SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Cystoleve Powders Numark Cystitis Treatment

Dr White’s Well Woman Powder for Cystitis Treatment Family Health Cystitis Treatment.

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Sodium citrate 4.0gm

3    PHARMACEUTICAL FORM

Powder for oral solution.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

To relieve the symptoms of cystitis in women.

4.2 Posology and method of administration

Route of administration: oral

Directions

Empty the contents of one sachet in a glassful of water. Stir well until dissolved and then drink all the solution.

Dosage

Take the contents of one sachet three times daily for 48 hours. It is important that the full course is taken. Not to be taken by children or men, except on medical advice.

Please read the enclosed leaflet carefully.

4.3    Contraindications

Impaired renal function, peripheral and pulmonary oedema, toxaemia of pregnancy, cardiac disease and hypertension

4.4    Special warnings and precautions for use

i)    Do not take Cystoleve without consulting your doctor if you have kidney or heart disease, high blood pressure, if you are pregnant or you have diabetes or are on a restricted salt diet

ii)    If symptoms persist after 48 hours treatment, consult your doctor

iii)    If symptoms of cystitis come back regularly, consult your doctor

iv)    Do not exceed the stated dose

v)    Keep out of the reach of children.

4.5    Interaction with other medicinal products and other forms of interaction

None known.

4.6    Pregnancy and lactation

Should not be used in pregnancy without first consulting your doctor.

4.7    Effects on ability to drive and use machines

None.

4.8    Undesirable effects

None.

4.9    Overdose

May give rise to hypernatraemia (i.e. a plasma sodium concentration of more than 147 mmols per litre) or oedema. Symptoms may include restlessness, weakness, thirst, reduced salivation and lachrymation, swollen tongue, flushing of the skin, pyrexia, dizziness, headache, oliguria, hypotension, tachycardia, delirium, hyperpnoea and respiratory arrest.

Treatment: For hypernatraemia, cease use and take large quantities of sodium free liquids. For oedema, restrict sodium and water intake and give a loop diuretic (e.g. Frusemide).

5.1 Pharmacodynamic properties

Reduces the discomfort of cystitis by making the urine alkaline. This reduces the buming/stinging pain felt on passing urine and inhibits the growth of bacteria. Also causes diuresis.

5.2 Pharmacokinetic properties

After absorption, sodium citrate is metabolised to bicarbonate. Bicarbonate ions are excreted in the urine along with sodium ions. The urine is then rendered alkaline.

5.3 Preclinical safety data

There are no preclinical 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

Lemon juice FOL 610406E Sodium saccharin Tartaric acid.

6.2 Incompatibilities

None

Shelf life

36 months unopened.

Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

50 gsm unicote/10 gsm polyethylene/7p aluminium foil/23-25 gsm polyethylene sachets,

95 x 75mm, containing 9.05gm powder.

Six sachets are packed in a carton.

6.6 Special precautions for disposal

Not applicable.

7    MARKETING AUTHORISATION HOLDER

AYRTON SAUNDERS LIMITED NORTH WAY

WALWORTH INDUSTRAIL ESTATE

ANDOVER

SP10 5AZ

UNITED KINGDOM

8 MARKETING AUTHORISATION NUMBER(S)

PL: 16431/0052

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

05/08/87 and 18/11/98

10    DATE OF REVISION OF THE TEXT

June 2001