SLOW K Coated tablet Ref.[49826] Active ingredients: Potassium chloride

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.

The insoluble tablet matrix may be present in the faeces. Patients should be advised that this is normal.

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 othe relectrolytes 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.

Observed Interactions resulting in a contraindication

Potassium-sparing diuretics

Concomitant treatment with potassium-sparing diuretics (spironolactone, triamterene, amiloride) is contraindicated (see also section 4.3 Contraindications). Drugs which interfere with potassium excretion may promote hyperkalemia when given together with Slow-K.

Anticipated interactions resulting in concomitant use not being recommended

Drugs causing hyperkalemia

Slow-K should be used with caution in patients receiving any drug known to have a potential for hyperkalemia, such as ACE inhibitors, angiotensin‑II-receptor‑antagonists, NSAIDs (e.g. indomethacin), beta-blockers, heparin, digoxin ciclosporin (see also section 4.4 Special warnings and precautions for use).

Interactions to be considered

Drugs causing hyperkalemia

Other drugs such as direct renin inhibitors (e.g. aliskerin) and proton pump inhibitors can cause hyperkalemia when used concomitantly with Slow-K. Thus, caution should be exercised in their concomitant use.

Anticholinergics

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.

Fertility

There are no special recommendations.

None known to date.

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

Adverse drug reactions from post-marketing experience (frequency not known)

The following adverse drug reactions have been derived from post-marketing experience with Slow‑K. Because these reactions
are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency which is
therefore categorized as not known. Adverse drug reactions are listed according to system organ classes in MedDRA. Within
each system organ class, ADRs are presented in order of decreasing seriousness.

Table 4-1. Adverse drug reactions from post-marketing experience (frequency not known):

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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

Not applicable.