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

Logo ANALGEN tablets
SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form):

ANALGEN tablets

COMPOSITION
Per tablet:
Acetylsalicylic acid 200 mg
Paracetamol 200 mg
Codeine phosphate 15 mg
Caffeine 50 mg

PHARMACOLOGICAL CLASSIFICATION
A 2.8 Analgesic combinations

PHARMACOLOGICAL ACTION
The analgesic and antipyretic properties of acetylsalicylic acid (aspirin) and paracetamol are well known, as is the anti-inflammatory action of aspirin. It inhibits the biosynthesis of prostaglandins.
Both ingredients are rapidly absorbed and pain relief can be expected within a short period, lasting for several hours.
Codeine has been added to enhance the analgesic effect.
The antipyretic effect of both aspirin and paracetamol is rapid and, as in the case of the pain relief, will last several hours.

INDICATIONS
1. Painful conditions such as: headaches, arthritis, fibrositis, muscle soreness, toothache, earache, sinusitis, dysmenorrhoea, pain after operations or physical injury
2. Fever, in conditions such as: colds, influenza and other virus infections or febrile conditions generally

CONTRA-INDICATIONS
ANALGEN TABLETS should be given with care to patients with impaired kidney or liver function. In common with aspirin-containing preparations, ANALGEN TABLETS should be administered with caution in patients prone to dyspepsia or with a clinical history of gastric lesions, peptic ulcers, haemophilia or hypersensitivity to any of the ingredients, and patients receiving oral anticoagulant therapy.

WARNINGS
DO NOT USE CONTINUOUSLY FOR LONGER THAN TEN (10) DAYS WITHOUT CONSULTING YOUR DOCTOR
DO NOT EXCEED THE RECOMMENDED DOSAGE
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
One to one and a half tablets three times per day, depending on age and mass
Children under six years: not recommended

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
ANALGEN TABLETS may cause irritation of the gastric mucosa and resultant dyspepsia.
Asthmatics may exhibit sensitivity to aspirin with resultant bronchospasm and dyspnoea.
ANALGEN TABLETS may also enhance the activity of oral anti-diabetic and sulfonamide preparations.
The prolonged use of high doses may lead to constipation, gastro-intestinal haemorrhage and renal papillary necrosis..
ANALGEN TABLETS are not recommended in the first trimester of pregnancy.

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.
Information regarding the treatment of overdosage of aspirin, paracetamol and codeine is freely available from all poison centres.
Treatment.
Gastric lavage and a saline purgative will reduce absorption of the drug.
Nalorphine, naloxone or levallorphan will antagonise the adverse effects of narcotic analgesics.

IDENTIFICATION
Pale yellow, flat tablet, with bevelled edges, scored on one side and with the letters "an" imprinted on the other side

PRESENTATION
Tablets: 20', 48' and 100'

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

REGISTRATION NUMBER
H/2.8/117

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

DATE OF PUBLICATION OF THIS PACKAGE INSERT
21 April 1976

NORISTAN SELFMED
Division of
NORISTAN LIMITED, WALTLOO, PRETORIA

        D 166/011

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