Package leaflet: Information for the user

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

Keep this leaflet to be able to read it again if necessary.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. 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 adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

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 pain symptoms occurring in 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 smooth muscle spasm in the gastrointestinal tract associated with conditions such as:

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

2. Important information before using Meteospasmyl

You must strictly follow all your doctor's instructions.
Please read this 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 that may indicate gastrointestinal obstruction (nausea, vomiting, abdominal pain of unknown origin, retention of gas and faeces).
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 its use in this patient group.

Meteospasmyl and 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 or 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 for use 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 affect your ability to drive or operate machinery.

3. How to use Meteospasmyl

This medicine should always be used as directed by the physician. If in doubt, consult a
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 an overdose, contact your physician immediately, as a drop in blood pressure may occur. In such a case, the physician will apply symptomatic treatment.
After ingestion of a higher than recommended dose, dizziness has been reported. If dizziness occurs, consult a doctor or pharmacist immediately.
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.
Discontinuation 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 gets them.
Adverse reactions are rare and transient.
If a drop in blood pressure, shock or laryngeal oedema occurs, the medicine must be discontinued immediately, and a doctor must be contacted promptly or the nearest hospital visited without delay.
Malaise, headache and dizziness, dry mouth, and allergic skin reactions such as urticaria may occur. In such cases, contact 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 (a severe allergic reaction occurring very rarely, i.e. in less than 1 in 10,000 patients).
Symptoms indicating impaired liver function. 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 in 10,000 patients).

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 symptoms occur, including any adverse symptoms not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Reporting adverse reactions allows the collection of additional information on the safety of medicine use.

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.
Do not store above 30°C.
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 capsule contains 60 mg of alverine citrate and 300 mg of simethicone.
Other components 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, packed in 2 or 4 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
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 in:
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 Authorisation Numbers 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 Licence Number: 207/18