Package Insert: Information for the Patient

Otilonio Cinfa 40 mg Film-Coated Tablets

Otilonium Bromide

Read this entire package insert carefully before taking this medicine, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for 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 any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

otilonio cinfa contains the active ingredient otilonio bromide, which belongs to a group of medicines that act by reducing intestinal contractions.

otilonio is used for the treatment of spasms and alterations in gastrointestinal motility in adults.

Do not take otilonium cinfa

• if you are allergic to otilonium bromide or to 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 cinfaif:

• You are taking several medicines and/or are an elderly patient
• You have glaucoma (increased eye pressure)
• You have benign prostatic hyperplasia (enlarged prostate)
• You have pyloric stenosis (difficulty in the passage of stomach contents to 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 gastroesophageal reflux (passage of stomach contents to 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

Inform your doctor or pharmacist if you are taking, have taken recentlyor may have to take any other medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

The safety of use of otilonium during pregnancy and breastfeeding has not yet been established.

Driving and operating 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; this is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is 1 otilonio tablet (40 mg of otilonio bromide) two or three times a day, as determined by your doctor.

Administration form:

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 reappearance of painful symptoms, your doctor should evaluate the convenience of initiating a new treatment.

If you take more otilonio cinfa than you should

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

If you forgot to take otilonio cinfa

Do not take a double dose to compensate for the missed doses.

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

Like all medications,this medication may produce adverse effects,although not all people will experience them.

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

• Headache
• Nausea, vomiting, stomach pain,
• Urticaria
• Dizziness
• Fatigue

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it ispossible adverse effects that do not appear in this prospectus.You can also report them directly to the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute toproviding more information about the safety of this medication.

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging after CAD.The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of packaging and unused medications.This will help protect the environment..

Composition ofotilonio cinfa

• The active ingredient is otilonio bromide. Each tablet contains 40 mg of otilonio bromide.
• The other components are:microcrystalline cellulose, pregelatinized cornstarch, carboxymethylcellulose sodium (type A)(from potato), glycerol diesterate, and dimethicone.
• The coating is: hypromellose, macrogol 6000, titanium dioxide (E-171), and talc.

Appearance of the product and content of the container

otilonio cinfa is presented in the form of coated tablets. The tablets areround and white in color.

It is presented in PVC/aluminum blisters that contain 60 coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Laboratorios Cinfa, S.A

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) – Spain

Responsible for manufacturing:

Neuraxpharm Pharmaceuticals S.L

Avda. Barcelona, 69

08970, Sant Joan Despí (Barcelona)

Spain

or

Laboratorios Cinfa, S.A

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) – Spain

Last review date of this leaflet:november 2021

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es/

You can access detailed and updated information about this medicine by scanning with your smartphone the QR code included in the leaflet and packaging. 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