OTILONIO QUALIGEN 40 mg FILM-COATED TABLETS
How to use OTILONIO QUALIGEN 40 mg FILM-COATED TABLETS
Translated with AI
This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
Show originalContents of the leaflet
Introduction
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.
- 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 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 leaflet. See section 4.
Contents of the package leaflet
- What Otilonium Qualigen is and what it is used for
- What you need to know before taking Otilonium Qualigen
- How to take Otilonium Qualigen
- Possible side effects
- Storage of Otilonium Qualigen
- Package contents and additional information
1. What Otilonium Qualigen is and what it is used for
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.
2. What you need to know before taking Otilonium Qualigen
Do not take Otilonium Qualigen:
- if you are allergic to otilonium bromide or any of the other ingredients of this medicine (listed in section 6).
- if you have intestinal obstruction.
Warnings and precautions
Consult your doctor or pharmacist before starting to take Otilonium Qualigen if:
- You are taking several medicines and/or are an elderly patient.
- you have glaucoma (increased eye pressure).
- you have prostatic hyperplasia (enlargement of the prostate).
- you have pyloric stenosis (difficulty in the passage of stomach contents into the intestine).
- you have liver or kidney problems.
- you have heart problems such as tachycardia (increased heart rate).
- you have hyperthyroidism (thyroid gland disorder with increased thyroid hormones).
- you have ulcerative colitis (inflammatory disease of the intestine).
- you have esophageal reflux (passage of stomach contents into the esophagus).
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".
3. How to take Otilonium Qualigen
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.
4. Possible side effects
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):
- headache
- nausea, vomiting, stomach pain,
- urticaria
- dizziness
- fatigue
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.
5. Storage of Otilonium Qualigen
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.
6. Package contents and additional information
Composition of Otilonium Qualigen
- The active substance is otilonium bromide. Each tablet contains 40 mg of otilonium bromide.
- The other ingredients are: microcrystalline cellulose, pregelatinized corn starch, sodium carboxymethyl potato starch (type A), glycerol diester, and dimethicone.
- The coating is hypromellose, macrogol 6000, titanium dioxide, and talc.
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/
- Country of registration
- Average pharmacy price11.02 EUR
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to OTILONIO QUALIGEN 40 mg FILM-COATED TABLETSDosage form: TABLET, 40 mgActive substance: otilonium bromideManufacturer: Laboratorios Cinfa S.A.Prescription requiredDosage form: TABLET, 40 mgActive substance: otilonium bromideManufacturer: Laboratorios Menarini S.A.Prescription requiredDosage form: TABLET, 10 mgActive substance: otilonium bromideManufacturer: Laboratorios Menarini S.A.Prescription required
Online doctors for OTILONIO QUALIGEN 40 mg FILM-COATED TABLETS
Discuss questions about OTILONIO QUALIGEN 40 mg FILM-COATED TABLETS, including use, safety considerations and prescription review, subject to medical assessment and local regulations.
Frequently Asked Questions
