INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
ABFLEX-4 TABLETS

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

ABFLEX-4 TABLETS

COMPOSITION:

Each tablet contains:	Paracetamol	450 mg
	Doxylamine succinate	5 mg
	Caffeine	30 mg
	Codeine phosphate	10 mg

PHARMACOLOGICAL CLASSIFICATION:
A 2.8 Analgesic combinations.

PHARMACOLOGICAL ACTION:
ABFLEX-4 has analgesic, antipyretic and antihistaminic properties.

INDICATIONS:
For mild to moderate pain associated with tension.

CONTRA-INDICATIONS:
Hypersensitivity to any of the active ingredients.
The dosage in renal functional impairment must be reduced.
Should be taken with caution by asthmatics.
Contra-indicated in respiratory depression, especially in the presence of cyanosis and excessive bronchial secretion, after operation 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 14 days of stopping such treatment.
Safety in pregnancy has not been established.

WARNINGS:
Codeine phosphate:
Exceeding the prescribed dose, together with prolonged and continuous use of this medication, may lead to dependency and addiction.
This medicine may lead to drowsiness and impaired concentration, which may be aggravated by simultaneous intake of alcohol, or other central nervous system depressant agents.
Patients should be warned against taking charge of vehicles or machinery or performing potentially hazardous tasks where loss of concentration may lead to accidents.
Dosage in excess of those recommended may cause severe liver damage.

DOSAGE AND DIRECTIONS FOR USE:

Adults and children 12 years and older:

2 tablets every 4 hours as needed. Do not exceed 8 tablets per day.

Do not use continuously for longer than 14 days without consulting your doctor.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Paracetamol
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 Phosphate
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, ureteric and biliary spasm and an antidiuretic effect.
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 elderly patients.
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.
Caffeine
Side-effects of caffeine include nausea, headache and insomnia. Large doses may cause restlessness, excitement, muscle tremor, tinnitus, scintillating scotoma, tachycardia and extrasystoles. Caffeine increases gastric secretion and may cause gastric ulceration.
Caffeine should be given with care to patients with a history of peptic ulceration.
Doxylamine Succinate
A common side-effect of doxylamine succinate is sedation. Other side-effects include gastro-intestinal disturbances, headache, blurred vision, tinnitus, elation or depression, irritability, nightmares, anorexia, difficulty in micturition, dryness of the mouth, tightness of the chest, and tingling, heaviness and weakness of the hands.
Symptoms of stimulation in adults include insomnia, nervousness, tachycardia, tremors, muscle twitching and convulsions.
Large doses may precipitate fits in epileptics. Allergy and anaphylaxis may occur. Blood dyscrasias including agranulocytosis and haemolytic anaemia may occur.
Doxylamine succinate has anticholinergic properties and should be used with care in conditions such as glaucoma and prostatic hypertrophy. The effects of atropine and tricyclic antidepressants may be enhanced by doxylamine succinate.
Doxylamine succinate may mask the warning symptoms of damage caused by ototoxic drugs and may effect the metabolism of drugs in the liver.
Doxylamine succinate may enhance the sedative effects of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Overdosage of DOXYLAMINE SUCCINATE (an antihistamine) causes sedation.
Paracetamol
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 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 non-specific 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 7,5 g or more of paracetamol in the preceding 4 hours should undergo gastric lavage. Specific therapy with an antidote such as acetylcysteine or methionin 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. There is evidence that it is still effective up to 16 hours after overdosage with paracetamol and may be longer.

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.

Codeine Phosphate
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 nalaxone may be used to counteract severe respiratory depression.

IDENTIFICATION:
A yellow flat, bevelled edge tablet, scored on one side.

PRESENTATION:
Securitainers containing 18, 100 and 500 tablets.

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

REGISTRATION NUMBER:
28/2.8/0383

NAME AND BUSINESS ADDRESS OF APPLICANT:
Xeragen Laboratories (Pty) Ltd
10/11 Glen Park Industrial
Highdale Road
Glen Anil
4051

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
31 December 1996

        PAB 0021/5-97
        Pro-Print

Updated on this site: March 2004
Source: Pharmaceutical Industry
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