Slow K 600mg Prolonged-release Coated Tablets

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

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Vara einkenni Vara einkenni (SPC)
14-11-2020

Virkt innihaldsefni:

Potassium chloride

Fáanlegur frá:

Essential Pharma (M) Limited

ATC númer:

A12BA; A12BA01

INN (Alþjóðlegt nafn):

Potassium chloride

Skammtar:

600 milligram(s)

Lyfjaform:

Prolonged-release tablet

Lækningarsvæði:

Potassium; potassium chloride

Leyfisstaða:

Not marketed

Leyfisdagur:

2016-05-26

Upplýsingar fylgiseðill

                                Slo600mgTab-LPL-IE-4
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Package Leaflet: information for the user
SLOW-K
®
600 MG
PROLONGED-RELEASE COATED TABLETS
POTASSIUM CHLORIDE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if their symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side
effects not listed in this
leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET
1. What Slow-K is and what it is used for
2. Before you take Slow-K
3. How to take Slow-K
4. Possible side effects
5. How to store Slow-K
6. Further information
1
WHAT SLOW-K IS AND WHAT IT IS USED FOR
The name of your medicine is Slow-K 600mg Prolonged-release Coated
Tablets (called Slow-K in
this leaflet). It contains a medicine called potassium chloride. It
has a special slow-release system
that releases your medicine evenly throughout the day.
Slow-K is used to treat or prevent low levels of potassium in your
body. This might be because:

you have sickness or diarrhoea

you are using certain medicines

you have a kidney or gut problem

you have certain metabolic diseases

you do not get enough potassium from your normal diet

you have an illness that runs in your family (genetic disease)
Slow-K is usually used in people who cannot take potassium chloride as
a liquid or tablet that
dissolves.
Slo600mgTab-LPL-IE-4
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2
BEFORE YOU TAKE SLOW K
DO NOT TAKE SLOW-K IF:

you are allergic to potassium chloride or any of the other ingredients
of this medicine (listed in
Section 6)

you have kidney failure

you have severe or long-lasting diarrhoea

you have untreated Addison’s Syndrome (underactive adrenal glands)

you have a hormone problem called “hypo-aldosteronism”

any part of your food pipe, stomach or gut has a narrowing in it
(called a “strict
                                
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Vara einkenni

                                Health Products Regulatory Authority
13 November 2020
CRN00C15N
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
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, see section 6.1, list of excipients.
3 PHARMACEUTICAL FORM
Coated tablet
Pale orange, round, biconvex, polished sugar-coated tablets.
4 CLINICAL PARTICULARS
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 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.
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 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 hypo
                                
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