Each film-coated tablet contains:
Active ingredient:
Paracetamol | 650 mg |
Excipients: Pregelatinized starch, croscarmellose sodium, silicon dioxide, povidone K30, magnesium stearate, HPMC 606, PEG 6000.
POSOLOGY AND METHOD OF ADMINISTRATION
DOSAGE
Adults and children 12 years and over: 1 tablet every 4 – 6 hours, not exceeding 6 tablets per day.
ADMINISTRATION
PARALMAX 650 is administered orally.
CONTRAINDICATIONS
Hypersensitivity to paracetamol or to the excipients.
Patients with G6PD enzyme deficiency.
WARNINGS AND PRECAUTIONS
Not recommended for children under 12 years old.
Patients should be advised that paracetamol may cause severe skin reactions. If a skin reaction such as skin reddening, blisters, or rash occurs, they should stop use and seek medical assistance right away.
Thrombocytopenia, leukopenia, reducing whole blood were occurred when use the p-aminophenol derivatives, especially use the prolongation of large dose. Decreasing neutrophil and hemorrhage have been reported after using paracetamol. Agranulocytosis was happened.
Caution for patients with anemia.
Drinking alcohol too much and using paracetamol for a long time may increase the risk of liver toxicity, should avoid using alcohol.
Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment.
Do not take it with any other products containing paracetamol.
Doctors should warn the patients about the signs of serious skin side-effects such as Steven-Johnson syndrome (SJS), toxic epidermal necrolysic (TEN) or Lyell syndrome, acute generalized exanthematous pustulosis (AGEP).
PREGNANCY AND LACTATION
Pregnancy
Epidemiological studies in human pregnancy have shown no adverse effects due to paracetamol when used in the recommended dosage, but patients should follow the advice of the doctor regarding its use.
Lactation
Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breastfeeding.
STORAGE CONDITION
In a dry place, below 30°C, protect from light.
SHELF-LIFE
36 months from the manufacturing date. Do not use it after the expiry date.
Box of 15 blisters x 12 film-coated tablets.