Meteospasmil

Leaflet attached to the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Meteospasmyl, 60 mg + 300 mg, soft capsules

Alverine citrate+ Simeticone

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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 using Meteospasmyl
• 3. How to use Meteospasmyl
• 4. Possible side effects
• 5. How to store Meteospasmyl
• 6. Contents of the packaging and other information

1. What is Meteospasmyl and what is it used for

Meteospasmyl relieves painful symptoms occurring in functional disorders of the digestive tract. It contains two active substances: alverine and simeticone. Alverine acts as a spasmolytic, especially on the smooth muscles of the digestive tract. The action of simeticone is to reduce the surface tension of intestinal gas bubbles.

Indications for use

Meteospasmyl is used for the symptomatic treatment of spastic conditions of the smooth muscles of the digestive tract in disorders such as:

• irritable bowel syndrome,
• painful diverticulosis of the colon, especially if it occurs with bloating.

2. Important information before using Meteospasmyl

You should carefully follow all the doctor's instructions.
You should read the contents of the leaflet before using the medicine.

When not to use Meteospasmyl

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

Warnings and precautions

Before starting to take Meteospasmyl, you should discuss it with your doctor or pharmacist.
You should be cautious in case of 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 condition of the liver.
Increased liver enzyme activity may cause the doctor to discontinue Meteospasmyl treatment.

Children and adolescents

Meteospasmyl is not recommended for use in children, due to the lack of clinical data on its use in this patient group.

Meteospasmyl and other medicines

You should tell your doctor or pharmacist about all the 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 or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
Meteospasmyl is not recommended for use 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 use Meteospasmyl

This medicine should always be used exactly as your doctor has instructed. If you are unsure, you should consult 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 medicine is too strong or too weak, you should consult your doctor.

Using a higher dose of Meteospasmyl than recommended

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

Missing a dose of Meteospasmyl

You should continue treatment according to the previously established schedule.
You should not take a double dose to make up for a missed dose.

Stopping Meteospasmyl treatment

If you have any further doubts about using this medicine, you should 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 are usually temporary.
In case of a drop in blood pressure, shock, or laryngeal edema, you should immediately stop using the medicine, 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, you should consult your doctor.
There have been isolated reports of hepatitis, which resolved after the medicine was discontinued.
If you experience any of the following side effects, you should immediately consult your doctor:
‐ 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, which occurs very rarely, i.e., in less than 1 in 10,000 patients).
‐ Symptoms indicating liver dysfunction. These include: yellowing of the skin or whites of the eyes, dark urine, loss of appetite, nausea, or vomiting (such an effect on the liver occurs 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 any side effects not listed in this leaflet, you should 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

The medicine should be stored out of sight and reach of children.
You should not use Meteospasmyl after the expiry date stated on the packaging.
The expiry date refers to the last day of the month stated.
Store in a temperature below 30°C.
Store in the original packaging.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Meteospasmyl contains

• The active substances of Meteospasmyl 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 packaging contains

Meteospasmyl is available in the form of soft capsules.
A cardboard box contains 20 soft capsules packaged in 2 blisters of 10 capsules each.
To obtain more detailed information, you should 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:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Authorization number in France, the country of export:343 259-1
332 540-6
34009 343 259 15
34009 332 540 63
Parallel import authorization number:359/12
Date of leaflet approval: 28.04.2022
[Information about the trademark]