This information is intended for use by health professionals

1. Name of the medicinal product

POTASSIUM TABLETS EFFERVESCENT BPC 1968

2. Qualitative and quantitative composition

Each tablet contains 500mg Potassium Hydrogen Carbonateand 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 Contraindications

• 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.

4.4 Special warnings and 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 Interaction 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 potassium-sparing 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 sodium-potassium 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 Preclinical 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 in a cool dry place and keep airtight.

6.5 Nature and contents 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 Special precautions for disposal and other handling

Not applicable.

Administrative data
7. Marketing authorisation holder

Name or style and permanent address of registered place of business of the holder of the Marketing Authorisation:

Actavis UK Limited

(Trading style: Actavis)

Whiddon Valley

BARNSTAPLE

N Devon EX32 8NS

8. Marketing authorisation number(s)

PL 0142/5567 R

9. Date of first authorisation/renewal of the authorisation

11.7.86

Product Licence of Right: 20.4.73

Renewed: 10.9.92; 23.09.97; 23.09.02

10. Date of revision of the text

04/01/2016