Paracetamol ................................... 250 mg
Chlorpheniramine maleate .................. 2 mg
Excipients: q.s ……………………………… 1 tablet
Effervescent granules.
Product description: The preparation is orange, dry, loose, fragrant granules.
Box of 24 sachets x 1.5 g. Box of 50 sachets x 1.5 g
ATC code: N02BE51
Paracetamol produces analgesia, antipyresis. The drug acts on the hypothalamus to produce antipyresis; heat dissipation is increased as a result of vasodilation and increased peripheral blood flow. Paracetamol lowers body temperature in patients with fever but rarely lowers normal body temperature.
Chlorpheniramine maleate is an antihistamine. By competitive blockage of histamine H1-receptor, chlorpheniramine inhibits histamine on smooth muscle, on capillary permeability and hence reduction or disappear of hypersensitivity reactions, particularly in the upper respiratory tract.
Paracetamol is rapidly and completely absorbed by the gastrointestinal tract. The elimination half-life of paracetamol varies from about 1.25 to 3 hours. Paracetamol is N-hydroxylated by cytochrome P450 to a reactive intermediate metabolite (N-acetyl-benzoquinoneimine). This metabolite reacts with sulfhydryl groups in glutathione and is deactivated. However, if high doses of paracetamol are taken, this metabolite is formed in a sufficient amount to deplete hepatic glutathione; in that situation, its response to the sulfhydryl group of liver proteins increases and liver necrosis may have been reported. The drug is excreted by the kidneys.
Chlorpheniramine maleate is well absorbed by oral administration. Chlorpheniramine is rapidly and extensively metabolized. Unchanged drug and active metabolites are excreted primarily in the urine; excretion is dependent on urinary pH and flow-rate. The half-life is about 12 to 15 hours.
The drug must not be administered while operating machines, driving, working at height, and other cases.
Pregnancy: The drug should be administered to pregnant women if really necessary. Serious reactions (including epilepsy) in a newborn baby can happen if chlorpheniramine is used in the last trimester of pregnancy.
Lactation: The drug is contraindicated in breast-feeding mothers.
Avoid co-administration of Hapacol 250 Flu and coumarin anticoagulants, indandione derivatives, phenothiazine, anticonvulsants (including phenytoin, barbiturate, carbamazepine), isoniazid, sedatives, alcoholic drinks, and monoamine oxidase inhibitors.
Cholestyramine: The speed of absorption of paracetamol is reduced by cholestyramine. Therefore, the cholestyramine should not be taken within one hour if maximal analgesia is required.
Metoclopramide and Domperidone: The absorption of paracetamol is increased by metoclopramide and domperidone. However, concurrent use needs not be avoided.
Warfarin: The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.
Chloramphenicol: Increased plasma concentration of chloramphenicol.
Paracetamol:
Uncommon: rash, nausea, vomiting, kidney disease, renal toxicity due to long-term abuse; neutropenia, pancytopenia, and anemia.
Rare: hypersensitivity reactions.
Chlorpheniramine:
Common: somnolence, sedation, dry mouth. Rare: dizziness, nausea.
Please inform your doctor of all undesirable effects upon drug administration.
Paracetamol toxicity may result from a single toxic dose, from repeated ingestion of large doses of paracetamol (e.g. 7.5 - 10 g daily for 1 - 2 days), or from chronic ingestion of the drug. Dose-dependent, hepatic necrosis is the most serious acute toxic effect associated with overdosage and potentially fatal.
Symptoms of paracetamol overdosage include nausea, vomiting, abdominal pain, cyanosis on skin, mucosa, and nails.
Management: In the event of severe paracetamol intoxication, full supportive measures should also be instituted. Gastric lavage should be carried out especially if the overdose was taken within the previous 4 hours.
The main detoxication therapy is use of sulfhydryl compound. N-acetylcysteine gives its effect followed by oral route or an intravenous infusion. N-acetylcysteine should be administered as soon as possible, preferably within 36 hours of overdosage. N-acetylcysteine is more effective if administered within 10 hours of overdosage. It can be diluted with water or alcohol-free drinks to a 5% solution and orally taken within 1 hour. Oral N-acetylcysteine is given as a 140 mg/kg body-weight initial dose followed by 70 mg/kg body-weight every four hours for 17 more doses.
Methionine, activated charcoal and/or salt cleaners are also used to treat overdose.
Symptoms of chlorpheniramine overdosage include sedation, paradoxical excitation of the CNS, psychosis, seizure, apnea, convulsions, anti-acetylcholine effect, dystonic reactions and cardiovascular collapse, arrhythmias.
Management: Symptomatic and supportive measures giving special attention to hepatic, renal, respiratory, cardiac functions and fluid - electrolytes balance. Gastric lavage or induced emesis with ipecacuanha syrup should be given. Administration of activated charcoal and cathartic should be then used to reduce the absorption. Treat hypotension and arrhythmias vigorously. Convulsions may be treated with i.v. diazepam or phenytoin. Haemoperfusion may be used in severe cases.
Store in dry places, not exceeding 300C, protect from light
Dermatologic reactions including pruritic maculopapular rash and urticaria have been reported and other sensitivity reactions including laryngeal oedema, angioedema, and anaphylactoid reactions may occur rarely. Thrombocytopenia, leukopenia, and pancytopenia have been associated with the use of p-aminophenol derivatives, especially with prolonged administration of large doses. Neutropenia and thrombocytopenic purpura have been reported with paracetamol use. Rarely, agranulocytosis has been reported in patients receiving paracetamol.
Individuals with phenylketonuria and other individuals who must restrict their intake of phenylalanine should avoid co-administration of paracetamol and aspartame-containing drugs or food. Patients with hypersensitivity (asthma) should not use concurrently paracetamol and sulfite-containing food or drugs. Cautions should be taken in patients with previous anemia, hepatic and renal impairments. Because chronic, excessive consumption of alcohol may increase the risk of paracetamol-induced hepatotoxicity, it is advised to avoid chronic ingestion of alcohol.
Chlorpheniramine can increase the risk of urine retention, particularly in patients with prostatic hyperplasia, urinary obstruction, pyloro-duodenal obstruction; it causes more severity in myasthenia gravis patients. Sedative effect of chlorpheniramine has been increased by ingestion of alcohols and co-administration with other tranquillisers. Chlorpheniramine should be used with caution in patients with chronic lung disease, apnee or breathing troubles, glaucoma, and in the elderly. Risk of tooth decay occurs in patients undergoing long-term treatment.
For the paracetamol-containing drugs, the physician should warn patients of serious signs of skin reactions such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) or Lyell's syndrome, acute generalized exanthematous pustulosis (AGEP).
For the treatment of symptoms of feverish cold, headache, muscular and osteoarticular pains accompanied by coryza, catarrhal mucitis, sinusitis caused by flu or seasonal allergy.
Hypersensitivity to any components of the drug. Patients with glucose - 6 - phosphate dehydrogenase deficiency. Patients with narrow-angle glaucoma, acute course of asthma, prostatic hyperplasia, bladder neck stenosis, gastric ulcer, pyloro-duodenal obstruction. Patients receiving MAOIs within 14 days before, up to the time of treatment with chlorpheniramine. Breast-feeding mothers.
Dissolve the drug in water (suitable for children) until ending effervescence. Orally taken every 4 - 6 hours, not more than 5 times/ day.
Children aged 4 - 6 years: oral dose of 1 sachet each time.
Or as directed by a physician.
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