Paracetamol
Overview
Paracetamol
Rectal suppositories, 125 mg / 250 mg
COMPOSITION
Each suppository contains the active substance paracetamol 125 mg or 250 mg, depending on the strength.
Excipient: semi-synthetic solid glycerides.
WHAT IT IS USED FOR
A medicine with antipyretic (fever-reducing) and analgesic (pain-relieving) action, for the symptomatic treatment of mild to moderate pain and feverish states in children.
It is used as an antipyretic in colds, flu, childhood infectious diseases (chickenpox, rubella, whooping cough, measles, scarlet fever, mumps) and post-vaccination reactions, and as an analgesic for teething, dental pain, earache in otitis media and sore throat.
The 125 mg suppositories are for children aged 6–18 months (weight 7–10 kg); the 250 mg suppositories are for children aged 2–7 years (weight 13–20 kg).
HOW IT WORKS
Paracetamol acts mainly in the central nervous system, on the pain and temperature-regulating centres, thereby reducing pain and fever.
HOW TO USE
Administered rectally. The dose depends on age and weight: the recommended single dose is 10–15 mg/kg, 3–4 times a day at 6-hour intervals; the maximum daily dose must not exceed 60 mg/kg.
children 7–10 kg (6–18 months): 125 mg 3–4 times a day at 6-hour intervals;
children 13–20 kg (2–7 years): 250 mg 3–4 times a day at 6-hour intervals.
Do not give more than 4 suppositories a day. Do not use for more than 3 days without a doctor's advice.
WHEN IT SHOULD NOT BE USED
hypersensitivity to paracetamol or to any of the excipients;
recent inflammation or bleeding of the rectum, diarrhoea;
severe liver and/or kidney disease;
blood disorders;
glucose-6-phosphate dehydrogenase deficiency;
age under 6 months (for the 125 mg strength);
age under 2 years (for the 250 mg strength).
Important to know
Do not use other paracetamol-containing medicines at the same time and do not exceed the recommended dose: high doses can cause serious, sometimes fatal liver damage. In case of overdose, seek medical help immediately, even if the child seems well.
Use with caution in mild/moderate liver or kidney disorders and in Gilbert's syndrome. Tell your doctor if the child takes other medicines (for example anticoagulants, certain antiepileptics or antibiotics). In case of diarrhoea, use another pharmaceutical form. If symptoms do not improve, stop treatment and consult a doctor. Read the package leaflet carefully before use.
Possible side effects
Local: signs of irritation of the anus and rectum.
Very rare: allergic reactions (skin rash, urticaria, itching, angioedema, severe skin reactions), blood disorders (reduced blood cell counts), liver damage, bronchospasm in people sensitive to acetylsalicylic acid or other anti-inflammatory medicines.
If side effects occur, stop using the product and consult a doctor or pharmacist.
STORAGE
Store below 25 °C. Do not freeze. Keep out of the reach of children. Shelf life: 36 months.
PACK SIZE
5 or 6 suppositories per blister; one blister of 6 or two blisters of 5, together with the package leaflet, in a carton box.
QUESTIONS AND CONTACTS
For questions about the medicine, please consult your doctor or pharmacist. Manufacturer: FARMAPRIM SRL, 5 Crinilor str., Porumbeni village, Criuleni district, Republic of Moldova, MD-4829. Pharmacovigilance: safety@farmaprim.md.
Brief information prepared on the basis of the approved Summary of Product Characteristics. It does not replace consultation with a doctor or pharmacist and does not contain all information about the medicine. Always read the package leaflet.