Country: United Kingdom
Bahasa: Inggeris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Fosfomycin trometamol
Zambon UK Ltd
J01XX01
Fosfomycin trometamol
3gram
Granules for oral solution
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010700; GTIN: 5060045110008
WHAT IN THIS LEAFLET 1. What Monuril is and what it is used for 2. What you need to know before you take Monuril 3. How to take Monuril 4. Possible side effects 5. How to store Monuril 6. Contents of the pack and other information. 1. WHAT MONURIL IS AND WHAT IT IS USED FOR Monuril contains the active substance fosfomycin trometamol. Fosfomycin trometamol is an antibiot ic that works by killing bacteria which can cause infections. Monuril is used to treat or prevent uncomplicated infections of the bladder. Monuril is not suitable for the treatment of children below 12 years of age. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MONURIL DO NOT TAKE MONURIL IF YOU: - are allergic to fosfomycin trometamol or any of the other ingredients of this medicine (listed in section 6) - have severe kidney problems (creatinine clear ance below 10 ml/min) - are undergoing haemodialysis. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Monuril if you have: - an allergic reaction during treatment (see section 4) - an intolerance to some sugars (see end of sec tion 2) - previously had diarrhoea after taking any other antibiotics - kidney problems, but your creatinine clearance is above 10 ml/min. CHILDREN AND ADOLESCENTS Do not give this medicine to children less than 12 years of age, as its safety and efficacy have not been established in this age group. OTHER MEDICINES AND MONURIL Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medi cines, including medicines obtained without a pre scription. This is especially important if you are taking: - METOCLOPRAMIDE or other drugs that increase the movement of food through the stomach and intestines, because they may reduce the uptake of fosfomycin trometamol by your body - ANTICOAGULANTS, as their ability to prevent your blood from clotting might be altered by fosfomy cin trometamol and other antibiotics. PREGNANCY, BREAST-FEEDING AND FERTILITY If you are pregnant or breastfeeding, think you may be pregnant or Baca dokumen lengkap
OBJECT 1 MONURIL 3G GRANULES FOR ORAL SOLUTION Summary of Product Characteristics Updated 30-Jul-2016 | Profile Pharma Limited 1. Name of the medicinal product Monuril 3 g granules for oral solution 2. Qualitative and quantitative composition One sachet contains 5.631 g of fosfomycin trometamol equivalent to 3.0 g fosfomycin Excipient(s) with known effect: One sachet contains 2.213 g of sucrose, see section 4.4. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Granules for oral solution. 4. Clinical particulars 4.1 Therapeutic indications Monuril is indicated in the treatment of acute lower uncomplicated urinary tract infections, caused by pathogens sensitive to fosfomycin in adult and adolescent females. Monuril is also indicated for prophylaxis in diagnostic and surgical transurethral procedures. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 Posology and method of administration Posology Acute lower uncomplicated urinary tract infections: _Adults: and adolescent females (>12 years of age):_ 1 sachet (3 g) once Prophylaxis of urinary tract infections for surgery and diagnostic procedure involving the lower urinary tract: _Adults: _One Monuril 3 g sachet 3 hours before surgery. A second dose of 3 g may be given 24 hours after surgery. Paediatric population The safety and efficacy of Monuril 3 g in children below 12 years of age have not been established. Method of administration Monuril is for oral administration. It should be taken on an empty stomach (about 2-3 hours before or 2-3 hours after a meal), preferably before bedtime and after emptying the bladder. The dose should be dissolved into a glass of water and taken immediately after its preparation. 4.3 Contraindications 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. 4.4 Special warnings and precautions for use Hypersensitiv Baca dokumen lengkap