Bobotic

Package Leaflet: Information for the Patient

Bobotic, 66.66 mg/ml, Oral Drops

Simeticone

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

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• -Keep this leaflet, you may need to read it again.
• -If you need advice or further information, ask your pharmacist.
• -If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• -If you do not feel better or if you feel worse, you should contact your doctor.

Table of Contents of the Leaflet

• 1. What is Bobotic and what is it used for
• 2. Important information before taking Bobotic
• 3. How to take Bobotic
• 4. Possible side effects
• 5. How to store Bobotic
• 6. Contents of the pack and other information

1. What is Bobotic and what is it used for

The active substance of Bobotic is simeticone, a surface-active agent that facilitates the passage of gas. Simeticone prevents the formation of larger gas-foam conglomerates that cause painful bloating. This bloating can occur, among other things, as a result of: swallowing air while eating, consuming difficult-to-digest meals, taking antacids (especially those containing carbonates). Simeticone is not absorbed from the gastrointestinal tract after oral administration and is excreted in the feces unchanged.

Indications:

• conditions of excessive gas accumulation in the gastrointestinal tract (feeling of fullness in the abdominal cavity, prolonged bloating, postoperative bloat);
• auxiliary agent in preparing patients for diagnostic tests of the abdominal cavity, such as radiological and ultrasonographic examinations, as well as gastroscopy and duodenoscopy.

2. Important information before taking Bobotic

When not to take Bobotic:

• if the patient is allergic to simeticone or any of the other ingredients of this medicine (listed in section 6);
• in infants under 28 days of life.

Bobotic and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. Some reports suggest that simeticone may interfere with the absorption of oral anticoagulants. The use of simeticone may give false-negative results in diagnostic tests using guaiac resin, but does not affect the results of the rapid urease test (diagnosis of Helicobacter pylori).

Bobotic with food and drink

Do not drink carbonated beverages while taking Bobotic.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Bobotic does not affect the ability to drive or operate machinery.

Bobotic contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium, and ethanol (from the aroma)

The medicine may cause allergic reactions (possible late reactions). The medicine contains less than 1 mmol (23 mg) of sodium per ml of drops, which means it is considered "sodium-free". The medicine contains 0.94 mg of alcohol (ethanol) per ml of drops. The amount of alcohol in 1 ml of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not have noticeable effects.

3. How to take Bobotic

Always take this medicine exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist. The medicine should be taken orally. 1 ml of the medicine contains approximately 27 drops. The usual dose of the medicine is: Excessive gas accumulation in the gastrointestinal tract: Children from 28 days to 3 years - 8 drops (20 mg simeticone) 4 times a day Children from 3 to 6 years - 14 drops (35 mg simeticone) 4 times a day Children from 6 years and adults - 16 drops (40 mg simeticone) 4 times a day The medicine is usually taken after 3 main meals and before bedtime. Preparation for diagnostic tests: Radiological and ultrasonographic examination of the gastrointestinal tract The day before the examination: Children from 28 days to 3 years - 10 drops (25 mg simeticone) 2 times a day Children from 3 to 6 years - 16 drops (40 mg simeticone) 2 times a day Children from 6 years and adults - 20 drops (50 mg simeticone) 2 times a day On the morning of the examination, on an empty stomach, repeat the single dose. Note: Before administration, shake the bottle several times to mix the medicine thoroughly. Bobotic can be mixed beforehand with a small amount of boiled, cooled water, normally used nutrition, or other non-carbonated liquid. The medicine does not contain sugar and can be taken by diabetics. Treatment should be continued until symptoms disappear. If necessary, Bobotic can be taken for a longer period.

Taking a higher dose of Bobotic than recommended

No cases of overdose or poisoning with the medicine have been reported. If you take more of the medicine than recommended, you should immediately contact your doctor or pharmacist.

Missing a dose of Bobotic

Do not take a double dose to make up for a missed dose. If you have any further doubts 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 related to the use of Bobotic have been reported.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. 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 Tel.: +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 Bobotic

Keep the medicine out of the sight and reach of children. Store in a temperature below 25°C. The opened package should be used within 2 months. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified 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. Contents of the pack and other information

What Bobotic contains

• The active substance of the medicine is simeticone (activated dimethicone). Each ml of drops contains 66.66 mg of simeticone.
• The other ingredients of the medicine are: sodium saccharin, sodium carmellose, methyl parahydroxybenzoate, propyl parahydroxybenzoate, citric acid monohydrate, raspberry flavor (including ethanol), purified water.

What Bobotic looks like and contents of the pack

Orange glass bottle with a polyethylene (HDPE) cap and a polyethylene (LDPE) dropper, containing 30 ml of drops, in a cardboard box.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A. ul. Pelplińska 19, 83-200 Starogard Gdański tel. +48 22 364 61 01

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A. Medana Branch in Sieradz ul. Władysława Łokietka 10, 98-200 Sieradz

Date of last revision of the leaflet: