Phosphoral Rompharm, 3 g

Urethritis, Urinary tract infectionsBacterial urinary tract infections of various localizations caused by fosfomycin-sensitive microorganisms: acute uncomplicated urinary tract infections; asymptomatic bacteriuria; prevention of urinary tract infections after surgical intervention and transurethral diagnostic tests.

Active ingredient

Composition

1 sachet contains:

Active ingredient:

Fosfomycin trometamol 5.631 g in terms of fosfomycin – 3.000 g;

Auxiliary substances:

Calcium hydroxide – 0.300 g,

Lemon flavoring – 0.200 g,

sodium saccharin – 0.010 g,

powdered sugar – up to 8,000 g.

How to take, the dosage

PHOSPHORAL ROMFARM is taken once on an empty stomach 2-3 hours before or after a meal, preferably before going to bed, after first emptying the bladder: adults and children over 12 years old in a daily dose of 3 g. The contents of the package is dissolved in 1/2 cup of water.

To prevent urinary tract infections during surgical interventions and diagnostic procedures, the above dose is taken 2 times – 3 hours before the intervention and 24 hours after it.

Interaction

The concomitant use of antacids or preparations containing calcium salts with metoclopramide should be avoided since this may lead to decreased serum and urinary concentrations of fosfomycin.

Simultaneous use with other drugs which increase gastrointestinal motility may also lead to decreased serum and urinary fosfomycin concentrations.

Special Instructions

The use of broad-spectrum antibiotics, including fosfomycin trometamol, may lead to antibiotic-associated colitis (including pseudomembranous colitis). Therefore, the possibility of this diagnosis in patients with severe diarrhea during or after administration of fosfomycin trometamol should be considered. If the diagnosis is confirmed, appropriate treatment should be initiated immediately, in which case peristalsis-inhibiting drugs are contraindicated.

The simultaneous intake of food slows down absorption of phosphomycin. Therefore, it is advisable to use the drug on an empty stomach or 2-3 hours after a meal.

FOSPHORAL ROMFARM contains sucrose.

Physicians with diabetes or those on diabetics must keep in mind that 1 sachet of PHOSPHORAL ROMFARM contains up to 186 g of sugar. PHOSPHORAL ROMFARM should not be used in patients with fructose intolerance, glucose-galactose malabsorption syndrome or deficiency of sucrose isomaltase.

Patients should be advised of the possibility of dizziness and should refrain from performing the specified activities if dizziness occurs.

Contraindications

– Hypersensitivity to phosphomycin or other drug components;

– Patients on dialysis;

– Severe renal impairment (CK≪ 10 ml/min);

– Children under 12 years of age;

– Sugars/isomaltase deficiencylt; 10 ml/min);

– children under 12 years of age;

– sucrose/isomaltase deficiency;

Side effects

Overdose

Pregnancy use

In pregnancy, use only if the estimated benefit to the mother exceeds the potential risk to the fetus.

If the drug is prescribed during lactation, breastfeeding should be stopped for the duration of therapy.

Similarities