Canesten Oasis

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

SODIUM CITRATE, DIHYDRATE

Available from:

Wrafton Laboratories Limited Wrafton, Braunton, North Devon, EX33 2DL, United Kingdom

ATC code:

G04BX

INN (International Name):

SODIUM CITRATE DIHYDRATE 4 g

Pharmaceutical form:

GRANULES FOR ORAL SUSPENSION

Composition:

SODIUM CITRATE DIHYDRATE 4 g

Prescription type:

OTC

Therapeutic area:

UROLOGICALS

Authorization status:

Withdrawn

Authorization date:

2006-10-30

Patient Information leaflet

F4T91LVJ1
CanesOasis
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU TAKE THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION YOU NEED TO KNOW.
This medicine is available without prescription,
however, you still need to use this product
carefully to get the best results from it.
Keep this leaflet as you may need to read it
again. Ask your pharmacist if you need more
information or advice.
1. WHAT IS THIS MEDICINE AND
WHAT IS IT USED FOR?
THIS MEDICINE CONTAINS:
•
SODIUM CITRATE, which is used to relieve
discomfort in urinary tract infections such as
cystitis, by making the urine less acidic.
These sachets are used for the relief of the
symptoms of cystitis in women. Cystitis is an
inflammation of the bladder, which causes
painful irritation and an unpleasant burning
sensation when passing water.
2. IS THIS MEDICINE SUITABLE FOR YOU?
DO NOT TAKE THIS MEDICINE IF YOU:
•
are ALLERGIC to sodium citrate or any of the
other ingredients
•
suffer from heart disease
•
have high blood pressure
•
have diabetes
•
have a history of kidney disease
•
are on a low sodium (salt) diet.
TALK TO YOUR DOCTOR IF YOU HAVE:
•
symptoms which carry on for more than 4
days after you start taking this medicine.
•
symptoms which keep recurring.
TALK TO YOUR DOCTOR OR PHARMACIST IF YOU
ARE TAKING:
•
lithium for manic depression
•
methenamine for urinary infections
•
other medicines as these may be affected
by taking this medicine.
PLEASE SEE YOUR DOCTOR OR PHARMACIST
BEFORE TAKING THIS MEDICINE IF YOU:
•
have an intolerance to some sugars.
OTHER IMPORTANT INFORMATION:
PREGNANCY AND BREASTFEEDING:
This medicine is not recommended if you
are pregnant or breastfeeding. Please see
your doctor or pharmacist before taking
this medicine.
INFORMATION ABOUT SOME OF THE INGREDIENTS
IN THIS MEDICINE:
CONTAINS SUCROSE. If you have been told by
your doctor that you have an intolerance to
some sugars, contact your doctor before
taking this medicinal product.
You can also report side effects directly via
the Yellow Card Scheme at

Summary of Product characteristics

Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
CanesOasis Cystitis Relief 4g granules for oral solution_ _
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium Citrate Dihydrate BP 4.0g
3
PHARMACEUTICAL FORM
Granules to be reconstituted for oral administration.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the relief of the symptoms of cystitis in women.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adult women: The contents of one sachet dissolved in a glass of water,
to be taken three times a
day for two days.
Men and children: Not recommended.
4.3
CONTRAINDICATIONS
Patients with diabetes, heart disease, hypertension, history of renal
disease or those on a low salt
diet.
During pregnancy and lactation.
4.4.
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
If symptoms persist after the two day course of treatment is
completed, medical attention should be sought. Do not
exceed the stated dose. Keep out of the sight and reach of children.
4.5.
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Page 2 of 4
Sodium containing preparations should be avoided by patients on
lithium because sodium is
preferentially absorbed by the kidney resulting in increased lithium
excretion and reduced plasma
levels.
Urinary alkalinisers should not be used with hexamine because it is
only effective in acid urine.
The effects of a number of drugs may be reduced or increased by the
alkalinisination of the urine
and reduction in gastric pH brought about by the active ingredients in
the product.
4.6
PREGNANCY AND LACTATION
Contraindicated during pregnancy and lactation.
4.7
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None stated.
4.8.
UNDESIRABLE EFFECTS
Mild diuresis.
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 ADR Repo