Meteospasmil

Package Leaflet: Information for the User

Meteospasmyl, 60 mg + 300 mg, Capsules

Alverine Citrate + Simeticone

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Meteospasmyl and What is it Used For

Meteospasmyl Relieves Painful Symptoms Occurring in Functional Gastrointestinal Disorders. It Contains Two Active Substances: Alverine and Simeticone. Alverine Acts as a Spasmolytic, Especially on the Smooth Muscles of the Gastrointestinal Tract. Simeticone Reduces the Surface Tension of Gas Bubbles in the Intestine.

Indications for Use

Meteospasmyl is Used for the Symptomatic Treatment of Spastic Conditions of the Smooth Muscles of the Gastrointestinal Tract in Disorders Such as:

• Irritable Bowel Syndrome,
• Painful Diverticulosis of the Colon, Especially if Accompanied by Bloating.

2. Important Information Before Taking Meteospasmyl

Follow the Doctor's Instructions Carefully. Read the Package Leaflet Before Taking the Medication.

When Not to Take Meteospasmyl

• If You are Allergic to Alverine and Simeticone or Any of the Other Ingredients of this Medication (Listed in Section 6).
• If You Have Symptoms of Gastrointestinal Obstruction.

Warnings and Precautions

Before Taking Meteospasmyl, Discuss it with Your Doctor or Pharmacist. Be Cautious in Case of Symptoms that May Indicate Gastrointestinal Obstruction (Nausea, Vomiting, Abdominal Pain of Unknown Cause, Gas and Stool Retention). Meteospasmyl May Increase Liver Enzyme Activity in the Blood (See Section 4). Your Doctor May Decide to Perform Blood Tests During Treatment to Check the Liver Condition. Elevated Liver Enzyme Activity May Cause Your Doctor to Discontinue Meteospasmyl Treatment.

Children and Adolescents

Meteospasmyl is Not Recommended for Children Due to the Lack of Clinical Data on its Use in this Patient Group.

Meteospasmyl and Other Medications

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. No Interactions Between Meteospasmyl and Other Medications are Known.

Pregnancy, Breastfeeding, and Fertility

If You are Pregnant or Breastfeeding, Think You May be Pregnant, or Plan to Have a Child, Consult Your Doctor or Pharmacist Before Taking this Medication. Meteospasmyl is Not Recommended During Pregnancy. Meteospasmyl Should Not be Used During Breastfeeding.

Driving and Operating Machines

It is Unlikely that Meteospasmyl Will Affect Your Ability to Drive or Operate Machines. However, Meteospasmyl May Cause Dizziness, Which May Affect Your Ability to Drive or Operate Machines.

3. How to Take Meteospasmyl

Always Take this Medication Exactly as Your Doctor has Told You. If You are Not Sure, Ask Your Doctor or Pharmacist. The Recommended Dose is 1 Capsule 2 to 3 Times a Day Before Meals. If You Feel that the Effect of the Medication is Too Strong or Too Weak, Consult Your Doctor.

Taking More Than the Recommended Dose of Meteospasmyl

In Case of Overdose, Contact Your Doctor Immediately, as it May Cause a Drop in Blood Pressure. In Such a Case, Your Doctor Will Provide Symptomatic Treatment. After Taking More Than the Recommended Dose, Dizziness Has Been Reported. If You Experience Dizziness, Consult Your Doctor or Pharmacist Immediately.

Missing a Dose of Meteospasmyl

Continue Treatment According to the Previously Established Schedule. Do Not Take a Double Dose to Make Up for a Missed Dose.

Stopping Meteospasmyl Treatment

If You Have Any Further Questions About Taking this Medication, Ask Your Doctor or Pharmacist.

4. Possible Side Effects

Like All Medications, Meteospasmyl Can Cause Side Effects, Although Not Everybody Gets Them. Side Effects are Rare and Transient. If You Experience a Drop in Blood Pressure, Shock, or Laryngeal Edema, Stop Taking the Medication Immediately, Inform Your Doctor, or Go to the Nearest Hospital. You May Experience Malaise, Pain, and Dizziness, Dry Mouth, Skin Allergic Reactions, Such as Urticaria. In Such Cases, Consult Your Doctor. Isolated Cases of Hepatitis Have Been Reported, Which are Reversible After Discontinuation of the Medication. If You Experience Any of the Following Side Effects, Contact Your Doctor Immediately:

• Symptoms of a Severe Allergic Reaction, Especially Facial, Lip, Oral, Tongue, and/or Pharyngeal Edema, Which May Cause Difficulty in Breathing or Swallowing, Skin Rash, Itching, Severe Dizziness with Increased Heart Rate and Profuse Sweating (Severe Allergic Reaction Occurring Very Rarely, i.e., in Less Than 1 in 10,000 Patients).
• Symptoms Indicating Liver Dysfunction, Including: Yellowing of the Skin or Whites of the Eyes, Dark Urine, Loss of Appetite, Nausea or Vomiting (Such Liver Effects Occur Very Rarely, i.e., in Less Than 1 in 10,000 Patients).

Other Side Effects Listed Below Have Been Reported with an Unknown Frequency (Frequency Cannot be Estimated from the Available Data):

• Skin Rash;
• Urticaria;
• Itching;
• Dizziness;
• Headache;
• Nausea;
• Increased Liver Enzyme Activity in the Blood (Aminotransferases, Alkaline Phosphatase) and Increased Bilirubin Levels (See Section 2).

Reporting Side Effects

If You Experience Any Side Effects, Including Any Not Listed in this Leaflet, Inform Your Doctor or Pharmacist. Side Effects Can be Reported Directly to the Department of Drug Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl. Side Effects Can Also be Reported 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 Meteospasmyl

Keep the Medication Out of Sight and Reach of Children. Do Not Use Meteospasmyl After the Expiration Date Stated on the Packaging. Store Below 25°C. Store in the Original Packaging. Medications Should Not be Disposed of via Wastewater or Household Waste. Ask Your Pharmacist How to Dispose of Medications No Longer Needed. This Will Help Protect the Environment. EXP - Expiration Date, Lot - Batch Number

6. Contents of the Pack and Other Information

What Meteospasmyl Contains

• The Active Substances are Alverine Citrate and Simeticone. Each Capsule Contains 60 mg of Alverine Citrate and 300 mg of Simeticone.
• The Other Ingredients are: Gelatin, Glycerol, Titanium Dioxide (E 171).

What Meteospasmyl Looks Like and What the Pack Contains

Meteospasmyl is Available in the Form of Capsules. The Carton Contains 20, 30, 40, or 64 Capsules Packed in 2, 3, or 4 Blisters of 10 Capsules or 4 Blisters of 16 Capsules.

Marketing Authorization Holder

LABORATOIRES MAYOLY SPINDLER, 3 Place Renault, 92500 Rueil-Malmaison, France

Manufacturer

MAYOLY SPINDLER Laboratoires, 6, avenue de l’Europe B.P.51, 78401 Chatou Cedex, France, Laboratoires GALENIQUES VERNIN, 20, rue Louis-Charles Vernin, 77190 Dammarie-les-Lys, France

Representative of the Marketing Authorization Holder in Poland

MAYOLY POLSKA Sp. z o.o., ul. Domaniewska 39B, 02-672 Warsaw, tel. 22 166 26 26, Date of Last Update of the Leaflet:07/2025