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

Logo STILPANE® CAPSULES

SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form):

STILPANE® CAPSULES

COMPOSITION:
Each capsule contains:

  Paracetamol         370 mg
  Meprobamate         185 mg
  Codeine Phosphate         8 mg

PHARMACOLOGICAL CLASSIFICATION:
A 2.8 Analgesic combinations

PHARMACOLOGICAL ACTION:
Stilpane capsules act as an analgesic in pain-tension states.

INDICATIONS:
Stilpane relieves pain-tension states

CONTRA-INDICATIONS:
Patients with severe liver or kidney complications. Patients with acute intermittent porphyria or with a history of hypersensitivity to meprobamate or any of the active ingredients. Meprobamate may induce convulsions in patients with a history of epilepsy.
Contra- indicated in respiratory depression, especially in the presence of cyanosis and excessive bronchial secretion, after operations on the biliary tract, acute alcoholism, head injuries and conditions in which intracranial pressure is raised. It should not be given during an attack of bronchial asthma or in heart failure secondary to chronic lung disease.
Contra-indicated in patients taking monoamine oxidase inhibitors or within fourteen days of stopping such treatment.

WARNING:
Do not use continuously for more than ten (10) days without consulting your doctor.
Paracetamol dosages in excess of those recommended may cause severe liver damage.
Exceeding the prescribed dose, together with prolonged and continuous use of this medication, may lead to dependency and addiction.

DOSAGE AND DIRECTIONS FOR USE:
One to two capsules three or four times a day as directed by the physician. Not recommended for children under 12 years of age.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects of paracetamol are usually mild, though haematological reactions have been reported. Dosage in excess of those recommended may cause severe liver damage. Sensitivity reactions resulting in reversible skin rash or blood disorders may occur, but these are rare. Patients suffering from liver or kidney disease should take paracetamol under medical supervision. Consult your doctor if no relief is obtained from the recommended dosage.
In normal doses the more common side-effects of codeine phosphate are constipation, nausea and vomiting, dizziness and drowsiness. Dry mouth, facial flushing, vertigo, bradycardia, palpitations, faintness, sedation, restlessness, changes of mood, and miosis may also occur. These effects occur more commonly in ambulant patients than in those at rest in bed. Raised intracranial pressure occurs in some patients. Orthostatic hypotension, hypothermia and difficulty in micturition may occur.
Codeine should be given with caution to patients with hypothyroidism, adrenocortical insufficiency, impaired liver function, prostatic hypertrophy or shock. It should be used with caution in patients with inflammatory or obstructive bowel disorders. The dosage should be reduced in elderly and debilitated patients.
The depressant effects of codeine are enhanced by depressants of the central nervous system such as alcohol, anaesthetics, hypnotics and sedatives, and phenothiazines.
The prolonged use of high doses of codeine has produced dependence of the morphine type.
Due to the histamine-releasing effect allergic reactions such as urticaria pruritus, and itching of the nose occur in some individuals and idiosyncrasy to codeine and other narcotic analgesics is fairly common.
Drowsiness is the most frequent side-effect of meprobamate. Other effects include nausea, vomiting, diarrhoea, paraesthesia, weakness, and central effects such as headache, excitement, dizziness, ataxia and disturbances of vision. There may be hypotension, tachycardia, and cardiac arrhythmias.
The use of this medicine may cause drowsiness and care should be taken when driving or operating machinery. Reduce dosage if necessary.
Patients receiving meprobamate should be warned that their tolerance to ingested alcohol and other depressants of the central nervous system may be lowered with consequent impairment of judgement and co-ordination.
Hypersensitivity reactions may occur. These may be limited to skin rashes, urticaria and purpura or may be more severe with angioneurotic oedema, bronchospasm or anuria. Erythema multiforme has been reported. Treatment should be discontinued as soon as these reactions occur. Blood disorders including agranulocytosis, eosinophilia, leucopenia, thrombocytopenia, and aplastic anaemia have been reported. Symptoms of porphyria may be exacerbated. There is a serious dependence risk with a typical withdrawal syndrome. Meprobamate may induce the hepatic microsomal enzymes involved in medicine metabolism.

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 30 g in 250 mL water should be given to aid peristalsis. Naloxone hydrochloride 40 microgram is given subcutaneously, intramuscularly, or intravenously, repeated at intervals of 2 to 3 minutes if necessary. Respiration may be assisted.

IDENTIFICATION:
Opaque green capsule printed with Lennon logo and “LENNON”on one part and “STILPANE”on the other.

PRESENTATION:
Packs of 24, 100 and 500 capsules.

STORAGE INSTRUCTIONS:
Store below 25°C.
Protect from light and moisture.
KEEP OUT OF REACH OF CHILDREN.

APPLICATION NUMBER:
B624 (Act 101/1965)

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

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
20.03.1969

                G945
        A & S PRINTERS.

Updated on this site: February 2001

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