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OTILONIO QUALIGEN 40 mg FILM-COATED TABLETS

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About the medicine

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.

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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

  1. What Otilonium Qualigen is and what it is used for
  2. What you need to know before taking Otilonium Qualigen
  3. How to take Otilonium Qualigen
  4. Possible side effects
  5. Storage of Otilonium Qualigen
  6. 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.

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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.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

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 Green symbol with a circular shape and arrows indicating a continuous cycle with a cross in the center 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/

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.

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Doctor

Dmytro Horobets

Family medicine 7 years exp.

Dr. Dmytro Horobets is a licensed family medicine physician in Poland, specialising in endocrinology, diabetology, obesity management, gastroenterology, pediatrics, general surgery, and pain medicine. He offers online consultations for adults and children, providing personalised medical support for a wide range of acute and chronic health concerns.

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Whether you need help managing diabetes, tackling weight-related health issues, interpreting lab results, or receiving general family medicine support, Dr. Horobets provides professional online care tailored to your specific health goals.

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Doctor

Tomasz Grzelewski

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques. For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance. Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults. In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions. Patients commonly seek his care for: 

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Yevgen Yakovenko

General surgery 12 years exp.

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

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Frequently Asked Questions

Is a prescription required for OTILONIO QUALIGEN 40 mg FILM-COATED TABLETS?
OTILONIO QUALIGEN 40 mg FILM-COATED TABLETS requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in OTILONIO QUALIGEN 40 mg FILM-COATED TABLETS?
The active ingredient in OTILONIO QUALIGEN 40 mg FILM-COATED TABLETS is otilonium bromide. This information helps identify medicines with the same composition but different brand names.
How much does OTILONIO QUALIGEN 40 mg FILM-COATED TABLETS cost in pharmacies?
The average pharmacy price for OTILONIO QUALIGEN 40 mg FILM-COATED TABLETS is around 11.02 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures OTILONIO QUALIGEN 40 mg FILM-COATED TABLETS?
OTILONIO QUALIGEN 40 mg FILM-COATED TABLETS is manufactured by Neuraxpharm Spain S.L.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of OTILONIO QUALIGEN 40 mg FILM-COATED TABLETS online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether OTILONIO QUALIGEN 40 mg FILM-COATED TABLETS is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to OTILONIO QUALIGEN 40 mg FILM-COATED TABLETS?
Other medicines with the same active substance (otilonium bromide) include OTILONIO CINFA 40 mg FILM-COATED TABLETS, SPASMOCTYL 40, SPASMOCTYL PEDIATRIC. 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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