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About the medicine

How to use BETAHISTINE QUALIGEN 8 mg TABLETS

Contents of the leaflet

  1. Introduction
  2. What is Betahistina Qualigen and what is it used for
  3. What you need to know before taking Betahistina Qualigen
  4. How to take Betahistina Qualigen
  5. Possible side effects
  6. Storage of Betahistina Qualigen
  7. Contents of the pack and further information

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Betahistina Qualigen 8mg 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 doubts, 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 Qualigen and what is it used for
  2. What you need to know before taking Betahistina Qualigen
  3. How to take Betahistina Qualigen
  4. Possible side effects
  5. Storage of Betahistina Qualigen
  1. Contents of the pack and further information

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

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

Betahistina Qualigen is used for the treatment of Meniere's Syndrome, a disorder characterized by the following symptoms: vertigo (with nausea and vomiting), hearing loss, and tinnitus (ringing in the ears).

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

2. What you need to know before taking Betahistina Qualigen

Do not take Betahistina Qualigen:

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

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 stomach ulcers.

Other medications and Betahistina QualigenInform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

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

Taking Betahistina Qualigen with food and drinks:

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

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

Children and adolescentsThe use of Betahistina Qualigen is not recommended in children under 18 years of age.

Pregnancy and breastfeeding

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. Betahistina Qualigen should not be taken during pregnancy, unless your doctor considers it necessary.

Betahistina Qualigen should not be taken during breastfeeding.

Driving and using machines

Betahistina Qualigen does not affect your ability to drive or use machines.

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

3. How to take Betahistina Qualigen

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

Remember to take your medication.

The effect of the medication usually does not manifest until after a few weeks.

The dose varies depending on the person and their response to treatment. However, a initial dose of 16 mg (2 tablets) three times a day is generally recommended, which means a maximum daily dose of 48 mg (6 tablets) divided into 3 doses.

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

The tablets can be taken with food.

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

If you take more Betahistina Qualigen than you should:

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

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Phone: 91.562.04.20

In case you take more Betahistina Qualigen 8 mg than you should, it is recommended to provide symptomatic treatment, as there is no specific antidote.

If you forget to take Betahistina Qualigen:

Do not take a double dose to make up for forgotten doses. If you forget to take a dose, wait until the next dose and continue with the normal treatment.

If you interrupt treatment with Betahistina Qualigen:

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

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Frequent side effects (at least 1 in 100 patients) are nausea and dyspepsia.

In some cases (the frequency of these side effects is not known), anaphylaxis (severe allergic reaction) has been reported.

In some cases (the frequency of these side effects is also not known), mild stomach discomfort, such as vomiting, stomach pain, and abdominal bloating, have occurred, which can be alleviated by taking the medication with food.

Very rarely, allergic skin reactions such as angioedema (severe and brief swelling), itching, urticaria (skin rash), and rash (generalized skin rash and itching) have been observed.

If you consider that any of the side effects you experience is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Reporting 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 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 Qualigen

Keep this medication out of sight and reach of children. Store below 25°C.

Do not use this medication after the expiration date shown on the packaging after CAD. 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 your 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. Contents of the pack and further information

Composition of Betahistina Qualigen 8mg tablets

  • The active ingredient is betahistine in the form of dihydrochloride of betahistine.
  • 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 in the form of white, round, biconvex tablets without a score.

Each pack contains 60 tablets.

Other presentations:

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:

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

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

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

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Frequently Asked Questions

BETAHISTINE QUALIGEN 8 mg TABLETS requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.

The active ingredient in BETAHISTINE QUALIGEN 8 mg TABLETS is betahistine. This information helps identify medicines with the same composition but different brand names.

The average pharmacy price for BETAHISTINE QUALIGEN 8 mg TABLETS is around 2.73 EUR. Prices may vary depending on the manufacturer and dosage form.

BETAHISTINE QUALIGEN 8 mg TABLETS is manufactured by Neuraxpharm Spain S.L.. Pharmacy brands and packaging may differ depending on the distributor.

Doctors such as Psychiatrists, Neurologists, General medicine doctors, Pain medicine doctors, Anaesthesiologists may assess whether BETAHISTINE QUALIGEN 8 mg TABLETS is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.

The prescription is issued by a doctor after assessing your health. In Spain, BETAHISTINE QUALIGEN 8 mg TABLETS is then dispensed in pharmacies with that prescription. An online consultation does not guarantee that a prescription will be issued: the decision always rests with the doctor.

To request an assessment, you can use Oladoctor:

Other medicines with the same active substance (betahistine) include BETAHISTINE ACCORD 24 mg TABLETS, BETAHISTINE AUROVITAS 16 mg TABLETS, BETAHISTINE AUROVITAS 8 mg TABLETS. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.

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