Esputicon

Package Leaflet: Information for the Patient

Esputicon, 50 mg, Soft Capsules

Dimeticone

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

This Medication Should Always be Taken Exactly as Described in the Patient Leaflet or as Advised by a Doctor or Pharmacist.

• Keep this Leaflet, You May Need to Read it Again.
• If You Need Advice or Further Information, Consult a Pharmacist.
• If You Experience any Side Effects, Including those not Listed in the Leaflet, Tell Your Doctor or Pharmacist. See Section 4.
• If There is no Improvement or You Feel Worse, Contact Your 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. It Causes Larger Gas Bubbles to Break Down into Smaller Bubbles that are More Easily Absorbed. When Taken Orally, it Relieves Bloating and Removes Excess Gas from the Gastrointestinal Tract. The Medication is Used:

• In Case of Bloating and Excessive Gas in the Intestines;
• In Preparing Patients for Certain X-ray and Ultrasound Exams.

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 Medication (Listed in Section 6).

Warnings and Precautions

There are no Special Warnings or Precautions for Use.

Children

Children can Take Esputicon as Advised by a Doctor.

Esputicon and Other Medications

Esputicon can be Taken with Other Medications.

Esputicon with Food and Drink

There are no Special Requirements for Taking the Medication with Meals.

Pregnancy and Breastfeeding

If the Patient is Pregnant or Breastfeeding, Thinks they may be Pregnant or are Planning to have a Child, they Should Consult a Doctor Before Taking this Medication.
Pregnancy
No Unwanted Effects of Esputicon have been Found During Pregnancy.
Breastfeeding
No Unwanted Effects of Esputicon have been Found During Breastfeeding.

Driving and Operating Machines

Esputicon has no Influence or an Insignificant Influence on the Ability to Drive and Operate Machines.

Taking Esputicon in Elderly Patients

Elderly Patients can Take Esputicon.

3. How to Take Esputicon

This Medication Should be Taken Exactly as Described in the Patient Leaflet or as Advised by a Doctor or Pharmacist. In Case of Doubt, Consult a Doctor or Pharmacist.
Oral Administration.
Usual Dose: 4 Times a Day, 1 Capsule After Meals and Before Bedtime; if Necessary, 3 Times a Day, 2 Capsules.
Preparation for X-ray or Ultrasound Exams
Two Days Before the Exam, 4 Times a Day, 1 Capsule; on the Day of the Exam, 2 Capsules on an Empty Stomach.
The Medication does not Contain Sugar and can be Taken by Diabetic Patients.
Take with an Appropriate Amount of Liquid, e.g., a Glass of Water.

Taking a Higher than Recommended Dose of Esputicon

There is no Risk of Overdose with Esputicon.

Missing a Dose of Esputicon

Do not Take a Double Dose to Make up for a Missed Dose.
In Case of any Further Doubts About Taking this Medication, Consult a Doctor or Pharmacist.

4. Possible Side Effects

Like all Medications, this Medication can Cause Side Effects, although not Everybody gets them.
No Side Effects have been Found with Esputicon so far.

Reporting Side Effects

If You Experience any Side Effects, including those not Listed in the Leaflet, Tell Your Doctor or Pharmacist. Side Effects can be Reported Directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Phone: 22 49-21-301, Fax: 22 49-21-309, Email: [email protected]
Reporting Side Effects will Help to Gather more Information on the Safety of this Medication.

5. How to Store Esputicon

Store Below 25°C.
Keep the Medication out of Sight and Reach of Children.
Do not Use this Medication After the Expiry Date Stated on the Carton. The Expiry Date Refers to the Last Day of the Month.
Medications should not be Disposed of via Wastewater or Household Waste. Ask Your Pharmacist how to Dispose of Medications that are no Longer Needed. This will Help Protect the Environment.

6. Package Contents and Other Information

What Esputicon Contains

• The Active Substance of the Medication is Dimeticone. One Capsule Contains 50 mg of Dimeticone.
• Other Ingredients are: Gelatin, Glycerol, Silica Colloidal Anhydrous, Purified Water.

What Esputicon Looks Like and What the Package Contains

Esputicon is a Round, Soft Gelatin Capsule, Straw-colored, Packed in Blisters of Aluminum/PVC and a Cardboard Box.
Package Types:
25 Capsules (1 Blister of 25)
100 Capsules (4 Blisters of 25)
Not all Package Sizes may be Marketed.

Responsible Entity 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 Responsible Entity:
Poland
Pharmaceutical-Chemical Company "Synteza" Ltd.
ul. Św. Michała 67/71
61-005 Poznań
Phone: 61 879-20-81

Date of the Last Update of the Leaflet: