Source: Health Products Regulatory Authority (IE) Revision Year: 2024 Publisher: Clonmel Healthcare Ltd, Waterford Road, Clonmel, Co. Tipperary, E91 D768, Ireland
For the symptomatic treatment of mild to moderate pain and fever in children of 8 months or older and with body weight of at least 7.5kg.
Details on the posology are available in the following tables. The dosage of Tefin for children and young persons depends on the patient’s age and body weight. In general, the single dose is 7 to 10 milligrams per kilogram body weight and the maximum daily dose 30 milligrams per kilogram body weight.
The dosage interval depends on the symptoms and the maximum daily dose and should be at least six hours.
If Tefin is required for three days or if symptoms worsen, a doctor should be consulted.
| Age | Body weight | Single dose | Maximum daily dose |
|---|---|---|---|
| 8 to 12 months | 7.5 to 10 kilogram | 1 Suppository (75 milligram) | 3 Suppositories (225 milligram daily) |
| 12 months to 3 years | 10 to 15 kilogram | 1 Suppository (75 milligram) | 4 Suppositories (300 milligram daily) |
Tefin suppositories should be put deep into the rectum after bowel movement. They may be warmed up in the hands or dipped for a short time into warm water to improve their sliding properties.
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms (see section 4.4).
No adjustment of dosage is required. Due to possible side-effects (see section 4.4), elderly people should be carefully monitored.
No reduction of dosage is required in patients with slightly to moderately impaired renal function (patients with severe renal insufficiency: see section 4.3.).
No reduction of dosage is required in patients with slightly to moderately impaired liver function (patients with severe liver disorder: see section 4.3.).
Due to the dosage of their active substance, Tefin 75 milligram suppositories are not suitable for the treatment of children with a body weight below 7.5 kilograms (8 months).
A dose in excess of 200mg/kg carries a risk of causing toxicity.
Overdosing may lead to CNS-related disorders like headache, dizziness, somnolence and unconsciousness (in children also myoclonic spasms) and abdominal pain, diarrhoea, nausea and vomiting.
Tinnitus, headache, nystagmus, blurred vision, hypotension and gastrointestinal bleeding are also possible. In more serious poisoning, toxicity is seen in the central nervous system, manifesting as dizziness, drowsiness, loss of consciousness, occasionally excitation and disorientation or coma.
Occasionally patients develop convulsions. In serious poisoning, metabolic acidosis may occur and the prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating clotting factors. Acute renal failure and liver damage may occur. Exacerbation of asthma is possible in asthmatics.
There is no specific antidote. Patients should be treated symptomatically as required. Use supportive care where appropriate. Management should include the maintenance of a clear airway and monitoring of cardiac and vital signs until stable. If frequent or prolonged, convulsions should be treated with intravenous diazepam or lorazepam, give bronchodilators for asthma.
5 years.
Do not store above 25°C.
Blister strips of aluminium/polyethylene containing five suppositories.
Pack sizes of 10 suppositories and hospital-only 100 pack sizes (10 × 10).
Not all pack sizes may be marketed.
No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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