Span K potassium chloride 600 mg tablet bottle (new formulation)

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

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Ladda ner Bipacksedel (PIL)
04-03-2020
Ladda ner Produktens egenskaper (SPC)
20-11-2020

Aktiva substanser:

potassium chloride, Quantity: 600 mg

Tillgänglig från:

Aspen Pharmacare Australia Pty Ltd

Läkemedelsform:

Tablet, modified release

Sammansättning:

Excipient Ingredients: macrogol 6000; ethylcellulose; cocoa powder; stearic acid; magnesium stearate; titanium dioxide; hypromellose; triacetin

Administreringssätt:

Oral

Enheter i paketet:

100 200 500 1000, bulk, 6 30 60 90

Receptbelagda typ:

(S4) Prescription Only Medicine

Terapeutiska indikationer:

Treatment of all types of potassium deficiencies, particularly hypochloraemic or hypokalaemic alkalosis associated with prolonged or intensive diuretic therapy, eg. in hypertension, cardiac failure or massive oedema (potassium replacement is particularly important to patients receiving digitalis, as the clinical response to this drug is seriously affected by hypokalaemia), in renal disease associated with increased potassium excretion eg. nephrotic syndrome; vomiting and diarrhoea, ulcerative colitis, steatorrhoea, diabetes insipidus, and uncontrolled diabetes mellitus; ileostomy or colostomy patients, cirrhosis; Cushing's syndrome and dietary insufficiency; during prolonged or intensive treatment with corticosteroids, ACTH or carbenoxolone; hyperaldosteronism in megaloblastic anaemia, during the early stages of treatment. Here Span-K is indicated if a diet rich in potassium cannot be guaranteed.

Produktsammanfattning:

Visual Identification: White film-coated tablet; Container Type: Bottle; Container Closure: Child resistant closure

Bemyndigande status:

Registered

Tillstånd datum:

2020-02-17

Bipacksedel

                                SPAN-K
1
SPAN-K
_Potassium chloride _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Span-K. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Span-K
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT SPAN-K IS USED
FOR
Span-K tablets are used to provide
extra potassium for people who have
lost potassium from their bodies
because of illness or treatment with
certain medicines. Span-K is also
used for people who do not have
enough potassium in their regular
diet or cannot replace the potassium
they have lost from their diet alone.
Potassium is essential for life and
health. Vegetables, potatoes and fruit
are good sources of dietary
potassium.
Too much potassium can be harmful.
That is why it is important to take
Span-K only as prescribed by your
doctor.
The dose of Span-K may need to be
adjusted if your diet is rich in natural
sources of potassium. However,
never change your dose without first
checking with your doctor.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY SPAN-K HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another purpose.
BEFORE YOU TAKE SPAN-
K
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE SPAN-K AND TALK TO
YOUR DOCTOR OR PHARMACIST IF:
1.
YOU HAVE AN ALLERGY TO IT OR TO
ANY OF THE INGREDIENTS LISTED AT
THE END OF THIS LEAFLET.
Some of the symptoms of an
allergic reaction may include
shortness of breath, wheezing or
difficulty breathing; swelling of
the face, lips or tongue; skin rash,
itching or hives.
2.
YOU HAVE ANY OF THE FOLLOWING
MEDICAL CONDITIONS:
•
Severe burns or other serious
injury
•
Kidney failure
•
Significant dehydration
•
Blockage in food passage,
stomach or gut
•
Untreated Addison's Di
                                
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Produktens egenskaper

                                1
AUSTRALIAN PRODUCT INFORMATION
SPAN K (POTASSIUM CHLORIDE) MODIFIED RELEASE TABLET
1
NAME OF THE MEDICINE
Potassium chloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Potassium chloride 600 mg (= potassium 8 mmol, chloride 8 mmol).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Tablets, modified release (white film-coated)
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Treatment of all types of potassium deficiencies, particularly
hypochloraemic or
hypokalaemic alkalosis, associated with prolonged or intensive
diuretic therapy, e.g. in
hypertension, cardiac failure or massive oedema (potassium replacement
is particularly
important to patients receiving digitalis, as the clinical response to
this drug is seriously
affected by hypokalaemia), in renal disease associated with increased
potassium excretion,
e.g. nephrotic syndrome; vomiting and diarrhoea, ulcerative colitis,
steatorrhoea, diabetes
insipidus, and uncontrolled diabetes mellitus; ileostomy or colostomy
patients, cirrhosis;
Cushing's syndrome and dietary insufficiency; during prolonged or
intensive treatment with
corticosteroids, ACTH or carbenoxolone; hyperaldosteronism in
megaloblastic anaemia,
during the early stages of treatment. Here Span-K is indicated if a
diet rich in potassium
cannot be guaranteed.
4.2
D
OSE AND METHOD OF ADMINISTRATION
An average dose is 1 or 2 tablets two or three times daily, each
tablet swallowed whole with
a little water, preferably during meals. Where Span-K is given
routinely with an average
daily maintenance dose of an oral diuretic, 1 or 2 tablets daily may
be sufficient.
4.3
C
ONTRAINDICATIONS

Severe tissue destruction including burns;

Advanced renal failure, untreated Addison's disease, acute
dehydration,
hyperkalaemia;

In the presence of obstruction in the digestive tract (e.g. resulting
from compression
of the oesophagus due to dilatation of the left atrium or from
stenosis of the gut);

History of allergic reaction to Span-K or any of the ingredients
                                
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