INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
SPECIFIC NERVE PAIN REMEDY. (Liquid and tablet unit pack).

SCHEDULING STATUS:
Not scheduled.

PROPRIETARY NAME:
(and dosage form)

SPECIFIC NERVE PAIN REMEDY. (Liquid and tablet unit pack).

COMPOSITION:
Each 10 mL of the mixture contains:
        Salicylamide        350 mg
        Caffeine        30 mg
        Alcohol        13,9% v/v
Preserved with Spirits of Chloroform        3% v/v

Each tablet contains:
        Aspirin        300 mg

PHARMACOLOGICAL CLASSIFICATION:
A2.9 - Other Analgesics.

PHARMACOLOGICAL ACTION:
Specific Nerve Pain Remedy has analgesic, anti-inflammatory and antipyretic actions.

INDICATIONS:
For the symptomatic relief of mild to moderate pain and fever such as headaches, toothache, colds and flu. Also for the alleviation of rheumatic pains.

CONTRA-INDICATIONS:
Should not be taken by patients taking anti-coagulants, by patients suffering from gastrointestinal ulcers, haemophilia, severe kidney damage or by patients who are allergic to aspirin.

WARNINGS:
TABLETS:
1.        DO NOT USE CONTINUOUSLY FOR MORE THAN 10 DAYS WITHOUT CONSULTING YOUR DOCTOR.

2.        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:
10 mL in water with a tablet every three hours, if necessary.

Children 5 - 10 years:
2,5 mL to 5 mL in water with a quarter to half a tablet every three hours, if necessary.

Do not use continuously for longer than 10 days without consulting your doctor.
Excessive and prolonged use of this medicine may be dangerous.
Not to be taken during the first and third trimesters of pregnancy except under the advice and supervision of a medical doctor.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Aspirin and Salicylamide:
Dizziness or irritation of the gastric mucosa and resultant dyspepsia, haematemesis and melaena may occur in some cases. Some persons, especially asthmatics, exhibit notable sensitivity to aspirin which may provoke various hypersensitivity reactions which may include skin eruptions, paroxysmal bronchospasm and dyspnoea. It should be administered with caution to patients with impaired renal function, dyspepsia, anaemia and when the patient is dehydrated.

Aspirin may enhance the activity of coumarin anti-coagulants and oral anti-diabetic preparations, sulphonamides and methotrexate. Aspirin diminishes the effects of anti-gout preparations such as probenecid and sulphinpyrazone. Barbiturates and other sedatives may mask the respiratory symptoms of aspirin overdosage and have been reported to enhance its toxicity. Prolonged use of high doses may lead to anaemia, blood dyscrasias, gastro-intestinal haemorrhage, peptic ulceration and renal papillary necrosis.

Caffeine:
Include nausea, headache, insomnia, increases gastric secretions and may cause gastric ulceration, headaches, irritability and symptoms of anxiety neurosis.

SPECIAL PRECAUTIONS:
The use of this medicine during the first and third trimester of pregnancy is not advised.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Aspirin:
These include dizziness, tinnitus, deafness, sweating, nausea, vomiting, mental confusion, headache, fever, restlessness, hyperventilation, respiratory alkalosis, metabolic acidosis, ketosis and depression of the central nervous system. In children, serious signs of overdosage may develop rapidly.

Salicylamide:
Overdosage results in hypotension, depression of the central nervous system and respiratory arrest.

Caffeine:
Large doses may cause restlessness, excitement, muscle tremor, tinnitus, scintillating scotoma, tachycardia and extrasystoles.

In cases of overdosage, consult your doctor immediately.
Treatment is supportive and symptomatic.

IDENTIFICATION:
Liquid: Reddish suspension with a white, easy re-suspendable sediment.
Tablet: A plain white convex tablet.

PRESENTATION:
Bottles of 100 mL with a packet of 10 aspirin tablets.

STORAGE INSTRUCTIONS:
Store in a cool (below 25°C), dry place. Protect from light. Exposure to air should be minimum.
Keep out of reach of children.

REGISTRATION NUMBER:
Tablet        J/2.9/6
Suspension        J/2.9/7

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Group Laboratories SA (Pty) Limited
21 Wrench Road, Isando, 1600
Transvaal

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
27 February 1984

        Rosside 2l279
SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996-2003