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Generic Name : PARACETAMOL, DIPHENHYDRAMINE HCl
Active Ingredient: Paracetamol,
Diphenhydramine HCL
COMPOSITION:
Each tablet contains paracetamol 500 mg and
diphenhydramine hydrochloride 25 mg.
PHARMACOLOGICAL ACTION
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.
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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 TREATMEN :
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.
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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:
Paracetamol
500mg, Diphenhydramine HCL 25mg
film-coated tablets
STORAGE INSTRUCTIONS
Store below 25°C. Protect from moisture and
light. Keep out of reach of children.
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Notice
The products discussed herein may have different
product labeling in different countries. The product
information provided in this site is intended only
for the residents of India.
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