Patient Information Leaflet

Simetikon Hasco
80 mg, soft capsules
Simeticonum
Please read this leaflet carefully before taking this medicine because it contains important information for you.
You should always use this medicine exactly as described in this patient leaflet or as directed by your doctor, pharmacist, or nurse.

Keep this leaflet as you may need to read it again.
If you need advice or further information, please contact your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
If your symptoms do not improve or worsen, contact your doctor.

Contents of the leaflet:

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

1. What Simetikon Hasco is and what it is used for
Simeticonum is a medicine used against bloating and excessive accumulation of gas. It acts in the stomach and intestines by altering the surface tension at the interface between the liquid contents of the gastrointestinal tract and gas bubbles. This facilitates the coalescence of gas bubbles accumulated in food content and saliva, allowing them to pass through the intestine. Gases are eliminated from the gastrointestinal tract via belching, flatulence, or increased absorption into the bloodstream. Due to its anti-foaming properties, simeticonum is used as an adjunct to remove gases prior to diagnostic examinations: ultrasound, radiography, and endoscopy of the abdominal cavity.
Simetikon Hasco is indicated for:

symptomatic treatment of discomfort associated with excessive accumulation of intestinal gas and a sensation of abdominal fullness,
adjunctive use prior to diagnostic examinations: ultrasound, radiography, and endoscopy of the abdominal cavity, to remove excess gas before the examination.

2. Important information before taking Simetikon Hasco

When not to take Simetikon Hasco

if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting Simetikon Hasco, discuss it with your doctor, pharmacist, or nurse.
Simetikon Hasco and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
No interactions between simeticonum and other medicines have been observed to date.
Simetikon Hasco with food and drink
The medicine should be taken after meals.
On the day of a diagnostic examination, the medicine should be taken on an empty stomach.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and operating machinery
Simetikon Hasco has no effect on the ability to drive or operate machinery.
Simetikon Hasco contains Quinoline Yellow
This medicine may cause allergic reactions.

3. How to use Simetikon Hasco

This medicine should always be taken exactly as described in this patient leaflet or as advised by a doctor, pharmacist, or nurse. If in doubt, consult a doctor, pharmacist, or nurse.
The medicine is taken orally.
Adults: 1 capsule (80 mg) 4 times daily.
Preparation of patients for diagnostic examinations of the abdominal cavity: 1 capsule (80 mg) 3 times daily the day before the scheduled diagnostic examination, and one capsule in the morning on an empty stomach on the day of the examination.
The medicine should be taken after meals and before bedtime.
Do not exceed the dose of 6 capsules per day.
Taking more than the recommended dose of Simetikon Hasco
If more than the recommended dose has been taken, contact a doctor immediately.
Missing a dose of Simetikon Hasco
Do not take a double dose to make up for a missed dose.
If you have any further questions about 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 will experience them.
To date, no adverse reactions have been observed.
If any adverse symptoms not mentioned in this leaflet occur, inform your doctor or pharmacist.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Faks: + 48 22 49 21 309
e-mail: [email protected]

Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Simetikon Hasco

Store in the original packaging at a temperature not exceeding 25°C.
Keep the medicine out of sight and reach of children.
Do not use this medicine 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 required. This will help protect the environment.

6. Contents of the pack and other information

What Simetikon Hasco contains
The active substance is simeticone.
The other ingredients (excipients) are: gelatin, glycerol (E 422), quinoline yellow (E 104).

What Simetikon Hasco looks like and contents of the pack
Simetikon Hasco is in the form of oval, yellow, soft capsules, hermetically filled with a solution, having a smooth and glossy surface. One pack of Simetikon Hasco contains 25, 50 or 100 soft capsules, placed in a cardboard box.

Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Information on the medicinal product
tel. 22 742 00 22
e-mail [email protected]