Cystopurin 3g granules for oral solution

Sachet containing pink-brown granular powder.

4.1 Therapeutic indications For the symptomatic relief of mild urinary tract infections (cystitis).4.2 Posology and method of administration Orally: Dissolved in water. Adults: One 3g sachet, dissolved in 200mls of cold water, three times daily for two days. All six sachets must be taken to complete the treatment. Elderly As adults Children Not recommended for children under six years of age. For children over six years of age use adult dosage.4.3 Contraindications There are no specific contraindications but use with caution in patients with impaired renal function or cardiac disease.4.4 Special warnings and precautions for use Intended for short term treatment. Patients should seek doctor's advice if symptoms persist after 48 hours treatment. This product also contains aspartame, a source of phenylalanine. This may be harmful to people with phenylketonuria. This medicine contains less than 1mmol sodium (23 mg) per sachet, that is to say essentially 'sodium-free'.4.5 Interaction with other medicinal products and other forms of interaction Concurrent administration of the following drugs may lead to hyperkalaemia: potassium sparing diuretics, ACE inhibitors, aliskiren, angiotensin-II receptor antagonists, ciclosporin and tacrolimus. Avoid concomitant use with methenamine. The activity of cardiac glycosides is to some extent dependent upon serum potassium levels. Therefore, there is a possible interaction and caution is advised.4.6 Pregnancy and lactation There is no, or inadequate epidemiological evidence of safety of the ingredients of Cystopurin sachets in human pregnancy but they have been in wide use for many years without apparent ill consequence. If drug therapy is needed in pregnancy, this drug can be used if there is no safer alternative. However, pregnant women should be advised to seek medical advice on the treatment of cystitis rather than using OTC medicines.4.7 Effects on ability to drive and use machines There is no evidence to suggest that the ability to drive or to use machines of the patient will be affected.4.8 Undesirable effects Some patients may experience mild diuresis. Potassium salts may give rise to gastric irritation, the effects of which may be minimised by diluting sachet contents well with water. Doses may also be given with or after meals. **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 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.4.9 Overdose Hyperkalaemia may occur on prolonged high dosage. (Each Cystopurin sachet contains 27.8 mmol K+). This may be controlled by a number of methods including the use of calcium gluconate, glucose or glucose and insulin, sodium bicarbonate, cationic exchange resins, haemodialysis or peritoneal dialysis.

5.1 Pharmacodynamic properties Potassium citrate after absorption is metabolised and renders the urine less acid. A mild diuresis usually follows treatment with potassium citrate.5.2 Pharmacokinetic properties None stated.5.3 Preclinical safety data Not applicable.

6.1 List of excipients Mannitol (E421) Citric Acid (Anhydrous) Aspartame (E951) Natural flavouring Cranberry type 14666: Maltodextrin, Natural Flavouring Substances, Flavouring Preparations (including natural cranberry juice concentrate\), Silicon Dioxide (E551), Carmine\ (E120), Triacetin (E1518) \*contain trace amounts of sodium, see section 4.4.6.2 Incompatibilities None stated.6.3 Shelf life 36 months.6.4 Special precautions for storage Store below 25°C.6.5 Nature and contents of container Hermetically sealed foil laminate sachet. Pack sizes: 6 sachets.6.6 Special precautions for disposal and other handling None.