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

Logo TYLENOL™ Extended Relief Caplets

SCHEDULING STATUS:
Schedule 1

PROPRIETARY NAME
(and dosage form):

TYLENOL™ Extended Relief Caplets

COMPOSITION:
Each caplet contains 650 mg
paracetamol.

PHARMACOLOGICAL CLASSIFICATION:
A. 2.8 Analgesic combinations.

PHARMACOLOGICAL ACTION:
Paracetamol has analgesic and antipyretic properties. TYLENOL Extended Relief has a bi-layer. The first layer dissolves quickly to provide prompt relief while the second layer dissolves gradually to provide up to 8 hours of relief.

INDICATIONS:
Paracetamol is indicated for the temporary relief of minor aches and pains associated with cold, sore throat, headache, toothache, muscular aches, premenstrual and menstrual cramps; and minor pain of arthritis and for the reduction of fever.

CONTRA-INDICATIONS:
Hyper sensitivity to paracetamol.
Severe liver function impairment.

WARNINGS:
Dosages in excess of those recommended may cause severe liver damage.
Patients suffering from liver or kidney disease should take paracetamol under medical supervision.
Consult a doctor if no relief is obtained from the recommended dosage. Do not use continuously for more than 10 days without consulting a doctor.

DOSAGE AND DIRECTIONS FOR USE:
Adults and children 12 years and older:
Take two caplets every 8 hours. Do not exceed 6 caplets in any 24 hour period.
Take two caplets with water, swallow each caplet whole.
DO NOT CRUSH, CHEW OR DISSOLVE THE CAPLET.
Not for use in children under 12 years of age.

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.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
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 a 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 intravenously as soon as possible.
Acetylcysteine:
Acetylcysteine should be administered as soon as possible, preferably 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. Acetylcysteine is effective if administered within 8 hours of overdosage.

IDENTIFICATION:
White, odourless, film coated, capsule shaped tablet (caplet), debossed with TYLENOL ER.

PRESENTATION:
Bottles containing 24 caplets.

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

REGISTRATION NUMBER:
30/2.8/0420

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
JANSSEN–CILAG
Janssen Pharmaceutica (Pty) Ltd.
(Reg. No. 1980/11127/07)
15th Road
Halfway House 1685.
© Janssen Pharmaceutica (Pty) Ltd., S.A.
Website: www.janssencilag.co.za

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
8 July 1996

        Code: 023222
        2002E
        Britepak

Updated on this site: December 2002
Current: May 2005
Source: Pharmaceutical Industry

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