Indications
Fever of various origins (also during viral infections).
Pain of various origins of mild to moderate intensity (including earache occurring in inflammation of the middle ear).
The product does not contain sugar.
Active substance: Ibuprofen
Composition
5 ml of suspension contains 200 mg of ibuprofen (Ibuprofenum)
The medicinal product contains: glycerol, sodium benzoate (E 211), liquid maltitol.
For a full list of excipients, see section 6.1.
Dosage
When determining the dose of ibuprofen, the patient’s body weight (BW) and age should be taken into account. The usual single dose of ibuprofen is 7 to 10 mg/kg BW, up to a maximum daily dose of 30 mg/kg BW.
For precise dosing, a syringe-type dispenser is included in the package.
Shake the bottle before use.
The drug is administered after meals, with plenty of fluids. There should be at least a 6-hour break between subsequent doses.
Do not exceed the maximum daily dose.
| Body weight (patient age) | Single dose | Maximum daily dose |
| 10 – 12 kg
(children from 1 to 2 years old) |
2.5 ml (equivalent to 100 mg ibuprofen) | 7.5 ml (equivalent to 300 mg ibuprofen) |
| 13 – 19 kg
(children from 3 to 5 years old) |
2.5 ml (equivalent to 100 mg ibuprofen) | 10 ml (equivalent to 400 mg ibuprofen) |
| 20 – 29 kg
(children from 6 to 9 years old) |
5.0 ml (equivalent to 200 mg ibuprofen) | 15 ml (equivalent to 600 mg ibuprofen) |
| 30 – 39 kg
(children from 10 to 12 years old) |
5.0 ml (equivalent to 200 mg ibuprofen) | 20 ml (equivalent to 800 mg ibuprofen) |
| Over 40 kg
(children and adolescents from 12 years of age and adults) |
5.0 – 10 ml (equivalent to 200 – 400 mg ibuprofen) | 30 ml (equivalent to 1200 mg ibuprofen) |
Do not use for longer than 3 days without consulting a doctor.
Medicinal product intended for occasional use. If symptoms persist, worsen or if new symptoms occur, the patient should contact a doctor.
Once the package has been opened it should be used within 6 months.
Elderly patients: No dose adjustment required. Elderly patients should be monitored for adverse reactions.
Patients with renal impairment: There is no need to reduce the dose in patients with mild to moderate renal impairment.
Patients with hepatic impairment: There is no need to reduce the dose in patients with mild and moderate hepatic impairment.
Use of the drug in children and adolescents
The medicinal product is contraindicated in children weighing less than 10 kg (up to 1 year of age) because the dose of the medicinal product is inappropriate due to the higher content of ibuprofen.
Contraindications
The medicinal product is contraindicated in patients:
– with hypersensitivity to ibuprofen or any of the excipients of the product and to other non-steroidal anti-inflammatory drugs (NSAIDs),
– who have ever had allergy symptoms such as runny nose, hives or bronchial asthma after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs),
– with active gastric and/or duodenal ulcer, or a history of perforation or bleeding, including those associated with NSAID therapy (see section 4.4),
– with severe hepatic failure, severe renal failure or severe heart failure (see section 4.4),
– taking other non-steroidal anti-inflammatory drugs concomitantly, including COX-2 inhibitors (increased risk of adverse reactions – see section 4.5),
– in patients with cerebrovascular bleeding or other active bleeding,
– in patients with hemorrhagic diathesis or unexplained disorders of the hematopoietic system,
– in patients with severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake),
– in the third trimester of pregnancy (see section 4.6).
The medicinal product is contraindicated in children weighing less than 10 kg (up to 1 year of age) because the dose of the medicinal product is inappropriate due to the higher content of ibuprofen.
Notes on use
Do not use after the expiry date which is stated on the package. The expiry date refers to the last day of the month. The medicine can be used within 6 months of first opening the bottle. Store below 25ºC. Store in the original package. Keep the bottle tightly closed. Store out of the reach and sight of children. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines that are no longer required. These actions will help protect the environment.
Contents: The package contains 40 ml.
Storage method: below 25°C
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