Veltassa 8.4g oral powder sachets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Patiromer sorbitex calcium

Available from:

Vifor Pharma UK Ltd

ATC code:

V03AE09

INN (International Name):

Patiromer sorbitex calcium

Dosage:

8.4gram

Pharmaceutical form:

Powder

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF:

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VELTASSA 8.4 G POWDER FOR ORAL SUSPENSION
VELTASSA 16.8 G POWDER FOR ORAL SUSPENSION
VELTASSA 25.2 G POWDER FOR ORAL SUSPENSION
patiromer (as patiromer sorbitex calcium)
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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 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 possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Veltassa is and what it is used for
2.
What you need to know before you take Veltassa
3.
How to take Veltassa
4.
Possible side effects
5.
How to store Veltassa
6.
Contents of the pack and other information
1.
WHAT VELTASSA IS AND WHAT IT IS USED FOR
Veltassa is a medicine that contains the active substance patiromer.
Veltassa is used to treat adults with high levels of potassium in
their blood.
Too much potassium in the blood can affect how your nerves control
your muscles. This can lead to
weakness or even paralysis. High potassium levels can also result in
an abnormal heartbeat, which can
cause serious effects on your heart rhythm.
Veltassa works by attaching to potassium in your gut. This prevents
potassium from entering your
bloodstream and lowers potassium levels in your blood back to normal.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VELTASSA
DO NOT TAKE VELTASSA
•
if you are allergic to patiromer or any of the other ingredients of
this medicine (listed in
section 6).
2
WARNINGS AND PRECAUTIONS
Tal

Summary of Product characteristics

OBJECT 1
VELTASSA (PATIROMER)
Summary of Product Characteristics Updated 07-Aug-2017 | Vifor
Fresenius Medical Care Renal Pharma
UK Ltd
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1. Name of the medicinal product
Veltassa 8.4 g powder for oral suspension
Veltassa 16.8 g powder for oral suspension
Veltassa 25.2 g powder for oral suspension
2. Qualitative and quantitative composition
Each sachet contains 8.4 g patiromer (as patiromer sorbitex calcium)
Each sachet contains 16.8 g patiromer (as patiromer sorbitex calcium)
Each sachet contains 25.2 g patiromer (as patiromer sorbitex calcium)
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for oral suspension.
Off white to light brown powder, with occasional white particles.
4. Clinical particulars
4.1 Therapeutic indications
Veltassa is indicated for the treatment of hyperkalaemia in adults.
4.2 Posology and method of administration
Posology
The recommended starting dose is 8.4 g patiromer once daily.
The daily dose may be adjusted in intervals of one week or longer,
based on the serum potassium level
and the desired target range. The daily dose may be increased or
decreased by 8.4 g as necessary to reach
the desired target range, up to a maximum dose of 25.2 g daily. If
serum potassium falls below the desired
range, the dose should be reduced or discontinued.
If a dose is missed, the missed dose should be taken as soon as
possible on the same day. The missed dose
should not be taken with the next dose.
Administration of Veltassa should be separated by 3 hours from other
oral medicinal products (see section
4.5).
The onset of action of Veltassa occurs 4 – 7 hours after
administration. Veltassa should not replace
emergency treatment for life threatening hyperkalaemia.
_Patients on dialysis_
There is limited data on the use of Ve