Meteospasmil

Package Leaflet: Information for the User

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Meteospasmyl

60 mg + 300 mg, soft capsules

Alverine citrate + Simeticone

Read the leaflet carefully before taking the medicine, 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 only. 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, tell your doctor, pharmacist, or nurse. 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 of 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 works by reducing 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 leaflet before taking the medicine.

When Not to Take Meteospasmyl

• If you are allergic to alverine and simeticone or any of the other ingredients of this medicine (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 if you experience 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 liver function. Increased 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 Medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take. There are no known interactions between Meteospasmyl and other medicines.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Meteospasmyl is not recommended during pregnancy. Meteospasmyl should not be used during breastfeeding.

Driving and Using Machines

It is unlikely that Meteospasmyl will affect your ability to drive or use machines. However, Meteospasmyl may cause dizziness, which may affect your ability to drive or use machines.

3. How to Take Meteospasmyl

Always take this medicine 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 Meteospasmyl is too strong or too weak, talk to your doctor.

Overdose of Meteospasmyl

If you have taken more Meteospasmyl than you should, contact your doctor immediately, as this may cause a drop in blood pressure. In such cases, your doctor will provide symptomatic treatment. After taking more Meteospasmyl than recommended, dizziness has been reported. If you experience dizziness, consult your doctor or pharmacist immediately.

Missed Dose of Meteospasmyl

Continue treatment according to the previously established schedule. Do not take a double dose to make up for a forgotten dose.

Stopping Meteospasmyl Treatment

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Meteospasmyl can cause side effects, although not everybody gets them. Side effects are rare and temporary. If you experience a drop in blood pressure, shock, or throat swelling, stop taking the medicine immediately, inform your doctor, or go to the nearest hospital. You may experience malaise, pain, and dizziness, dry mouth, skin allergic reactions such as hives. In such cases, consult your doctor. There have been reports of isolated cases of hepatitis, which resolved after the medicine was discontinued.

If You Experience Any of the Following Side Effects, Contact Your Doctor Immediately:

• Symptoms of a severe allergic reaction, especially swelling of the face, lips, mouth, tongue, and/or throat, which may cause difficulty breathing or swallowing, skin rash, itching, severe dizziness with increased heart rate and excessive sweating (severe allergic reaction occurs very rarely, i.e., in less than 1 in 10,000 patients).
• Symptoms indicating liver function disorders, 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 Unknown Frequency (Frequency Cannot Be Estimated from Available Data):

• Skin rash;
• Hives;
• 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, tell your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Meteospasmyl

Keep the medicine out of the sight and reach of children. Do not use Meteospasmyl after the expiry date stated on the packaging. Do not store above 30°C. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

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 Contents of the Pack

Meteospasmyl is available in the form of soft capsules. The cardboard box contains 20 or 40 capsules, packaged in 2 or 4 blisters of 10 capsules each. For more detailed information, contact the marketing authorization holder or the parallel importer.

Marketing Authorization Holder in France, the Country of Export:

Laboratoires Mayoly Spindler
6, Avenue de L’Europe
BP 51
78401 Chatou Cedex
France

Manufacturer:

Laboratoires Mayoly Spindler
6, Avenue de L’Europe
BP 51
78401 Chatou Cedex
France

Parallel Importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Laboratorium Galenowe Olsztyn Sp. z o.o.
ul. Spółdzielcza 25A
11-001 Dywity
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
IVA Pharm Sp. z o.o.
ul. Drawska 14/1
02-202 Warszawa
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing authorization number in France, the country of export: 34009 332 540 6 3
332 540-6
34009 333 799 3 3
333 799-3
34009 343 259 1 5
343 259-1
Parallel import authorization number: 207/18
Date of leaflet approval: 21.04.2023
[Information about the trademark]