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

Logo PANADO-CO® Tablets

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

PANADO-CO® Tablets

COMPOSITION:
Each tablet contains
paracetamol 500 mg, codeine phosphate 8 mg and 0,1% m/m potassium sorbate as preservative.
Sugar free

PHARMACOLOGICAL CLASSIFICATION:
A 2.8 Analgesic Combinations.

PHARMACOLOGICAL ACTION:
PANADO-CO® TABLETS have analgesic and antipyretic actions.

INDICATIONS:
Recommended for relief of mild to moderate pain and fever such as headaches, toothache and pain associated with colds and flu.

CONTRA-INDICATIONS:
Hypersensitivity to paracetamol.
Severe liver function impairment.

WARNINGS:
Codeine: Exceeding the prescribed dose, together with prolonged and continuous use of this medication may lead to dependence and addiction.
Dosages in excess of those recommended may cause severe liver damage.
Patients suffering from liver or kidney disease should take paracetamol under medical supervision. Do not use continuously for more than 10 days without consulting a doctor.

INTERACTIONS:
The depressant effects of codeine are enhanced by depressants of the central nervous system such as alcohol, anaesthetics, hypnotics and sedatives, and phenothiazines.

DOSAGE AND DIRECTIONS FOR USE:
Adults:                1 - 2 tablets
Children 9-12 years: ½ - 1 tablet
May be taken 6 hourly, if necessary, with a maximum of 4 doses in 24 hours. Not recommended for children under 9 years.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Special Precautions:
1. Consult a doctor if no relief is obtained from the recommended dosage.
2. Store in a safe place out of reach of children.
Paracetamol:
Skin rashes and other allergic reactions may occur. The rash is usually erythematous or urticarial but sometimes more serious and may be accompanied by fever and mucosal lesions. The use of paracetamol has been associated with the occurrence of neutropenia, pancytopenia and leucopenia.
Codeine:
Codeine may be habit forming. Codeine may cause nausea, vomiting, constipation, drowsiness, confusion, dry mouth, sweating, facial flushing, vertigo, bradycardia, palpitations, orthostatic hypotension, hypothermia, restlessness, change of mood and miosis. 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 should be given with caution to patients with hypothyroidism, adrenocortical insufficiency, 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.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
In the event of overdosage or suspected overdose and notwithstanding the fact that the person may be asymptomatic, the nearest doctor, hospital or Poison Control Centre must be contacted immediately.
Paracetamol:
Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur.
Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage.
Cardiac arrhythmias have been reported.
Symptoms during the first 2 days of acute poisoning do not reflect the potential seriousness of the overdosage.
Nausea, vomiting, anorexia and abdominal pain may persist for a week or more. Liver injury may become manifest on the second day, (or later) initially by elevation of serum transaminase and lactic dehydrogenase activity, increased serum bilirubin concentration and prolongation of prothrombin time. The liver damage may progress to encephalopathy, coma and death.
Cerebral oedema and non-specific myocardial depression have also occurred.
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.
Prompt treatment is essential. Any patient who has ingested about 7,5 g of paracetamol in the preceding 4 hours should undergo gastric lavage. Specific therapy with an antidote such as acetylcysteine or methionine may be necessary. If decided upon, acetylcysteine should be administered IV as soon as possible.
Acetylcysteine:
Acetylcysteine should be administered as soon as possible, preferably within 8 hours of overdosage.
IV: An initial dose of 150 mg/kg in 200 mL glucose injection, given intravenously over 15 minutes, followed by an intravenous infusion of 50 mg/kg in 500 mL glucose injection over the next 4 hours, and then 100 mg/kg in 1000 mL over the next 16 hours. The volume of intravenous fluids should be modified for children.
Orally: 140 mg/kg as a 5% solution initially, followed by a 70 mg/kg solution every 4 hours for 17 doses.
Acetylcysteine is effective if administered within 8 hours of overdosage.

Codeine:
Symptoms of overdosage include excitement and in children, convulsions may occur. Large doses produce respiratory depression. Treatment of overdosage is symptomatic and supportive.

IDENTIFICATION:
White biconvex tablet with "P" imprinted on the upper face, with a breakbar on the lower face.

PRESENTATION:
Blister packs of 20 sealed tablets, securitainers of 20, 100 and 500 tablets and buckets of 5 000 tablets.

STORAGE INSTRUCTIONS:
Store in a well closed container protected from light. Store below 25°C. Exposure to air should be kept to a minimum. KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
B/2.8/1141

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:
Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Ave,
Bryanston Ext. 77
Private Bag X69, Bryanston, 2021

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
August 1989        09/2005        03.108.05.00/Eaf.                P13603

Updated on this site: Oct 2006
Source: Hospital Pharmacy

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