Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2016 Publisher: ZAMBON S.p.A., Via Lillo Del Duca, 10, 20091 Bresso (Milan) – Italy, Tel: +39 02 665 241, Fax: +39 02 665 01 492
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Patients with severe renal insufficiency (creatinine clearance <10 ml/min).
Patients undergoing haemodialysis.
Hypersensitivity reactions, including anaphylaxis and anaphylactic shock, may occur during fosfomycin treatment and may be life-threatening (see section 4.8). If such reaction occurs, fosfomycin should never be re-administrated and an adequate medical treatment is required.
Antibiotic-associated diarrhoea has been reported with use of nearly all antibacterial agents, including fosfomycin and may range in severity from mild diarrhoea to fatal colitis. Diarrhoea, particularly if severe, persistent and/or bloody, during or after treatment with Monuril (including several weeks after treatment), may be symptomatic of Clostridium difficile-associated disease (CDAD). It is therefore important to consider this diagnosis in patients who develop serious diarrhoea during or after treatment with Monuril. If CDAD is suspected or confirmed, appropriate treatment should be initiated without delay (see section 4.8). Anti-peristaltic medicinal products are contra-indicated in this clinical situation.
Renal insufficiency: urinary concentrations of fosfomycin remain effective for 48 hours after a usual dose if creatinine clearance is above 10 ml/min.
Monuril contains sucrose. Its use is not recommended in patients with hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.
Experience in children with Monuril 3 g is limited. The product is not recommended for children below the age of 12.
Concomitant administration of metoclopramide has been shown to lower serum and urinary concentrations of fosfomycin and should be avoided.
Other drugs that increase gastrointestinal motility may produce similar effects.
Interaction studies have only been performed in adults.
Food may delay the absorption of the active ingredient of Monuril, with consequent slight decrease in peak plasma levels and urinary concentrations. It is therefore preferable to take the medicine on an empty stomach or about 2–3 hours after meals.
Specific problems concerning the alteration in INR. Numerous cases of increased antivitamin K antagonists activity have been reported in patients receiving antibiotics. Risk factors include severe infection or inflammation, age and poor general health. Under these circumstances, it is difficult to determinate whether the alteration in INR is due to the infectious disease or its treatment. However, certain classes of antibiotics are more often involved and in particular: fluoroquinolones, macrolides, cyclins, cotrimoxazole and certain cephalosporins.
At the present time, single-dose antibacterial treatments are not suitable to treat urinary tract infections in pregnant women.
However, for fosfomycin trometamol, animal studies do not indicate reproductive toxicity. A large amount of data concerning effectiveness of fosfomycin during pregnancy is available. Only moderate amount of safety data on pregnant women is available and does not indicate any malformative or foetal/neonatal toxicity of fosfomycin.
The use of Monuril may be considered during pregnancy, if necessary.
Fosfomycin is excreted into human milk at low level after a single injection. Therefore fosfomycin can be used during breastfeeding, after a single oral dose.
No effect on fertility has been reported in animal studies. No data are available in human.
No specific studies have been performed but patients should be informed that dizziness has been reported. This may influence some patients' ability to drive and use machines.
The most common adverse reactions following the single-dose administration of fosfomycin trometamol involve the gastrointestinal tract, mainly diarrhoea. These events are usually self-limited in duration and resolve spontaneously.
The following table displays ADRs that have been reported with the use of Monuril from either clinical-trial or post-marketing experiences.
The displayed frequency categories use the following convention:
Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated form the available data).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Common: Vulvovaginitis
Not known: Anaphylactic reactions including anaphylactic shock, hypersensitivity
Common: Headache, dizziness
Common: Diarrhoea, nausea
Uncommon: Vomiting, abdominal pain
Not known: Antibiotic-associated colitis (see section 4.4)
Uncommon: Rash, urticaria, pruritus
Not known: Angioedema
Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system website: www.mhra.gov.uk/yellowcard.
Not applicable.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
