Partamol 650 eff.

OTC

Indications

• For treatment of mild to moderate pain and fever, especially in patients in whom salicylates are contraindicated or not tolerated.
• The drug is most effective in relieving low intensity pain of non-visceral origin.

Dosage

• Paracetamol should not be used for self-medication of pain for longer than 10 days in adults or 5 days in children, of marked fever (greater than 39.5 C), fever persisting longer than 3 days, or recurrent fever.
• Adults and children ≥ 12 years of age: 1 tablet every 4 – 6 hours as necessary, but should not exceed 6 tablets daily.
• Renal impairment:
  In children with Clcr < 10 ml/min, the doses should be given every 8 hours.
  In adults:
  Clcr 10 – 50 ml/min: every 6 hours;
  Clcr < 10 ml/min: every 8 hours.
• Hepatic impairment:
  Use with caution and low doses. Avoid prolonged use.

Usage

• Partamol 650 eff. is administered orally.
• Place the tablets in a full tumbler of water and allow to dissolve completely before swallowing.

• Patients with known hypersensitivity to paracetamol or any of the ingredients.
• Severe hepatic impairment.

• Serious skin reactions such as Stevens-Johnson syndrome, Lyell’s syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis occur rarely, but potentially fatal. If patients get a rash or other skin manifestations, to stop taking drug and notify your physicians.
• Skin rash and other allergic reactions occur occasionally. The rash is usually erythematosus or urticarial, but sometimes it is more serious and may be accompanied by fever and mucosal lesions. If patients have fever, blisters around the natural cavity, consider Stevens-Johnson syndrome, be discontinued paracetamol immediately.
• Paracetamol overdose can lead to severe liver damage and sometimes acute tubular necrosis.
• Patients who show hypersensitivity reactions to the salicylates only rarely exhibit sensitivity to paracetamol and related drugs. In a few isolated cases, the use of paracetamol has been associated with neutropenia, thrombocytopenia and pancytopenia.

• Paracetamol is relatively nontoxic in therapeutic doses. Dermatologic have sometimes reactions including pruritic maculopapular rash and urticaria; other sensitivity reactions including laryngeal edema, 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.
• Paracetamol should be used with caution in patients with preexisting anemia, since cyanosis may not be apparent despite dangerously high blood concentrations of methemoglobin.
• Excessive intake of alcohol may increase the risk of paracetamol induced hepatotoxicity; avoid or limit alcohol intake.
• Caution is recommended when giving to patients with hepatic or renal impairment, chronic alcoholism, chronic malnutrition or dehydration.
• The physicians need to warn the patients of the signs of serious skin reactions known as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) or Lyell’s syndrome, acute generalized exanthematous pustulosis (AGEP).
• Partamol 650 eff. is considered high in sodium. This should be particularly taken into account for those on a low salt diet.
• Partamol 650 eff. contains aspartame, may be harmful if you have phenylketonuria (PKU).
• Paracetamol should be only used in pregnant women when clearly needed.
• In nursing mothers who were given paracetamol, no adverse effects were noted in infants receiving mother’s milk.
• There is no evidence that paracetamol affects the ability to drive or to operate machinery.