Duspatalin 135 mg film-coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Duspatalin 135 mg coated tablets
Mebeverine hydrochloride
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
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Keep this leaflet, as you may need to read it again.
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If you have any questions, consult your doctor or pharmacist.
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This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, since it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if these are effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Duspatalin is and what it is used for
- What you need to know before taking Duspatalin
- How to take Duspatalin
- Possible side effects
- How to store Duspatalin
- Contents of the pack and other information
1. What Duspatalin is and what it is used for
Duspatalin contains as its active ingredient mebeverine hydrochloride, which belongs to a group of medicines known as antispasmodics that act on the intestine.
What Duspatalin is used for
Duspatalin is used to relieve the symptoms of irritable bowel syndrome (IBS) and other similar conditions such as irritable colon in adults.
Irritable bowel syndrome is a very common condition that causes spasms and pain in the intestine.
The intestine is a long muscular tube through which food passes to be digested. When spasms occur in the intestine and the pressure becomes too strong, pain results.
Symptoms vary from person to person but may include:
- stomach pain and cramps
- a feeling of bloating and gas
- diarrhoea, constipation, or a combination of both
- small, hard, fragmented, or ribbon-like bowel movements (stools).
Your diet and lifestyle can also help manage irritable bowel syndrome (IBS)
A high-fibre diet may be beneficial; however, consult your doctor or pharmacist first for further information. Relaxation may also help reduce IBS symptoms.
2. What you need to know before starting Duspatalin
Do not take Duspatalin - If you are allergic to mebeverine hydrochloride or to any of the other ingredients of this medicine (listed in section 6)
If you have intestinal obstruction (paralytic ileus).
Warnings and precautions
Consult your doctor or pharmacist before starting to take Duspatalin.
If you develop new symptoms or if your symptoms worsen
Other medicines and Duspatalin
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Pregnancy and breastfeeding
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.
Duspatalin is not recommended during pregnancy or breastfeeding.
Driving and using machines
This medicine is unlikely to affect your ability to drive or operate tools or machinery.
Duspatalin contains lactose and sucrose
This medicine contains lactose and sucrose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.
3. How to take Duspatalin
Follow exactly the instructions for use of this medicine provided by your doctor. Consult your doctor or pharmacist if you have any doubts.
Taking this medicine
- Duspatalin is indicated for use in adults.
- Swallow the tablets whole with a full glass of water. Do not crush or chew them.
- Try to take the tablets at the same time each day. This will help you remember to take your medication.
Use in adults
- The usual dose is one tablet three times a day.
- The tablets work best if taken 20 minutes before a meal, and if you leave the same number of hours between each dose.
Use in children and adolescents
This medicine is not recommended for use in children and adolescents under 18 years of age due to insufficient data available.
If you take more Duspatalin than you should:
If you have taken more Duspatalin than you should, consult your doctor, pharmacist, or the Toxicology Information Service at telephone number 91 562 04 20, or go immediately to a hospital.
Take the packaging and this leaflet with you.
If you forget to take Duspatalin:
Do not take a double dose to make up for missed doses.
If you stop taking Duspatalin
Do not stop treatment with Duspatalin without first consulting your doctor.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
Stop taking Duspatalin and see a doctor immediately if you experience any of the following serious adverse effects, as you may require urgent medical treatment:
- Difficulty breathing, swelling of the face, neck, lips, tongue or throat. You may be experiencing a severe allergic (hypersensitivity) reaction to the medicine.
Other adverse effects include:
- You may experience a milder allergic (hypersensitivity) reaction to the medicine: for example, skin rash, redness and itching.
- Cases of dizziness, drowsiness, confusion and nausea have been observed very rarely.
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 can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Duspatalin
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging, after CAD or EXP. The expiry date refers to the last day of the month indicated.
Store below 25 °C.
Medicines must 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 have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Duspatalin
??The active substance is mebeverine hydrochloride. Each tablet contains 135 mg of
mebeverine hydrochloride.
??The other components (excipients) are: monohydrate lactose, sodium carboxymethyl starch (type A) (derived from potato starch), povidone, talc, magnesium stearate, sucrose, arabic gum, gelatin and carnauba wax.
Appearance of the product and contents of the pack
Round, white coated tablets.
Duspatalin is available in cardboard boxes containing 60 coated tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland
Manufacturer
RECIPHARM PARETS, S.L.
Ramon y Cajal, 2
08150 Parets del Valls, Spain
For further information about this medicinal product, contact the local representative of the Marketing Authorization Holder:
Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 - Madrid
Spain
Date of the most recent revision of this leaflet: February 2020.
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) https://www.aemps.gob.es/