REMEDOL Suppository Ref.[50371] Active ingredients: Paracetamol

Posology

Remedol 125 mg suppositories

The dosage depends on the patient’s age and body weight. The single dose is between 10 mg and 25 mg of paracetamol per kg b.wt. Maximum daily dose: about 50 mg of paracetamol per kg b.wt.

The dosage schedule in mg per kg b.wt. applies to the treatment of pain and fever. The single dose can be given at 6 hour intervals. Infants weighing up to 7 kg should receive 1 suppository as a single dose and should not be given more than 3 suppositories daily. Infants weighing 7 to 10 kg may be treated with this single dose up to four times daily.

The dosage should be reduced or the interval between doses should be longer in patients with impaired liver or kidney function or with Gilbert’s syndrome.

Remedol 250 mg suppositories

The dosage depends on the patient’s age and body weight. The single dose is between 10 mg and 25 mg of paracetamol per kg b.wt. Maximum daily dose: about 50 mg of paracetamol per kg b.wt.

The dosage schedule in mg per kg b.wt. applies to the treatment of pain and fever. The single dose can be given at 6 hour intervals. Children weighing up to 15 kg should receive 1 suppository as a single dose and should not be given more than 3 suppositories daily. Children weighing up to 22 kg may be treated with this single dose up to four times daily.

The dosage should be reduced or the interval between doses should be longer in patients with impaired liver or kidney function or with Gilbert’s syndrome.

Remedol 500 mg suppositories

The dosage depends on the patient’s age and body weight. The single dose is between 10 mg and 25 mg of paracetamol per kg b.wt. Maximum daily dose: about 50 mg of paracetamol per kg b.wt.

The single dose-in general 1 suppository- can be given at 6 hour intervals. Children weighing up to 30 kg should not be given more than 2 to 3 suppositories daily. Children weighing more than 40 kg may be treated with single doses of 1 to 2 suppositories and should not be given more than 8 suppositories daily.

The dosage schedule in mg per kg b.wt. applies to children, young people and adults alike and to the treatment of pain and fever.

The dosage should be reduced or the interval between doses should be longer in patients with impaired liver or kidney function or with Gilbert’s syndrome.

Method of administration

Rectal use.

Overdosing may result in toxicity signs having a latency of 24 to 48 hours. Disorders of liver function due to hepatocellular necrosis including hepatic coma with fatal outcome may occur. In other cases, kidney damage caused by tubular necrosis has been described.

The following symptoms of paracetamol poisoning may appear:

• Phase 1 (day 1): nausea, vomiting, sweating, drowsiness and malaise.
• Phase 2 (day 2): subjective improvement, but mild abdominal pain (especially in the right epigastric region), hepatomegaly, increase in transaminase and bilirubin levels, prolonged thromboplastin time, reduced urinary excretion.
• Phase 3 (day 3): high transaminase levels, jaundice, disorders of blood coagulation, hypoglycaemia, development of hepatic coma.

Therapeutic measures in case of overdosage

The following measures should be adopted, when paracetamol poisoning is suspected:

• In the first 24 hours after use of the drug (preferably between 8 and 16 hours), the intravenous/oral administration of SH group donators such as acetylcysteine is advisable. In severe cases, antidote therapy should be continued until the central nervous system-related symptoms have subsided.
• The elimination of paracetamol can be hastened by dialysis or haemoperfusion with activated charcoal.
• Determinations of plasma paracetamol levels are desirable.

The risk of given patient can be assessed and the effectiveness of the measures taken to prevent the absorption of the drug and accelerate its elimination can be monitored by determining the paracetamol concentrations in plasma.

Further action taken to fight paracetamol poisoning corresponds to the measures usually adopted in intensive care units and depends on the extent and stage of the intoxication and the clinical symptoms.

3 years.

Store below 25°C. Protect from light and moisture.

PVC strips. Pack size of 10 suppositories.

None.