DUSPATALIN 135 mg FILM-COATED TABLETS

Introduction

Duspatalin 135 mg coated tablets

Mebeverine hydrochloride

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

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.

• 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 or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Duspatalin and what is it used for
2. What you need to know before taking Duspatalin
3. How to take Duspatalin
4. Possible side effects
5. Storage of Duspatalin
6. Package contents and additional information

1. What is Duspatalin and what is it used for

Duspatalin contains mebeverine hydrochloride as the active ingredient, which belongs to the group of medications called antispasmodics, which act on the intestine.

What is Duspatalin used for

Duspatalin is used to relieve symptoms of irritable bowel syndrome (IBS) and other similar diseases, such as irritable colon in adults.

Irritable bowel syndrome is a very common disease that causes spasms and pain in the intestine.

The intestine is a long muscular tube through which food passes to be digested. If a spasm occurs in the intestine and the pressure is too strong, it causes pain.

Symptoms vary from person to person but may include:

• stomach pain and colic
• feeling of abdominal distension and gas
• diarrhea, constipation, or a combination of both
• small, hard, fragmented, or pellet-like stools.

Your diet and lifestyle can also help treat irritable bowel syndrome (IBS)

A high-fiber diet may be helpful, but consult your doctor or pharmacist beforehand for more information. Relaxation can help reduce IBS symptoms.

2. What you need to know before taking Duspatalin

Do not take Duspatalin- If you are allergic to mebeverine hydrochloride or any of the other components of this medication (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 have worsened.

Other medications and Duspatalin

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Pregnancy and breastfeeding

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.

Duspatalin is not recommended during pregnancy or breastfeeding.

Driving and using machines

It is unlikely that this medication will affect your ability to drive or operate tools or machines.

Duspatalin contains lactose and sucrose

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

3. How to take Duspatalin

Follow the exact administration instructions for this medication as indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

Taking this medication

• Duspatalin is indicated for 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 every day. This will help you remember to take the 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 leaving the same number of hours between one dose and the next.

Use in children and adolescents

This medication is not recommended for use in children and adolescents under 18 years of age due to insufficient data.

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, phone 91 562 04 20, or go immediately to a hospital.

Bring the packaging and this leaflet with you.

If you forget to take Duspatalin:

Do not take a double dose to make up for forgotten doses.

If you stop treatment with Duspatalin

Do not stop treatment with Duspatalin without consulting your doctor first.

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

4. Possible side effects

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

Stop taking Duspatalin and see a doctor immediately if you experience any of the following serious side effects, as you may need urgent medical treatment:

• Difficulty breathing, swelling of the face, neck, lips, tongue, or throat. You may be experiencing a severe allergic reaction (hypersensitivity) to the medication.

Other side effects are:

• You may experience a milder allergic reaction (hypersensitivity) to the medication: for example, skin rash, redness, and itching.
• Very rare cases of dizziness, drowsiness, confusion, and nausea have been reported.

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Duspatalin

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

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

Store below 25°C.

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. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

6. Package contents and additional information

Composition of Duspatalin

The active ingredient is mebeverine hydrochloride. Each tablet contains 135 mg of mebeverine hydrochloride.

The other ingredients (excipients) are: lactose monohydrate, sodium carboxymethyl starch (type A) (derived from potato starch), povidone, talc, magnesium stearate, sucrose, gum arabic, gelatin, and carnauba wax.

Appearance of the product and package contents

White, round, coated tablets.

Duspatalin is available in boxes of 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 Valles, Spain

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

Date of the last revision of this leaflet: February 2020.

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