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

Logo VACUDOL FORTE Tablets

SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form):

VACUDOL FORTE Tablets

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

PHARMACOLOGICAL CLASSIFICATION:
A 2.8 Analgesic combinations.

PHARMACOLOGICAL ACTION:
VACUDOL FORTE tablets have analgesic and skeletal muscle-relaxing properties.

INDICATIONS:
Pain and pain associated with tension.

CONTRA-INDICATIONS:
Hypersensitivity to any of the ingredients. It should not be administered to patients with acute intermittent porphyria. Patients with renal or hepatic insufficiency. Use of VACUDOL FORTE 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 leads to drowsiness which is aggravated by the simultaneous intake of alcohol 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.
VACUDOL FORTE contains tartrazine which may cause allergic-type reactions (including bronchial asthma) in certain individuals. The overall incidence of tartrazine sensitivity is low, it is however, frequently seen in patients who also have aspirin sensitivity.

DOSAGE AND DIRECTIONS FOR USE:
Not recommended for children.
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.
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 antidiuretic effect.
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. Hypersensitivity reactions such as skin rashes, urticaria and purpura may occur or may be more severe with angioneurotic oedema, bronchospasm or anuria.
Erythema multiform has been reported. Blood disorders 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 dependence potential, meprobamate should be gradually withdrawn after long-term treatment.
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 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.
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 naloxone may be used to counteract severe respiratory depression.
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 and metabolic acidosis may occur. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias have been reported.
Symptoms during the first 2 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 occurred.
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 preceding 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 1 000 mL over the next 16 hours. The volume of intravenous fluids 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.

IDENTIFICATION:
Green, round, flat tablet, bisected on the one side.

PRESENTATION:
Blister packs in strips of 10 packed in cartons containing 20 and 500 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:
27/2.8/0231

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
XIXIA Pharmaceuticals (Pty) Ltd
15 Thora Crescent
Wynberg Ext. 3
Sandton
P.O. Box 2080, Gallo Manor, 2052

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
23 December 1992 P1735

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