Package leaflet: Information for the user

Esputicon, 980 mg/g, oral drops
Dimeticonum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist.

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 possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If your symptoms do not improve or if you feel worse, you should 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 pack 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 helps eliminate excess gas from the gastrointestinal tract. The medicine is used:

in the case of bloating and excessive intestinal gas;
in patient preparation for certain X-ray and ultrasound examinations.

2. Important information before using Esputicon

When not to use Esputicon:

if the patient is allergic to simethicone or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
No special warnings or precautions for use are required.
Children
Children may use Esputicon according to medical advice.
Esputicon with other medicines
Esputicon may be used together with other medicines.
Esputicon with food and drink
There are no special requirements regarding taking the medicine with meals.
Pregnancy and breastfeeding
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.
Pregnancy
No adverse effects of Esputicon during pregnancy have been observed.
Breastfeeding
No adverse effects of Esputicon during breastfeeding have been observed.
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 be used exactly as described in the patient leaflet or as directed by a
physician. If in doubt, consult a doctor or pharmacist.
Oral administration.
Recommended dose: adults, 2 drops 4 times daily after meals and before bedtime;
if necessary, 5 drops 3 times daily.
Preparation for X-ray or ultrasound examinations
Two days before examination: 2 drops 4 times daily; on the day of examination: 5 drops on an empty stomach.
Children
Infants and young children from 1 month of age: for abdominal bloating, 1 to 2 drops twice daily.
The medicine can be administered on a sugar cube, mixed with juice or another liquid.
It is odourless and tasteless, and may be added to a child's food.
Esputicon does not contain sugar and therefore may be used by diabetic patients.
Before use, shake the bottle vigorously several times.
Use of a higher than recommended dose of Esputicon
There is no risk of overdose with Esputicon.
Missed dose of Esputicon
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 everybody gets them.
To date, no adverse reactions have been observed as a result of using the medicine
Esputicon.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, patients should inform their doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, telephone: 22 49-21-301, fax: 22 49-21-309, e-mail: [email protected]
By reporting adverse reactions, it is possible to gather more information about 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 carton. The expiry date refers to the last day of the specified 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 Esputicon contains

The active substance is dimethicone. One drop contains approximately 20 mg of dimethicone.
The other ingredient is: anhydrous colloidal silica.

What Esputicon looks like and contents of the pack
Esputicon is a colourless oily liquid, packed in a plastic bottle (LDPE) with a dropper (LDPE), cap (HDPE), and a cardboard box.
1 pack contains 5 g of product.

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