


Ask a doctor about a prescription for BETAHISTINE QUALIGEN 16 mg TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER
Betahistina Qualigen 16mg tablets EFG
Dihydrochloride of betahistine
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Contents of the pack
Betahistina Qualigen belongs to a group of medicines 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).
Do not take Betahistina Qualigen:
Warnings and precautions
Other medicines and Betahistina QualigenTell your doctor or pharmacist if you are taking or have recently taken 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 effect of Betahistina Qualigen, so it can be taken before, during, or after meals.
If stomach upset occurs, it is recommended to take Betahistina Qualigen during meals.
Children and adolescentsThe use in children under 18 years is not recommended.
Pregnancy and lactation
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. 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 medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.
Follow exactly the administration instructions of this medicine as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.
Remember to take your medicine.
The effect of the medicine usually does not manifest until after a few weeks.
The dose varies depending on the person and how they respond to treatment. However, a initial dose of 16 mg (1 tablet) three times a day is generally recommended, which means a maximum daily dose of 48 mg (3 tablets) divided into 3 doses.
Depending on your response, your doctor will indicate the maintenance dose.
The tablets can be taken with meals.
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 obtained.
The score line is only for breaking the tablet if you find it difficult to swallow whole.
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 than you should, it is recommended to provide symptomatic treatment since 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 stop taking Betahistina Qualigen:
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets 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 general allergic reaction) has been reported.
In some cases (the frequency of these side effects is also not known), mild stomach upset, such as vomiting, stomach pain, and abdominal bloating, have occurred, which can be alleviated by taking the medicine with meals.
Very rarely, allergic skin reactions such as angioedema (a short, violent form of edema), itching, urticaria (skin rash), and rash (generalized skin rash and itching) have been observed.
If you think any of the side effects you are experiencing is serious or if you notice any side effects not mentioned in this leaflet, tell your doctor or pharmacist.
Reporting of side effects:
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children. Store below 25°C.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
Composition of Betahistina Qualigen 16mg tablets
Appearance and packaging
Betahistina Qualigen 16 mg is presented in the form of white, round, biconvex tablets, marked with B16 on one side and scored on the other.
Each pack contains 30 tablets.
Other presentations
Betahistina Qualigen 8 mg tablets Packs of 60 tablets.
Marketing authorisation 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 last revision of this leaflet: May 2021
Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/
The average price of BETAHISTINE QUALIGEN 16 mg TABLETS in November, 2025 is around 2.73 EUR. Prices may vary depending on the region, pharmacy, and whether a prescription is required. Always check with a local pharmacy or online source for the most accurate information.
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Discuss dosage, side effects, interactions, contraindications, and prescription renewal for BETAHISTINE QUALIGEN 16 mg TABLETS – subject to medical assessment and local rules.