Slow-K 600mg tablets

Negara: Inggris

Bahasa: Inggris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Unduh Selebaran informasi (PIL)
01-02-2015
Unduh Karakteristik produk (SPC)
30-09-2019

Bahan aktif:

Potassium chloride

Tersedia dari:

Lexon (UK) Ltd

Kode ATC:

A12BA01

INN (Nama Internasional):

Potassium chloride

Dosis:

600mg

Bentuk farmasi:

Modified-release tablet

Rute administrasi :

Oral

Kelas:

No Controlled Drug Status

Jenis Resep:

Valid as a prescribable product

Ringkasan produk:

BNF: 09020101

Selebaran informasi

                                Artwork Information
Product Title:
Slow-K PIL
Date:
Product Size:
140mm x 333mm
Label Number:
Colours Used:
Black
Fonts Used:
Helvetica Condensed
Font size (min):
9pt
23-03-15
15-008, 15-009, 15-010
Version 5
PATIENT INFORMATION LEAFLET
SLOW-K
® 600 MG PROLONGED-RELEASE TABLETS
potassium chloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told you.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible 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
Slow-K belongs to a group of medicines called potassium supplements.
Slow-K contains potassium and is used to treat or prevent low levels
of potassium in your body. Slow-K tablets are
prolonged-release tablets which means that the potassium is released
slowly from the tablet.
Whilst on this medicine your doctor will want to measure your blood
levels of potassium on a regular basis.
2. WHAT YOU NEED TO KNOW 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)
•
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
                                
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Karakteristik produk

                                SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Slow-K 600mg prolonged-release tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 600mg potassium chloride as active substance
equivalent to 8
mmol potassium ion (K
+
).
Excipients with known effect:
Sucrose 96.425mg.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Prolonged-release tablet.
Pale orange, round, biconvex, sugar-coated tablets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The correction and/or prevention of hypokalaemia in those patients who
cannot
tolerate and/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
For oral administration.
Slow-K is advised to be given with meals to minimize gastric
irritation.
It is important that the tablets should be swallowed whole, with
fluid, whilst the
patient is sitting upright.
_Adults:_
The dosage of Slow-K should be adapted to the cause, degree and
duration of
potassium depletion. 2 to 3 tablets daily are usually an adequate
supplement. In
states of severe potassium deficiency, a higher dose of 9 to 12
tablets daily may be
needed.
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 hypokalaemia has been corrected.
_Renal impairment: _
In patients with a Glomerular Filtration Rate (GFR) <60mL/min, Slow K
should be
given with extreme caution, with frequent serum potassium monitoring
due to
increased risk of hyperkalaemia. Slow-K is contraindicated in patients
with a GFR
<20mL/min (see also section 4.3 Contraindications).
_Hepatic impairment: _
No studies have been performed in hepatically impaired patients.
_Paediatric population:_
                                
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