Betahistidine Qualigen 16 mg tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Betahistina Qualigen 16mg tablets EFG
Betahistine dihydrochloride
Read the entire 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, 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 it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Leaflet contents
- What Betahistina Qualigen is and what it is used for
- What you need to know before taking Betahistina Qualigen
- How to take Betahistina Qualigen
- Possible side effects
- How to store Betahistina Qualigen
- 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. Before taking 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 condition 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 taking or have recently taken any other medicines, including those obtained without a prescription.
To date, no interactions between betahistine and other medicines are known.
Taking Betahistina Qualigen with food and drink:
Food does not affect the action of Betahistina Qualigen, so it may 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 is not recommended in children and adolescents 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 medicine. Betahistina Qualigen must not be taken during pregnancy unless considered essential by your doctor.
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 him before taking this medicine.
3. How to take Betahistina Qualigen
Follow exactly the instructions given by your doctor for taking this medicine. 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 dose varies depending on the individual and their response to treatment. However, the recommended initial dose is 16 mg (1 tablet) three times a day, meaning a maximum daily dose of 48 mg (3 tablets) divided into three doses.
Depending on your response, your doctor will advise you on the maintenance dose.
The tablets may be taken with food.
You should take Betahistina Qualigen for as long as your doctor recommends; do not stop treatment prematurely, as the expected results will not be achieved.
The score line is intended only for splitting the tablet if you find it difficult to swallow whole.
If you take more Betahistina Qualigen than you should:
Contact your doctor, pharmacist, or 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 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 the next scheduled dose and continue with your normal treatment.
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 can cause adverse effects, although not everyone experiences them.
The frequently observed adverse effects (in at least 1 out of 100 patients) are nausea and dyspepsia.
In some cases (frequency of these adverse effects is not known), cases of anaphylaxis (severe generalized allergic reaction) have been reported.
In some cases (frequency of these adverse effects is also unknown), 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 angioedema (a type of severe and brief swelling), 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 the 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 refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE Point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Package contents and additional information
Composition of Betahistina Qualigen 16 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), monohydrate lactose, anhydrous colloidal silica, crospovidone, and stearic acid (E-570).
Appearance of the product and contents of the container
Betahistina Qualigen 16 mg is presented as white, round, biconvex tablets, marked with "B16" on one side and scored on the other.
Each pack contains 30 tablets.
Other pack sizes:
Betahistina Qualigen 8 mg tablets, packs of 60 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 most recent revision of the leaflet: May 2021
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/