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

Logo GRAND-PA HEADACHE Tablets
GRAND-PA HEADACHE Powders
SCHEDULING STATUS:
Not-Scheduled

PROPRIETARY NAME
(and dosage form):

GRAND-PA HEADACHE Tablets
GRAND-PA HEADACHE Powders

COMPOSITION:
Grand-Pa Headache Tablets: Each tablet contains:
  Aspirin 226,8 mg
  Paracetamol 162,0 mg
  Caffeine 32,4 mg
Grand-Pa Headache Powders: Each powder contains
  Aspirin 453,6 mg
  Paracetamol 324,0 mg
  Caffeine 64,8 mg
PHARMACOLOGICAL CLASSIFICATION:
A2.8 - Analgesic combinations

PHARMACOLOGICAL ACTION:
Grand-Pa Headache Tablets and Grand-Pa Headache Powders have analgesic, antipyretic and anti-inflammatory properties.

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

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

WARNINGS:
1. Dosages in excess of those recommended may cause severe liver damage.
2. Do not use continuously for more than 10 days without consulting your doctor.
3. 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.

In the event of overdosage and notwithstanding the fact that the person may be asymptomatic, the nearest doctor, hospital or Poison Control Centre must be contacted immediately.

Do not exceed the recommended daily dose.

DOSAGE AND DIRECTIONS FOR USE:
Tablets: Adults: Two tablets to be taken with water every three hours.

Powders: Adults: One powder to be taken with water every three hours. Do not use more than one powder every 3 to 4 hours if necessary and not more than 6 powders during a 24 hour period.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Aspirin: Dizziness or irritation of the gastric mucosa and resultant dyspepsia, haemetemesis 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 anticoagulants and oral anti-diabetic preparations and sulphonamides. 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.

Paracetamol: Sensitivity reactions resulting in reversible skin rash or blood disorders may occur.

Special precautions:
1. Consult your doctor it no relief is obtained with the recommended dosage.
2. The medicine is not suitable for use by children.
3. Patients suffering from liver or kidney disease should take the medicine under medical supervision.
4. The use of the medicine during the first and third trimesters of pregnancy is not advised.
Caffeine: Side-effects of caffeine include nausea, headache, insomnia, increases gastric secretions and may cause gastric ulceration.

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

Paracetamol: Liver damage which may be fatal may only appear after a few days. Symptonms of overdosage include nausea and vomiting. Acute intoxication causes kidney failure.

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

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.
The latest information regarding the treatment of overdosage can be obtained from the nearest poison centre.

IDENTIFICATION:
Grand-Pa Headache Tablets: Round bisected white tablet embossed with a chevron.
Grand-Pa Headache Powders: Fine, white powder.

PRESENTATION:
Grand-Pa Headache Tablets: In packs of 2, 10, 50 and 100 tablets
Grand-Pa Headache Powders: In packs of 10, 25 and 50 powders and in single doses

STORAGE INSTRUCTIONS:
Store in a safe place out of reach of children. Store in a cool (below 25°C) dry place.

REGISTRATION NUMBER:
Grand-Pa Headache Tablets: P/2.9/22
Grand-Pa Headache Powders: B/2.9/1113

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

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
10 September 1981

Distributed by SmithKline Beecham Consumer Brands for
Group Laboratories SA (Pty) Ltd.

809-5501-01 Rosside 24670

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