INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo EMPAPED 125 Suppositories
EMPAPED 250 Suppositories

SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form):

EMPAPED 125 Suppositories
EMPAPED 250 Suppositories

COMPOSITION:
  Each suppository contains 125 mg Paracetamol or
    250 mg Paracetamol.
PHARMACOLOGICAL CLASSIFICATION:
A 2.7 (Anti-pyretic or anti-pyretic and anti-inflammatory analgesics).

PHARMACOLOGICAL ACTION:
Empaped has analgesic and anti-pyretic actions.

INDICATIONS:
For the relief of mild to moderate pain and fever when oral therapy is not feasible.

CONTRA-INDICATIONS:
Empaped should not be used in the presence of:
  hypersensitivity to paracetamol;
  impaired kidney or liver function;
  glucose-6-phosphate dehydrogenase deficiency.
WARNINGS AND SPECIAL PRECAUTIONS:
Warnings:
Dosages in excess of those recommended may cause severe liver damage.

Special precautions:
1. Consult your doctor if no relief is obtained with the recommended dosage.
2. Do not use continuously for longer than 7 days without consulting your doctor.
3. Store in a safe place out of reach of children.
4. Patients suffering from liver or kidney disease should take paracetamol under medical supervision.
DOSAGE AND DIRECTIONS FOR USE:
Unless otherwise instructed:
  INFANTS (3 to 12 months): One 125 mg suppository 2 - 3 times daily.
  SMALL CHILDREN (1 - 5 years): One 250 mg suppository 2 - 3 times daily.
  The suppository should be inserted rectally.
SIDE-EFFECTS:
Paracetamol: Skin rashes and other allergic reactions may occur. The rash is usually erythematous or urticarial but sometimes more serious and may be accompanied by drug fever and mucosal lesions. The use of paracetamol has been associated with the occurrence of neutropenia, pancytopenia and leucopenia.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Paracetamol: Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrythmias have been reported.

Symptoms during the first two days of acute poisoning do not reflect the potential seriousness of the overdosage. Nausea, vomiting, anorexia and abdominal pain may persist for a week or more. Liver injury may become manifest on the second day, (or later) initially by elevation of serum transaminase and lactic dehydrogenase activity, increased serum bilirubin concentration and prolongation of prothrombin time. The liver damage may progress to encephalopathy, coma and death. Cerebral oedema and nonspecific myocardial depression have also occurred.

In the event of overdosage consult a doctor or take the patient to the nearest hospital immediately. Specialised treatment is essential as soon as possible.

Prompt treatment is essential. Any patient who has ingested 7,5 g or more of paracetamol in the preceeding 4 hours should undergo gastric lavage. Specific therapy with an antidote such as acetylcysteine or methionine may be necessary. If decided upon, acetylcysteine should be administered IV as soon as possible.

Acetylcysteine: Acetylcysteine should be administered as soon as possible, preferably within 8 hours of overdosage. There is evidence that it is still effective up to 16 hours after overdosage with paracetamol and may be longer.

IV: An initial dose of 150 mg/kg in 200 mL glucose injection, given intravenously over 15 minutes, followed by an intravenous infusion of 50 mg/kg in 500 mL of glucose injection over the next 4 hours, and then 100 mg/kg in 1000 mL over the next 16 hours. The volume of intravenous fluid should be modified for children.

Orally 140 mg/kg as a 5% solution initially, followed by a 70 mg/kg solution every 4 hours for 17 doses. Acetylcysteine is effective if administered within 8 hours of overdosage.

IDENTIFICATION:
White to Ivory coloured, torpedo shaped suppositories of approximately 26 mm length.

PRESENTATION:
Aluminium strips of 5 suppositories each. Available in packs of 10 and 100 suppositories.       

STORAGE INSTRUCTIONS:
Store at room temperature (below 25°C). Protect from light. Keep out of reach of children.

REGISTRATION NUMBER:

NAME AND BUSINESS ADDRESS OF APPLICANT:
Madaus Pharmaceuticals (Pty) Ltd
2nd Road (Cnr 16th Road)
Randjespark
Midrand
1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
21 APRIL 1995.

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