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

Logo GERTGES PAIN POWDERS

SCHEDULING STATUS:
Not scheduled.

PROPRIETARY NAME
(and dosage form):

GERTGES PAIN POWDERS

COMPOSITION:
Each powder contains:

Aspirin 750 mg
Caffeine Citrate 150 mg

PHARMACOLOGICAL CLASSIFICATION:
B.2.8 Analgesic combinations.

PHARMACOLOGICAL ACTION:
Gertges Pain Powders have analgestic, anti-inflammatory and anti-pyretic actions, and inhibit the biosynthesis of prostaglandins.

INDICATIONS:
Mild to moderate pain such as headaches, colds, flu and fever.

CONTRA-INDICATIONS:
Intolerance or hypersensitivity to aspirin, caffeine, other nonsteroidal aniti-inflammatory agents and other xanthines. Patients with peptic ulcers, haemophilia or other bleeding disorders, severe renal impairment and patients receiving oral anticoagulants, heparin and monoamine oxidase inhibitors should not use these powders. Contra-indicated in patients with a history of cardiac disease, kidney disease, epilepsy and all convulsive states.
Not to be taken during the first and third trimesters of pregnancy. Regular use of NSAIDS during the third trimester of pregnancy may result in premature closure of the foetal ductus arteriosus in utero and possibly in persistent pulmonary hypertension of the newborn. The onset of labour may be delayed and its duration increased. The use of this product during lactation should be avoided.

WARNING:
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. Do not use continuously for more than 10 days without consulting your doctor. Avoid the use of aspirin several days before scheduled surgical procedures, unless otherwise directed by your doctor.
Patients sensitive to tartrazine may be sensitive to aspirin.

DOSAGE AND DIRECTIONS FOR USE:
Adults:
One powder to be taken with water, may be repeated in 4 hours if necessary. Do not exceed 5 powders per day.
Not recommended for children.
DO NOT USE CONTINUOUSLY FOR LONGER THAN 10 DAYS WITHOUT CONSULTING YOUR DOCTOR. EXCESSIVE AND PROLONGED USE OF THIS MEDICINE MAY BE DANGEROUS.
Gastro-intestinal symptoms may be reduced by taking this medication after food.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Aspirin: Dizziness, or irritation of the gastric mucosa and resultant dyspepsia, nausea, vomiting, ulceration, increased bleeding time and decreased platelet adhesiveness, haematemesis and melaema may occur. Some persons, especially asthmatics, exhibit notable sensitivity to aspirin, which may include skin eruptions, paroxysmal bronchospasm and dyspnoea. It should be administered with caution to patients with impaired renal function, dyspepsia, anaemia, vitamin K deficiencies, gout, hypertension, hepatic impairment, asthma, thyrotoxicosis, glucose-6-phosphate dehydrogenase deficiency and when the patient is dehydrated. Aspirin may enhance the activity of coumarin anticoagulants, oral anti-diabetic preparations, sulphonamides, methotrexate, phenytoin, and valproic acid. Concomitant use of aspirin with other nonsteroidal anti-inflammatory agents, vancomycin or zidovudine should be avoided. Barbiturates and sedatives may mask the respiratory symptoms of aspirin overdosage and have been reported to enhance its toxicity. The risk of gastrointestinal bleeding and ulceration is increased when used with corticosteroids.
Prolonged use of high doses may lead to anaemia, blood dyscrasias, gastro-intestinal haemorrhage, peptic ulceration and renal papillary necrosis. Aspirin diminishes the effects of antigout preparations such as probenecid, and sulphinpyrazone.
Caffeine: Can cause insomnia, central nervous system stimulation, headache and nausea in some cases. With prolonged use some degree of tolerance and psychic dependence may occur. Use with caution in patients with anxiety disorders, hypertension, insomnia and hepatic function impairment.
This product must be taken with care by persons with a history of peptic ulceration or hyperacidity. Consult your doctor if no relief is obtained with the recommended dosage.
Store in a safe place, out of reach of children.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Aspirin: These include dizziness and lightheadedness, tinnitus, deafness, sweating, nausea, vomiting, headache, mental confusion, hyperventilation, fever, restlessness, respiratory alkalosis, metabolic acidosis, ketosis and depression of the central nervous system. Cardiovascular collapse and respiratory failure may also occur.
Caffeine: Overdosage may cause excessive central nervous system stimulation, restlessness, excitement, muscle tremor, tinnitus, nausea and vomiting, headache, abdominal or stomach pain, confusion or delirium, convulsions, dehydration, frequent urination and tachycardia. Prolonged administration or overdosage may cause gastric ulceration.
In cases of overdosage consult your doctor immediately. In children serious signs of overdosage my develop rapidly. Treatment is supportive and symptomatic.

IDENTIFICATION:
Fine pink powders individually wrapped.

PRESENTATION:
Cartons with 10 powders individually wrapped.

STORAGE INSTRUCTIONS:
Store well closed, below 25°C. Exposure to air should be minimal. KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
B/2.8/1099

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
TECHNIKON LABORATORIES (PTY) LTD
1073 Anvil Road, Robertville, Florida. Tel: (011) 674-1091

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
08/05/97

New addition to this site: February 2007
Source: Pharmaceutical Industry

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