COMPOSITIONS :
Metamizole Sodium Monohydrate Caplet 500 mg, each caplet contains : Metamizole sodium monohydrate 500 mg.
DESCRIPTIONS :
Metamizole Sodium Monohydrate containing Metamizole sodium monohydrate is available as caplet 500 mg and injection 1000 mg/2 ml.
INDICATIONS :
Severe pain, acute or chronic e.g., in association with rheumatic diseases, headache, toothache or tumours and after injuries or operations.
Severe pain associated with smooth muscle spasms, acute or chronic e.g., muscular spasm or colic affecting the gastrointestinal tract, biliary passages, kidneys or lower urinary tract.
Metamizole sodium is not to be used in trivial complaints.
DOSAGE AND ADMINISTRATIONS :
Metamizole Sodium Monohydrate Caplet :
Adults and adolescents aged 15 years or over : As single dose : 1 caplet.
As daily dose : Up to 4 times daily.
CONTRAINDICATIONS :
Metamizole sodium must not administered to patients with Pyrazolone allergy (hypersensitivity to medicines containing Metamizole, Isopropylaminophenazone, Propyphenazone, Phenazone or Phenylbutazone), metabolic diseases (hepatic porphyria, congenital glucose-6-phosphate dehydrogenase deficiency (G6PD).
Metamizole sodium is not indicated in pregnant women and during lactation.
WARNINGS AND PRECAUTIONS :
Especially careful consideration of the necessity for Metamizole sodium is essential in patients whose blood pressure is below 100 mmHg.
Metamizole sodium should be prescribed with caution in patients who suffer from pre-existing defective blood formation/blood abnormalities and in patients with liver or renal failure.
Metamizole sodium should be prescribed with caution in patients suffering from bronchial asthma or chronic respiratory tract infections and hypersensitivity patient. Should be consulted with physician before use.
Patients with hypersensitivity to Metamizole sodium.
Metamizole sodium caplet is not suitable for the treatment of children < 15 years of age, because of the possibility interference with renal function.
Metamizole sodium should not be given to infants less than 3 months of age or less than 5 kg body weight, unless there is a compelling indication.
Medical supervision is also recommended for infants more than 3 months of age and for young children.
During pregnancy, especially in the first 3 months and the last 6 weeks, Metamizole sodium must not be used except upon the instructions of the doctor.
Metamizole sodium is not recommended to be taken continuously in long periods of time as it may lead to agranulocytosis and neuropathy.
DRUG INTERACTIONS :
In case of concomitant treatment with Cyclosporine, a fall in Cyclosporine level may occur. Regular controls are therefore necessary.
Metamizole sodium and Alcohol may have a reciprocal influence on their effects.
ADVERSE REACTIONS :
Hypersensitivity reactions : Allergy (urticaria).
The most serious are blood dyscrasias (agranulocytosis, leucopenia, thrombocytopenia) and shock.
The other major form of hypersensitivity reactions is shock.
PRESENTATIONS :
Metamizole Sodium Monohydrate Caplet 500 mg Box, 10 blisters @ 10 caplets
Reg. No. GKL9302317304A2
STORAGE :
STORE BELOW 30ºC, PROTECT FROM LIGHT
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
