Product Name:

Simecol Forte 240, 30 capsules

Product type:

Medicinal medical device

Product description:

INDICATIONS
SIMECOL Forte 240 is a medical device recommended in case of flatulence, feeling of fullness, excessive gas accumulation and belching, as well as for patients before diagnostic tests of the abdominal cavity.

ACTION
SIMECOL Forte 240 is intended for use to relieve the feeling of fullness, bloating, belching, and symptoms associated with excessive accumulation of gases and air in the digestive tract, which cause tension and pressure in the intestines.

SIMECOL Forte 240 is intended to be used as an adjunct to prepare patients for diagnostic examinations of the abdominal cavity (ultrasound, endoscopy, radiography and colonoscopy), in order to remove gases and air from the digestive tract, which improves the quality of the images obtained.

List of ingredients:

Ingredients: simethicone, shell ingredients (pork gelatin, glycerol).

Ingredient quantities:

Ingredients content: 1 capsule:

Simethicone 240 mg

Suggested dosage/Instructions for use:

SIMECOL Forte 240 is taken orally, before or after a meal, with an appropriate amount of liquid (e.g. 1 glass of water). It is not recommended to drink carbonated drinks while using the preparation.

Symptoms related to tension and pressure in the intestines:

Adults: as needed, 1 capsule, 2–4 times a day; maximum 4 capsules a day (960 mg simethicone).
Pregnant women: dosage and method of use according to the recommendations of a doctor or pharmacist.
No dosage change is required in people with diabetes.
Children from 12 to 18 years of age: as needed, 1 capsule a day.

Preparation for diagnostic tests:

Adults: 1 capsule in the evening on the day before the diagnostic test and 1 capsule in the morning, on an empty stomach, on the day of the diagnostic test.
Pregnant women: dosage and method of use according to the recommendations of a doctor or pharmacist.
No dosage change is required in people with diabetes.
Children from 12 to 18 years of age: 1 capsule in the evening on the day before the diagnostic test and 1 capsule in the morning, on an empty stomach, on the day of the diagnostic test.

The product can be used by people with diabetes and people with sugar digestion disorders. The use of the product during pregnancy and breastfeeding requires consultation with a doctor or pharmacist. Due to the action of simethicone and its lack of absorption from the gastrointestinal tract into the body, no harmful effects are expected when using the product during pregnancy and breastfeeding.

If you forget to use SIMECOL Forte 240 : Do not take a double dose to make up for the missed dose. The single dose can be refilled at any time.

Contraindications:

Do not use the SIMECOL Forte 240 medical device : in case of hypersensitivity to simethicone or any of the ingredients of the product; in children under 12 years of age; in case of confirmed or suspected perforation or obstruction of the gastrointestinal tract.

Storage conditions:

Store in a dry place at a temperature below 25 °C, out of the reach of small children. Protect from light.

Precautions:

Do not use more than 4 capsules a day in adults and 1 capsule a day in children over 12 years of age.

Simethicone may reduce the bioavailability of concomitantly taken medications. If it is necessary to use the product simultaneously with other drugs, there should be a break of at least one hour between taking the SIMECOL Forte 240 medical device and other preparations. If in doubt, consult your doctor or pharmacist. In case of simultaneous use of levothyroxine and simethicone, a 4-hour interval should be maintained. If symptoms worsen or persist for a long time, seek medical advice.

Driving and using machines: No data are available on the effect of the product on the use of machines and vehicles.

Name of the company producing the product/Entity address:

NORIS Pharma AG

Gutenbergstrasse 1

CH-8002 Zürich, Switzerland

CE 1434.

Important information regarding the medical device

This is a medical device.

Use it according to the instructions for use or label.

A medical device intended for self-monitoring - has the CE marking.

It has an EU declaration of conformity.

Includes an operating manual in Polish.