Macronit

Nitrofurantoinum

Macronit Macrocrystal 50 mg: each capsule contains nitrofurantoin (as macrocrystals) 50 mg. Macronit Macrocrystal 100 mg: each capsule contains nitrofurantoin (as macrocrystals) 100 mg. Excipient with known effect: lactose monohydrate.

Indication: Treatment and prophylaxis of acute or recurrent, uncomplicated infections of the lower urinary tract or pyelitis, occurring spontaneously or following surgical procedures, caused by susceptible strains (Escherichia coli, Enterococci, Staphylococci, Citrobacter, Klebsiella, Enterobacter); not indicated for renal cortical or perirenal abscesses. Official guidance on appropriate use of antibacterial agents should be taken into account.

Contraindications (SmPC sec. 4.3): 4.3 Contraindications − Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 − Patients with renal impairment (GFR below 45 mL/min) − G6PD deficiency − Acute porphyria − Infants under 3 months of age and pregnant women at term (during labour or delivery) because of the theoretical possibility of foetal or neonatal haemolytic anaemia due to immature erythrocyte enzyme systems.

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use Nitrofurantoin is not effective for treating parenchymal infections of a non-functioning unilateral kidney. In recurrent or severe cases, any condition requiring surgical intervention must be excluded. Because pre-existing conditions may mask adverse reactions, nitrofurantoin should be used with caution in patients with renal impairment, pulmonary disease, hepatic dysfunction, neurological disorders, and allergic diathesis. Nitrofurantoin should be used with caution in patients with anaemia, diabetes mellitus, electrolyte imbalance, severe underlying conditions, and vitamin B deficiency (particularly folate). Hepatotoxicity Hepatic reactions, including hepatitis, autoimmune hepatitis, cholestatic jaundice, chronic active hepatitis and hepatic necrosis, occur rarely. Fatal cases have been reported. The onset of chronic hepatitis […]