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

Logo ANALGEN-SA tablets

SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form):

ANALGEN-SA tablets

COMPOSITION
Per tablet:
Aluminium acetylsalicylate 200 mg
Paracetamol 200 mg
Chlorphenoxamine HCl 2 mg
Codeine phosphate 15 mg
Caffeine 50 mg
Phenobarbitone 5 mg

PHARMACOLOGICAL CLASSIFICATION
A 2.8 Analgesic combinations

PHARMACOLOGICAL ACTION
ANALGEN-SA contains a well-balanced combination of ingredients with analgesic, antipyretic and anti-allergic properties.

ANALGEN-SA breaks the grip of tension and relieves symptoms of influenza. The ingredients are rapidly absorbed and pain relief can be expected within a short period, lasting for several hours.

INDICATIONS
As an analgesic for conditions such as:
Tension headaches, toothache, earache, sinusitis
Painful arthritic or rheumatic conditions
Pain after operations or physical injury
Neuralgia, fibrositis menstrual pains
As an antipyretic in colds, influenza and other virus infections. Febrile conditions in general.

CONTRA-INDICATIONS
It should not be administered to patients who are hypersensitive to any of the constituents.

WARNINGS
DO NOT USE CONTINUOUSLY FOR LONGER THAN TEN (10) DAYS WITHOUT CONSULTING YOUR DOCTOR
THIS MEDICINE MAY LEAD TO DROWSINESS AND IMPAIRED CONCENTRATION, WHICH MAY BE AGGRAVATED BY SIMULTANEOUS INTAKE OF ALCOHOL OR OTHER CENTRAL NERVOUS SYSTEM DEPRESSANTS
DO NOT EXCEED THE RECOMMENDED DOSAGE
CONSULT YOUR DOCTOR IF NO RELIEF HAS BEEN OBTAINED WITH THE RECOMMENDED DOSE
PATIENTS SUFFERING FROM LIVER OR KIDNEY DISEASE SHOULD TAKE PARACETAMOL CONTAINING PREPARATIONS ONLY UNDER MEDICAL SUPERVISION
Aspirin has been implicated in Reye's syndrome, a rare but serious illness, in children and teenagers with chickenpox and influenza. A doctor should be consulted before aspirin is used in such patients.

DOSAGE AND DIRECTIONS FOR USE
Adults: one to two tablets two or three times a day
Children: half the adult dose
Children under six years: not recommended

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Individual ingredients of Analgen-SA have been known to be associated with side-effects:

Aluminium Acetylsalicylate
Irritation of the gastric mucosa resulting in gastro-intestinal disturbances such as nausea, dyspepsia and vomiting, erosion, peptic ulceration with haematemesis and melaena in some sensitive cases.
Some persons especially asthmatics exhibit sensitivity to aspirin which may include skin rashes, angioedema, rhinitis, paroxysmal bronchospasm and dyspnoea.
Aspirin increases the bleeding time, decreases platelet adhesiveness, and, in large doses may cause hypoprothrombinaemia. Mild chronic salicylate intoxication, or salicylism, usually occurs only after repeated administration of large doses. Blood disorders include neutropenia, pancytopenia and leucopenia. Prolonged use of high doses may lead to anaemia, blood dyscrasias and renal papillary necrosis.
ANALGEN-SA should be administered with caution to patients with impaired renal or hepatic functions, anaemia or when the patient is dehydrated.

Effects of Acetylsalicylate on other medication
The activity of coumarin anticoagulants, oral diabetic preparations, sulphonamides and methotrexate may be enhanced. Aspirin may diminish the effects of anti-gout preparations, probenecid and sulphinpyrazone.

Barbiturates and other sedatives may mask the respiratory symptoms of aspirin overdosage, and have been reported to enhance it's toxicity.

Paracetamol
Side-effects of paracetamol are usually mild.
Haematological reactions including thrombocytopenia, leucopenia, pancytopenia, neutropenia and agranulocytosis have been reported.
Sensitivity reactions resulting in reversible skin reactions occur occasionally. These are usually erythematous or urticarial. Sometimes reactions are more serious and may be accompanied by fever and mucosal lesions.
Paracetamol should be given with care to patients with renal or liver impairment or patients taking other drugs that affect the liver.

Chlorphenoxamine HCl
Hypersensitivity may occur and present as a skin rash or conjunctivitis.
Other effects which have been reported, include: nausea, dizziness, dryness of the mouth, mydriasis, sedation and cardiac palpitation or arrhythmias, although these are unlikely at the prescribed dosage.

Codeine phosphate
Codeine may cause nausea, vomiting, constipation, drowsiness, confusion, dryness of the mouth, sweating, facial flushing, vertigo, bradycardia or palpitations, orthostatic hypotension, breathlessness, changes of mood and myosis.
Skin reactions such as urticaria and pruritus may occur in some individuals.
Micturition may be difficult and there may be ureteric or biliary spasm. Raised intracranial pressure has been reported.
Depressant effects of codeine are enhanced by CNS depressants such as alcohol, anaesthetics, hypnotics and sedatives, and phenothiazines.
Codeine should be given with care or caution to patients with hypothyroidism, adrenocortical insufficiency, impaired liver function, prostatic hypertrophy, shock, or patients with inflammatory, obstructive bowel disorders, or patients with myasthenia gravis. The dosage should be reduced in elderly or debilitated patients.
The prolonged use of high doses of codeine may produce dependence.

Caffeine
Adverse effects commonly affect the gastro-intestinal tract and CNS. Reported side-effects are: nausea, vomiting, headache, insomnia, vertigo and abdominal pain. Large doses may cause restlessness, excitement, muscle tremor, tachycardia and increased gastric acid secretion.

Phenobarbitone
Sedation and respiratory depression may occur. Allergic skin reactions, usually of the maculopapular type, or sometimes scarlatiniform, fixed-drug eruptions and photosensitivity may occur. Purpura, exfoliative dermatitis, erythema multiforme (the Stevens-Johnson syndrome) and toxic epidermal necrolysis have occasionally been reported. Hepatitis and cholestasis have been associated with barbiturate administration.
With excessive doses nystagmus and ataxia, irritability or hyperexcitability may occur particularly in children or in the elderly.
Prolonged administration of Analgen-SA or administration during the first and third trimesters of pregnancy is not advised. Therefore, phenobarbitone effects such as folate deficiency or other effects on the fetus should not be relevant.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
See SIDE-EFFECTS
Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 24 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 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 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. Any patient who has ingested about 7,5 g of paracetamol in the preceding 4 hours should undergo gastric lavage. Specialised therapy with an antidote such as acetylcysteine or methionine may be necessary. If decided upon, acetylcysteine should be administered I.V. as soon as possible.

Acetylcysteine:
Acetylcysteine should be administered as soon as possible, preferably within 8 hours of overdosage.

I.V.: 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.

IDENTIFICATION
Yellowish tablet with Noristan emblem on one side and scored on the reverse side

PRESENTATION
Tablets: 20' and 100' in securitainers

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

REFERENCE NUMBER
B544 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF THE APPLICANT
NORISTAN LIMITED
326 MARKS STREET, WALTLOO, PRETORIA

DATE OF PUBLICATION OF THIS PACKAGE INSERT
4 October 1995

NORISTAN LABORATORIES
Division of
NORISTAN LIMITED, WALTLOO, PRETORIA

        D 152/024

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