1. Name Of The Medicinal Product
Cystitis Relief
Cystocalm
2. Qualitative And Quantitative Composition
Sodium Citrate Dihydrate BP 4.0g
3. Pharmaceutical Form
Granules to be reconstituted for oral adminstration.
4. Clinical Particulars
4.1 Therapeutic Indications
For the relief of the symptoms of cystitis in women.
4.2 Posology And Method Of Administration
For oral administration.
Adult women: The contents of one sachet dissolved in a glass of water, to be taken three times a day for 2 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 2 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
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Sucrose BP 1.5g, Colloidal Silicon Dioxide BP, Saccharin Sodium BP, Natural Lemon Flavour.
6.2 Incompatibilities
None stated.
6.3 Shelf Life
The granules have a two year shelf life.
The reconstituted solution should be used immediately.
6.4 Special Precautions For Storage
Store below 25°C in a dry place.
6.5 Nature And Contents Of Container
Foil laminate sachets (comprising of 44gsm clay coated kraft paper, 10 gsm polythene, 8 aluminium foil, 25gsm polythene) containing 5.535g of granule enclosed in a cardboard outer.
6.6 Special Precautions For Disposal And Other Handling
None stated.
7. Marketing Authorisation Holder
Galpharm Healthcare Limited
Hugh House,
Upper Cliffe Road
Dodworth Business Park
Dodworth
South Yorkshire
S75 3SP
8. Marketing Authorisation Number(S)
PL 16028/0017
9. Date Of First Authorisation/Renewal Of The Authorisation
22nd September 1997
10. Date Of Revision Of The Text
April 1998
