Novartis Ireland Limited

Slow K 600 mg Prolonged-release Coated Tablet

One sugar-coated tablet contains 600mg potassium chloride as active substance equivalent to 8mmol potassium ion (K⁺)

Excipients: Each tablet contains 96.4mg sucrose

For a full list of excipients, see section 6.1 List of Excipients.

Coated Tablet

Pale orange, round, biconvex, polished sugar-coated tablets .

For use in patients requiring supplemental potassium therapy.

Uses include:

Supplement to potassium depleting diuretics.

Hypokalaemia associated with prolonged corticosteroid therapy.

Where there is inadequate dietary intake due to poor dietary habits or malnutrition.

Increased gastrointestinal potassium loss due for example to vomiting (except pyloric stenosis) or diarrhoea.

Increased renal potassium loss in primary or secondary hyperaldosteronism, Cushing's syndrome and renal tubular disease.

Altered transcellular shifts of potassium as in hypokalaemic familial periodic paralysis. .

It is important that the tablets should be swallowed whole, with fluid during meals, whilst the patient is sitting upright.

Adults:

The dosage of Slow-K should be adjusted to the individual needs of each patient. 2-3 tablets daily are usually an adequate supplement to prevent hypokalaemia. In states of potassium deficiency doses of 5 to 6 tablets daily may be needed increasing up to 12 tablets daily in severe deficiency. If the dosage exceeds 16mmol K⁺ (2 tablets) it should be taken in divided doses. Where intermittent diuretic therapy is being used, it is advisable to give Slow K on intervening days between administration of the diuretic. The response to treatment should preferably be monitored by repeat determination of plasma potassium and Slow K continued until the hypokalaemia has been corrected.

Children:

Not recommended

Elderly:

No special dosage regime is usually necessary, but potential concurrent renal insufficiency should be taken into account (also see section 4.4 Special Warnings and special precautions for use)

All forms of hyperkalaemia as may occur in marked renal failure (even when not yet associated with manifest hyperkalaemia), untreated Addison's disease, hyporeninaemic hypoaldosteronism, acute dehydration and conditions involving extensive cell destruction (e.g. severe burns).

Hypersensitivity to potassium administration e.g. hyperkalaemic periodic paralysis and congenital paramyotonia, or hypersensitivity to any of the excipients.

All solid forms of potassium medication are contraindicated in the presence of obstructions in the digestive tract (e.g. resulting from compression of the oesophagus due to dilation of the left atrium or from stenosis of the gut).

In cases of metabolic acidosis, the hypokalaemia should be treated not with potassium chloride but with an alkaline potassium salt (e.g. potassium bicarbonate).

Concomitant treatment with potassium sparing diuretics (e.g. spironolactone, triamterene, amiloride) (See also section 4.5 Interaction with other medicinal products and other forms of interaction).

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Gastrointestinal disorders

Potassium chloride, alone or in combination with other medications may induce ulceration in the gastrointestinal tract, in particular the lower oesophagus and small bowel. This possibility is increased in patients with local, functional or mechanical disorders of the gastrointestinal tract, with cardiovascular disease, or in those on prolonged therapy or receiving anticholinergics. Symptoms or signs suggesting ulceration or obstruction of the tract should be regarded as reasons to discontinue medication immediately (See also section 4.8 Undesirable effects).

Patients with ostomies may have altered intestinal transit times and are better treated with other forms of potassium salts.

Hyperkalaemia

Potassium salts should only be administered with extreme caution to patients with renal dysfunction, hepatic disease (because of the risk of hyperkalaemia), history of or existent peptic ulceration. Monitoring of serum potassium and other electrolytes is particularly necessary in patients with diseases of the heart and kidneys.

Slow K should be used with caution in patients receiving any drug known to have a potential for hyperkalaemia, such as ACE inhibitors, angiotenin –II-receptor antagonists, NSAIDs (e.g. indomethacin), beta-blockers, heparin, digoxin and ciclosporin (see also section 4.5 Interaction with other medicinal products and other forms of interaction).

Treatment Monitoring

Periodic serum potassium determinations are recommended during long term supplementation, especially in clinical conditions which carry a risk of hyperkalaemia (e.g. impaired renal function or heart disease). (see also section 4.5 Interaction with other medicinal products and other forms of interaction).

Other

In some patients, diuretic induced magnesium deficiency will prevent restoration of intracellular deficits of potassium so that hypomagnesaemia should be corrected at the same time as hypokalaemia.

Slow-K contains sucrose (=saccharose). Patients with rare hereditary disorders like fructose-intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not use this medicine

Combined treatment with the following increase the risk of hyperkalaemia:

Angiotensin-converting enzyme inhibitors, cyclosporin, nonsteroidal anti-inflammatory drugs (NSAIDs), beta blockers, heparin, digoxin, potassium sparing diuretics (see Contraindications).

Since anticholinergic drugs may reduce gastrointestinal motility, they should be prescribed with great care when given concomitantly with solid oral potassium preparations, particularly in high dosage (see also section 4.4 Special warnings and precautions for use).

Pregnancy

For Slow-K no clinical data on exposed pregnancies are available.

There is no indication in animal studies of direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see also section 5.3 Preclinical safety data).

Lactation

The excretion of potassium in milk has not been studied in animals or human.

As a general rule, no drugs should be taken during the first three months of pregnancy and the risks and benefits of taking drugs should be carefully considered throughout pregnancy.

Because of gastrointestinal hypomotility associated with pregnancy, solid forms of oral potassium preparations should be given to pregnant women only if considered essential.

The normal K⁺ content of human milk is about 13mmol/litre. Since oral potassium becomes part of the body's potassium pool, provided this is not excessive, Slow K can be expected to have little or no effect on the potassium level in human milk.

Slow-K should only be given during breast-feeding when the expected benefit to the mother outweighs the potential risk to the baby.

None known to date

Side-effects are rare with Slow-K, as any excess potassium is rapidly excreted in the urine.

Gastrointestinal tract (GIT):

In rare cases, oral potassium preparations may provoke gastro-intestinal disturbances (nausea, vomiting, abdominal pains, diarrhoea) necessitating either a reduction in dosage or withdrawal of medication (see Precautions).

In isolated cases; obstruction, haemorrhage, and ulceration, with or without perforation of the upper or lower GIT, have been reported following administration of Slow K (see also section 4.4 Special warnings and precautions for use), usually associated with other factors known to predispose a patient to these effects (e.g. delayed GIT transit time, obstruction of GIT).

Skin:

Rare: Pruritus and/or skin rash, urticaria.

Electrolytes:

Hyperkalaemia may develop in patients having difficulty with either renal potassium excretion or potassium metabolism (see also section 4.3 Contraindications, 4.4 Special warnings and precautions for use, and 4.9 Overdose).

Mainly cardiovascular (hypotension, shock, ventricular arrhythmias, bundle-branch block, ventricular fibrillation leading possibly to cardiac arrest) and neuromuscular (paraesthesiae, convulsions, areflexia, flaccid paralysis of striated muscle leading possibly to respiratory paralysis). Beside elevation of serum potassium concentration, typical ECG changes are also encountered (increasing amplitude and peaking of T waves, disappearance of P wave, widening of QRS complex and S-T segment depression).

Pharmacotherapeutic group:

Potassium supplement, ATC code: A12BA01

Following a single dose of Slow K, potassium chloride is released over a period of approximately 4 hours. Renal excretion of potassium chloride following ingestion of Slow K occurs 30-60 minutes later than when the same dose is given in the form of a solution. In the presence of a normal potassium balance 90% of the potassium supplied by Slow K is excreted renally within 8 hours and more than 98% by 24 hours.

The acute and repeated-dose oral toxicity of potassium chloride (KCl) in animals is low. Gastrointestinal irritant effects have been observed in rhesus monkeys at high oral dosages of Slow-K. Some positive results in in vitro genotoxicity assays were attributed to very high concentrations of KCl. Carcinogenicity studies in rats administered KCl in-feed were negative. Limited information from developmental studies in rodents indicates there is no ill effect on offspring. There is no evidence from animal experiments that KCl exerts any teratogenic effects or reproductive toxicity which would be relevant to man.

Tablet Core:

Cetostearyl alcohol

Gelatin

Magnesium stearate

Tablet Coating:

Spray-dried acacia

Titanium dioxide

Purified talc special

Sucrose granulated

Dispersed buff 70753 containing red and yellow iron oxides (E172), Titanium dioxide (E171)

Carnauba Wax

Not applicable

5 years

Do not store above 30C.

Store in the original container.

Keep the container tightly closed.

Securitainer (PVC) in packs 500.

No special requirements.

Novartis Pharmaceuticals U.K. Limited

Frimley Business Park

Frimley

Camberley

Surrey GU16 7SR

England

PA 13/61/1

17^th February 1977 / 17 February 2007

February 2008