Fomnos 3g powder for oral solution

FOMNOS is indicated as a single dose in the treatment of acute uncomplicated lower urinary tract infections, caused by sensitive E. coli, in women and female children over the age of 12 years. FOMNOS is indicated for prophylaxis in diagnostic and surgical transurethral procedures in adult men.

Posology

Adults

The recommended dose for uncomplicated urinary tract infections in women, including the elderly up to seventy-five years, is a single 3 g dose. The recommended dose for prophylaxis prior to transurethral surgical and diagnostic procedures in adult men, including the elderly, is two doses of 3 g. The first dose should be taken three hours before surgery. The second dose should be taken twenty-four hours after surgery.

Paediatric population

Fosfomycin trometamol in a dose of 3 g is not suitable for children under the age of 12 years.

Method of administration

FOMNOS is administered orally as a single dose after reconstitution in water. To be taken at least two hours prior to the next meal. The contents of a sachet should be dissolved in water and taken immediately after its preparation. For instructions on reconstitution of the medicinal product before administration, see section 6.6.

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients with severe renal insufficiency (CLcr < 10 mu2113/min). Patients undergoing haemodialysis.

Prescribers must adhere to the principles of antibiotic stewardship.

Hypersensitivity reactions

Serious and occasionally fatal hypersensitivity reactions, including anaphylaxis and anaphylactic shock, may occur during fosfomycin treatment (see section 4.3 and 4.8). If such reactions occur, treatment with fosfomycin must be discontinued immediately and adequate emergency measures must be initiated.

Clostridioides difficile -associated diarrhoea

Clostridioides difficile -associated colitis and pseudo-membranous colitis have been reported with fosfomycin and may range in severity from mild to life-threatening (see section 4.8). Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of fosfomycin. Discontinuation of therapy with fosfomycin and the administration of specific treatment for Clostridioides difficile should be considered. Medicinal products that inhibit peristalsis should not be given.

Paediatric population

The safety and efficacy of FOMNOS in children below 12 years of age have not been established. Therefore, this medicine should not be used in this age group (see section 4.2).

Persistent infections and male patients

In case of persistent infections, a thorough examination and a re-evaluation of the diagnosis is recommended as this is often due to complicated urinary tract infections or the prevalence of resistant pathogens (e.g. Staphylococcus saprophyticus, see section 5.1). In general, urinary tract infections in male patients have to be considered as complicated UTIs for which this medicinal product is not indicated (see section 4.1).

Excipients

FOMNOS contains sucrose, which may have an effect on the glycaemic control of patients with diabetes mellitus. Patients with rare hereditary conditions such as fructose intolerance, glucose-galactose mal- absorption or sucrase-isomaltase insufficiency should not take FOMNOS.

Metoclopramide

Concomitant administration of metoclopramide has been shown to lower serum and urinary concentrations of fosfomycin as in FOMNOS and should be avoided. Other medicines that increase gastrointestinal motility may produce similar effects.

Food effect

Food may delay the absorption of the active ingredient of FOMNOS, 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 to 3 hours after meals.

Specific problems concerning the alteration in International Normalised Ratio (INR)

Numerous cases of increased oral anticoagulant activity have been reported in patients receiving antibiotic therapy. 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, co-trimoxazole and certain cephalosporins.

Paediatric population

Interaction studies have only been performed in adults.

Pregnancy

No evidence in animals or humans has been found to indicate adverse effects of FOMNOS in pregnancy. However, the safety and efficacy of single dose therapy has not been established for FOMNOS in pregnancy.

Breastfeeding

FOMNOS should not be given to lactating women. Fosfomycin has been shown to cross into breast milk.

Fertility

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 (see section 4.8).

Adverse reactions are listed below by System Organ Class and frequency according to the MedDRA frequency convention and System Organ Classification. The most common adverse reactions following the single-dose administration of fosfomycin involve the gastrointestinal tract, mainly diarrhoea. The following table displays ADRs that have been reported with the use of fosfomycin from either clinical trial or postmarketing experiences. FOMNOS is generally well tolerated.

System Organ Class Adverse reaction Frequency

Frequent Less frequent Frequency unknown

Infections and infestations Vulvovaginitis

Immune system disorders Anaphylactic reactions including anaphylactic shock, hypersensitivity (see section 4.4)

Nervous system disorders Headache, dizziness

Gastrointestinal disorders Diarrhoea, nausea, dyspepsia (heartburn, indigestion), abdominal pain, vomiting, Antibiotic-associated colitis (see section 4.4)

Skin and subcutaneous tissue disorders Rash, urticaria, Pruritus, Angioedema

Reproductive system and breast disorders Vaginitis, dysmenorrhoea

Musculoskeletal and connective tissue disorders Back pain

Respiratory, thoracic and mediastinal disorders Pharyngitis (sore throat), rhinitis (runny or stuffy nose)

General disorders and administration site conditions Pain (non-localised), asthenia

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8. Suspected adverse reactions can also be reported directly to the HCR via [email protected].

Experience regarding the overdose of oral fosfomycin is limited. In the event of overdose, the patient must be monitored (particularly for plasma/serum electrolyte levels), and treatment should be symptomatic and supportive. Rehydration is recommended to promote urinary elimination of the active substance. Fosfomycin is effectively cleared from the body by haemodialysis with a mean elimination half-life of approximately 4 hours.