CYSTOPURIN Granules for oral solution Ref.[49931] Active ingredients: Potassium citrate

Source: Health Products Regulatory Authority (IE)  Revision Year: 2021  Publisher: Bayer Limited, The Atrium, Blackthorn Road, Dublin 18, Ireland

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. 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; Website: www.hpra.ie.

6.2. Incompatibilities

Not applicable.

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