Package leaflet: Information for the user

S, 80 mg, chewable tablets
Simeticonum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient information leaflet or as directed by the doctor, pharmacist, or nurse.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.
If the patient does not get better or feels worse, contact the doctor.

Contents of the leaflet:

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

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, causing them to coalesce and facilitating the elimination of gas from the gastrointestinal tract. It is chemically and physically inert. It has no irritating effects. It does not affect gastrointestinal motility or digestive processes.
S is used in the treatment of conditions associated with excessive accumulation of gas in the gastrointestinal tract (bloating and feeling of fullness in the abdominal cavity).

2. Important information before taking medicine S

When not to use medicine S

if the patient is allergic to simethicone or any of the other ingredients of this medicine (listed in section 6);
in children;
in cases of suspected perforation or gastrointestinal obstruction.

Warnings and precautions
Before starting to take medicine S, discuss this with your doctor, pharmacist, or nurse.

Be cautious if the patient is taking other medicines simultaneously, as S may interfere with their absorption.
If the patient has been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Medicine S and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Taking medicine S may reduce the absorption, and thus the effectiveness, of other medicines taken simultaneously. At least a one-hour interval should be maintained between taking medicine S and other medicines.

S with food and drink
S should be taken after meals.
During treatment with medicine S, carbonated drinks should not be consumed.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
S does not affect the ability to drive or operate machinery.

S contains lactose and sorbitol.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to take S

This medicine should always be taken according to the doctor's or pharmacist's instructions.
If in doubt, consult your doctor or pharmacist.
Recommended dose of S:
Adults:
Orally, usually 1 chewable tablet 4 times daily. The tablet should be chewed thoroughly.
Do not swallow the tablet whole.
The medicine should be taken after meals and at bedtime, or when symptoms occur.
Do not exceed a dose of 6 tablets per day.

Taking more than the recommended dose of S
There are no known cases of overdose.
If more than the recommended dose of S has been taken, contact your doctor.

Missing a dose of S
Do not take a double dose to make up for a missed dose.

Stopping treatment with S
Discontinuing use of S may lead to worsening of symptoms related to excessive production and accumulation of intestinal gases.

If you have any further doubts regarding the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Simet is very well tolerated by patients.
Below are the adverse reactions observed during clinical trials of simethicone.
The frequency of occurrence of adverse reactions cannot be determined based on available data:
Gastrointestinal disorders: nausea, vomiting, diarrhoea, dyspeptic symptoms (indigestion)
Skin and subcutaneous tissue disorders: rash
Nervous system disorders: headache.
Reporting of adverse reactions
If any adverse symptoms occur, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to:
Department of Monitoring Adverse Reactions of Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
{current address, telephone and fax number of the above Department}
e-mail: [email protected]
Reporting of adverse reactions allows further information on the safety of the medicine to be collected.

5. How to store Simet

Keep the medicine out of sight and reach of children.
Store below 25°C.
Do not use Simet after the expiry date stated on the carton. The expiry date refers to the last day of the stated month.
Medicines must 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 packaging and other information

What S contains

The active substance is simeticone (Simeticonum). One chewable tablet contains 80 mg of simeticone.
Other ingredients are: sorbitol, monohydrate lactose, anhydrous colloidal silicon dioxide, levomenthol, magnesium stearate.

What S looks like and contents of the pack
S is in the form of chewable tablets. The tablets are white to almost white, biconvex, with a division line on both sides. The division line on the tablet is not intended for splitting the tablet.
S is packed in:
a) PVC/Aluminium blisters. Pack sizes: 5, 10, 20 tablets.
b) HDPE containers. Pack sizes: 30, 60 tablets,
all contained in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Laboratorium Galenowe Olsztyn Sp. z o.o.,
Spółdzielcza 25A Street,
11-001 Dywity