Paracetamol 500mg, Codeine phosphate hemihydrate 8mg (White, round convex,
13mm diameter tablet inscribed with "SL" on one side)
Paracetamol 400mg, Codeine phosphate sesquihydrate 30mg (White, round
convex, 12 mm diameter tablet inscribed with "SL" on one side and breakline
on the other).
Paracetamol appears to produce analgesia at a subcorticol site of the brain,
and may also block pain impulses by a depressant effect on peripheral
chemoreceptors, mainly by inhibiting and interfering with the prostaglandin
synthesis. Paracetamol lowers body temperature by acting in the hypothalamus
to produce antipyresis.
Codeine phosphate has a central action especially in the cortex, thereby
raising the threshold of pain.
Paracetamol and Codeine phosphate are well absorbed from the
gastro-intestinal tract. The peak concentrations in plasma are attained in
about 1 hour. The half-life is about 1 to 3 hours for paracetamol and about
2.5 to 3 hours for Codeine phosphate after therapeutic doses. The duration
of action varies between 4-6 hours.
Metabolism and Excretion
Following therapeutic doses, about 80% of the paracetamol undergoes
conjugation with glucoronic acid in the liver, and only 3 % is excreted as
Codeine phosphate is metabolised in the liver and excreted primarily as an
inactive metabolites, two-third of these within 6 hours of ingestion
For the relief of moderate to severe pain such as headache and dysmenorrhea.
Hypersensitivity to the active ingredients. Acute hepatitis. It should be
given with care to patients with impaired kidney or liver function, and also
patients taking other drugs that affect the liver.
Mild drowsiness. Sensitive patients may experience constipation and biliary
dyskinesia. High doses of paracetamol may increase the activity of coumarin
Codeine phosphate potentiates the effect of alcohol and other central
depressive drugs. Other adverse reactions include allergic reactions,
euphoria, dysphoria, abdominal pain and prutitus.
Do not exceed the recommended dose. At high doses codeine has most of the
disadvantages of morphine, including respiratory depression. Codeine can
produce drug dependence and therefore has the potential of being abused.
Codeine may impair the mental and/or physical abilities required for the
performance of potentially hazardous tasks.
Adults: 1-2 tablets every 4-6 hours
Over 12 years old 1 tab up to 4 times daily
6-12 years old 1/2 tab up to 4
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. In severe poisoning, hepatic
failure may progress to encephalopathy, coma and death. Acute renal failure
with acute tubular necrosis may develop even in the absence of severe liver
damage. Cardiac arrhythmias have been reported.
Overdosage may produce central nervous stimulation, nausea, drowsiness,
respiratory depression, cyanosis, coma. Convulsion may occur in infants and
Aspiration or gastric lavage, followed by oral administration of activated
If necessary, combined with anti-convulsion therapy and control of
respiration. Antidote, 0.4 mg Naloxone hydrochloride may be given
intravenously and repeated every 3-4 minutes until normal respiration is
restored. Observed the patient for 24 hours.
Intravenous administration of 300mg N-acetylcysteine per kg over 20-hour
period or oral treatment with 1330 mg N-acetylcysteine per kg over 72-hour
period is accepted. Treatment should be started within 8 hours after
overdose but is still indicated at least as late as 24 hours after
Blister pack of 100x10's / box
Blister pack of 50x10's / box
Store in a dry place, protected from direct light and humidity and at below
Paralgin -- 3 years;
Paralgin Forte -- 4 years.
This preparation contains
PARACETAMOL. Do not take any other pracetamol containing medicines at
the same time.