Bayer Limited
Summary of Product Characteristics last updated on medicines.ie: 17/2/2015
Cystopurin 3g Granules for Oral Solution
1. NAME OF THE MEDICINAL PRODUCT
Cystopurin 3g Granules for oral solution.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains 3g of Potassium Citrate.
Excipients - contains aspartame (E951) 0.04g/sachet.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Granules for oral solution.
Pink-brown granules for dissolution in water.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
For the symptomatic relief of mild urinary tract infections (cystitis).
4.2 Posology and method of administration
For oral administration.
Adults (including the elderly and children over 6 years):
One 3 g sachet, dissolved in 200 ml of cold water, three times daily for two days. All six sachets must be taken to complete the treatment.
Not recommended for children under six years of age.
4.3 Contraindications
Use in patients with renal insufficiency.
4.4 Special warnings and precautions for use
This product is intended for short term treatment. Patients should seek doctor's advice if symptoms persist after 48 hours treatment.
This product should only be used with caution in patients with cardiac disease.
This product contains a source of phenylalanine. May be harmful for people with phenylketonuria.
4.5 Interaction with other medicinal products and other forms of interaction
Concurrent administration of potassium sparing diuretics or ACE inhibitors may lead to hyperkalaemia. The activity of cardiac glycosides is to some extent dependant upon serum potassium levels. Therefore, there is a possible interaction and caution is advised.
4.6 Fertility, pregnancy and lactation
There is no information available from animal studies and there is no 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
None.
4.8 Undesirable effects
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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.
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.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: potassium ATC code: A12BA02
Potassium citrate, after absorption, is metabolised and acts to make the urine less acid. A mild diuresis usually follows treatment with potassium citrate.
5.2 Pharmacokinetic properties
Potassium citrate is metabolised, after absorption, to bicarbonate. Bicarbonate ions are excreted in the urine, which is rendered alkaline, and there is an accompanying diuresis.
5.3 Preclinical safety data
None available.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Mannitol (E421)
Citric Acid (Anhydrous) (E330)
Aspartame (E951)
Natural flavouring Cranberry type 14666:
maltodextrin, natural flavouring substances, flavouring preparations, silicon dioxide (E551), carmine (E120), triacetin (E1518).
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and contents of container
Hermetically sealed paper/foil/polythene laminate sachets contained in a cardboard outer carton. Each carton contains 6 sachets.
6.6 Special precautions for disposal and other handling
No special requirements.
7. MARKETING AUTHORISATION HOLDER
Bayer Limited
The Atrium
Blackthorn Road
Dublin 18
Ireland
8. MARKETING AUTHORISATION NUMBER(S)
PA 1410/42/1
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 19th September 1995
Date of last renewal: 19th September 2010
10. DATE OF REVISION OF THE TEXT
February 2015