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

Logo PAINAMOL® PLUS TABLETS
SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

PAINAMOL® PLUS TABLETS

COMPOSITION:
Each tablet contains: Codeine phosphate         8 mg
  Paracetamol         500 mg
  Sugar 20 mg
Preservative: Sodium metabisulphite 0,081% m/m
Contains TARTRAZINE

PHARMACOLOGICAL CLASSIFICATION:
Category A. 2.8 Analgesic combinations

PHARMACOLOGICAL ACTION:
Painamol® Plus has a analgesic and antipyretic action.

INDICATIONS:
Painamol® Plus tablets are indicated for the relief of mild to moderate pain and for the reduction of temperature in febrile conditions.

CONTRA-INDICATIONS:
Hypersensitivity to any of the ingredients.
Codeine is contra-indicated in respiratory depression especially in the presence of cyanosis and excessive bronchial secretion and after operations on the biliary tract; in the presence of acute alcoholism head injuries and conditions in which intracranial pressure is raised, during an attack of bronchial asthma or in heart failure secondary to lung disease.
Exceeding the prescribed dose, together with prolonged and continuous use of this medication, may lead to dependency and addiction.

WARNING:
Do not use continuously for more than 10 days without consulting your doctor.
Dosages in excess of those recommended may cause severe liver damage.
Codeine should be given with extreme caution in patients taking monoamine oxidase inhibitors or within 14 days of stopping such treatment.
Painamol® Plus tablets contain 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:
Adults: One or two tablets every four to six hours.
Children over 12 years: One tablet every four to six hours.
Children 6 to 12 years: Half to one tablet every six hours.
Do not exceed an adult dose of 8 tablets per day.
Do not use continuously for longer than ten (10) days without consulting your doctor.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Paracetamol:
Sensitivity reactions resulting in reversible rash or blood disorders may occur.
Patients suffering from liver or kidney disease should take paracetamol under medical supervision.
Consult your doctor if no relief is obtained with the recommended dosage.
Store in a safe place out of reach of children.
Codeine:
Codeine may cause nausea, vomiting, constipation, drowsiness, confusion, dry mouth, sweating, facial flushing, vertigo, bradycardia, palpitations, orthostatic hypotension, hypothermia, restlessness, changes of mood and miosis, circulatory failure, hypotension, deepening coma, and muscle rigidity. Micturition may be difficult and there may be ureteric or biliary spasm. Raised intracranial pressure may occur. Reactions such as urticaria and pruritus may occur. Codeine may have an antidiuretic effect.
Codeine should be given with caution to patients with hypothyroidism, adrenocortical insufficiency, myasthenia gravis, impaired renal function, impaired liver function, prostatic hypertrophy or shock. It should be used with caution in patients with inflammatory or obstructive bowel disorders. The dosage should be reduced in elderly and debilitated patients.
The depressant effects of codeine are enhanced by depressants of the central nervous system such as alcohol, anaesthetics, hypnotics and sedatives, phenothiazines, tricyclic antidepressants.
The prolonged use of high doses of codeine has produced dependence of the morphine type.
The administration of codeine during labour may cause respiratory depression in the new born infant.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT.
Paracetamol:
Symptoms include nausea and vomiting. Liver damage which may be fatal may only appear after a few days.
Kidney failure has been described following acute intoxication.
In the event of overdosage, consult your 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.
Codeine:
Symptoms include restlessness, excitement, respiratory depression and hypotension with circulatory failure and coma. In children convulsions may occur. The specific antagonist, naloxone hydrochloride is used to counteract the severe respiratory depression. In the event of overdosage, consult a doctor or take the patient to the nearest hospital immediately.
Treatment is supportive and symptomatic.

IDENTIFICATION:
Flat yellow and red mottled tablet scored on the one side and a "b" embossed on the other side.

PRESENTATION:
Cartons containing 2 x 10 tablets in push through blister packs. Containers with 100, 500 and 1000 tablets. Blue/green plastic buckets containing 5000 tablets. Patient ready packs of different pack sizes.

STORAGE DIRECTIONS:
Store below 25°C, and protect from strong light in a well closed container. Protect from moisture. Exposure to air should be minimum.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
P/2.9/311 (S.A.)
B9314840 (Botswana)

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:
BE-TABS PHARMACEUTICALS (PTY) LTD.
14 Lautre Road
Stormill, Ext. 1
Roodepoort
1724
South Africa

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
27 February 1996

CODE:IBC/9
                        JET PRINTERS 6/03

Updated on this site: June 2006
Source: Hospital Pharmacy

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