Hapacol/Hapacol Junior

Hapacol/Hapacol Junior

paracetamol

Manufacturer:

Hoe Pharma

Distributor:

Zuellig Pharma
Full Prescribing Info
Contents
Paracetamol.
Description
Hapacol: Each tablet contains Paracetamol 500 mg.
When dissolved or dispersed in water, the tablet effervesces to produce a slightly opaque solution with scent and sweet taste.
Hapacol Junior: Each sachet contains Paracetamol 250 mg.
When dissolved in water, the powder effervesces to produce an orange yellow, clear or slightly opaque solution with scent and slight sweet.
Action
Pharmacotherapeutic Group: Hapacol: Other Analgesics and Antipyretics - Anilides. Hapacol Junior: Other Analgesics and Antipyretics. ATC Code: N02BE01.
Pharmacology: Pharmacodynamics: Paracetamol is an effective analgesic and antipyretic agent. The drug has no effect on the cardiovascular and respiratory systems, and it does not cause gastric irritation or bleeding like salicylates.
Pharmacokinetics: Hapacol: Paracetamol is readily absorbed from the gastro-intestinal tract with peak plasma concentrations occurring 30 minutes to 2 hours after ingestion. It is distributed in most body tissues; it crosses the placenta and is present in breast milk. Plasma protein binding is negligible at usual therapeutic concentrations but increases with increasing concentration. The elimination half life varies from about 1 to 3 hours.
Paracetamol is metabolised in the liver and excreted in the urine mainly as the glucuronide and sulphate conjugates. Less than 5% is excreted unchanged as paracetamol. A minor hydroxylated metabolite which is usually produced in very small amounts by mixed-function oxidases in the liver and which is usually detoxified by conjugation with liver glutathione, may accumulate following paracetamol overdosage and cause liver damage.
Hapacol Junior: Absorption: The absorption of paracetamol by the oral route is complete and rapid. Maximum plasma concentrations are reached 30 to 60 minutes after ingestion.
Distribution: Paracetamol is distributed rapidly in all tissues. Concentrations are comparable in blood, saliva and plasma. Plasma protein binding is low.
Metabolism: Paracetamol is metabolized primarily in the liver. The two major metabolic pathways are glycuroconjugation and sulphoconjugation. The latter pathway is rapidly saturable at dosages above therapeutic doses. A minor route, catalyzed by cytochrome P450, is the formation of a reactive intermediate (N-acetyl benzoquinone imine), which under normal conditions of use, is rapidly detoxified by reduced glutathione and eliminated in the urine after conjugation with cysteine and mercaptopuric acid. On the other hand, during mass poisoning, the quantity of this toxic metabolite is increased.
Elimination: The elimination is essentially urinary. 90% of the ingested dose is eliminated by the kidney in 24 hours, mainly in glycuroconjugate (60-80%) and sulfoconjugate (20-30%).
Less than 5% is eliminated as unchanged.
The elimination half-life is about 2 hours.
Pathophysiological changes: Renal insufficiency: In patients with severe renal insufficiency (creatinine clearance less than 10 ml/min), the elimination of paracetamol and its metabolites is delayed.
Elderly: The conjugation capacity is not modified.
Indications/Uses
Hapacol: For the relief of mild to moderate pain including headache, migraine, muscle ache, dysmennorhoea, sore throat, musculoskeletal pain, toothache and pain of osteoarthritis.
For the relief of fever.
Hapacol Junior: For the relief of mild to moderate pain and fever.
Dosage/Direction for Use
Recommended Dosage: Hapacol: Adults (including the elderly) and children aged 12 years and over: 1 to 2 tablets (500mg to 1000mg paracetamol), dissolved in at least half a tumbler of water every 4 to 6 hours as required.
Children 6 to 11 years: No more than 4 doses in any 24-hour period.
Maximum duration of continued use without medical advice: 3 days.
Maximum daily dose: 60mg/kg to be administered in divided doses of 10-15mg/kg throughout the 24-hour period.
Children 6 to 8 years: ½ tablet (250mg) dissolved in at least half a tumbler of water.
Children 9 to 11 years: 1 tablet (500mg) dissolved in at least half a tumbler of water.
Children under 6 years: Not recommended for children under the age of 6 years.
Hapacol Junior: Pour the contents of the sachet into a glass and add a small amount of water. Drink the whole solution immediately after complete dissolution.
The recommended dose is approximately 60 mg/kg to be administered in divided doses of 10 - 15 mg/kg throughout the 24-hour period.
Child: 6 - 12 years: 250 mg (1 sachet) - 500 mg (2 sachets) per dose. Repeat every 4 - 6 hours when necessary. Maximum of 4 doses in 24 hours.
Route of Administration: For oral administration.
Overdosage
Hapacol: Liver damage is possible in adults who have taken 10g or more of paracetamol.
Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see as follows).
Risk Factors: If the patient: Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.
Or regularly consumes ethanol in excess of recommended amounts.
Or is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.
Symptoms: Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.
Management: Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see as follows.
Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or a liver unit.
Hapacol Junior: Poisoning is to be feared in the elderly and especially in young children (therapeutic overdose or frequent accidental intoxication) in which it can be fatal.
Symptoms: Nausea, vomiting, anorexia, pallor, abdominal pain usually appear within the first 24 hours.
Overdosage with 10 g of paracetamol as a single dose in adults and 150 mg/kg of body weight as a single dose in children results in hepatic cytolysis resulting in complete and irreversible necrosis and also causes hepatocellular insufficiency, metabolic acidosis, encephalopathy which can lead to coma and death.
At the same time, there is an increase in hepatic transaminases, lactic dehydrogenase, bilirubin and decreased prothrombin levels that may occur 12 to 48 hours after ingestion.
Emergency: Immediately transfer to hospitals.
Take a tube of blood to make the initial plasma dose of paracetamol.
Rapid evacuation of the product ingested by gastric lavage.
Treatment of overdosage typically involves administration as early as possible of the N-acetylcysteine antidote IV or orally if possible before the tenth hour.
Contraindications
Hapacol: Hypersensitivity to paracetamol or any of the other ingredients.
Hapacol Junior: Hypersensitivity to paracetamol or other constituents.
Hepatocellular insufficiency.
Phenylketonuria (due to the presence of aspartame).
Warnings
This preparation contains PARACETAMOL. Do not take any other paracetamol containing medicines at the same time.
Special Precautions
Hapacol: The tablets also contain aspartame (a source of phenylalanine) and so should not be taken by people with phenylketonuria.
Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. Patients with alcohol dependence could also be at risk in taking paracetamol. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.
Each tablet contains sodium and may be harmful to people on a low sodium diet.
Do not exceed the recommended dose.
Immediate medical advice should be sought in the event of an overdose even if the patient feels well, because of the risk of delayed serious liver damage.
Allergy alert: Paracetamol may cause severe skin reactions. Symptoms may include skin reddening, blisters or rash.
These could be signs of a serious condition. If these reactions occur, stop use and seek medical assistance right away.
Effects on Ability to Drive and Use Machines: None known.
Hapacol Junior: Unsuitable for phenylketonurics.
To avoid a risk of overdose, check the absence of paracetamol in the composition of other medicines.
Recommended maximum doses: In children less than 37 kg, the total dose of paracetamol should not exceed 80 mg/kg/day (see Overdosage).
In children between 38 kg and 50 kg, the total dose of paracetamol should not exceed 3 g per day (see Overdosage).
In adults and children over 50 kg, the total dose of Paracetamol must not exceed 4 grams per day (see Overdosage).
Precautions for use: In children treated with 60 mg/kg/day of paracetamol, the combination of another antipyretic is justified only in cases of ineffectiveness.
Each sachet contains sodium and may be harmful to people on a low sodium diet.
Allergy alert: Paracetamol may cause severe skin reactions. Symptoms may include skin reddening, blisters or rash.
These could be signs of a serious condition. If these reactions occur, stop use and seek medical assistance right away.
Effects on Ability to Drive and Use Machines: Not applicable.
Use In Pregnancy & Lactation
Pregnancy: Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use.
Breastfeeding: Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast feeding.
Adverse Reactions
Cutaneous hypersensitivity reactions including skin rashes, angioedema, Stevens Johnson Syndrome/Toxic Epidermal Necrolysis have been reported.
Hapacol: Side effects are usually mild, although haematological reactions have been reported. Rashes and other allergic reactions occur occasionally. There have been isolated reports of thrombocytopenia, purpura, methaemoglobinaemia and agranulocytosis.
Hapacol Junior: A few rare cases of hypersensitivity reactions such as anaphylactic shock, erythema, urticaria have also been reported. Their occurrence requires the discontinuation of this medicinal product and related medicinal products.
Very rare cases of thrombocytopenia, leukopenia and neutropenia have been reported.
Drug Interactions
Hapacol: Alcohol reduces liver capacity to deal with paracetamol. The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine.
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.
Hapacol Junior: Associations subject to precautions for use: Oral anticoagulants: Risk of increased effect of oral anticoagulant and hemorrhagic risk if paracetamol is taken at maximum doses (4 g/d) for at least 4 days. Regular monitoring of INR. Possible adaptation of the dosage of the anticoagulant during treatment with paracetamol and after discontinuation.
Interaction with paraclinic examinations: Taking paracetamol may distort the blood glucose test by the glucose oxidase-peroxidase method in abnormally high concentrations.
Taking paracetamol can distort the dosage of blood uric acid by the phosphotungstic acid method.
Storage
Store in dry place, not exceeding 30°C, protect from light.
ATC Classification
N02BE01 - paracetamol ; Belongs to the class of anilide preparations. Used to relieve pain and fever.
Presentation/Packing
Hapacol effervescent tab 500 mg (white to off-white, round, plain on both sides, undamaged sides and edges) x 4 x 4's. Hapacol Junior effervescent powd 250 mg (dry, loose, orange with scent in sachet) x 1.5 g x 24's.
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