Cystopurin 3g Granules for Oral Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Potassium citrate

Available from:

Imbat Limited

ATC code:

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 citrate

Authorization status:

Authorised

Authorization date:

2011-04-08

Patient Information leaflet

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
CYSTOPURIN
® 3G GRANULES FOR ORAL SOLUTION
(Potassium Citrate)
Your medicine is available using the name Cystopurin 3g granules
for oral solution but will be referred to as Cystopurin throughout
this leaflet.
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
This medicine is available without prescription. However, you still
need to take Cystopurin carefully to get the best results from it.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or advice.

You must contact a doctor if your symptoms worsen or do
not improve.

If you have any unusual effects after using this product, tell
your doctor or pharmacist.
IN THIS LEAFLET:
1.
What is Cystopurin and what is it used for?
2.
Before you take Cystopurin
3.
How to take Cystopurin
4.
Possible side effects
5.
How to store Cystopurin
6.
Further information
1.
WHAT IS CYSTOPURIN AND WHAT IS IT 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.

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,

Summary of Product characteristics

Health Products Regulatory Authority
20 February 2020
CRN0096S2
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
Potassium Citrate 3g/sachet
Also contains aspartame (E951).
For a full list of excipients, see Section 6.1
3 PHARMACEUTICAL FORM
Granules for Oral Solution
_Product imported from the UK:_
Pink-brown granules for dissolution in water.
4 CLINICAL PARTICULARS
As per PA1410/042/001.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
4.3 CONTRAINDICATIONS
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
4.8 UNDESIRABLE EFFECTS
4.9 OVERDOSE
5 PHARMACOLOGICAL PROPERTIES
As per PA1410/042/001.
5.3 PRECLINICAL SAFETY DATA
Health Products Regulatory Authority
20 February 2020
CRN0096S2
Page 2 of 3
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Mannitol (E421)
Citric acid (E330)
Aspartame (E951) (a source of phenylalanine)
Cranberry flavour
(flavour contains natural cranberry extracts with maltodextrin,
silicon dioxide (E551), carmine (E120) and triacetin (E1518)).
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the sachets and outer package of the product as marketed
in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25
o
C.
Store in the original carton.
6.5 NATURE AND CONTENTS OF CONTAINER
Over-labelled outer carton containing sachets.
Pack size 6.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF THE PRODUCT
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Imbat Limited
Unit L2
North Ring Business Park
Santry
Dublin 9
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1151/144/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 8th April 2011
Health Products Regulatory Authority
20 February 2020
CRN0096S2
Page 3 of 3
10 DATE OF REVISION OF THE TEXT
February