Otilonium Qualigen 40 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Otilonio Qualigen 40 mg film-coated tablets EFG

otilonium bromide

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet. 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. Do not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these effects are not listed in this leaflet. See section 4.

Leaflet contents

1. What Otilonio Qualigen is and what it is used for
2. What you need to know before taking Otilonio Qualigen
3. How to take Otilonio Qualigen
4. Possible adverse effects
5. How to store Otilonio Qualigen
6. Contents of the pack and other 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 for the treatment of spasms and gastrointestinal motility disorders in adults.

2. What you need to know before starting to take Otilonium Qualigen

Do not take Otilonium Qualigen:

• if you are allergic to otilonium bromide or to any of the other ingredients of this medicine (listed in section 6).
• if you suffer from intestinal obstruction.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Otilonium Qualigen if:

• You are taking multiple medications and/or are an elderly patient
• you have glaucoma (increased pressure in the eye)
• you have prostate hypertrophy (enlarged 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 bowel disease)
• you have gastroesophageal 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

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to 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 using otilonium during pregnancy and breastfeeding has not yet been established.

Driving and use of machines

Otilonium does not interfere with the ability to drive or operate machinery.

Important information about some of the components of Otilonium Qualigen

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Otilonio Qualigen

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in 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 judgment.

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 duration of treatment is 4 weeks.

In case of recurrence of painful symptoms, your doctor should evaluate the convenience of starting a new treatment.

If you take more Otilonio Qualigen than you should

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service at telephone number: 915620420, indicating the medicine and the amount ingested.

If you forget to take Otilonio Qualigen

Do not take a double dose to make up for forgotten doses.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Adverse effects of unknown frequency (cannot be estimated from the available data):

• headache
• nausea, vomiting, stomach pain
• urticaria
• dizziness
• fatigue

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 listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products at www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Otilonium Qualigen

Keep this medicine out of 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 refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the package and other information

Composition of Otilonium Qualigen

• The active substance is otilonium bromide. Each tablet contains 40 mg of otilonium bromide.
• The other components are: microcrystalline cellulose, pregelatinized corn starch, sodium carboxymethyl potato starch (type A), glycerol diesterate, and dimethicone.
• The coating consists of hypromellose, macrogol 6000, titanium dioxide, and talc.

Appearance of the medicinal product and contents of the pack

Otilonium Qualigen is presented as film-coated tablets. The tablets are round and white in colour.

It is available 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 most recent review of this leaflet: June 2023

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.es/