Esputicon

Package Leaflet: Information for the Patient

Esputicon, 200 mg, Soft Capsules

Dimeticone

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

• 1. What is Esputicon and what is it used for
• 2. Important information before taking Esputicon
• 3. How to take Esputicon
• 4. Possible side effects
• 5. How to store Esputicon
• 6. Package contents and other information

1. What is Esputicon and what is it used for

Esputicon contains the active substance dimeticone, which is a low surface tension compound that changes the surface tension of gas bubbles in the gastrointestinal tract.
This causes larger gas bubbles to break down 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 the patient for diagnostic tests of the abdominal cavity using imaging techniques (ultrasound, endoscopy, radiology) by removing excess gas from the gastrointestinal tract. Removing excess gas from the patient's gastrointestinal tract improves the quality of the images obtained and eliminates diagnostic difficulties;
• to relieve symptoms caused by the accumulation of excess gas in the stomach and intestines, such as bloating, colic, feeling of pressure and fullness, belching;
• in cases of increased gas production during the postoperative period under medical supervision.

2. Important information before taking Esputicon

When not to take Esputicon

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

Warnings and precautions

There are no special warnings or precautions for use.

Children

Do not use in children under 14 years of age.

Esputicon and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and any medicines you plan to take.
Some reports suggest that dimeticone medicines (e.g., dimeticone, simeticone) may interfere with the absorption of levothyroxine (a medicine used for hypothyroidism), oral anticoagulants (e.g., etylbiscumacetate), and antidiabetic medicines (e.g., gliclazide, glibenclamide).

Esputicon with food and drink

There are no special requirements for taking the medicine with meals.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
No adverse effects of Esputicon have been found during pregnancy or breastfeeding. There are no available data on the effect on fertility in women and men.

Driving and using machines

Esputicon has no influence or negligible influence on the ability to drive and use machines.

Taking Esputicon in elderly patients

Elderly patients can take Esputicon.

3. How to take Esputicon

Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.
Oral administration.

Adults and adolescents over 14 years

Dosage

• For diagnostic preparations: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.
• To relieve symptoms associated with excess gas:1 capsule 1-2 times a day, unless otherwise directed by the doctor.

Children

Do not use in children under 14 years of age.
The medicine does not contain sugar and can be taken by diabetic patients.
Take with a sufficient amount of liquid, e.g., a glass of water.

Overdose of Esputicon

There is no risk of overdosing with Esputicon.

Missed dose of Esputicon

If a dose is missed, take it as soon as possible, and then return to the regular dosing schedule. Do not take a double dose to make up for the missed dose.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
No side effects have been found with Esputicon.
Reporting side effects
If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Esputicon

Store in a temperature below 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 month.
Medicines should 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. Package contents and other information

What Esputicon contains

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

What Esputicon looks like and contents of the pack

Esputicon is a round, soft gelatin capsule, yellowish in color, packaged in aluminum/PVC/PVDC blisters in a cardboard box.
Pack sizes:
15 soft capsules (1 blister of 15)
30 soft capsules (2 blisters of 15)
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Pharmaceutical-Chemical Company "Synteza" Ltd.
ul. Św. Michała 67/71
61-005 Poznań
phone: 61 879-20-81
To obtain more detailed information, contact the local representative of the marketing authorization holder:
Poland
Pharmaceutical-Chemical Company "Synteza" Ltd.
ul. Św. Michała 67/71
61-005 Poznań
phone: 61 879-20-81

Date of last revision of the leaflet: