Meteospasmil

Leaflet attached to the packaging: 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 doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you by a doctor. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell 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. Package contents and other information

1. What is Meteospasmyl and what is it used for

Meteospasmyl relieves painful symptoms occurring in functional disorders of the gastrointestinal tract. It contains two active substances: alverine and simeticone. Alverine acts as a spasmolytic, especially on the smooth muscles of the gastrointestinal tract. The action of simeticone is to reduce 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 it occurs with 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 intestinal obstruction.

Warnings and precautions

Before taking Meteospasmyl, discuss it with your doctor or pharmacist. Be cautious if you experience symptoms that may indicate intestinal 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 order blood tests during treatment to check the liver condition. 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 the medicines you are taking or have recently taken, as well as any medicines you plan to take. There are no known interactions between Meteospasmyl and other medicines.

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 medicine. Meteospasmyl is not recommended during pregnancy. Meteospasmyl should not be taken 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.

Taking a higher dose of Meteospasmyl than recommended

If you take more Meteospasmyl than you should, contact your doctor immediately, as it may cause a drop in blood pressure. In this case, your doctor will provide symptomatic treatment. After taking a higher dose of Meteospasmyl than recommended, 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 doubts about taking this medicine, consult 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 single reports 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 sweating (severe allergic reaction, which occurs very rarely, i.e., in less than 1 in 10,000 patients).
• Symptoms indicating liver function disorders. These include: 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;
• 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 those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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. The expiry date refers to the last day of the month. Store below 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. Package contents and other information

What Meteospasmyl contains

• The active substances are alverine citrate and simeticone. Each soft 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 as soft capsules. The cardboard box contains 20 soft capsules packed in 2 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, B.P. 51, 78401 Chatou Cedex, France

Manufacturer:

Laboratoires Mayoly Spindler, 6, avenue de l’Europe, B.P. 51, 78401 Chatou Cedex, France

Parallel importer:

PharmaVitae Sp. z o.o. sp. k., ul. E. Orzeszkowej 3/35, 59-820 Leśna

Repackaged by:

Pharma Innovations Sp. z o.o., ul. Jagiellońska 76, 03-301 Warszawa, LABOR Przedsiębiorstwo Farmaceutyczno-Chemiczne Sp. z o.o., ul. Długosza 49, 51-162 Wrocław, Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź, CANPOLAND SPÓŁKA AKCYJNA, ul. Beskidzka 190, 91-610 Łódź, SHIRAZ PRODUCTIONS Sp. z o.o., ul. Tymiankowa 24/28, 95-054 Ksawerów

Marketing authorization number in France, the country of export:

34009 332 540 6 3, 332 540-6, 333 799-3, 34009 333 799 3 3, 343 259-1, 34009 343 259 1 5, Parallel import authorization number:598/12, Date of leaflet approval: 05.10.2022