OTILONIO CINFA 40 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

OtiloniumCinfa 40 mg film-coated tablets

otilonium bromide

Read the entire 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, consult 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 leaflet

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

1. What Otilonium Cinfa is and what it is used for

Otilonium Cinfa 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 Cinfa

Do not take Otilonium Cinfa

• 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 Cinfa if:

• You are taking several medicines and/or are an elderly patient.
• you have glaucoma (increased pressure in the eye).
• 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 (alteration of the thyroid gland 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

Elderly patients should take this medicine with caution.

Other medicines and Otilonium Cinfa

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.

Driving and using machines

Otilonium does not interfere with the ability to drive vehicles or use machines.

Otilonium Cinfa contains sodium

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

3. How to take Otilonium Cinfa

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 of otilonium (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 Cinfa than you should

In case of overdose or accidental ingestion, go immediately to your doctor or pharmacist or call the Toxicology Information Service, phone: 915 62 04 20, indicating the medicine and the amount ingested.

If you forget to take Otilonium Cinfa

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 Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Otilonium Cinfa

Keep this medicine out of the sight and reach of children.

This medicine does not require special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after CAD. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If you have any questions, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of Otilonium Cinfa

• The active substance is otilonium bromide. Each tablet contains 40 mg of otilonium bromide.
• The other ingredients are: microcrystalline cellulose, pregelatinized starch (from corn), sodium carboxymethyl starch (type A) (from potato), glycerol diester, and dimethicone.
• The coating is: hypromellose, macrogol 6000, titanium dioxide (E-171), and talc.

Appearance and packaging of the product

Otilonium Cinfa 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:

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer:

Neuraxpharm Pharmaceuticals S.L.

Avda. Barcelona, 69

08970, Sant Joan Despí (Barcelona)

Spain

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Date of last revision of this leaflet:November 2021

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/79384/P_79384.html.

QR code to: https://cima.aemps.es/cima/dochtml/p/79384/P_79384.html.