Ország: Egyesült Királyság
Nyelv: angol
Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)
Methenamine hippurate
Viatris UK Healthcare Ltd
J01XX05
Methenamine hippurate
1gram
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05011300; GTIN: 0000050485826
Patient Information Leaflet Hiprex 1g tablets Methenamine hippurate Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet: 1. What Hiprex is and what it is used for 4. Possible side effects 2. What you need to know before you take Hiprex 5. How to store Hiprex 3. How to take Hiprex 6. Contents of the pack and other information. 1. What Hiprex is and what it is used for Hiprex contains the active substance methenamine hippurate and belongs to a group of medicines called anti-bacterials. These work by killing many different types of bacteria which cause infections. Hiprex is used to treat infections of the urinary tract and stop them from coming back. The urinary tract is a collective name for the parts of the body that produce, store and transport urine. These include the kidney, bladder and tubes called the ureter and urethra. It is also used to avoid urinary tract infections in patients with catheters from their bladders (a tube that helps with incontinence) and in people undergoing certain medical procedures. 2. What you need to know before you take Hiprex Do not use Hiprex if: • You are allergic to methenamine hippurate or any of the other ingredients of this medicine (listed in section 6) • You are taking antibiotic medicines called sulphonamides. These can damage your kidneys when taken at the same time as Hiprex • You are severely dehydrated • You have serious problems with your kidneys • You have problems with your liver • You have gout • You have a condition called metabolic acid Olvassa el a teljes dokumentumot
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Hiprex 1 g Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Hiprex tablet contains methenamine hippurate 1 g. For the full list of excipients, see 6.1. 3 PHARMACEUTICAL FORM A white to creamy-white oblong shaped tablet coded HX with break line on one face and break line on the other face with or without 3M. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hiprex is indicated in the prophylaxis and treatment of urinary tract infections: As maintenance therapy after successful initial treatment of acute infections with antibiotics. As long-term therapy in the prevention of recurrent cystitis. To suppress urinary infection in patients with indwelling catheters and to reduce the incidence of catheter blockage. To provide prophylaxis against the introduction of infection into the urinary tract during instrumental procedures. Asymptomatic bacteriuria. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults: _1g twice daily. In patients with catheters the dosage may be increased to 1g three times daily. _Paediatric population:_ _Children under 6 years: _Not recommended. _Children: 6-12 years: _500mg twice daily. _Older people: _ _ _ No special dosage recommendations. Method of administration The tablets may be halved, or they can be crushed and taken with a drink of milk or fruit juice if the patient prefers. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Hepatic dysfunction, renal parenchymal infection, severe dehydration, metabolic acidosis, severe renal failure (creatinine clearance or GFR<10 ml/min.) or gout. Hiprex may be used where mild (20-50 ml/min.) to moderate (10-20 ml/min.) renal insufficiency is present. (If the GFR is not available the serum creatinine concentration can be used as a guide.). Hiprex should not be administered concurrently with sulphonamides because of the possibility of crystalluria, or with alkalising agents, such as a mixture of potassium citrat Olvassa el a teljes dokumentumot