OTILONIO QUALIGEN 40 mg FILM-COATED TABLETS

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.

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/