SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Effercitrate Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Ingredients

Each tablet contains potassium bicarbonate and anhydrous citric acid. When dissolved in water, the solution will contain the equivalent of 1.5g potassium citrate and 0.25g citric acid.

3 PHARMACEUTICAL FORM

Effervescent Tablets

White circular, flat effervescent tablets.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For the treatment of cystitis, symptoms of cystitis and as an initial therapy in mild symptomatic cystitis prior to an MSU result. Confirmed bacterial infections should then be treated with an appropriate course of an antibacterial agent.

4.2 Posology and method of administration Posology

Adults and Children over 6 years: Two tablets to be dissolved in a glass of

water up to three times daily.

Children under 6 years:    Not recommended.

Elderly:    As adult dose.

Sufficient should be given to render and maintain the urine alkaline.

4.3 Contraindications

None.

4.4 Special warnings and precautions for use

Caution should be observed in patients with kidney disease, hypertension or heart disease.

If symptoms persist or worsen, patients should seek medical advice.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Fertility, Pregnancy and lactation

Patients should consult a doctor before taking Effercitrate in pregnancy or lactation.

4.7 Effects on ability to drive and use machines

Not applicable .

4.8 Undesirable effects

Gastric irritation may occur. The tablets should always be well diluted with water. Gastric effects may be minimised by taking with, or after meals.

4.9 Overdose

Hyperkalaemia may occur. Below 6.5mmol/litre poisoning is minimal, moderate up to 8mmol/litre and severe above 8mmol/litre. Absolute toxicity is governed by pH and sodium levels. Hyperkalaemia symptoms may be transiently controlled with calcium gluconate, glucose or glucose and insulin, sodium bicarbonate or hypertonic sodium infusions, cationic exchange resins or haemo and peritoneal dialysis. Patients who are digitalized may experience acute digitalis intoxication during potassium removal.

5.1 Pharmacodynamic properties

Potassium citrate renders the urine alkaline.

5.2 Pharmacokinetic properties

Alkalisation of the urine affects the growth of pathogens. The growth of ESCH COLI is inhibited at a pH above 7.5. Alkalised urine is soothing to the epithelium of the bladder and urethra than the natural acid urine (symptoms of cystitis).

5.3 Preclinical safety data

The active ingredients of Effercitrate tablets are simple compounds with a well established medical use and recognised efficacy and an acceptable level of safety.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Saccharin Sodium Lemon Flavour Lime Flavour Polyethylene glycol 6000 Polyvinylpyrrolidone Magnesium Stearate

6.2 Incompatibilities

None known.

6.3 Shelf life

Three years.

6.4 Special precautions for storage

Do not store above 25°C. Replace cap securely to protect the tablets from moisture.

6.5 Nature and contents of container

Polypropylene tube with plastic cap incorporating a desiccant disc, containing 12 effervescent tablets.

6.6 Special precautions for disposal

Not applicable.

7 MARKETING AUTHORISATION HOLDER

Cambridge Healthcare Supplies Limited

Unit 1 Chestnut Drive

Wymondham

Norfolk

NR18 9SB

8    MARKETING AUTHORISATION NUMBER(S)

PL 16794/0009

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

30 January 1980

10 DATE OF REVISION OF THE TEXT

29/04/2016