Numark Cystitis Treatment
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
6.3
Shelf life
36 months unopened.
Special precautions for storage
6.4
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