Package Leaflet: Information for the User

Eldicet 50 mg Film-Coated Tablets

Pinaverium Bromide

Read this leaflet carefully before you start taking this medicine because 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, pharmacist or nurse.

−This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours, as it may harm them.

−If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet (see section 4).

1. What is Eldicet and what it is used for

2. What you need to know before you take Eldicet

3. How to take Eldicet

4. Possible side effects

5. Storage of Eldicet

6. Contents of the pack and additional information

The active ingredient of Eldicet is pinaverium bromide, which belongs to the group of medications

for functional intestinal disorders.

This medication acts by reducing intestinal and biliary spasms and alleviating pain.

Eldicet is indicated in the following cases:

- Symptomatic treatment of pain, intestinal transit disorders, and intestinal discomfort related to functional intestinal alterations (e.g., irritable bowel syndrome, spastic colitis)

- Symptomatic treatment of pain related to functional disorders of the biliary ducts (e.g., biliary dyskinesia (difficulty with biliary movements)

- Preparation for barium enema

Do not take Eldicet:

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Eldicet

• This medication is not recommended for use in children.
• It is essential to take Eldicet correctly. This is because it may irritate the digestive tube (esophagus):
  - Always take the tablets in the middle of a meal.
  - Swallow them whole with a full glass of water. Do not crush, chew, or suck on them.
• It is crucial that you take Eldicet correctly, as described above, if:
  - You have problems with your digestive tube (esophagus)
  - When a small part of the stomach moves up into your chest (hiatal hernia).

If any of the above cases occur (or you are unsure), speak with 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 group, only in strictly necessary cases.

Use of Eldicet with other medications

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

Especially, inform your doctor if you are taking medications to relieve spasms of your intestine or bile duct (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, believe you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Eldicet is not recommended during pregnancy or breastfeeding.

Driving and operating machines

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

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

Eldicet contains lactose.This medication contains lactose. If your doctor has indicated 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 (1mmol) 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.

Instructions for proper use of the medication:

It is essential to take Eldicet correctly. This is because it may cause irritation of the esophagus (the tube that connects the mouth with the stomach):

- Always take the tablets during a meal.

- Swallow them whole with a full glass of water. Do not crush, chew, or chew them.

- Space 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 the preparation for the barium enema, the dose is 50 mg four times a day, in the 3 days before the test.

Use in children:

It is not recommended to use Eldicet 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 Toxicological Information Service immediately, indicating the medication and the amount ingested. Phone number: 91 562 04 20.

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 compensate for the missed doses.

If you interrupt treatment with Eldicet:

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

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

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

With an unknown frequency (cannot be estimated from available data) the following adverse effects have been produced:

•Problems with your stomach or intestines, such as difficulty swallowing, abdominal pain, diarrhea, nausea, or vomiting.

•Skin problems such as itching, rash, urticaria, and erythema (skin redness)

•Hypersensitivity reactions (allergy) to the medication such as difficulty breathing, swelling of your face, lips, tongue, or throat. If this occurs, stop taking Eldicet and visit your doctor immediately - you may need emergency medical treatment.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: www.notificaram.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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 that appears on the packaging after EXP. 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 unused packaging and medications. By doing so, you will help protect the environment.

Composition of Eldicet

−The active ingredient is pinaverium bromide. Each tablet contains 50 mg of pinaverium bromide.

−The other components are microcrystalline cellulose, lactose monohydrate, pregelatinized cornstarch, colloidal hydrated silica, magnesium stearate, talc, basic butylated methacrylate copolymer, sodium lauryl sulfate, stearic acid, hydroxypropyl methylcellulose, red iron oxide, and yellow iron oxide.

Appearance of the product and contents of the packaging

Orange-coated tablets.

Each package contains 50 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing

Mylan Laboratories SAS

Route de Belleville Lieu dit Maillard

01400 Châtillon-sur-Chalaronne

France

For more information about this medication, please contact the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 Madrid

Spain

This leaflet was approved in February 2014

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