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

Logo PYNMED-TABLETS

SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form):

PYNMED-TABLETS

COMPOSITION:
Each tablet contains:
  Paracetamol 320 mg
  Codeine phosphate 8 mg
  Caffeine anhydrous 32 mg
  Meprobamate 150 mg
Preservative:
  Nipastat 0,025% m/m
Contains TARTRAZINE

PHARMACOLOGICAL CLASSIFICATION:
A 2.8 Analgesic combinations

PHARMACOLOGICAL ACTION:
PYNMED-TABLETS have analgesic and skeletal muscle-relaxing properties.

INDICATIONS:
Pain and pain associated with tension.

CONTRA-INDICATIONS:
Sensitivity to any of the ingredients. It should not be administered to patients with acute intermittent porphyria. Patients with renal or hepatic insufficiency. Use of PYNMED during pregnancy should be avoided. Asthma, respiratory depression, head injuries and conditions in which intracranial pressure is raised, heart failure secondary to chronic lung disease, a history of cardiac disease, epilepsy, and all convulsive states, patients taking monoamine oxidase inhibitors or within 14 days of stopping such treatment.

WARNINGS:
The use of this medicine may lead to drowsiness and impaired concentration which is aggravated by the sumultaneous intake of alcohol or other central nervous system depressant agents and it is dangerous to drive a vehicle or be in charge of machinery while on treatment with this product. Paracetamol administration in excess of the recommended dosage may cause severe liver damage. 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.

PYNMED-TABLETS contain tartrazine which may cause allergic-type reactions, including bronchial asthma, in certain individuals. Although the overall incidence of tartrazine sensitivity is low, it is frequently seen in patients who also have aspirin sensitivity.

DOSAGE AND DIRECTIONS FOR USE:
Not recommended for children, under the age of 12 years.
Adults: Two tablets every 6 to 8 hours.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
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.

Caffeine may cause headache, nausea, insomnia, restlessness, excitement and muscle tremor. Caffeine increases gastric secretion and may cause gastric ulceration.

Meprobamate may cause drowsiness, nausea, vomiting, diarrhoea, paraesthesia, hypotension, tachycardia, cardiac arrhythmias, weakness and central effects such as headache, excitement, dizziness, ataxia and disturbances of vision. Sensitivity reactions such as skin rashes, urticaria and purpura may occur or may be more severe with angioneurotic oedema, bronchospasm or anuria.

Erythema multiforme and exfoliative or bulbous dermatitis have been reported. Blood disorders such as agranulocytosis, eosinophilia, leucopenia, thrombocytopenia and aplastic anaemia have been reported. Symptoms of porphyria may be exacerbated. Meprobamate may lower tolerance to alcohol and other central nervous system depressants. It may induce the hepatic microsomal enzymes involved in drug metabolism.

Due to the dependance potential, meprobamate should be gradually withdrawn after long-term treatment. Codeine may cause respiratory depression, bradycardia, circulatory failure, hypotension, orthostatic hypotension, palpitations, deepening coma, confusion, drowsiness, euphoria, mood changes, restlessness, vertigo, flushing, hypothermia, increased intracranial pressure, miosis, dry mouth, muscle rigidity, nausea, vomiting, constipation, pruritus, urticaria, sweating, urinary retention, uteric and biliary spasm, and an antiduiretic effect.

Precautions:
Codeine should be used with caution in patients with obstructive bowel disorders, liver impairment, myasthenia gravis, prostatic hypertrophy, impaired renal function or shock.

It should be used with caution or in reduced doses in patients with adrenocortical insufficiency and hypothyroidism.

Dosages should be reduced in debilitated and in elderly patients.

Interactions:
Codeine may affect the activity of other medicines by delaying their absorption. The depressant effects are aggravated by alcohol, anaesthetics, hypnotics, sedatives, tricyclic antidepressants and phenothiazines.

Meprobamate may lower the tolerance to alcohol and other central nervous system depressants.

Meprobamate may enhance the metabolism of oral contraceptives, corticosteroids, phenytoin, phenothiazines and tricyclic antidepressants.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
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 occured.

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 about 7,5 g 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.

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.

Meprobamate: Symptoms of overdosage are mainly due to the depressant effect on the central nervous system.
See also "Side-effects and special precautions".

Following recent ingestion of an overdose the stomach may be emptied by gastric lavage and aspiration. Patients should be managed with intensive symptomatic and supportive therapy, with particular attention being paid to the maintenance of cardiovascular, respiratory and renal functions, and to the maintenance of the electrolyte balance.

Symptoms of overdosage with codeine phosphate include the following: nausea, vomiting, restlessness, sensory disturbances, muscle tremor, diuresis, palpitations, stupor, shock, central stimulation with exhilaration, convulsions, drowsiness, respiratory depression, hypotension with circulatory failure, respiratory collapse, cyanosis and coma.

Codeine phosphate: In acute poisoning the stomach should be emptied by aspiration and lavage. Intensive supportive therapy may be necessary to correct respiratory failure and shock. The specific antagonist nalaxone may be used to counteract severe respiratory depression.
IDENTIFICATION:
Green, round, biconvex tablet, bisected on the one side.

PRESENTATION:
Packaged in push-through blister packs of 10 tablets in containers of 20 and 100 tablets and bottles of 1 000 tablets.

STORAGE INSTRUCTIONS:
Store in a dry place below 25°C. Protect from strong light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
X/2.8/298

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Medpro Pharmaceutica (Pty) Ltd
Unit 9 & 10 Rosen Heights
Pasita Street
ROSENPARK
7530

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
17 December 1991

SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996-2000