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Logo STILPANE® SYRUP

SCHEDULING STATUS:
S2

PROPRIETARY NAME:
(and dosage form):

STILPANE® SYRUP

COMPOSITION :
Each 5 mL contains:
  Paracetamol 120 mg
  Promethazine HCl 6,5 mg
  Codeine Phosphate 5 mg
  Camphorated Opium Tincture 0,3 mL
  Alcohol (100%) 16,7% v/v
Preservatives:
  Methylparaben 0,090% m/v
  Propylparaben 0,01% m/v
PHARMACOLOGICAL CLASSIFICATION:
A.2.9 Special analgesic combinations.

PHARMACOLOGICAL ACTION:
Stilpane Syrup is an analgesic and antipyretic agent having antihistaminic and antitussive properties.
The analgesic and antipyretic properties of Paracetamol are similar to those of aspirin, but it has no anti-inflammatory or antirheumatic effects. It is quickly and completely absorbed from the gastro-intestinal tract, and its concentration in the plasma is at a peak in 30 minutes to one hour.

Codeine Phosphate is well absorbed after oral administration, and provides additional analgesic effects. It also suppresses the urge to cough.
Camphorated Opium Tincture has a diaphoretic action.
The antihistamine, Promethazine Hydrochloride, relieves sneezing and the itching of eyes nose and throat - symptoms often accompanying the common cold. It also has an antitussive effect which is due to its depressant action on the central nervous system.

INDICATIONS:
Stilpane Syrup reduces fever and relieves the pain associated with febrile conditions, such as headache, neuralgia, influenza.
It also acts as a cough suppressant.

CONTRA-INDICATIONS:
Patients who are sensitive to paracetamol or codeine, or have liver or kidney complications should not take Stilpane Syrup.
It is not recommended for the treatment of new-born infants, unless prescribed by a physician.
Stilpane Syrup is contra-indicated in respiratory depression.

WARNING:
This medicine may lead to drowsiness and impaired concentration, which may be aggravated by the simultaneous intake of alcohol or other central nervous system depressant agents.
Do not use continuously for more than 10 days without consulting your doctor.
Exceeding the prescribed dose, together with prolonged and continuous use of this medication, may lead to dependency and addiction.

DOSAGE AND DIRECTIONS FOR USE:
Under 1 year: 2,5 mL
1 - 3 years: 5 mL
3 - 7 years: 10 mL
7 - 12 years: 15 mL
Adults: 20 mL
To be taken morning and night or as directed by the physician.
In children, the daily dosage must not exceed 50 mL.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects are rare at the recommended dosage levels. Paracetamol is usually well tolerated. Skin rashes and other allergic reactions occur occasionally. The rash is usually erythematous or urticarial but sometimes more serious and may be accompanied by drug fever and mucosal lesions. In a few cases the use of paracetamol has been associated with the occurrence of neutropenia, pancytopenia and leucopenia.
Side-effects due to the antihistamine may also occur. These include dizziness, headache, blurred vision inability to concentrate, drowsiness and sedation as well as gastro-intestinal disturbances such as nausea. These effects disappear when treatment is stopped.
Stilpane Syrup should be given with care to patients with impaired kidney or liver function. The dosage in renal functional impairment must be reduced. As little as 10g paracetamol can lead to fatal liver necrosis in an adult, especially if malnourished.
Care should be exercised in using Stilpane Syrup concurrently with alcohol, barbiturates, hypnotics sedatives and tranquillisers as the sedative effects may be enhanced. The effects of anticholinergic drugs, such as atropine and tricyclic antidepressants, may be enhanced by the concomitant administration of Stilpane Syrup.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Constipation, nausea, vomiting, anorexia, dizziness, drowsiness, abdominal pain, gastro-intestinal haemorrhage, potentially fatal liver damage, cerebral oedema and renal tubular necrosis, hyperglycaemia and hypoglycaemia. Central stimulation and exhilaration, followed by cardiovascular collapse, respiratory depression, and coma.
The stomach should be emptied by aspiration and lavage. A saline purgative such as sodium sulphate 30g in 250 mL water should be given to aid peristalsis. Naloxone hydrochloride 400 µg is given subcutaneously, intramuscularly, or intravenously, repeated at intervals of 2 to 3 minutes if necessary. Respiration may be assisted.

IDENTIFICATION:
A clear, red, syrupy liquid with a blueish tinge.

PRESENTATION:
Packs of 100 mL and 2,5 L.

STORAGE INSTRUCTIONS:
Store below 25°C
KEEP OUT OF THE REACH OF CHILDREN.

APPLICATION NUMBER:
G968 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF APPLICANT:
Lennon Limited
7 Fairclough Road
PORT ELIZABETH
6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
2.1.78 K444A
  Tradepak P.E.

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