ELDICET 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Eldicet 50 mg film-coated tablets

Pinaverium bromide

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.

If you have any doubts, consult your doctor, pharmacist, or nurse.

• This medication 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, pharmacist, or nurse, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

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

1. What is Eldicet and what is it used for

The active substance of Eldicet is pinaverium bromide, which belongs to the group of medications for functional intestinal disorders.

This medication acts by reducing spasms of the intestine and bile ducts and relieving pain.

Eldicet is indicated in the following cases:

• Symptomatic treatment of pain, intestinal transit disorders, and intestinal discomfort related to functional intestinal disorders (e.g., irritable bowel syndrome, spastic colitis)
• Symptomatic treatment of pain related to functional disorders of the bile ducts (e.g., biliary dyskinesia)
• Preparation for barium enema

2. What you need to know before taking Eldicet

Do not take Eldicet:

• If you are allergic to the active substance or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before taking Eldicet

• The use of this medication is not recommended in children.
• It is essential that you take Eldicet correctly. This is because it can irritate the digestive tract (esophagus): - Always take the tablets during a meal. - Swallow them whole with a full glass of water. Do not crush, chew, or suck them.
• It is crucial that you take Eldicet correctly, as described above, if: - You have problems with your digestive tract (esophagus) - When a small part of your stomach rises towards your chest (hiatal hernia).

If you experience any of the above cases (or are unsure), talk to your doctor before taking Eldicet.

Children and adolescents

Experience in children is limited. The doctor will decide on the possible administration of Eldicet to this population group, only in strictly necessary cases.

Using Eldicet with other medications

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Especially, inform your doctor if you are taking medications to relieve intestinal or biliary tract spasms (also called anticholinergic medications). Eldicet may increase their effect against spasms.

Taking Eldicet with food, drinks, and alcohol

Take the medication with a glass of water during meals.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Eldicet is not recommended during pregnancy or breastfeeding.

Driving and using machines

No studies have been conducted on the effects on the ability to drive and use machines.

See how this medication affects you before performing any of these activities.

Eldicet contains lactose.This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

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

3. How to take Eldicet

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

Instructions for proper use of the medication:

It is essential that you take Eldicet correctly. This is because it can cause esophageal irritation (the tube that connects the mouth to the stomach):

• Always take the tablets during a meal.
• Swallow them whole with a full glass of water. Do not crush, chew, or suck them.
• Space out the intake of Eldicet regularly throughout the day.
• Try to take Eldicet at the same time every day.

Adults:

The recommended dose is 50 mg, 3 or 4 times a day.

Exceptionally, your doctor may increase this dose to 50 mg, six times a day.

In preparation for the barium enema, the dose is 50 mg, four times a day, for the 3 days prior to the test.

Use in children:

The use of Eldicet is not recommended in children. See section 2.

If you take more Eldicet than you should:

If you have taken more Eldicet than you should, consult your doctor, pharmacist, or the Toxicology Information Service (tel: 91 562 04 20), indicating the medication and the amount ingested.

If you forget to take Eldicet:

If you have forgotten to take a dose, skip the missed dose. Then, take the next dose at the usual time. Do not take a double dose to make up for the missed doses.

If you stop taking Eldicet

Do not stop taking Eldicet. Your doctor will indicate the duration of your treatment with Eldicet.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

With an unknown frequency (cannot be estimated from the available data), the following side effects have occurred:

• Stomach or intestine problems, such as difficulty swallowing, abdominal pain, diarrhea, nausea, or vomiting.

• Skin problems, such as itching, rash, urticaria, and erythema (redness of the skin)
• Hypersensitivity reactions (allergy) to the medication, such as difficulty breathing, swelling of the face, lips, tongue, or throat. If this happens, stop taking Eldicet and visit your doctor immediately - you may need urgent medical treatment.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Eldicet

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

No special storage conditions are required.

Do not use this medication after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and unused medications at the SIGRE collection point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Eldicet

• The active substance is pinaverium bromide. Each tablet contains 50 mg of pinaverium bromide.
• The other components are microcrystalline cellulose, lactose monohydrate, pregelatinized corn starch, hydrophobic colloidal silica, magnesium stearate, talc, butylated methacrylic acid copolymer, sodium lauryl sulfate, stearic acid, hydroxypropyl methylcellulose, red iron oxide, and yellow iron oxide.

Appearance of the product and contents of the pack

Orange film-coated tablets.

Each pack contains 50 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

Mylan Laboratories SAS

Route de Belleville Lieu dit Maillard

01400 Châtillon-sur-Chalaronne

France

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 Madrid

Spain

This package leaflet was approved in February 2014

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