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

Logo TENSOLVE TENSION HEADACHE TABLETS

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

TENSOLVE TENSION HEADACHE TABLETS

COMPOSITION:
Each tablet contains:

Paracetamol                         400 mg
Codeine Phosphate         10 mg
Diphenhydramine Hydrochloride         5 mg
Caffeine Anhydrous         50 mg
Preservative:  
Nipastat 0,02% m/m

PHARMACOLOGICAL CLASSIFICATION:
A 2.9 special analgesic combinations.

PHARMACOLOGICAL ACTION:
Tensolve Tension Headache Tablets have analgesic, antipyretic and antihistaminic properties.

INDICATIONS:
For mild to moderate pain.

CONTRA-INDICATIONS:
Patients with severe liver or kidney complications. Hypersensitivity to any of the ingredients. The use of monoamine oxidase inhibitors or within 10 days of stopping such treatment.

WARNINGS:
Do not use continuously for more than 10 days without consulting your doctor. Also consult your doctor if no relief is obtained with the recommended dosage.
Due to the paracetamol content dosages in excess of those recommended may cause severe liver damage. Patients suffering from liver or kidney disease should take paracetamol under medical supervision. Care should be taken when administering this preparation during the first trimester of pregnancy.
The use of this medicine may lead to drowsiness and impaired concentration which may be aggravated by the simultaneous intake of alcohol and other central nervous system depressant agents. Patients should not operate hazardous machinery or drive motor vehicles when under medication. Must not be taken with sedatives or tranquillizers.

DOSAGE AND DIRECTIONS FOR USE:
Adults and children over 12 years:
One to two tablets every 3 or 4 hours, with a maximum of 8 tablets daily.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects of Paracetamol:
Haematological reactions have been reported. Skin eruptions have also occurred.
Side-effects of Codeine Phosphate:
Constipation, nausea and vomiting, dizziness and drowsiness. Dry mouth, facial flushing, vertigo, bradycardia, palpitations, faintness, sedation, restlessness, changes of mood and miosis may also occur. Raised intracranial pressure may also occur.
Its depressant effects are enhanced by anaesthetics, hypnotics, sedatives and phenothiazines. It should be taken with caution by patients with impaired liver function or prostatic hypertrophy, elderly patients and after operations on the biliary tract. Due to the histamine-releasing effect allergic reactions such as urticaria, pruritis and itching of the nose occur in some individuals and idiosyncrasy to codeine and other narcotic analgesics is fairly common.
Side-effects of Diphenhydramine Hydrochloride:
Sedation varying from slight drowsiness to deep sleep including inability to concentrate, lassitude, dizziness, hypotension, muscular weakness and inco-ordination. Other side-effects include gastro-intestinal disturbances such as nausea, vomiting, diarrhoea or constipation, colic and epigastric pain. It may also produce hallucinations, blurred vision, tinnitus, elation or depression, irritability, anorexia, difficulty in micturition, dryness of the mouth, tightness of the chest and weakness of the hands. Large doses of antihistamines may precipitate fits in epileptics.
Blood dyscrasias, including agranulocytosis, haemolytic anaemia and thrombocytopenic purpura, though rare, have been reported.
Side-effects of Caffeine :
Nausea, headache and insomnia. Caffeine increases gastric secretion and may cause gastric ulceration.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Paracetamol:
Liver damage which may be fatal may only appear after a few days. Symptoms of overdosage include nausea and vomiting. Acute intoxication causes kidney failure.
Diphenhydramine Hydrochloride:
In the small child the dominant effect is excitement including hallucinations, ataxia, inco- ordination, athetosis and convulsions. Fixed, dilated pupils with a flushed face and fever are common. In the adult fever and flushing are not usually in evidence, the phase of excitement leading to convulsions and postictal depression is not uncommonly preceded by drowsiness and coma.
Codeine Phosphate:
Produces central stimulation with exhilaration and, in children, convulsions, followed by vomiting, drowsiness, respiratory depression and cyanosis and coma.
Caffeine Anhydrous:
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:
Yellow, flat, bisected tablets with bevelled edges.

PRESENTATION:
Blister packs which contain 10, 18 or 54 tablets.
Containers of 20, 50 and 500 tablets.

STORAGE INSTRUCTIONS:
Store in well-closed containers below 25°C. Protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
R/2.9/189

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
PHARMACARE LIMITED
7 Fairclough Road
Korsten
Port Elizabeth
6020

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
11 January 1984

308130        020922

        Harry's Printers K00000 J02

New addition to this site: March 2005
Source: Pharmaceutical Industry

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