Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Meteospasmyl, 60 mg + 300 mg, soft capsules
Alverini citras + Simeticonum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet

What Meteospasmyl is and what it is used for
Important information before taking Meteospasmyl
How to take Meteospasmyl
Possible side effects
How to store Meteospasmyl
Contents of the pack and other information

1. What Meteospasmyl is and what it is used for

Meteospasmyl relieves painful symptoms associated with functional gastrointestinal disorders. It contains two active substances: alverine and simeticone. Alverine has a spasmolytic effect, particularly on the smooth muscles of the gastrointestinal tract. Simeticone acts by reducing the surface tension of intestinal gas bubbles.
Indications
Meteospasmyl is indicated for symptomatic treatment of spastic conditions of the gastrointestinal smooth muscles in disorders such as:

irritable bowel syndrome,
painful diverticulosis of the large intestine, especially when associated with bloating.

2. Important information before using Meteospasmyl

You must strictly follow all your doctor's instructions.
Read this entire leaflet carefully before using the medicine.

When not to use Meteospasmyl

If the patient is allergic to alverine and simethicone, or to any of the other ingredients of this medicine (listed in section 6).
If the patient has symptoms of gastrointestinal obstruction.

Warnings and precautions
Before starting treatment with Meteospasmyl, discuss it with your doctor or pharmacist.
Exercise caution if experiencing symptoms suggesting gastrointestinal obstruction (nausea, vomiting, abdominal pain of unknown origin, retention of gas and stool).
Meteospasmyl may increase liver enzyme activity in the blood (see section 4).
Your doctor may decide to order blood tests during treatment to monitor liver function.
Elevated liver enzyme activity may lead your doctor to discontinue treatment with Meteospasmyl.

Children and adolescents
Meteospasmyl is not recommended for use in children due to lack of clinical data on safety and efficacy in this patient group.

Meteospasmyl with other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
No interactions between Meteospasmyl and other medicines are known.

Pregnancy, breastfeeding and fertility
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Meteospasmyl is not recommended during pregnancy.
Meteospasmyl should not be used during breastfeeding.

Driving and operating machinery
It is unlikely that Meteospasmyl affects the ability to drive or operate machinery. However, Meteospasmyl may cause dizziness, which could impair the ability to drive or operate machinery.

3. How to use Meteospasmyl

This medicine should always be used as directed by a physician. In case of doubt, consult your
doctor or pharmacist.
The recommended dose is 1 capsule 2 to 3 times daily before meals.
If you feel the effect of the medicine is too strong or too weak, consult your doctor.
Use of a higher than recommended dose of Meteospasmyl
In case of exceeding the recommended dose, contact your doctor immediately, as a drop in blood pressure may occur. In such cases, the doctor will provide symptomatic treatment.
Dizziness has been reported after taking a higher than recommended dose. If dizziness occurs, consult your doctor or pharmacist without delay.
Missed dose of Meteospasmyl
Continue treatment according to the previously established regimen.
Do not take a double dose to make up for a missed dose.
Stopping the use of Meteospasmyl
If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Adverse reactions are rare and transient.
If a drop in blood pressure, shock, or laryngeal edema occurs, stop using the medicine immediately, contact a doctor without delay or go to the nearest hospital.
General malaise, pain, dizziness, dry mouth, and skin allergic reactions such as urticaria may occur. In such cases, consult a doctor.
Isolated cases of hepatitis have been reported, which resolved after discontinuation of the medicine.
If any of the following adverse reactions occur, contact a doctor immediately:

Symptoms of a severe allergic reaction, especially swelling of the face, lips, mouth, tongue, and/or throat, 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 patient per 10,000).
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 effect on the liver occurs very rarely, i.e. in less than 1 patient per 10,000).
Other adverse reactions listed below have been reported with unknown frequency (frequency cannot be estimated from the available data):
Skin rash;
Urticaria;
Itching;
Dizziness;
Headache;
Nausea;
Increased liver enzyme activity in blood (aminotransferases, alkaline phosphatase) and increased bilirubin concentration (see section 2).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions allows the collection of further information on the safety of the medicine.

5. How to store Meteospasmyl

Keep this medicine out of 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 stated month.
Store below 30°C.
Keep in the original packaging.
Medicines must 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 in this medicine are alverine citrate and simethicone. Each soft capsule contains 60 mg of alverine citrate and 300 mg of simethicone.
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 soft capsules packed in 2 blisters of 10 capsules each.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
Marketing Authorisation Numbers in France, the country of export: 343 259-1
332 540-6
34009 343 259 15
34009 332 540 63
Parallel Import Licence Number: 359/12