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Bayer plc

Bayer House, Strawberry Hill, Newbury, Berkshire, RG14 1JA
Telephone: +44 (0)1635 563 000
Fax: +44 (0)1635 563 393
WWW: http://www.bayer.co.uk

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Summary of Product Characteristics last updated on the eMC: 28/05/2010
SPC Canesten Oasis


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1. NAME OF THE MEDICINAL PRODUCT

Cystitis Relief

Cystofem

Canesten Oasis

Paramed Cystitis Relief Sachets

Cysto S


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Sodium Citrate Dihydrate BP 4.0g


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3. PHARMACEUTICAL FORM

Granules to be reconstituted for oral administration.


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

For the relief of the symptoms of cystitis in women.


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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.


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4.3 Contraindications

Patients with diabetes, heart disease, hypertension, history of renal disease or those on a low salt diet.

During pregnancy and lactation.


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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.


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4.5 Interaction with other medicinal products and other forms of interaction

None stated.


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4.6 Pregnancy and lactation

Contraindicated during pregnancy and lactation.


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4.7 Effects on ability to drive and use machines

None stated.


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4.8 Undesirable effects

None stated.


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4.9 Overdose

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


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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

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


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5.2 Pharmacokinetic properties

None relevant.


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5.3 Preclinical safety data

None stated.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Sucrose BP (1.5 g)

Colloidal Silicon Dioxide BP

Saccharin Sodium BP

Cranberry Flavouring


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6.2 Incompatibilities

None stated.


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6.3 Shelf life

The granules have a three year shelf life.

The reconstituted solution should be used immediately.


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6.4 Special precautions for storage

Store below 25°C, in dry place.


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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.


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6.6 Special precautions for disposal and other handling

None stated.


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7. MARKETING AUTHORISATION HOLDER

Wrafton Laboratories Limited

Wrafton

Braunton

North Devon

EX33 2DL

United Kingdom


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8. MARKETING AUTHORISATION NUMBER(S)

PL 12063/0045.


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

4 December 2003.


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10. DATE OF REVISION OF THE TEXT

26 October 2009.



More information about this product

Link to this document from your website: http://www.medicines.org.uk/emc/medicine/4413/SPC/


Active Ingredients/Generics

 
   sodium citrate dihydrate