Nurofenbaby early childhood 60 mg - anti-inflammatory analgesic 10 suppositories

Product Description

Suppositories

Composition:

Each suppository contains: ibuprofen 60 mg. For the full list of excipients, see section 6.1.

Excipients

Solid semi-synthetic glycerides.

Therapeutic indications

Symptomatic treatment of mild to moderate pain. Symptomatic treatment of fever. Nurofenbaby suppositories are indicated when oral administration is inadvisable, e.g. in case of vomiting.

Contraindications

Hypersensitivity to ibuprofen, to other non-steroidal anti-inflammatory drugs (NSAIDs) or to any of the excipients. History of bronchospasm, asthma, rhinitis, or urticaria associated with previous treatment with acetylsalicylic acid or other NSAIDs. History of gastrointestinal bleeding or perforation associated with previous treatment with NSAIDs. In the presence or history of recurrent peptic ulcer/haemorrhage (two or more confirmed episodes of ulceration or bleeding). Severe renal insufficiency, severe hepatic insufficiency, or severe heart failure. In the last trimester of pregnancy (see section 4.6). Children weighing less than 6.0 kg (3 months of age).

Dosage

Rectal use. Nurofenbaby should be administered to children over 3 months of age and weighing at least 6.0 kg. The maximum single dose should not exceed 10 mg/kg of body weight. The interval between one administration and the next should not be less than 6 hours. The maximum daily dose of ibuprofen is 20–30 mg/kg of body weight, divided into 3 or 4 doses. This means: Children weighing 6.0–8.0 kg (approximately 3–9 months): 1 suppository at the start of treatment, to be repeated if necessary, after at least 6–8 hours. No more than 3 suppositories should be administered in a 24-hour period. Children weighing 8.0–12.5 kg (approximately 9 months to 2 years): 1 suppository at the start of treatment, to be repeated if necessary, only after 6 hours. No more than 4 suppositories should be administered in a 24-hour period. Administration in patients with renal or hepatic impairment should take place after consulting a doctor. Nurofenbaby should be administered for a maximum of 3 days. If symptoms persist or worsen during this period, the patient should consult a doctor. Undesirable effects can be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).

Warnings and precautions

The use of the medicine requires particular caution in patients with: Systemic lupus erythematosus or mixed connective tissue disease (see section 4.8). History of hypertension and/or heart failure as fluid retention and oedema have been reported in association with NSAID therapy. Avoid administering Nurofenbaby concomitantly with other NSAIDs, including selective COX-2 inhibitors. Undesirable effects can be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms. Caution is advised (see advice from a doctor or pharmacist) before administering Nurofenbaby to patients with a history of hypertension and/or heart failure, as fluid retention, hypertension, and edema have been reported following NSAID therapy. Cardiovascular and cerebrovascular effects: Clinical studies and epidemiological data suggest that the use of ibuprofen, particularly at high doses (2400 mg/day) and in long-term treatment, may be associated with a modest increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke). In general, epidemiological studies do not indicate that low doses of ibuprofen (e.g.