Section 4.3 Now includes the following red text:
Hypersensitivity to potassium administration, eg hyperkalaemic periodic paralysis, congenital paramyotonia, or hypersensitivity to any of the excipients.
Concomitant treatment with potassium sparing diuretics (eg spironolactone, triamterene, amiloride) (see also section 4.5 Interactions with other medicaments and other forms of interaction).
Section 4.4 Now includes the following red text:
If a patient under treatment with Slow-K develops severe vomiting, severe abdominal pains or flatulence, or gastro-intestinal haemorrhage, the preparation should be withdrawn at once, because in the presence of an obstruction it could conceivably give rise to ulceration or perforation (see also section 4.8 Undesirable effects).
Caution should be exercised when prescribing solid oral potassium preparations, particularly in high dosage, in patients concurrently receiving anticholinergics, because of their potential to slow gastro-intestinal motility (see also section 4.5 Interactions with other medicaments and other forms of interaction).
Section 4.5 now includes the following red text:
Drugs which interfere with potassium excretion may promote hyperkalaemia when given together with Slow-K.
Combined treatment with the following increase the risk of hyperkalaemia: ACE inhibitors, angiotensin-II-receptor antagonists, ciclosporin, NSAIDs, b-blockers, heparin, digoxin, potassium sparing diuretics (see Section 4.3 Contra-indications).
Section 4.6 now includes the following red text:
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/fetal development, parturition or postnatal development (see also section 5.3 Preclinical safety data).
As a general rule, no drugs should be taken during the first 3 months of pregnancy, and the benefits and risks of taking drugs should be carefully considered throughout the whole of pregnancy, solid forms of oral potassium preparations should be given to pregnant women only if clearly needed.
Lactation
The excretion of potassium in milk has not been studied in animals or human.
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.
Section 5.1 now includes the following text:
Pharmacotherapeutic group: Potassium supplement
ATC code: A12 BA01
Section 5.3 now includes the following text:
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.
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