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

Logo Children's TYLENOL® COLD and FLU Chewable tablets

SCHEDULING STATUS
Schedule 2.

PROPRIETARY NAME
(and dosage form)

Children's TYLENOL® COLD and FLU Chewable tablets

COMPOSITION
Each chewable tablet contains
paracetamol 80 mg, chlorpheniramine maleate 0,5 mg and pseudoephedrine hydrochloride 7,5 mg.

PHARMACOLOGICAL CLASSIFICATION
A. 5.8 Preparations for the common cold including nasal decongestants and antihistaminics.

PHARMACOLOGICAL ACTION
Children's TYLENOL COLD and FLU Chewable tablets has decongestant, antipyretic and antihistaminic properties.

INDICATIONS
For the relief of symptoms of nasal stuffiness, runny nose, sneezing, minor aches and pains, headaches and fever due to the common cold, hayfever or other nasal allergies.

CONTRA-INDICATIONS
Do not use this product if you are allergic to any of the ingredients.
Do not use this product if you are being treated with monoamine-oxidase inhibitors, or within two weeks of stopping treatment with these medications.
Paracetamol should not be used in patients with severe liver disease.
Pseudoephedrine should not be used in patients suffering from any of the following: heart disease (especially coronary insufficiency or arrhythmias), high blood pressure (hypertension), an overactive thyroid gland (hyperthyroidism), tumour of the adrenal gland (phaeochromocytoma) and raised intraocular pressure (closed-angle glaucoma).
Pseudoephedrine should be avoided in patients receiving chloroform, cyclopropane, halothane or other halogenated anaesthetics.
Do not take this product during pregnancy or whilst breastfeeding.

WARNINGS
Taking more than the recommended dose may cause severe liver damage.
Patients suffering from liver or kidney disease should take paracetamol only if instructed to do so by the doctor.
This medicine may lead to drowsiness and impaired concentration, which may be aggravated by simultaneous intake of alcohol or other agents which slow down the nervous system activity. Patients should be warned against taking charge of vehicles or machinery or performing potentially dangerous tasks where loss of concentration may lead to accidents.
Consult your doctor if no relief is obtained with the recommended dosage.
Do not use continuously for longer than 10 days without consulting your doctor.
Patients with phenylketonuria should be aware that this product contains phenylalanine.

DOSAGE AND DIRECTIONS FOR USE
Children aged 2 - 5 years: TWO chewable tablets.
Children aged 6 - 11 years:FOUR chewable tablets.
Doses may be repeated every 4 - 6 hours as needed. Do not exceed 4 doses in 24 hours.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Paracetamol may cause allergic reactions and skin rash. The rash usually appears as red areas or allergic wheals, and may be accompanied by fever and involvement of the mucous membranes. The use of paracetamol has been associated with the occurrence of neutropenia, pancytopenia and leucopenia.
Pseudoephedrine may cause giddiness, headache, nausea, vomiting, sweating, thirst, rapid or irregular heart beat (tachycardia, ventricular arrhythmia), pain in front of the heart (precordial pain), palpitations, raised blood pressure (hypertension), difficulty in urination, muscular weakness, tremors, anxiety, restlessness and inability to sleep. Tolerance with dependence may occur after continued use.
The effects of pseudoephedrine are lessened by medicines containing guanethidine, reserpine, methyldopa and may be diminished or enhanced by tricyclic antidepressants. It may increase the possibility of irregular heart beat in patients taking digitalis.
The most common side-effect due to chlorpheniramine is sedation varying from slight drowsiness to deep sleep, including lassitude, dizziness, and incoordination. Paradoxical, central nervous system stimulation, may occur, especially in children, with insomnia, nervousness, euphoria, irritability, tremors, and rarely nightmares, hallucinations, and convulsions.
Antimuscarinic effects such as blurred vision, difficulty in micturition, dysuria, dryness of mouth and tightness of the chest may also occur.
Gastro-intestinal disturbances such as nausea, vomiting, diarrhoea or constipation, anorexia or increased appetite, and epigastric pain may occur.
Blood disorders including agranulocytosis, leucopenia and haemolytic anaemia have been reported.
Elderly patients are more susceptible to central nervous system depressant hypotensive effects.
Interactions
Antihistamines may enhance the sedative effects of central nervous system depressants including alcohol, barbiturates, hypnotics, analgesics, sedatives and tranquillisers.
The side-effects of anticholinergic substances may be enhanced by the concomitant administration of antihistamines.
Monoamine-oxidase inhibitors may enhance the antimuscarinic effects of antihistamines.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
If more than the recommended dose has been taken, speak to your doctor or take the patient to the nearest hospital immediately.
For additional emergency information, call your nearest poison centre.
Paracetamol
At first (during the first 24 hours ), a patient who has taken a large overdose of this medicine may be pale and nauseous, and begin to vomit, have a lack of appetite, and stomach pain. Symptoms during the first two days of severe poisoning do not reflect the potential seriousness of the overdosage. Liver, kidney or heart damage may all result from paracetamol overdose. Specialised treatment is essential as soon as possible.
Information for the doctor
Initial symptoms in the first 24 hours are nausea, vomiting, anorexia, and abdominal pain and these may persist for a week or more. Liver injury may become apparent from 12 to 48 hours after ingestion and may manifest by metabolic acidosis, abnormalities of glucose metabolism, 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, cardiac arrhythmias and non-specific myocardial depression have also occurred. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage.
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 intravenously as soon as possible. Acetylcysteine is effective if administered within 8 hours of overdosage.
Intravenously: 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 of 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.
Pseudoephedrine hydrochloride
Symptoms from pseudoephedrine overdose consist most often of mild anxiety, increased rate of heart beat and/or mild high blood pressure. Symptoms usually appear within 4 to 8 hours of being taken.

Chlorpheniramine maleate
Overdosage with chlorpheniramine may be fatal especially in infants and children in whom the main symptoms are central nervous system stimulation and antimuscarinic effects, including ataxia, excitement, hallucinations, muscle tremor, convulsions, dilated pupils, dry mouth, flushed face and hyperpyrexia. Deepening coma, cardiorespiratory collapse, and death may occur with 18 hours. In adults the usual symptoms are central nervous depression with drowsiness, coma and convulsions. Hypotension may also occur.
Treatment is symptomatic and supportive.

IDENTIFICATION
A grape flavoured, flat faced, bevelled edge tablet embossed with TYLENOL COLD on one side and TC on the other side.

PRESENTATION
Cartons containing blister strips with 10, 20 or 30 tablets each.
Bottles containing 20 tablets.

STORAGE INSTRUCTIONS
Store below 25°C. Protect from moisture and light.
KEEP OUT OF REACH OF CHILDREN

REGISTRATION NUMBER
29/5.8/0005

NAME AND BUSINESS ADDRESS OF THE APPLICANT
JANSSEN - CILAG
JANSSEN PHARMACEUTICA (PTY) LTD
(Reg. No. 80/11122/07)
15th Road, HALFWAY HOUSE, 1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT
23 August 1995

                        Code No.: 23105
                        95K

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