Chlorvescent

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Potassium bicarbonate 384mg;  ; Potassium carbonate 152mg;  ;  ; Potassium chloride 595mg;  ;  

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Potassium bicarbonate 384 mg

Pharmaceutical form:

Effervescent tablet

Composition:

Active: Potassium bicarbonate 384mg   Potassium carbonate 152mg     Potassium chloride 595mg     Excipient: Acesulfame potassium Aspartame Citric acid Leucine Macrogol 6000 Ribes nigrum Sorbitol

Units in package:

Tube, plastic, PP with PE stopper, 30 tablets

Class:

Pharmacy only

Prescription type:

Pharmacy only

Manufactured by:

Kirsch Pharma GmbH

Therapeutic indications:

The treatment of potassium deficiency (particularly hypochloremic or hypokalemic alkalosis) associated with diuretic and steroid therapy, vomiting and diarrhoea, ulcerative colitis, steatorrhoea, diabetes insipidus and uncontrolled diabetes mellitus, ileostomy or colostomy patients, cirrhosis and dietary insufficiency.

Product summary:

Package - Contents - Shelf Life: Tube, plastic, PP with PE stopper - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Tube, plastic, PP with PE stopper - 60 tablets - 36 months from date of manufacture stored at or below 25°C

Authorization date:

1973-05-17

Summary of Product characteristics

J:\Regulatory Affairs\Regaff\Chlorvescent\+New Zealand\SACN (Updat
data sheet to SPC format) May2019\working
files\Chlorvescent Data Sheet May19 - Clean.doc
NEW ZEALAND DATA SHEET
1.PRODUCT NAME
Chlorvescent Tablets
2.QUALITATIVE AND QUANTITATIVE COMPOSITION
Chlorvescent effervescent tablet contains potassium chloride,
potassium bicarbonate
and citric acid, providing 14mmol potassium (548 mg) and 8 mmol
chloride (298 mg) in
the form of an acceptable drink.
For full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
White or white to yellow, round and flat tablets
4.CLINICAL PARTICULARS
4.1 INDICATIONS
Treatment of potassium deficiency (particularly hypochloremic or
hypokalemic
alkalosis) associated with diuretic and steroid therapy, vomiting and
diarrhoea,
ulcerative colitis, steatorrhoea, diabetes insipidus and uncontrolled
diabetes mellitus,
ileostomy or colostomy patients, cirrhosis and dietary insufficiency.
4.2 DOSE AND METHOD OF ADMINISTRATION
1 tablet in half a glass full of water per day is normally sufficient
to correct potassium
and chloride deficiencies. In more severe depletion, up to 4 tablets
(56 mmol
potassium and 32 mmol chloride) can be taken daily in divided doses in
water.
4.3 CONTRAINDICATIONS
Potassium supplements are contraindicated in patients with
hyperkalemia since a
further increase in serum potassium concentration in such patients can
produce
cardiac arrest. Hyperkalemia may complicate any of the following
conditions: chronic
renal impairment, metabolic acidosis such as diabetic acidosis, acute
dehydration,
extensive tissue breakdown as in severe burns or adrenal
insufficiency.
Hypokalemia should not be treated by the concomitant administration of
potassium
salts and a potassium-sparing diuretic (eg. spironolactone or
triamterene) since the
simultaneous administration of these agents can produce severe
hyperkalemia. (see
also section 4.5, Interaction with other medicines and other forms of
interactions)
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Caution is required in cases of