Package leaflet: Information for the patient

Esputicon, 200 mg, soft capsules
Dimeticonum
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
If your condition does not improve or worsens, contact your doctor.

Contents of the leaflet

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

1. What Esputicon is and what it is used for

Esputicon contains the active substance dimethicone, a compound with low surface tension that alters the surface tension of gas bubbles in the gastrointestinal tract.
It breaks down larger gas bubbles into smaller ones, which are more easily absorbed.
When taken orally, it relieves bloating and removes excess gas from the gastrointestinal tract.
The medicine is used:

to prepare patients for imaging diagnostic examinations of the abdominal cavity (ultrasonography, endoscopy, radiology) by removing excess gas from the gastrointestinal tract. Elimination of excess gas improves image quality and reduces diagnostic difficulties;
to relieve discomfort caused by accumulation of excessive gas in the stomach and intestines, such as bloating, colic, feeling of pressure and fullness, belching;
in cases of increased gas formation in the postoperative period, under medical supervision.

2. Important information before using Esputicon

When not to use Esputicon

if the patient is allergic to dimethicone or any of the other ingredients of this medicine (listed in section 6);
in case of intestinal obstruction or perforation.

Warnings and precautions
No special warnings and precautions for use apply.
Children
Do not use in children under 14 years of age.
Esputicon and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
There have been reports suggesting that medicines belonging to the dimethicone group (e.g. dimethicone, simethicone) may interfere with the absorption of levothyroxine (a medicine used for hypothyroidism), oral anticoagulants (e.g. ethyl biscumacetate), and antidiabetic drugs (e.g. gliclazide, glibenclamide).
Esputicon with food and drink
No special requirements regarding administration with meals.
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 her doctor before using this medicine.
No adverse effects of Esputicon have been observed during pregnancy or breastfeeding. There are no available data on the effect on fertility in women and men.
Driving and operating machinery
Esputicon has no effect or has a negligible effect on the ability to drive and operate machinery.
Use of Esputicon in elderly patients
Elderly patients may use Esputicon.

3. How to use Esputicon

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Oral administration.
Adults and adolescents over 14 years of age
Dosage

For preparation prior to diagnostic examinations: usually 1–2 capsules in the evening on the day before the examination, and 1 capsule in the morning on an empty stomach on the day of the examination.
For relief of symptoms related to excessive gas accumulation: 1 capsule 1–2 times daily, unless otherwise directed by a physician.

Children
Do not use in children under 14 years of age.
This medicine does not contain sugar and may be used by diabetic patients.
Take with an adequate amount of liquid, e.g. a glass of water.
Taking more Esputicon than recommended
There is no risk of overdose with Esputicon.
If you forget to take Esputicon
If a dose is missed, take it as soon as possible, then return to the regular dosing schedule. Do not take a double dose to make up for a missed dose.
If you have any further doubts concerning the use of 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.
To date, no adverse reactions have been reported following the use of the medicinal product
Esputicon.

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects 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 of the 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
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Esputicon

Store below 25°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. 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 package and other information

What Esputicon contains

The active substance is dimethicone.
One capsule contains 200 mg of dimethicone.
The other ingredients are: gelatin, glycerol (E422), colloidal anhydrous silica, purified water.

What Esputicon looks like and contents of the pack
Esputicon is a round, soft gelatin capsule, straw-coloured, packed in aluminium./PVC/PVDC foil blisters within a cardboard box.
Pack sizes:
15 soft capsules (1 blister containing 15 capsules)
30 soft capsules (2 blisters containing 15 capsules each)
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Przedsiębiorstwo Farmaceutyczno-Chemiczne „Synteza” Sp. z o.o.
ul. Św. Michała 67/71
61-005 Poznań
tel. 61 879-20-81

For further information, please contact the local representative of the Marketing Authorisation Holder:
Poland
Przedsiębiorstwo Farmaceutyczno-Chemiczne „Synteza” Sp. z o.o.
ul. Św. Michała 67/71
61-005 Poznań
tel. 61 879-20-81