Meteospasmyl

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 taking this medicine because it contains
important information for the patient.

• Keep this leaflet as you may need to read it again.
• If you have any doubts, please 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 someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Meteospasmyl is and what it is 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 Meteospasmyl is and what it is used for

Meteospasmyl relieves pain symptoms occurring in functional gastrointestinal disorders. It contains two active substances: alverine citrate and simethicone. Alverine has a spasmolytic effect, particularly on the smooth muscles of the gastrointestinal tract. Simethicone acts by reducing the surface tension of intestinal gas bubbles.
Indications
Meteospasmyl is used for symptomatic treatment of smooth muscle spasms in the gastrointestinal tract 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 the 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, consult 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 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 the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a 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 affect the ability to drive or operate machinery.

3. How to use Meteospasmyl

This medicine should always be used as directed by the 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.
Taking a higher than recommended dose of Meteospasmyl
Contact your physician immediately if you take more than the recommended dose of this medicine, as it may cause a drop in blood pressure. In such a case, the physician will provide symptomatic treatment.
Dizziness has been reported after taking a higher than recommended dose of the medicine. If dizziness occurs, consult your doctor or pharmacist immediately.
Missing a 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 Meteospasmyl
If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions are rare and transient.
If a drop in blood pressure, shock, or laryngeal oedema occurs, stop using the medicine immediately, contact a doctor without delay or go to the nearest hospital.
Poor general condition, pain and dizziness, dryness of the mouth, skin allergic 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, particularly 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 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 patient per 10,000).

Other adverse reactions listed below have been reported with unknown frequency (frequency cannot be determined from 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 of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more 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.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. 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.
• 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:
PharmaVitae Sp. z o.o. sp. k., ul. E. Orzeszkowej 3/35, 59-820 Leśna
Repackaged in:
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 authorisation numbers 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 authorisation number: 598/12