor recommends, so do not stop the treatment prematurely, as otherwise the expected results will not be achieved.

If you take more Betahistina Qualigen than you should:

Contact your doctor, pharmacist, or go to the nearest hospital immediately.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 91.562.04.20

If you take more Betahistina Qualigen 8 mg than you should, symptomatic treatment is recommended, as there is no specific antidote.

If you forget to take Betahistina Qualigen:

Do not take a double dose to make up for missed doses. If you forget a dose, wait until your next scheduled dose and continue your treatment as normal.

If you stop taking Betahistina Qualigen:

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

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone experiences them.

The frequently observed adverse effects (in at least 1 in 100 patients) are nausea and dyspepsia.

In some cases (the frequency of these adverse effects is not known), cases of anaphylaxis (a severe generalized allergic reaction) have been reported.

In some cases (the frequency of these adverse effects is also not known), mild stomach discomfort has occurred, such as vomiting, stomach pain, and abdominal bloating, which may be relieved by taking the medicine with food.

Very rarely, skin allergic reactions have been observed, such as angioneurotic edema (a form of severe and brief edema), itching, urticaria (skin rash), and rash (generalized skin eruption and itching).

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

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 mentioned 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 Qualigen

Keep this medicine out of 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 is the last day of the month indicated.

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

6. Contents of the pack and other information

Composition of Betahistina Qualigen 8 mg tablets

• The active substance is betahistine in the form of betahistine dihydrochloride.
• The other components are: povidone K90 (E-1201), microcrystalline cellulose (E-460i), lactose monohydrate, colloidal anhydrous silica, crospovidone, and stearic acid (E-570).

Appearance of the product and contents of the pack

Betahistina Qualigen 8 mg is presented as white, round, biconvex tablets without a score line.

Each pack contains 60 tablets.

Other pack sizes:

Betahistina Qualigen 16 mg tablets: Packs of 30 tablets.

Marketing Authorization Holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Manufacturer responsible for manufacturing:

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

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

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