SLOW K Coated tablet (2020)

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Περιεχόμενα

1. Name of the medicinal product

Slow K 600mg Prolonged-release Coated Tablets.

2. Qualitative and quantitative composition

One sugar-coated tablet contains 600 mg potassium chloride as active substance equivalent to 8 mmol potassium ion (K+). Excipients: Each tablet contains 96.4mg sucrose. For a full list of excipients, ...

3. Pharmaceutical form

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

4.1. Therapeutic indications

For use in patients requiring supplemental potassium therapy. Uses include: Supplement to potassium depleting diuretics. Hypokalaemia associated with prolonged corticosteroid therapy. Where there ...

4.2. Posology and method of administration

It is important that the tablets should be swallowed whole, with fluid during meals, whilst the patient is sitting upright. General Populations The dosage of Slow-K should be adjusted to the individual ...

4.3. Contraindications

All forms of hyperkalaemia as may occur in marked renal failure (even when not yet associated with manifest hyperkalaemia), untreated Addisons disease, hyporeninaemic hypoaldosteronism, acute dehydration ...

4.4. Special warnings and precautions for use

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 ...

4.5. Interaction with other medicinal products and other forms of interaction

Observed Interactions resulting in a contraindication Potassium-sparing diuretics Concomitant treatment with potassium-sparing diuretics (spironolactone, triamterene, amiloride) is contraindicated (see ...

4.6. Fertility, pregnancy and lactation

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, ...

4.7. Effects on ability to drive and use machines

None known to date.

4.8. Undesirable effects

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 ...

4.9. Overdose

The clinical picture of acute overdosage (intoxication) with potassium is characterized chiefly by hyperkalemia together with cardiovascular and neuromuscular disturbances, which, in the presence of renal ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Potassium supplement ATC code: A12BA01 Potassium, as the most abundant intracellular cation, plays an essential role in several important physiological functions, ...

5.2. Pharmacokinetic properties

Absorption 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 ...

5.3. Preclinical safety data

Preclinical data do not support a special hazard for humans based on conventional studies of acute toxicity, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction. ...

6.1. List of excipients

Tablet Core: Cetostearyl alcohol Gelatin Magnesium stearate Tablet Coating: Spray-dried acacia Gelatin Titanium dioxide (E171) Purified talc special Sucrose granulated Dispersed buff 70753 ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Do not store above 30°C. Store in the original container. Keep the container tightly closed.

6.5. Nature and contents of container

Securitainer (PP) in packs of 500.

6.6. Special precautions for disposal and other handling

No special requirements.

7. Marketing authorization holder

Essential Pharma (M) Limited, Vision Exchange Building, Triq it-Territorjals, Zone 1, Central Business District, Birkirkara, CBD 1070, Malta

8. Marketing authorization number(s)

PA22644/002/001

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 17th February 1977 Date of last renewal: 17th February 2007

10. Date of revision of the text

September 2020

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