Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Mylan Products Ltd., Station Close, Potters Bar, Hertfordshire, EN6 1TL, UK
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 citrate.
None.
Methenamine hippurate should not be given/administered concurrently with sulphonamides because of the possibility of crystalluria, or with alkalising agents such as potassium citrate. Concurrent use with acetazolamide should be avoided as the desired effect of hexamine will be lost.
Depending on the type of analysing method used, methenamine can affect the determination of steroids, catecholamines and 5 hydroxyindole acetic acid from urine and give false results.
There is inadequate evidence of safety of methenamine hippuratein human pregnancy, but it has been in wide use for many years without apparent ill consequence. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of methenamine hippurate during pregnancy.
Methenamine is excreted in breast milk but the quantities will be insignificant to the infant. Mothers can therefore breast feed their infants.
There are no human data available on fertility. Data from studies in rats do not indicate any effects on female fertility, effects on male fertility have not been adequately tested (see section 5.3).
None.
Adverse events are listed below by system organ class and frequency. Frequencies are defined as:
Very common (≥1/l0)
Common (≥1/100 and <1/10)
Uncommon (≥1/1000 and <1/100)
Rare (≥1/10,000 and <1/1000)
Very rare (<1/10,000)
Not known (cannot be estimated from the available data)
Uncommon: gastric irritation, irritation of the bladder, nausea, vomiting
Not known: Diarrhoea, abdominal pain
Uncommon: Rash, pruritus
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 professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Not applicable.
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