Expiration date: 09/2025

The composition and form of issue:

Suppositories for rectal use for children, 1 supp. contains:

ibuprofen 60 mg

auxiliary substances: fat hard 1 (Witepsol H15) fat solid 2 (Witepsol W45) 

in blister 5 PCs the paper cartons 2 blister.

Description of dosage form:

Suppositories are torpedo-like, smooth, white or almost white.

Description of the pharmacological action:

The mechanism of action of ibuprofen is caused by inhibition of biosynthesis of PG mediators of pain and inflammation.

The effect of the drug (in the form of suppositories) lasts up to 8 hours.

Indications:

For children from 3 months to 2 years:

as antipyretic — ARI, SARS, influenza and other infectious and inflammatory diseases accompanied by fever postprevious reaction

as a painkiller — pain syndrome of weak or moderate intensity (including headache and toothache, migraine, neuralgia, pain in the ears and throat, pain in sprains), etc.

Contraindications:

• hypersensitivity to ibuprofen or to any of the components of the drug, acetylsalicylic acid (or other NSAIDs)
  
• bronchial asthma, urticaria, rhinitis, provoked by taking salicylates or other NSAIDs
  
• the presence of a child with ulcerative lesions of the gastrointestinal tract
  
• active gastrointestinal bleeding
  
• inflammatory bowel disease
  
• confirmed hypokalemia.
  
• diseases of the blood (hypocoagulation, leukopenia, haemophilia)
  
• renal and/or hepatic insufficiency
  
• depression of hearing.
  

Side effect:

When using the drug, it is rarely possible to have the following side effects:

From the digestive tract: nausea, vomiting, discomfort or pain in the epigastric, laxative effect, the occurrence of erosive and ulcerative lesions, bleeding.

From the nervous system: headache, dizziness, psychomotor excitation, insomnia.

From the side of blood: anemia, thrombocytopenia, agranulocytosis, leukopenia.

From the urinary system: impaired renal function, cystitis.

Allergic reactions: skin rash, itching, urticaria, exacerbation of bronchial asthma, angioedema, anaphylactoid reactions, anaphylactic shock, bronchospasm, fever, multiform exudative erythema (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome).

From the cardiovascular system: tachycardia, increased blood PRESSURE.

Drug interaction:

The simultaneous use of Nurofen for children with anticoagulants can lead to increased action. Increases the concentration of digoxin, phenytoin, methotrexate, lithium in plasma. Reduces the effectiveness of diuretics and antihypertensive agents. Enhances the side effects of mineral and glucocorticoids.

Method of application and doses:

Per rectum. Dosage for children depends on the age and body weight of the child.

Postimmunisation fever: children under 1 years — 1 supp., older than 1 year, if necessary, another 1 supp. in 6 hours.

Fever and pain

Single dose of 5-10 mg/kg of body weight 3-4 times per day. The maximum daily dose - no more than 30 mg/kg/day.

Children aged 3-9 months (5, 5-8, 0 kg) — 1 supp. (60 mg) 3 times within 24 hours after 6-8 hours, no more than 180 mg/day from 9 months to 2 years (8, 0-12, 5 kg) — 1 supp. (60 mg) 4 times for 24 hours after 6 hours, but not more than 240 mg/day.

Duration of treatment: as a antipyretic — no more than 3 days as an anesthetic — no more than 5 days.

If fever persists, consult your doctor.

Overdose:

Symptoms: abdominal pain, nausea, vomiting, headache, noise in ears, metabolic acidosis, coma, acute renal failure, reducing AD, aetiology, tachycardia.

Treatment: forced diuresis, symptomatic therapy.

Precautionary measures:

It is obligatory to consult a doctor when taking other painkillers, a history of peptic ulcer disease, gastritis, ulcerative colitis, bleeding from the gastrointestinal tract, liver or kidney disease, bronchial asthma, urticaria, reception of indirect anticoagulants (drugs for oral administration, reducing blood clotting), drugs to reduce blood PRESSURE, GCS, antiplatelets, diuretics, lithium preparations, methotrexate in the presence of H. pylori.