HAPACOL EFFERVESCENT

Product Description

Paracetamol is an effective analgesic - antipyretic. Paracetamol acts o­n heat-regulating center of hypothalamus for hypothermia, increase in thermolysis due to vasodilation and peripheral hypervolemia leading to hypothermia in patients with fever, but rarely in the normal. Paracetamol is analgesic by the elevation of the pain threshold.

At therapeutic dose, the analgesic and antipyretic effect is equivalent to aspirin; however, paracetamol causes no adverse effects o­n cardiovascular and respiratory systems, no change of acid - base equilibrium, no irritation, scratch or gastrorrhagia like salicylate, no action o­n glomeruli or bleeding time. So, paracetamol is used for a replacement therapy in patients with intolerance of aspirin. However, paracetamol does not have anti-inflammatory property like aspirin.

Hapacol contains **0 mg of paracetamol, is prepared in the dosage form of effervescent tablets, is dissolved in water before oral administration; therefore, it is suitable for patients meeting difficulty in taking pills. The drug is dissolved in water before oral administration, so it is easily absorbed by the digestive system and quickly brings into play its effect to attain a high effectiveness.
INDICATIONS
For treatment of painful and/or febrile symptoms in cases of:
Cold, flu, headache, musculoskeletal pains, sprain, arthralgia, backache, toothache, dysmenorrhea, traumatic injuries, neuralgia,…
Upper respiratory tract infections: otalgia, pharyngalgia, sinusitis due to infections or weather, …
Postoperative dental pain, tooth extraction, tonsillectomy.
CONTRAINDICATIONS
Hypersensitivity to paracetamol. Patients with anemia, cardiopathy, pneumopathy, renopathy.
In some cases e.g. glucose**-phosphate dehydrogenase deficiency; impaired hepatic function.
PRECAUTIONS
Taking much alcoholic drinks may enhance hepatotoxicity of Paracetamol; therefore, avoid or limit drinking alcohol.
Patients o­n low-sodium or sodium-free diets are warned that the drug contains **2 mg of ion sodium.
INTERACTIONS
Concurrent use with anticoagulant (warfarin) may enhance the effect of anticoagulant.
Anticonvulants, isoniazide may enhance risk of hepatotoxicity of paracetamol.
ADVERSE EFFECTS
Allergic reactions have been rarely reported. High doses and prolonged use of the drug may cause hepatic impairment (due to hepatolysis).
Long-term administration of Hapacol may occur nausea, vomiting, hypoleukemia, anemia, toxicity to kidney.
Inform the physician about any adverse effects occur during the treatment.
DOSAGE & ADMINISTRATION
Dissolve the effervescent tablet in some fresh water until bubbling completely. The interval between oral doses should be over 4 hours and do not take more than 8 tablets daily.
Adults and children over *2 years of age: oral dose of 1 tablet. Severe pain: adults may be given 2 tablets.
* In case of patients with severe renal impairment (creatinine clearance < *0 ml/min.), the interval between oral doses should be at least 8 hours. Or as directed by the physician.
Notes:
* Maximum dose / *4 hours: Not more than 4 g, the interval between oral doses should be over 4 hours.