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

Logo Children's TYLENOL® Cold and Flu Liquid

SCHEDULING STATUS
Schedule 2.

PROPRIETARY NAME
(and dosage form)

Children's TYLENOL® Cold and Flu Liquid

COMPOSITION
Each 5 mL contains
paracetamol 160 mg, chlorpheniramine maleate 1 mg and pseudoephedrine hydrochloride 15 mg.
Preservatives: Benzoic acid 0,05% m/v; sodium benzoate 0,15% m/v.

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

PHARMACOLOGICAL ACTION
Children's TYLENOL COLD and FLU Liquid has decongestant, analgesic, 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 intra-ocular pressure (closed-angle glaucoma).
Do not take this product during pregnancy or whilst breast-feeding.
Pseudoephedrine should be avoided in patients receiving chloroform, cyclopropane, halothane or other halogenated anaesthetics.

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.

DOSAGE AND DIRECTIONS FOR USE
Not recommended for children under the age of two years.
Children aged 2 –5 years: One 5 mL teaspoonful.
Children aged 6 –11 years: Two 5 mL teaspoonsful.
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.
Chlorpheniramine may cause sedation, lassitude, dizziness, incoordination; central nervous system stimulation (insomnia, nervousness, euphoria, irritability, tremors, nightmares, hallucinations and convulsions) especially in children; antimuscarinic effects (e.g. dry mouth, thickened respiratory-tract secretions and tightness of the chest, blurred vision, urinary difficulty and retention, disturbances affecting the stomach and intestines resulting in constipation, and increased gastric reflux); vomiting, diarrhoea, epigastric pain, nausea and anorexia; headache; ringing in the ears; parathesias (tingling sensation); and hypotension (low blood pressure). In high doses, slight slowing of the heart beat may occur, followed by an increased heart rate and irregular heart beats.
Hypersensitivity reactions, particularly of the skin, and cross-sensitivity to related medicines may occur; photosensitivity (sensitivity to sunlight) and blood disorders have been reported.
Chlorpheniramine should be given with care to patients with raised pressure in the eye (glaucoma), difficulty in passing urine, enlargement of the prostate gland, pyloroduodenal obstruction, patients with epilepsy or severe cardiovascular disorders, unless it is prescribed by your doctor.
Other central nervous system depressants, such as alcohol, barbiturates, hypnotics, opioid analgesics, anxiolytic sedatives and neuroleptics, if taken together will increase the chance of sedation.
Be careful when taking medicines containing, tricyclic antidepressants or atropine together.
Elderly patients are more susceptible to many of the adverse effects including antimuscarinic effects, sedation and lowering of blood pressure.
The warning signs of damage caused by ototoxic medicines may be masked by chlorpheniramine.
Chlorpheniramine may interfere with the results of skin tests and should be stopped several days before such tests.

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 nonspecific 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: 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 overdosage being taken.
Chlorpheniramine: Overdosage may result in antimuscarinic, extrapyramidal, gastro-intestinal and central nervous system effects. In children and infants, central nervous system stimulation predominates over depression causing ataxia, excitement, tremors, psychoses, hallucinations and convulsions; hyperpyrexia may also occur. Deepening coma and cardiorespiratory collapse may occur.
In adults, central nervous system depression is more common with drowsiness, coma and convulsions progressing to respiratory failure or possibly cardiovascular collapse. In severe overdosage, the stomach should be emptied. Convulsions, may be controlled with diazepam. Other treatment is supportive and related to symptoms.

IDENTIFICATION
Bottles of clear, purple, grape flavoured liquid.

PRESENTATION
100 mL bottles.

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

REGISTRATION NUMBER
29/5.8/0691

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
12 July 1995                       

                Code No. 023152
                        97F
® = TRADEMARK

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