Eldicet 50 mg film-coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Eldicet 50 mg film-coated tablets
Pinaverium bromide
Read the entire 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 and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet contents:
- What Eldicet is and what it is used for
- What you need to know before taking Eldicet
- How to take Eldicet
- Possible side effects
- How to store Eldicet
- Contents of the pack and other information
1. What Eldicet is and what it is used for
The active substance of Eldicet is pinaverium bromide, which belongs to the group of medicines used for intestinal functional disorders.
This medicine works by reducing spasms in the intestine and bile ducts and relieving pain.
Eldicet is indicated in the following cases:
- Symptomatic treatment of pain, disturbances in intestinal transit, and intestinal discomfort associated with functional intestinal disorders (e.g., irritable bowel syndrome, spastic colitis)
- Symptomatic treatment of pain related to functional disorders of the biliary tract (e.g., biliary dyskinesia (difficulty in bile movement))
- Preparation for barium enema
2. What you need to know before starting to take Eldicet
Do not take Eldicet:
- If you are allergic to the active substance or to any of the other components of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before starting to take Eldicet
- The use of this medicine is not recommended in children.
- It is important that you take Eldicet correctly, because it may irritate the digestive tract (esophagus):
- Always take the tablets during a meal.
- Swallow them whole with a full glass of water. Do not crush, suck, or chew the tablets.
- It is essential that you take Eldicet correctly as described above if:
- You have problems with your digestive tract (esophagus)
- You have a condition in which a small part of the stomach moves up into the chest (hiatal hernia).
If any of the above apply to you (or if you are unsure), speak with your doctor before taking Eldicet.
Children and adolescents
Experience in children is limited. The doctor will decide whether administration of Eldicet is appropriate for this population group, and only in strictly necessary cases.
Taking Eldicet with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
In particular, inform your doctor if you are taking medicines used to relieve spasms in your intestine or biliary tract (also known as anticholinergic medicines). Eldicet may increase their antispasmodic effect.
Taking Eldicet with food, drinks, and alcohol
Take the medicine with a glass of water during meals.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
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 or operate machinery.
See how this medicine affects you before performing these activities.
Eldicet contains lactose. This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.
Eldicet contains sodium. This medicine contains less than 23 mg of sodium (1 mmol) per tablet; therefore, it is essentially “sodium-free”.
3. How to take Eldicet
Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, please consult your doctor or pharmacist again.
Instructions for proper use of the medicine:
It is important that you take Eldicet correctly, as it may cause irritation of the esophagus (the tube connecting 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 the tablets.
- Space the doses of Eldicet evenly throughout the day.
- Try to take Eldicet at the same time every day.
Adults:
The recommended dose is 50 mg three or four times a day.
Exceptionally, your doctor may increase this dose to 50 mg six times a day.
For barium enema preparation, the dose is 50 mg four times a day for the 3 days prior to the procedure.
Use in children:
Eldicet is not recommended for use in children. See section 2.
If you take more Eldicet than you should:
If you have taken more Eldicet than you should, contact your doctor, pharmacist, or the Toxicology Information Service immediately, telephone 91 562 04 20, stating the medicine 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 your usual time. Do not take a double dose to make up for a missed dose.
If you stop taking Eldicet:
Do not stop treatment with Eldicet. Your doctor will advise you on the duration of your treatment with Eldicet.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
The following adverse effects have occurred with unknown frequency (cannot be estimated from the available data):
-
Problems with your stomach or intestine, such as difficulty swallowing, abdominal pain, diarrhea, nausea, or vomiting.
-
Skin problems such as itching, rash, hives, and erythema (redness of the skin).
-
Hypersensitivity reactions (allergy) to the medicine, such as difficulty breathing, swelling of the face, lips, tongue, or throat. If this happens, stop taking Eldicet and see your doctor immediately—you may require emergency medical treatment.
Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Eldicet
Keep this medicine out of the 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 unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Eldicet
- The active substance is pinaverium bromide. Each tablet contains 50 mg of pinaverium bromide.
- The other components are microcrystalline cellulose, monohydrate lactose, pregelatinized corn starch, colloidal hydrous silica, magnesium stearate, talc, butylated methacrylate copolymer, sodium lauryl sulfate, stearic acid, hypromellose, red iron oxide, and yellow iron oxide.
Appearance of the medicinal 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
Further information on this medicinal product is available from 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
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/