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

Logo STILPANE® TABLETS

SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form):

STILPANE® TABLETS

COMPOSITION:
Each tablet contains:

Paracetamol         320 mg
Codeine Phosphate         8 mg
Caffeine Anhydrous         32 mg
Meprobamate         150 mg
Preserved with Nipastat         0,02% m/m

PHARMACOLOGICAL CLASSIFICATION:
A 2.9 Other analgesics.

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

INDICATIONS:
Stilpane relieves pain-tension states.

CONTRA-INDICATIONS:
Porphyria, pregnancy and lactation.
Patients with severe liver or kidney complications and in the presence of pulmonary insufficiency.
Hypersensitivity to meprobamate or any of the active ingredients.
Meprobamate may induce convulsions in patients with a history of epilepsy.
The use of meprobamate in patients with acute forms of porphyria, especially variegate porphyria and to a lesser extent acute intermittent porphyria and hereditary coproporphyria, is dangerous and Stilpane should thus not be used in these patients.
Contra-indicated in obstructive airways disease, 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 to comatosed patients. Stilpane 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.
Exceeding the prescribed dose together with the prolonged continuous use of this medication may lead to dependancy and addiction.
Paracetamol dosages in excess of those recommended may cause severe liver damage. Prolonged excessive use can cause irreversible kidney damage.
The use of this medicine may lead to drowsiness and impaired concentration which may be aggravated by the simultaneous intake of alcohol or central nervous system depressants. Affected patients should not drive or operate machinery.

DOSAGE AND DIRECTIONS FOR USE:
Two tablets three or four times a day as required.
Not recommended for children under 12 years of age.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Paracetamol:
Side-effects of paracetamol are usually mild, though haematological reactions have been reported. Dosages 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. 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 occurence of neutropaenia, pancytopaenia, leucopaenia, thrombocytopaenia and agranulocytosis. 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. Paracetamol should be given with care to patients taking other drugs that affect the liver, eg barbiturates.
Codeine Phosphate:
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, hallucinations, 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. Muscle rigidity has been reported following high doses. Larger doses of codeine can cause excitement and convulsions. Orthostatic hypotension, hypothermia and difficulty in micturation may occur.
Codeine should be given with caution to patients with hypothyroidism, adrenocortical insufficiency, asthma, impaired liver function, prostatic hypertrophy, hypotension, or shock. It should be used with caution in patients with inflammatory or obstructive bowel disorders, and myasthenia gravis. The dosage should be reduced in elderly and debilitated patients. Their administration during labour may cause respiratory depression in the newborn infant.
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, contact dermatitis and itching of the nose occur in some individuals and idiosyncrasy to codeine and other narcotic analgesics is fairly common.
Caffeine anhydrous:
Side-effects commonly encountered are gastro-intestinal irritation and stimulation of the central nervous system. Caffeine may cause nausea, vomiting, abdominal pain, gastro-intestinal bleeding, insomnia, headache, anxiety, restlessness, vertigo, palpitations, tremor and hypotension
Sever overdosage or idiosyncrasy due to caffeine may lead to agitation, diuresis, repeated vomiting with extreme thirst, delirium, hyperthermia, cardiac arrhythmias including tachycardia, electrolyte disturbances, convulsions and death.
Caffeine should be given with caution to patients with peptic ulceration, hyperthyroidism, hypertension, epilepsy, cardiac arrhythmias, or other cardiovascular disease, as these conditions may be exacerbated. Caffeine should also be given with caution to patients with heart failure, hepatic dysfunction, chronic alcoholism, acute febrile illness, neonates and elderly, since in all of these circumstances the clearance may be decreased resulting in increases in serum concentrations of caffeine and serum half life.
Meprobamate
Drowsiness is the most frequent side-effects 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. Meprobamate is best avoided in elderly and debilitated patients and in those with mental depression.
Meprobamate should be used with caution in patients with impaired hepatic or renal function, and, as with all sedatives, in patients with impaired respiratory functions.
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, leucopaenia, thrombocytopaenia, 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: the metabolism of agents such as oral contraceptives, corticosteroids, phenytoin, phenothiazines, and tricyclic antidepressants may be enhanced if given concurrently.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
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. The consequences can be extremely serious because of the narrow margin between therapeutic and toxic doses. The latest information regarding the treatment of overdosage can be obtained from the nearest poison centre.
Gastric lavage should be carried out especially if the overdose was taken within the previous 4 hours.
Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 - 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 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. 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 non specific myocardial depression have also occured.
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, preferably within 8 hours of overdosage.
ACETYLCYSTEINE
IV:                An initial dose of 150 mg/kg in 200 mL glucose injection, given intravenously over 15 minutes, followed by and 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.
Other symptoms include central stimulation and exhilaration, followed by cardiovascular collapse and coma.
Overdosage with barbiturates can cause severe or even fatal hypotension, respiratory depression, shock, heart failure and ultimately death.
Patients should be managed with intensive symptomatic and supportive therapy with particular attention being paid to the maintenance of cardiovascular, respiratory, renal function and to the maintenance of the electrolyte balance.

IDENTIFICATION:
Green biconvex, bisected tablet on the one side, engraved with the Lennon logo (mortar and pestle) on the other side.

PRESENTATION:
PVC Blister Packs of 100 tablets.
Amber PVC Bottles with 1000 tablets.
Securitainers with 500 tablets.

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

REGISTRATION NUMBER:
M/2.9/2

NAME AND ADDRESS OF APPLICANT:
Pharmacare Limited
7 Fairclough Road
Korsten
PORT ELIZABETH
6020

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
23/11/1979

                D200
                A & S PRINTERS

Updated on this site: March 2001
Current: December 2004
Source: Community Pharmacy

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