Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use
Before therapy with cefditoren is instituted, careful inquiry should be made to determine whether the patient has had any previous hypersensitivity reactions to cefditoren, cephalosporins, penicillins, or other beta-lactam active substances.
Cefditoren should be given with caution to patients who have had any other type of hypersensitivity reaction to a penicillin or any other beta-lactam active substance.
Antibiotic-associated diarrhoea, colitis and pseudomembranous colitis have all been reported with the use of cefditoren. These diagnoses should be considered in any patient who develops diarrhoea during or shortly after treatment. Cefditoren should be discontinued if severe, and/or bloody diarrhoea occurs during treatment and appropriate therapy instituted.
Cefditoren should be used with caution in individuals with a previous history of gastro-intestinal disease, particularly colitis.
In patients with moderate to severe renal impairment the rate and extent of exposure to cefditoren is increased (see section 5.2). For this reason, the total daily dosage should be reduced when cefditoren is administered to patients with acute or chronic moderate to severe renal insufficiency in order to avoid potential clinical consequences, such as seizures (see section 4.2).
Cephalosporin antibiotics should be given with caution to patients receiving concurrent treatment with nephrotoxic active substances such as aminoglycoside antibiotics or potent diuretics (such as furosemide) as these combinations may have undesirable effects on renal function and have been associated with ototoxicity.
Prolonged use of cefditoren may result in the overgrowth of non-susceptible organisms, such as enterococci and Candida spp.
During treatment with cephalosporins, a decrease in prothrombin activity may occur. Therefore, the prothrombin time should be monitored in patients at risk, such as patients with renal or hepatic insufficiency or patients being treated with anticoagulant therapy.
Administration of pivalate prodrugs has been associated with decreases in plasma carnitine concentrations. However, clinical studies concluded that no clinical effects of carnitine decrease were associated with the administration of cefditoren pivoxil.
Spectracef 200 mg film-coated tablets contain less than 23 mg sodium (1 mmol) per tablet, that is to say, essentially “sodium-free”.
Spectracef 400 mg film coated tablets contains 1.14 mmol (about 26.2 mg) sodium per dose. This must be taken into consideration by patients on a controlled sodium diet.

Effects on Driving

4.7 Effects on ability to drive and use machines
Spectracef has minor or moderate influence on the ability to drive and use machines. Cefditoren pivoxil may cause dizziness and somnolence (see section 4.8).