Cystopurin 3g Granules for oral solution
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
05-12-2022
Summary of Product characteristics
(SPC)
05-12-2022
Active ingredient:
Potassium citrate
Available from:
Bayer Limited
ATC code:
A12BA; A12BA02
INN (International Name):
Potassium citrate
Dosage:
3 gram(s)
Pharmaceutical form:
Granules for oral solution
Prescription type:
Product not subject to medical prescription
Therapeutic area:
Potassium; potassium citrate
Authorization status:
Marketed
Authorization date:
1995-09-19
Patient Information leaflet
BCH22024
CYSTOPURIN
3g GRANULES FOR ORAL SOLUTION
POTASSIUM CITRATE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor, pharmacist or nurse have
told you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
• You must talk to a doctor if you do not feel better or if you feel
worse after 2 days.
WHAT IS IN THIS LEAFLET:
1. What Cystopurin is and what it is used for
2. What you need to know before you take Cystopurin
3. How to take Cystopurin
4. Possible side effects
5. How to store Cystopurin
6. Contents of the pack and other information
1. WHAT CYSTOPURIN® IS AND WHAT IT IS USED FOR
Cystopurin is used to relieve the symptoms of cystitis.
The active substance in Cystopurin is potassium citrate. Potassium
citrate helps to relieve the symptoms
of cystitis by making your urine less acidic, reducing the discomfort
caused by acidic urine.
Cystitis is a distressing condition caused by an infection and/or
inflammation of the bladder. It is
normally no more than a painful nuisance and only rarely becomes more
serious. Cystitis will occur in 4
out of 5 women at least once in their lifetime, so it is a very common
complaint and the attacks usually
cause no lasting damage.
CYSTITIS CAN ALSO OCCUR IN MEN AND CHILDREN, BUT THIS IS QUITE RARE
AND MEDICAL ADVICE SHOULD BE SOUGHT.
There are two types of cystitis: bacterial cystitis and non-bacterial
cystitis.
BCH22024
• Bacterial cystitis is caused by bacteria that reach the bladder
from the bowel. This may occur during
sexual intercourse, or be due to ineffective/infrequent hygiene.
• Non-bacterial cystitis can be caused by a number of triggers
including certain soaps, deodorants,
insufficient water-b
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
05 December 2022
CRN00D655
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
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
Posology
_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.
_Paediatric population_
Not recommended for children under six years of age.
Method of administration
For oral administration.
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
Health Products Regulatory Authority
05 December 2022
CRN00D655
Page 2 of 3
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
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