Lokelma
Country: European Union
Language: English
Source: EMA (European Medicines Agency)
Patient Information leaflet
(PIL)
11-01-2024
Summary of Product characteristics
(SPC)
11-01-2024
Public Assessment Report
(PAR)
05-04-2018
Active ingredient:
sodium zirconium cyclosilicate
Available from:
AstraZeneca AB
ATC code:
V03AE10
INN (International Name):
sodium zirconium cyclosilicate
Therapeutic group:
All other therapeutic products
Therapeutic area:
Hyperkalemia
Therapeutic indications:
Lokelma is indicated for the treatment of hyperkalaemia in adult patients.
Product summary:
Revision: 9
Authorization status:
Authorised
Authorization date:
2018-03-22
Patient Information leaflet
25
B. PACKAGE LEAFLET
26
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LOKELMA 5 G POWDER FOR ORAL SUSPENSION
LOKELMA 10 G POWDER FOR ORAL SUSPENSION
sodium zirconium cyclosilicate
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 any further questions, ask your doctor, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Lokelma is and what it is used for
2.
What you need to know before you take Lokelma
3.
How to take Lokelma
4.
Possible side effects
5.
How to store Lokelma
6.
Contents of the pack and other information
1. WHAT LOKELMA IS AND WHAT IT IS USED FOR
Lokelma contains the active substance sodium zirconium cyclosilicate.
Lokelma is used to treat hyperkalaemia in adults. Hyperkalaemia means
that there is a high level of
potassium in the blood.
Lokelma lowers the high levels of potassium in your body and helps to
keep it at a normal level. As
Lokelma passes through your stomach and gut it attaches to potassium
and the two are carried together
out of the body in your stools, lowering the amount of potassium in
the body.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LOKELMA
DO NOT TAKE LOKELMA
If you are allergic to the active substance.
WARNINGS AND PRECAUTIONS
Monitoring
Your doctor or nurse will check your blood potassium level when you
start taking this medicine:
This is to make sure you are getting the correct dose. The dose may be
raised or lowered based
on your blood potassium level.
Treatment may be stopped if your blood potassium level becomes too
low.
Tell your doctor or nurse if you are taking any medicines which can
change your blood
potassium lev
Read the complete document
Summary of Product characteristics
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Lokelma 5 g powder for oral suspension
Lokelma 10 g powder for oral suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lokelma 5 g powder for oral suspension
Each sachet contains 5 g sodium zirconium cyclosilicate
Each 5 g sachet contains approximately 400 mg sodium.
Lokelma 10 g powder for oral suspension
Each sachet contains 10 g sodium zirconium cyclosilicate
Each 10 g sachet contains approximately 800 mg sodium.
3.
PHARMACEUTICAL FORM
Powder for oral suspension
White to grey powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lokelma is indicated for the treatment of hyperkalaemia in adult
patients (see section 4.4 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Correction phase _
The recommended starting dose of Lokelma is 10 g, administered three
times a day orally as a
suspension in water. When normokalaemia is achieved, the maintenance
regimen should be followed
(see below).
Typically, normokalaemia is achieved within 24 to 48 hours. If
patients are still hyperkalaemic after
48 hours of treatment, the same regimen can be continued for an
additional 24 hours. If
normokalaemia is not achieved after 72 hours of treatment, other
treatment approaches should be
considered.
_Maintenance phase_
When normokalaemia has been achieved, the minimal effective dose of
Lokelma to prevent recurrence
of hyperkalaemia should be established. A starting dose of 5 g once
daily is recommended, with
possible titration up to 10 g once daily, or down to 5 g once every
other day, as needed, to maintain a
normal potassium level. No more than 10 g once daily should be used
for maintenance therapy.
Serum potassium levels should be monitored regularly during treatment
(see section 4.4).
_Missed dose_
If a patient misses a dose they should be instructed to take the next
usual dose at their normal time.
3
_Special populations_
_Patients with renal impairment_
No changes from the normal doses are required for patients with renal
impai
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