Summary of Product Characteristics (SmPC) - Cystopurin
1 NAME OF THE MEDICINAL PRODUCT
Cystopurin
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Potassium Citrate 3.0 g
Excipient(s) with known effect:
Aspartame (E951) 40 mg
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Sachet containing a pink-brown granular powder.
Clinical particulars
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 Contra-indications
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 Interactions with other medicaments and other forms of interactions
Concurrent administration of the following drugs may lead to hyperkalaemia: potassium sparing diuretics and aldosterone antagonists, 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 Fertility, 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 symptoms, emergency procedures, antidotes
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.
Pharmacological properties
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 PHARMACEUTICAL PARTICULARS
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 Major 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
None.
7 MARKETING AUTHORISATION HOLDER
Bayer plc
400 South Oak Way
Reading
RG2 6AD
8. Marketing authorisation number
PL 00010/0322
9. Date of the first authorisation or renewal
01/09/2005
10 DATE OF REVISION OF THE TEXT
05/03/2021