Slow-K

Pajjiż: Malta

Lingwa: Ingliż

Sors: Medicines Authority

Ixtrih issa

Ingredjent attiv:

POTASSIUM CHLORIDE

Disponibbli minn:

Novartis Pharmaceuticals UK Limited Frimley Business Park, Frimley Camberley, Surrey GU16 7SR, United Kingdom

Kodiċi ATC:

A12BA01

INN (Isem Internazzjonali):

POTASSIUM CHLORIDE 600 mg

Għamla farmaċewtika:

TABLET

Kompożizzjoni:

POTASSIUM CHLORIDE 600 mg

Tip ta 'preskrizzjoni:

POM

Żona terapewtika:

MINERAL SUPPLEMENTS

L-istatus ta 'awtorizzazzjoni:

Withdrawn

Data ta 'l-awtorizzazzjoni:

2005-12-22

Fuljett ta 'informazzjoni

                                PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SLOW-K
®
600 MG TABLETS
Potassium chloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU
-
Keep this leaflet. You may need to read it again.
-
If you have further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may
harm them, even if their signs of illness are the same as yours.
-
If you get any side effects talk to your doctor or pharmacist. This
includes any side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1
What Slow-K
®
is and what it is used for
2
What you need to know before you take Slow-K
3
How to take Slow-K
4
Possible side effects
5
How to store Slow-K
6
Contents of the pack and other information
1
WHAT SLOW-K IS AND WHAT IT IS USED FOR
WHAT SLOW-K IS
Slow-K is available as 600 mg sugar-coated sustained release tablets
containing potassium
chloride.
WHAT SLOW-K IS USED FOR
Slow-K
is
intended
for
oral
potassium
supplementation
to
correct
or
prevent
lack
of
potassium in the blood.
Potassium supplements may be needed by patients who do not take enough
potassium in their
regular diet or who have lost too much potassium because of illnesses
like diarrhoea, renal or
intestinal diseases, muscle paralysis, anaemia or certain metabolic
diseases or treatment with
certain medicines.
Slow-K
is
indicated
in
those
patients
who
cannot
tolerate
or refuse to take liquid or
effervescent potassium chloride.
HOW SLOW-K WORKS
Slow-K
is
a
sustained-release
formulation
containing
potassium
chloride
(KCl).
This
formulation controls the release of KCl so that adequate amounts of
KCl are available in your
body throughout the day. Potassium is fundamentally involved in many
body processes, such
as fluid balance, acid-alkali balance, protein synthesis, nerve
conduction, energy production,
muscle contraction, synthesis of nucleic acids and control of
heartbeat and kidney function.
MONITORING DURING YOUR T
                                
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                                Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
SLOW-K
®
600 mg sugar-coated sustained release 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
+
).
3
PHARMACEUTICAL FORM
Slow-K 600 mg sugar-coated tablets are a prolonged-release dosage form
for oral administration.
Tablets
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Slow-K is indicated for the correction and/or prevention of
hypokalaemia in patients who cannot
tolerate or refuse to take liquid or effervescent potassium chloride,
or when there is a problem of
compliance with these preparations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
GENERAL RULES
The usual dietary intake of potassium by the average adult is 50 to
100 mmol per day. As a rule,
potassium depletion sufficient to cause hypokalemia does not occur
until at least 200 mmol of
potassium has been lost from the total body store.
Dosage must be adjusted to the individual needs of each patient and to
the cause and degree of the
manifest or potential hypokalaemic state. Where intermittent diuretic
therapy is being used, it is
advisable to give Slow-K on the intervening days between
administration of the diuretic.
The sugar-coated tablets must not be crushed, chewed, or sucked, but
should be swallowed whole
during meals with an adequate amount of fluid while the patient is
sitting upright. If the dosage
exceeds 20 mmol K
+
, it should be taken in divided doses, so that not more than 20 mmol
is given in
a single dose.
GENERAL POPULATION
Adults
Depending on the patient’s individual needs, a daily dosage of 2 to
3 sugar-coated tablets (16 to 24
mmol K
+
) should generally suffice to prevent hypokalaemia.
When correcting hypokalemia, doses of 40 to 50 up to 100 mmol K
+
(corresponding to 5 to 6 up to
12 sugar-coated tablets) may be required, depending on the initial
plasma
K
+
concentration.
Page 2 of 9
Treatment response should preferably be monitored by
                                
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