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POTASSIUM TABLETS EFFERVESCENT BPC 1968

Active substance(s): POTASSIUM HYDROGEN CARBONATE / POTASSIUM HYDROGEN TARTRATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
POTASSIUM TABLETS EFFERVESCENT BPC 1968

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500mg Potassium Hydrogen Carbonate and 300mg Potassium
Hydrogen Tartrate equivalent to 6.5mmol of potassium (K+)

3.

PHARMACEUTICAL FORM
White uncoated tablets.

4.

CLINICAL PARTICULARS

4.1.

Therapeutic Indications
Indicated in all cases of potassium depletion resulting from intensive or
prolonged diuretic therapy, an inadequate dietary potassium intake, and those
receiving digitalis - here the elderly population are a special risk. A lack of
cellular potassium in the diet can increase the toxic effect of digitalis.
Other indications include corticosteroid therapy, use of carbenoxolone sodium,
advanced hepatic cirrhosis, chronic renal disease, Cushing's syndrome,
diabetic ketosis, renal tubular or metabolic acidosis, patients on a low-salt diet
and in conditions requiring potassium supplementation due to prolonged or
chronic diarrhoea and vomiting.

4.2.

Posology and Method of Administration
Posology
Tablets should be dissolved in half a tumbler of cold water before drinking.
Adults: Usually 4-7 tablets daily (26-45.5mmol K+) but dosage should be
adjusted to the individual requirements of the patient, based on clinical and
laboratory evaluations.
Children: At the discretion of the physician.

Elderly: There are no special dosage requirements, but impairment of renal
function should be taken into account. The elderly require monitoring of
serum electrolytes.
Method of Administration
To be dissolved in water for oral administration

4.3

Contra-Indications








4.4

Hyperkalaemia or hyperkalaemic form of familial periodic paralysis;
Hypochloraemic states;
Plasma potassium greater than 5 mmol/L;
Severe renal impairment (acute or chronic) with anuria, oliguria or azotemia;
Untreated Addison’s disease;
Acute dehydration;
Extensive tissue destruction as occurs with severe burns.

Special Warnings and Special Precautions for Use
Administer with caution in hepatic disease or advanced renal dysfunction.
Potassium salts should not be administered with potassium-sparing diuretics,
such as amiloride, spironolactone and triamterene (see section 4.5).
Use with caution in patients with cardiac disease.
Use with caution in elderly patients as potassium excretion is reduced and
there is a high risk of hyperkalaemia.
Monitor plasma potassium and other electrolytes regularly.
Discontinue potassium if severe nausea, vomiting or abdominal distress
develops.

4.5
Interactions with other Medicinal Products and other Forms of
Interaction
Potassium salts should not be administered with potassium-sparing diuretics,
such as amiloride, spironolactone and triamterene. Potassium can result in
severe or life-threatening hyperkalaemia unless the potassium levels are well
controlled.
Potassium should not be given to patients taking ACE inhibitors unless serum
potassium levels can be closely monitored.
The combined use of potassium salts and ciclosporin or tacrolimus can lead to
hyperkalaemia.

4.6

Pregnancy and Lactation

Potassium may be indicated as replacement therapy for pregnant women with
low potassium levels such as those receiving diuretics. Serum levels should be
closely monitored.
Administration of potassium during lactation is considered to be safe
providing that maternal serum levels are maintained in the physiological
range.

4.7

Effects on Ability to Drive and Use Machines
None known.

4.8

Undesirable Effects
In rare instances patients may experience abdominal discomfort or pain,
nausea, vomiting, diarrhoea and flatulence.
Hyperkalaemia may cause muscle weakness, and in severe cases, chest pain
and paralysis.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal
product is important. It allows continued monitoring of the benefit/risk balance
of the medicinal product. Healthcare professionals are asked to report any
suspected adverse reactions via the Yellow Card Scheme; website:
www.mhra.gov.uk/yellowcard

4.9

Overdose
Hyperkalaemia is the most serious hazard of potassium therapy. Poisoning is
usually minimal below 6.5 mmol/L, moderate between 6.5 and 8 mmol/L and
severe above that level. Extremely high plasma potassium levels (8-11
mmol/L) can cause death from cardiac depression, arrhythmias or arrest. The
absolute toxicity is governed by both pH and associated sodium levels.
ECG changes are an indicator of potassium toxicity. Tall, peaked T waves,
depression of the ST segment, disappearing of the P wave, prolongation of the
QT interval and widening and slurring of the QRS complex are seen. Clinical
symptoms of potassium toxicity include: paraesthesia of the extremities,
listlessness, mental confusion, muscle weakness, flaccid paralysis, cold skin,
grey pallor, peripheral vascular collapse with a drop in blood pressure, cardiac
arrhythmias, heart block and cardiac arrest. Hyperkalaemia may be treated by
discontinuing administration of potassium-rich foods or drugs and potassiumsparing diuretics. Severe hyperkalaemic symptoms and particularly the ECG
effects, may be transiently controlled by calcium gluconate, administration of

glucose or glucose and insulin, sodium bicarbonate or hypertonic sodium
infusions, cation exchange resins or by haemodialysis and peritoneal dialysis.
If the ECG is near normal, excess potassium can be removed from the body
using an oral or rectal calcium or sodium polystyrene sulfonate. However,
care is required to prevent hypokalaemia.
Caution should be employed in patients who are digitalised and who may
experience acute digitalis intoxication in the course of potassium removal.

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic Properties
Potassium bicarbonate and potassium acid tartrate are potassium supplements.

5.2

Pharmacokinetic properties
Potassium salts other than the phosphate, sulfate and tartrate are generally
readily absorbed from the GI tract. Potassium is excreted mainly by the
kidneys; it is secreted in the distal tubules which are also the site for sodiumpotassium exchange. The capacity of the kidneys to conserve potassium is
poor and urinary excretion of potassium continues even when there is severe
depletion. Tubular secretion of potassium is influenced by several factors,
including chloride ion concentration, hydrogen ion exchange, acid-base
equilibrium, and adrenal hormnes. Some potassium is excreted in the faeces
and small amounts may also be excreted in saliva, sweat, bile and pancreatic
juice.

5.3

Pre-clinical 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

Also contains:

Docusate sodium
Magnesium stearate
Povidone
Saccharin sodium
Stearic acid
Sucrose
Citric acid (E330)
6.2

Incompatibilities
None known.

6.3

Shelf-Life
Shelf-life
Three years from the date of manufacture.
Shelf-life after dilution/reconstitution
Not applicable.
Shelf-life after first opening
Not applicable.

6.4

Special Precautions for Storage
Store below 25°C in a dry place and keep airtight.

6.5

Nature and Content of Container
The product containers are rigid injection moulded polypropylene or injection
blow-moulded polyethylene containers and snap-on polyethylene lids; in case
any supply difficulties should arise the alternative is amber glass containers
with screw caps.
An alternative closure for polyethylene containers is a polypropylene, twist on,
push down and twist off child-resistant, tamper-evident lid.
Also included in each pack is a 2g silica gel capsule.
Pack sizes: 28s, 30s, 56s, 60s, 84s, 90s, 100s, 112s
Product may also be supplied in bulk packs, for reassembly purposes only, in
polybags contained in tins, skillets or polybuckets filled with suitable
cushioning material. Also included are 5 x 50g silica gel bags.
Maximum size of bulk packs: 5000

6.6

Instruction for Use, Handling and Disposal
Not applicable.

7

MARKETING AUTHORISATION HOLDER
Actavis UK Limited
(Trading style: Actavis)
Whiddon Valley
BARNSTAPLE
N Devon
EX32 8NS

8.

MARKETING AUTHORISATION NUMBER
PL 00142/5567R

9.
DATE OF FIRST AUTHORISATION / RENEWAL OF THE
AUTHORISATION
21.7.86
(Renewed: 10.9.92)

10

DATE OF REVISION OF THE TEXT
04/01/2016

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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