Paracetamol, Pseudoephedrine HCL, Chlorpeniramine
Paracetamol ,Pseudoephedrine HCL, Chlopheniramine
Each tablet contains paracetamol 500 mg,
pseudoephedrine hydrochloride 25 mg and
chlorpheniramine maleate 2 mg.
PHARMACOLOGICAL CLASSIFICATION: Preparations
for the common cold including nasal decongestants
PHARMACOLOGICAL ACTION :Tablet has
decongestant, analgesic, antipyretic and
Short term relief of symptoms of the common cold,
hayfever or other nasal allergies such as minor
aches and pains, headache and fever, nasal
stuffiness, runny nose, sneezing, itchy and watery
Hypersensitivity 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.
Pseudoephedrine hydrochloride 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), raised
intraocular pressure (closed-angle glaucoma) and
diabetes mellitus. Pseudoephedrine hydrochloride
should be avoided in patients receiving chloroform,
cyclopropane, halothane or other halogenated
Pregnancy and lactation.
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 a 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
Consult your doctor if no relief is obtained with
the recommended dosage. Do not use continuously for
longer than 10 days without consulting a doctor.
DOSAGE AND DIRECTIONS FOR USE :
Do not exceed the stated
Adults and children over 12 years: Two
tablets every 6 hours - 8 hours. Do not exceed
8 tablets in 24 hours.
Not recommended for children under 12 years of age.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Paracetamol may cause pancreatitis, allergic
reactions in the form of a rash or blood disorders
(including neutropenia, pancytopenia, leucopenia,
agranulocytosis and thrombocytopenia). 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
The most common side-effect due to chlorpheniramine
is sedation varying from slight drowsiness to deep
sleep, including lassitude, dizziness, and inco-ordination.
Paradoxical central nervous system stimulation may
occur especially in children, with insomnia,
nervousness, euphoria, irritability, tremors, and
less frequently, nightmares, hallucinations, and
Other side effects may include dry mouth; thickened
respiratory tract secretions and tightness of the
chest, blurred vision, urinary difficulty and
retention, constipation and increased gastric
reflux. In addition, gastro-intestinal disturbances
may occur such as nausea, vomiting, diarrhoea or
Hypersensitivity reactions may occur. Blood
disorders including agranulocytosis, leucopenia,
haemolytic anaemia and thrombocytopenia, have been
reported. Other less frequently reported
side-effects include hypotension, tinnitus, headache
Chloropheniramine should be given with care to
patients with glaucoma, urinary retention, prostatic
hypertrophy or pyloroduodenal obstruction. Caution
is advised in patients with epilepsy and severe
Chlorpheniramine may enhance the sedative effect of
central nervous system depressants including
alcohol, barbiturates, hypnotic, analgesics,
sedatives and tranquillisers. Care should be taken
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
The warning signs of damage caused by ototoxic
medicines may be masked by chlorpheniramine.
Other central nervous system depressants, such as
alcohol, barbiturates, hyponotics, 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.
Pseudoephedrine hydrochloride 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), micturition, difficulty in
urination, muscular weakness, tremors, anxiety,
restlessness and inability to sleep, fear,
confusion, psychotic states, reduced appetite,
dyspnoea, sweating, hypersalivation, altered
metabolism including disturbance in glucose
metabolism. Tolerance with dependence may occur
after continued use.
The effects of pseudoephedrine hydrochloride 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.
Pseudoephedrine may increase blood pressure and
therefore special care is advisable in patients
receiving antihypertensive therapy.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF
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
non-specific myocardial depression have also
occurred. Acute renal failure with acute tubular
necrosis may develop even in the absence of severe
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.
Orally: 140 mg/kg as a 5% solution initially,
followed by a 70 mg/kg solution every 4 hours for
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 within 18 hours. In
adults the usual symptoms are central nervous
depression with drowsiness, coma and convulsions.
Hypotension may also occur.
Symptoms from pseudoephedrine hydrochloride
overdose consist most often of anxiety, increased
rate of heart beat and/or high blood pressure.
Symptoms usually appear within 4 to 8 hours of being
Treatment is symptomatic and supportive.
Store below 25°C. Protect from light. Keep out
of reach of children.
away any medication that is outdated or no longer
needed. Talk to your pharmacist about the proper
disposal of your medication.
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