Duspatalin Gastro

Package Leaflet: Information for the Patient

Duspatalin Gastro, 135 mg, Tablets

Mebeverine Hydrochloride

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

This Medication Should Always be Taken Exactly as Described in the Patient Leaflet or as Advised by a Doctor or Pharmacist.

• Keep this Leaflet, You May Need to Read it Again.
• If You Need Advice or Further Information, Consult a Pharmacist.
• If You Experience any Side Effects, Including those not Listed in this Leaflet, Tell Your Doctor or Pharmacist. See Section 4.
• If There is no Improvement or You Feel Worse After 5 Days, Consult a Doctor.

Table of Contents of the Leaflet

• 1. What is Duspatalin Gastro and What is it Used for
• 2. Important Information Before Taking Duspatalin Gastro
• 3. How to Take Duspatalin Gastro
• 4. Possible Side Effects
• 5. How to Store Duspatalin Gastro
• 6. Contents of the Pack and Other Information

1. What is Duspatalin Gastro and What is it Used for

What is Duspatalin Gastro

Duspatalin Gastro is in the Form of Tablets. Duspatalin Gastro Contains the Active Substance Mebeverine Hydrochloride. It Belongs to a Group of Medicines Called Antispasmodics, which Act on the Intestine. The Intestine is Part of the Digestive Tract. Its Walls are Made of Muscles. Digested Food Passes Through the Intestine. If the Intestinal Muscles Contract too Strongly, it Causes Pain. Duspatalin Gastro Acts to Relax the Muscles and Relieve Pain.

What is Duspatalin Gastro Used for

Duspatalin Gastro is Used in Adults and Children Over 10 Years of Age to Treat Symptoms of Abdominal Pain or Discomfort (e.g., Bloated Feeling, Feeling of Fullness) in the Abdominal Cavity, which may be Accompanied by Changes in Bowel Habits and Stool Consistency, Including Diarrhea and/or Constipation, Caused by Abnormal Functioning of the Digestive Tract. Duspatalin Gastro Should not be Taken for More than 5 Days Without Consulting a Doctor. If There is no Improvement or You Feel Worse After 5 Days, Consult a Doctor.

2. Important Information Before Taking Duspatalin Gastro

When Not to Take Duspatalin Gastro

• -in Children Under 10 Years of Age
• in Pregnant or Breastfeeding Women
• if the Patient is Allergic to the Active Substance or any of the Other Ingredients of this Medication (listed in Section 6).

Do not Take Duspatalin Gastro if any of the Above Applies to You. In Case of Doubt, Consult a Doctor or Pharmacist Before Taking the Medication.

Warnings and Precautions

Before Taking this Medication, Discuss it with Your Doctor if:

• You are Over 40 Years Old
• Someone in Your Family has been Diagnosed with Colon Cancer, Celiac Disease, or Inflammatory Bowel Disease
• You Experience Abdominal Pain at Night
• There is Blood in Your Stool
• You Experience Nausea or Vomiting
• You Have Lost Your Appetite or Have Lost Weight Quickly and Unexpectedly
• You are Pale and Feel Tired (Anemia)
• You Have Severe Constipation
• You Have a Fever, which can be a Sign of Inflammation
• You Have Recently Traveled Abroad
• You Have Recently Taken an Antibiotic
• You Have Difficulty or Pain when Urinating
• You Experience Abnormal Vaginal Bleeding or Discharge
• You are Pregnant or Think You Might be Pregnant. If any of the Above Applies to You (or in Case of Doubt), Consult a Doctor Before Taking Duspatalin Gastro.

Duspatalin Gastro and Other Medications

It is not Expected that Duspatalin Gastro will Affect the Action of any Other Medication You are Taking. However, Tell Your Doctor or Pharmacist About all Medications You are Currently Taking or Have Recently Taken, as well as any Medications You Plan to Take.

Pregnancy, Breastfeeding, and Fertility

If You are Pregnant, Breastfeeding, or Think You Might be Pregnant, or if You are Planning to Become Pregnant, Consult a Doctor or Pharmacist Before Taking this Medication.

• Tell Your Doctor if You are Pregnant or Think You Might be Pregnant. Duspatalin Gastro is not Recommended During Pregnancy. Your Doctor may Advise You to Stop Taking Duspatalin Gastro or Take a Different Medication Instead of Duspatalin Gastro.
• Tell Your Doctor if You are Breastfeeding or Plan to Breastfeed. Duspatalin Gastro is not Recommended for Breastfeeding Mothers. Your Doctor may Advise You to Stop Breastfeeding or Take a Different Medication While Breastfeeding.

Driving and Operating Machines

It is Unlikely that Duspatalin Gastro will Affect Your Ability to Drive or Operate Machines. Duspatalin Gastro Contains Lactose and Sucrose(Types of Sugars). If You have been Diagnosed with an Intolerance to some Sugars, Consult a Doctor Before Taking this Medication.

3. How to Take Duspatalin Gastro

Always Take this Medication Exactly as Described in the Patient Leaflet or as Advised by a Doctor or Pharmacist. If You are in Doubt, Consult a Doctor or Pharmacist.

How to Take the Medication

• Duspatalin Gastro can be Taken by Adults and Children Over 10 Years of Age.
• Swallow the Tablets Whole with a Sufficient Amount of Water (at Least 100 ml). Do not Crush or Chew the Tablets.
• Try to Take the Tablets at the Same Time Every Day. This will Help You Remember to Take Them.

How Much to Take

Adults and Children Over 10 Years of Age

• The Usual Dose is 1 Tablet of 135 mg, 3 Times a Day.
• Take the Medication 20 Minutes Before Meals, at Regular Intervals Throughout the Day.

Do not Give Duspatalin Gastro to Children Under 10 Years of Age.

Overdose of Duspatalin Gastro

If You Take More than the Recommended Dose, Contact a Doctor or Go to the Hospital Immediately. Take the Medication Packaging and the Patient Leaflet with You.

Missed Dose of Duspatalin Gastro

• If You Miss a Dose, Take the Next Dose at the Scheduled Time. Skip the Missed Dose.
• Do not Take a Double Dose to Make Up for a Missed Dose.

If You Have any Further Questions About Taking this Medication, Consult a Doctor or Pharmacist.

4. Possible Side Effects

Like all Medications, Duspatalin Gastro can Cause Side Effects, although not Everybody Gets Them. After Taking this Medication, the Following Side Effects may Occur:

Stop Taking Duspatalin Gastro and Contact a Doctor Immediately if You Experience any of the Following Serious Side Effects. You may Need Urgent Medical Attention:

• Difficulty Breathing, Swelling of the Face, Neck, Lips, Tongue, or Throat. This may be a Severe Allergic Reaction (Hypersensitivity) to the Medication. If You Experience any of the Above Symptoms, Stop Taking the Medication and Contact a Doctor Immediately.

Other Side Effects

• Milder Allergic Reactions (Hypersensitivity) to the Medication may Occur, such as Rash, Red, Itchy Redness on the Skin.

If You Experience any Side Effects, Including those not Listed in this Leaflet, Consult a Doctor or Pharmacist.

Reporting Side Effects

If You Experience any Side Effects, Including those not Listed in this Leaflet, Tell Your Doctor or Pharmacist. You can Report Side Effects Directly to the Department of Post-Marketing Surveillance of Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Phone: 22 49 21 301, Fax: 22 49 21 309, Website: https://smz.ezdrowie.gov.pl. You can also Report Side Effects to the Marketing Authorization Holder. By Reporting Side Effects, You can Help Provide More Information on the Safety of this Medication.

5. How to Store Duspatalin Gastro

• Keep the Medication Out of Sight and Reach of Children.
• Store in a Dry Place, at a Temperature Below 30°C.
• Do not Use this Medication After the Expiration Date Stated on the Carton. The Expiration Date is the Last Day of the Month Stated.
• Do not Dispose of Medications via Wastewater or Household Waste. Ask a Pharmacist How to Dispose of Medications that are no Longer Needed. This will Help Protect the Environment.

6. Contents of the Pack and Other Information

What Duspatalin Gastro Contains

• The Active Substance is Mebeverine Hydrochloride. Each Tablet Contains 135 mg of the Active Substance.
• The Other Ingredients are: Lactose Monohydrate, Corn Starch or Potato Starch, Povidone (K25), Talc, Magnesium Stearate. Coating: Talc, Sucrose, Gelatin, Gum Arabic, Carnauba Wax.

What Duspatalin Gastro Looks Like and Contents of the Pack

The Tablets are Round and White. The Tablets are Packaged in PVC/Al Blisters in a Cardboard Box. The Pack Contains 15 Tablets.

Marketing Authorization Holder

Viatris Healthcare Sp. z o.o. ul. Postępu 21B 02-676 Warsaw

Manufacturer

Mylan Laboratories SAS Route de Belleville, Lieu dit Maillard 01400 Châtillon sur Chalaronne, France

For More Detailed Information, Contact the Marketing Authorization Holder:

Viatris Healthcare Sp. z o.o. Phone: 22 546 64 00 Date of Last Update of the Leaflet:02/2024