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

Logo TYLENOL® NIGHTPAIN Tablets

SCHEDULING STATUS:
Schedule 2

PROPRIETARY NAME
(and dosage form):

TYLENOL® NIGHTPAIN Tablets

COMPOSITION
Each tablet contains
paracetamol 500 mg and diphenhydramine hydrochloride 25 mg.

PHARMACOLOGICAL CLASSIFICATION
A 2.9 Other.

PHARMACOLOGICAL ACTION
TYLENOL* NIGHTPAIN Tablets contain paracetamol which reduces fever, relieves pain and diphenhydramine, an antihistaminic agent with hypnotic properties.

INDICATIONS
For the short term treatment of insomnia in patients with co-existing pain.

CONTRA-INDICATIONS
Do not use this product if you are allergic to any of the ingredients.
Paracetamol should not be used in patients with severe liver disease.
Do not use this product if you are being treated with monoamine oxidase inhibitors, or within two weeks of stopping treatment with these medications.
Do not take this product during pregnancy or whilst breast-feeding.

WARNINGS
Taking more than the recommended dose of paracetamol 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.
Do not take concurrent medication containing paracetamol.
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.

Consult your pharmacist if taking concurrent medications containing paracetamol.

DOSAGE AND DIRECTIONS FOR USE
Adults and children over 16 years:
TWO tablets at bedtime. Do not exceed the recommended dose.
Not recommended for children under 16 years of age.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Paracetamol may cause allergic reactions in the form of a rash or blood disorders (including neutropenia, pancytopenia and leucopenia). These should disappear on stopping the treatment. The rash usually appears as red areas or allergic wheals, and may be accompanied by fever and involvement of the mucous membranes.
Diphenhydramine hydrochloride may cause sedation, disturbances affecting the stomach and intestines, headache, blurred vision, ringing in the ears, swings in mood (elation or depression), irritability, nightmares, lack of appetite, difficulty in urination, dryness of mouth, tightness of chest and tingling, heaviness and weakness of hands. Brain stimulation, particularly in children, allergy and anaphylaxis (sudden life threatening severe allergic reaction) may occasionally occur.
Diphenhydramine hydrochloride should be given with care to patients with raised pressure in the eye (glaucoma) or difficulty in passing urine due to enlargement of the prostate gland, unless it is prescribed by your doctor.
Other central nervous system depressants, such as alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers, if taken together, will increase the chance of sedation. Be careful when taking medicines containing tricyclic anti-depressants or atropine together.
Elderly patients are more susceptible to the central nervous system depressant and lowering of blood pressure effects even at dose quantities effective for treatment.
The warning signs of damage caused by ototoxic medicines may be masked by diphenhydramine.

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.
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 arrythmias 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.
Diphenhydramine hydrochloride toxicity should be treated as would an antihistamine or anticholinergic overdose and is likely to be present within a few hours after acute ingestion.
Treatment is supportive and related to symptoms.

IDENTIFICATION
Blue, flat, round tablet with bevelled edges embossed with TYLENOL on one surface and PM on the other.

PRESENTATION
Containers containing 20 tablets.

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

REGISTRATION NUMBER
28/2.9/0729

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
28 February 1996

                        Code No.: 023164
                        96H
                        Britepak
® = Trademark

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