Canesten Oasis

1. Name Of The Medicinal Product

Cystitis Relief

Cystofem

Canesten Oasis

Paramed Cystitis Relief Sachets

Cysto S

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 Precautions For Use

If symptoms persist after the two day course of treatment is completed, medical attention should be sought.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None stated.

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

None stated.

4.9 Overdose

In the unlikely event of overdosage occurring with this product, treatment should be symptomatic.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

The effect of sodium citrate is to render the urine less acidic.

5.2 Pharmacokinetic Properties

None relevant.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sucrose BP (1.5 g)

Colloidal Silicon Dioxide BP

Saccharin Sodium BP

Cranberry Flavouring

6.2 Incompatibilities

None stated.

6.3 Shelf Life

The granules have a three year shelf life.

The reconstituted solution should be used immediately.

6.4 Special Precautions For Storage

Store below 25°C, in dry place.

6.5 Nature And Contents Of Container

Foil laminate sachets

or

paper (outer surface layer) /polyethylene (outer layer) /aluminium foil (outer layer) /ionomer resin (inner layer) sachets

Each sachet contains 5.575 g of granule enclosed in a cardboard outer.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

Wrafton Laboratories Limited

Wrafton

Braunton

North Devon

EX33 2DL

United Kingdom

8. Marketing Authorisation Number(S)

PL 12063/0045.

9. Date Of First Authorisation/Renewal Of The Authorisation

4 December 2003.

10. Date Of Revision Of The Text

26 October 2009.