Package leaflet: information for the patient

Bobotic, 66.66 mg/ml, oral drops
Simeticonum
Please read the entire leaflet carefully before using this 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 the physician or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, consult your pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If your symptoms do not improve or worsen, consult your doctor.

Table of contents of the leaflet

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

1. What Bobotic is and what it is used for

The active substance in Bobotic is simethicone, a compound that reduces surface tension, facilitating gas elimination. Simethicone prevents the formation of larger gas-mucus aggregates that cause painful bloating. Such bloating may occur, among other reasons, due to: swallowing air during eating, consuming hard-to-digest meals, or taking gastric acid-neutralizing medicines (especially those containing carbonates).
Orally administered simethicone is not absorbed from the gastrointestinal tract and is excreted unchanged in the feces.
Indications:

Conditions involving excessive accumulation of gas in the gastrointestinal tract (feeling of abdominal fullness, prolonged bloating, postoperative tympanites);
An adjunct in patient preparation for abdominal diagnostic examinations, such as radiological and ultrasonographic examinations, and for gastro-duodenoscopy.

2. Important information before using Bobotic

When not to take Bobotic:

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

Bobotic and other medicines
Inform 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 simethicone may interfere with the absorption of oral
anticoagulant drugs.
Use of simethicone may lead to false-negative results in diagnostic tests using guaiac resin, but does not affect results of rapid urease tests (diagnosis of Helicobacter pylori).
Bobotic with food and drink
Do not consume carbonated beverages while taking Bobotic.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
Bobotic has no effect on the ability to drive or operate machinery.
Bobotic contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium, and ethanol (with flavour)
This medicine may cause allergic reactions (including delayed-type reactions).
This medicine contains less than 1 mmol (23 mg) of sodium per ml of drops, meaning it is considered "sodium-free".
This 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 cause 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 in doubt, consult your doctor or pharmacist.
This medicine is for oral use.
1 ml of the medicine contains approximately 27 drops.
The usual recommended dose is:
Symptoms of excessive gas accumulation in the gastrointestinal tract:
Infants from 28 days of life to 3 years - 8 drops (20 mg simethicone) 4 times daily
Children from 3 to 6 years - 14 drops (35 mg simethicone) 4 times daily
Children from 6 years and adults - 16 drops (40 mg simethicone) 4 times daily
The medicine is usually taken after the three main meals and at bedtime.

Preparation for diagnostic tests:
Radiological and ultrasonographic examinations of the gastrointestinal tract
The day before the examination:
Infants from 28 days of life to 3 years - 10 drops (25 mg simethicone) twice daily
Children from 3 to 6 years - 16 drops (40 mg simethicone) twice daily
Children from 6 years and adults - 20 drops (50 mg simethicone) twice daily
On the morning of the examination, on an empty stomach, repeat the single dose.

Note:
Shake the bottle several times to mix the medicine thoroughly before each use.
Bobotic may be mixed beforehand with a small amount of boiled, cooled water, regular formula, or another non-carbonated liquid.
The medicine does not contain sugar and may be used by diabetics.
Treatment should be continued until symptoms resolve.
If necessary, Bobotic may be administered for a prolonged period.

Taking more Bobotic than recommended
No cases of overdose or poisoning have been reported.
If more than the recommended dose is taken, consult a doctor or pharmacist immediately.

Missed dose of Bobotic
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicinal product may cause adverse reactions, although not everybody will experience them.
No adverse reactions related to the use of Bobotic have been reported.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, consult a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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

Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Bobotic medicine

Keep this medicine out of sight and reach of children.
Store below 25 °C.
Use the opened container 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 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 packaging and other information

What Bobotic contains

The active substance in the medicine is simethicone (activated dimethicone with silicon dioxide). Each ml of drops contains 66.66 mg of simethicone.
Other components of the medicine are: sodium saccharin, sodium carmellose, methyl parahydroxybenzoate, propyl parahydroxybenzoate, citric acid monohydrate, raspberry flavour (including ethanol), purified water.

What Bobotic looks like and contents of the pack
An amber glass bottle with a high-density polyethylene (HDPE) screw cap and a low-density polyethylene (LDPE) dropper, containing 30 ml of drops, packed in a cardboard box.
Marketing Authorisation Holder
POLPHARMA Pharmaceutical Works S.A.
Pelplińska Street 19, 83-200 Starogard Gdański
Phone +48 22 364 61 01
Manufacturer
POLPHARMA Pharmaceutical Works S.A.
Medana Division in Sieradz
Władysława Łokietka Street 10, 98-200 Sieradz