PHARMACOLOGICAL CLASSIFICATION: A 2.8 Analgesic combinations
Tenstontablets have analgesic, antipyretic and tranquillizing properties.
INDICATIONS: Mild to moderate pain and fever associated with tension states.
CONTRA-INDICATIONS: Severe liver and kidney complications. Patients with acute and intermittent porphyria or with a history of hypersensitivity to any of the ingredients. The presence of respiratory depression, acute alcoholism, head injuries and conditions in which intracranial pressure is raised. Bronchial asthma or heart failure secondary to chronic lung disease.
Patients taking monoamine oxidase inhibitors or within 14 days of stopping such treatment. Patients with peptic ulcers, haemophilia and patients receiving oral anticoagulant therapy.
WARNINGS: Aspirin has been implicated in Reyes syndrome, a rare but serious illness in children and teenagers with chicken pox and influenza. A doctor should be contacted before aspirin is used in such patients.
Do not use continuously for more than 10 days without consulting your doctor. Doses of paracetamol in excess of those recommended may cause liver damage. The use of this medicine leads to drowsiness which is aggravated by the simultaneous intake of alcohol or other central nervous system depressants and it is dangerous to drive a vehicle or be in charge of machinery while on treatment with this product.
This product contains FD & C Yellow no 5 (Tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of tartrazine sensitivity in the general population is currently thought to be low, it is frequently seen in patients who also have aspirin sensitivity.
DOSAGE AND DIRECTIONS FOR USE:
1 to 2 tablets four times daily.
6 -12 years: Half to 1 tablet four times daily.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS: Side-effects of aspirin include irritation of the gastric mucosa and resultant dyspepsia, haematouresis and melaena. Some persons, especially asthmatics exhibit notable sensitivity to aspirin which may include skin eruptions, paroxymal bronchospasm and dyspnoea. Tenstontablets should be administered with caution to patients with impaired renal functions, dyspepsia, anaemia and when patients are dehydrated. Aspirin may enhance the activity of coumarin anticoagulants, and antidiabetic 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, gastrointestinal haemorrhage, peptic ulceration and renal papillary necrosis.
Haematological reactions and skin eruptions have been reported with paracetamol. Meprobamate may cause drowsiness. Other side-effects of meprobamate include nausea, vomiting, diarrhoea, paraesthesia, weakness and central effects such as headache, excitement, dizziness, ataxia, and disturbance of vision. Hypotension, tachycardia and cardiac arrhythmias may occur. Hypersensitivity reactions may occur. These may include skin rashes, urticaria and purpura. More severe hypersensitivity reactions are angio-neurotic oedema, bronchospasm or anuria. Erythemia multiforme has been reported. Treatment should be discontinued as soon as these reactions occur. Blood disorders including agranulocytosis, eosinophilia, leucopenia, thrombocytopenia, and aplastic anaemia have been reported. Symptoms of porphyria may be exacerbated. There is serious dependence risk with a typical withdrawn syndrome.
Side-effects of caffeine include nausea, headache and insomnia. Caffeine increases gastric secretions and may cause gastric ulceration.
Side-effects of codeine phosphate are constipation, nausea and vomiting, dizziness and drowsiness. Dry mouth, facial flushing, vertigo, bradycardia, palpitations, faintness, sedation, restlessness, change of mood and miosis may occur. These effects are more common in ambulant patients than in those at rest in bed. Raised intracranial pressure occurs in some patients. Allergic reactions such as urticaria, pruritis and itching of the nose occur in some individuals and idiosyncrasy to codeine is fairly common.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: Liver damage which may be fatal may only appear after a few days. Kidney failure has been described following acute intoxication.
Nausea, vomiting, restlessness, drowsiness, abdominal pain, gastro-intestinal haemorrhage, potentially fatal liver damage, cerebral oedema and renal tubular necrosis, hyperglycaemia and hypoglycaemia. Central stimulation and exhilaration, followed by cardio vascular collapse, respiratory depression and coma.
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: Yellow scored tablets.
PRESENTATION: Containers with 20, 100 and 500 tablets.
STORAGE INSTRUCTIONS: Store below 25 °C in well closed containers.
KEEP OUT OF REACH OF CHILDREN.
REFERENCE NUMBER: B1127 (Act 101/1965)
NAME AND BUSINESS ADDRESS OF THE APPLICANT: Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Avenue
Bryanston Ext. 77
Private Bag X69
DATE OF PUBLICATION OF THIS PACKAGE INSERT: November 1980
Updated on this site: April 2005
Source: Community Pharmacy