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Febricol-Rx

COMPOSITION
Each tablet contains:
Paracetamol .........................500mg

Chlorpheniramine Maleate ........2mg

Phenylephrine Hydrochloride ....5mg

PHARMACODYNAMICS
Chlorpheniramine is a H1-blocker that reduces rhinorrhoea and sneezing. Phenylephrine is used as a nasal and bronchial decongestant. It is a direct selective alpha-adrenergic receptor agonist, and thus it does not cause the release of endogenous noradrenaline like pseudoephedrine does. Paracetamol has analgesic and antipyretic actions similar to those of aspirin. These actions are considered to be due to inhibition of the biosynthesis of prostaglandins.

PHARMACOKINETICS
Chlorpheniramine is well absorbed from the gastro-intestinal tract, following oral administration. It is extensively metabolised in the liver and excreted mainly as metabolites in the urine. Phenylephrine has reduced bioavailability from the gastrointestinal tract owing to irregular absorption and first-pass metabolism by monoamine oxidase in the gut and liver. Paracetamol is readily and effectively absorbed from the gastrointestinal tract, metabolised in the liver and excreted in the urine mainly as the glucuronide and sulphate conjugates.

INDICATIONS
Febricol-Rx is indicated for the symptomatic relief of headache, muscular ache, fever, sneezing, nasal congestion, itching and watery eyes associated with flu, common colds and allergic rhinitis.

DOSAGE AND ADMINISTRATION
Febricol-Rx is preferably taken after food.
Adults and Children over 12 years: 1 to 2 tablets every 4-6 hours. Maximum 8 tablets per day.

CONTRAINDICATIONS
Febricol-Rx is contraindicated in patients taking monoamine oxidase inhibitors or within two weeks after stopping such treatment, patients with severe hypertension or severe coronary artery disease and in patients with known hypersensitivity to any of the active constituent.

WARNINGS AND PRECAUTIONS
This medicine may cause drowsiness. If affected, do not drive motor vehicles or operate machinery. Do not drink alcohol or take drugs that may produce drowsiness while taking this medicine.

Febricol-Rx should be used with caution in patients with renal dysfunction and patients on antidepressant therapy. Patients with hypertension, hyperthyroidism, heart disease or who are receiving monoamine oxidase inhibitors should not take Febricol-Rx. Patients with diabetes, glaucoma, or prostatic enlargement should also avoid Febricol-Rx, unless directed by physician.

This preparation contains Paracetamol. Do not take any other paracetamol containing medicines at the same time.

DRUG INTERACTIONS
Febricol-Rx may interact with other sympathomimetic agents such as decongestants, tricyclic antidepressants, appetite suppressants and amphetamine-like psychostimulants, and monoamine oxidase inhibitors (MAOIs). It may also interact with bretylium, bethanidine, guanethidine, debrisoquine, methyldopa, alpha- and beta-adrenergic blocking agents.

PREGNANCY AND LACTATION
It is not advisable for use in pregnancy and lactation except under the advice and supervision of a physician.

SIDE EFFECTS
Most common side effect is sedation, including lassitute, dizziness and incoordination. CNS stimulation may occur, include anxiety, restlessness, insomnia, nervousness, euphoria, irritability, confusion and tremors. Gastrointestinal disturbances such as nausea, vomiting, diarrhoea, or epigastric pain have occurred. Other side effects include dry mouth, thickened respiratory-tract secretions and tightness of the chest; blurred vision; urinary retention in males where prostatic enlargement is present and constipation. Transient bradycardia followed by tachycardia with palpitations and arrhythmias and hypertension may also occur.

Side effects of paracetamol are rare and usually mild, though haematological reactions have been reported.

SYMPTOMS AND TREATMENT FOR OVERDOSAGE
With chlorpheniramine, convulsions, hyperpyrexia, tachycardia, nervousness and convulsions may occur. Treat nervous stimulation and convulsions with a sedative such as diazepam intramuscularly. In severe cases, the stomach should be emptied by aspiration and gastric lavage.

Severe overdosage of phenylephrine may produce hypertension and associated reflex bradycardia. Treatment measures include early gastric lavage and symptomatic and supportive measures. The hypertensive effects may be treated with an alpha-receptor blocking agent (such as phentolamine mesilate 6-10 mg) given intravenously, and the bradycardia treated with atropine, preferable only after the pressure has been controlled.

Paracetamol in massive overdosage may cause hepatic toxicity. Early symptoms of overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours postingestion. In adults and adolescents, regardless of the quantity of paracetamol reported to have been ingested, administer acetylcysteine immediately if 24 hours or less have elapsed from the reported time of ingestion. Promptly initiate gastric decontamination of the stomach. A plasma paracetamol assay should be obtained as early as possible, but no sooner than four hours following ingestion. If plasma level falls above the lower treatment line on the paracetamol overdose monogram, acetylcysteine therapy should be continued. Liver function studies should be obtained initially and repeated at 24-hour intervals. Serious toxicity or fatalities are extremely infrequent in children, possibly due to differences in the way they metabolise paracetamol.

STORAGE CONDITION

Store below 30C.

PRODUCT DESCRIPTION
Light green colour, round-shaped and flat bevelled edge tablet, embossed with logo and breakline on the reverse side. Available as blister strips of 10's in packing of 100 tablets per box.

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