Duspatalin 135 mg Coated Tablets

Mebeverine Hydrochloride

Read this leaflet carefully before you start to take 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, or pharmacist.

- This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

• If you experience any side effects, consult your doctor, or pharmacist, even if they are not listed in this leaflet. See section 4.

Duspatalin contains as its active ingredient hydrochloride of mebeverine, which belongs to the group of medications known asantispasmodics, which act on the intestine.

What is Duspatalin used for

Duspatalin is used to relieve the 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.

The symptoms vary from person to person but may include:

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

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

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

Do not take Duspatalin- If you are allergic to hydrochloride mebeverine or to 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

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

Pregnancy and lactation

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

Duspatalin is not recommended during pregnancy or lactation.

Driving and operating machines

This medication is unlikely to 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.

Follow exactly the administration instructions for this medication as indicated by your doctor. Consult your doctor or pharmacist if you have any 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 of day. This will help you remember to take the medication.

Use in adults

• The usual dose is one tablet three times a day.
• Tablets work better if taken 20 minutes before a meal and with the same number of hours between each dose.

Use in children and adolescents

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

If you take more Duspatalin than you should:

If you have taken Duspatalin more than you should, consult your doctor, pharmacist, or the Toxicological Information Service, telephone 91 562 04 20or 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 the missed doses.

If you interrupt 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.

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

Stop taking Duspatalin and seek medical attention immediately if you experience any of the following severe adverse 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 to the medication.

Other adverse effects are:

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

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:https://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.

Do not use this medication after the expiration date that appears 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 drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Duspatalín

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

hydrochloride of mebeverine.

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

Appearance of the product and contents of the packaging

Coated, round, white tablets.

Duspatalin is presented in boxes with 60 coated 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

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 holder of the marketing authorization:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Last review date of this leaflet: February 2020.

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