


Ask a doctor about a prescription for OTILONIO QUALIGEN 40 mg FILM-COATED TABLETS
Patient Information Leaflet
Otilonium Qualigen 40 mg film-coated tablets
otilonium bromide
Read this leaflet carefully before starting to take this medicine, as it contains important information for you.
Contents of the package leaflet
Otilonium Qualigen contains the active substance otilonium bromide, which belongs to a group of medicines that act by reducing intestinal contractions.
Otilonium is used to treat spasms and alterations of gastrointestinal motility in adults.
Do not take Otilonium Qualigen:
Warnings and precautions
Consult your doctor or pharmacist before starting to take Otilonium Qualigen if:
Children
Do not use this medicine in children and adolescents.
Elderly patients
Elderly patients should take this medicine with caution.
Taking Otilonium Qualigen with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
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.
The safety of otilonium during pregnancy and breastfeeding has not been established yet.
Driving and using machines
Otilonium does not affect the ability to drive vehicles or use machines.
Important information about some of the ingredients of Otilonium Qualigen
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".
Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.
The recommended dose is 1 tablet (40 mg of otilonium bromide) two or three times a day, according to medical criteria.
Method of administration:
The tablets are administered orally.
The tablets should be taken approximately 20 minutes before meals with half a glass of water.
The maximum treatment duration is 4 weeks.
In case of reappearance of painful symptoms, the doctor should evaluate the convenience of starting a new treatment.
If you take more Otilonium Qualigen than you should
In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service. Phone: 915620420, indicating the medicine and the amount ingested.
If you forget to take Otilonium Qualigen
Do not take a double dose to make up for forgotten doses.
If you have any other questions about the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects of unknown frequency (cannot be estimated from available data):
Reporting of side effects
If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use 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.
No special storage conditions are required.
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 should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE
collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.
Composition of Otilonium Qualigen
Appearance of the product and package contents
Otilonium Qualigen is presented in the form of film-coated tablets. The tablets are round and white.
It is presented in PVC/aluminum blisters containing 60 film-coated tablets.
Marketing authorization holder and manufacturer
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 leaflet:June 2023
Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/
The average price of OTILONIO QUALIGEN 40 mg FILM-COATED TABLETS in October, 2025 is around 11.02 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 OTILONIO QUALIGEN 40 mg FILM-COATED TABLETS – subject to medical assessment and local rules.