Alliance Pharmaceuticals

Do not take Slow-K:

·       if you are allergic (hypersensitive) to potassium chloride or any of the ingredients of Slow-K (see Section 6 Further information)

·       if you have been told by your doctor you have kidney failure

·       if you have Addison’s disease (which is a condition where your adrenal gland is not producing enough steroids)

·       if you have recently suffered from severe burns

·       if you suffer from digestive problems or have difficulty swallowing (due to a narrowing or blockage of your gullet (food pipe) or intestines)

·       if you have been told you have metabolic acidosis (a condition caused by increased acid levels in the blood)

·       if you are dehydrated (you may feel thirsty with a dry mouth)

·       if you have high blood potassium levels (which can cause an abnormal heartbeat)

·       if you suffer from a condition called hyporeninaemic hypoaldosteronism (where your body is low on an enzyme called renin and a hormone called aldosterone which normally helps to control your blood pressure)

·       if you are taking certain types of diuretics (water tablets); either potassium sparing diuretics (eg amiloride) or aldosterone antagonists (eg spironolactone and eplerenone)

if you are taking a potassium sparing diuretic (a specific type of water tablet) e.g. spironolactone or amiloride hydrochloride.
If you are taking a diurectic drug known as an aldosterone antagonist, e.g. eplerenone

·        

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severe vomiting, severe abdominal pains or flatulence, or gastro-intestinal haemorrhage, the preparation should be withdrawn at once, because in the presence of an obstruction it could conceivably give rise to ulceration or perforation (see also section 4.8 Undesirable effects).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.