Simet

1.

What S is and what it is used for
S contains the active substance simeticone.
It reduces the surface tension of gas bubbles in the stomach and intestines, which causes them to
merge and facilitates the removal of gas from the digestive tract. It is a chemically and physically inert substance. It does not have an irritating effect. It does not affect the motility of the digestive tract or the digestive processes.
S is used to treat conditions of excessive gas accumulation in the digestive tract (bloating and feeling of fullness in the abdominal cavity).

2.

Important information before taking S
When not to take S

• if you are allergic to simeticone or any of the other ingredients of this medicine (listed in section 6);
• in children;
• in cases of suspected perforation or obstruction of the digestive tract.

Warnings and precautions
Before taking S, you should discuss it with your doctor, pharmacist, or nurse.

• You should be cautious when taking other medicines at the same time, as S may interfere with their absorption.
• If you have been diagnosed with intolerance to some sugars, you should talk to your doctor before taking the medicine.

S and other medicines

You should 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.
Taking S may reduce the absorption and effectiveness of other medicines taken at the same time. You should leave at least a one-hour interval between taking S and other medicines.

S with food and drink

S should be taken after meals.
During treatment with S, you should not drink carbonated beverages.
Pregnancy, breast-feeding, and fertility
If you are pregnant, breast-feeding, or think you may be pregnant, you should consult your doctor or pharmacist before taking this medicine.

Driving and using machines

S does not affect the ability to drive or use machines.
S contains lactose and sorbitol.
If you have been diagnosed with intolerance to some sugars, you should talk to your doctor before taking the medicine.

3.

How to take S
This medicine should always be taken exactly as advised by your doctor or pharmacist. If you are unsure, you should talk to your doctor or pharmacist.
Recommended dose of S:
Adults:
orally, usually 1 chewable tablet 4 times a day. The tablet should be chewed thoroughly. It should not be swallowed.
The medicine should be taken after meals and before bedtime or when symptoms occur. You should not exceed the dose of 6 tablets per day.
Taking a higher dose of S than recommended
No cases of overdose have been reported.
If you take more than the recommended dose of S, you should talk to your doctor.
Missing a dose of S
You should not take a double dose to make up for a missed dose.

Stopping S

Stopping S may cause worsening of symptoms associated with excessive gas production and accumulation in the intestines.
If you have any further questions about the use of this medicine, you should talk to your doctor, pharmacist, or nurse.

4.

Possible side effects
Like all medicines, S can cause side effects, although not everybody gets them.
S is very well tolerated by patients.
Below are the side effects that occurred during simeticone studies.
The frequency of side effects cannot be determined from the available data:
Gastrointestinal disorders:nausea, vomiting, diarrhea, dyspeptic symptoms (indigestion)
Skin and subcutaneous tissue disorders:rash
Nervous system disorders:headache.
Reporting side effects
If you experience any side effects, including those not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to:
Department of Post-Marketing Surveillance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.
{current address, phone number, and fax of the above Department}
e-mail: [email protected]
Reporting side effects will help to gather more information on the safety of the medicine.

5.

How to store S
The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C.
Do not use S after the expiry date stated on the carton. The expiry date refers to the last day of the month stated.
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 pack and other information

What S contains

• The active substance of S is simeticone (Simeticonum). One chewable tablet contains 80 mg of simeticone.
• The other ingredients are: sorbitol, lactose monohydrate, colloidal anhydrous silica, levomenthol, magnesium stearate. What S looks likeS is a chewable tablet. The tablets are white to almost white, biconvex, with a score line on both sides. The score line is not intended for breaking the tablet. S is packaged in: a) PVC/Aluminum blisters. Available pack sizes: 5, 10, 20 tablets. b) HDPE containers. Available pack sizes: 30, 60 tablets, placed in a cardboard box.

Marketing Authorization Holder and Manufacturer

Laboratorium Galenowe Olsztyn Sp. z o.o.,
ul. Spółdzielcza 25A,
11-001 Dywity

Date of last revision of the leaflet: