Velphoro 500mg chewable tablets

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

Wirkstoff:

Sucroferric oxyhydroxide

Verfügbar ab:

Vifor Fresenius Medical Care Renal Pharma UK Ltd

ATC-Code:

V03AE05

INN (Internationale Bezeichnung):

Sucroferric oxyhydroxide

Dosierung:

500mg

Darreichungsform:

Chewable tablet

Verabreichungsweg:

Oral

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Valid as a prescribable product

Produktbesonderheiten:

BNF: ; GTIN: 7640114723773

Gebrauchsinformation

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VELPHORO 500 MG CHEWABLE TABLETS
Iron as sucroferric oxyhydroxide
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 Velphoro is and what it is used for
2.
What you need to know before you take Velphoro
3.
How to take Velphoro
4.
Possible side effects
5.
How to store Velphoro
6.
Contents of the pack and other information
1.
WHAT VELPHORO IS AND WHAT IT IS USED FOR
Velphoro is a medicine that contains the active substance sucroferric
oxyhydroxide, which is made up
from iron, sugar (sucrose) and starches. One tablet of Velphoro
corresponds to 500 mg iron. Each
tablet also contains 750 mg sucrose and 700 mg starches.
Velphoro is for use by adult patients who undergo haemodialysis or
peritoneal dialysis (procedures to
eliminate toxic substances from the blood) because of chronic kidney
disease; it is used in order to
help control the phosphorus level in their blood when it is too high
(hyperphosphataemia).
Too much phosphorus in the blood can lead to calcium being deposited
in tissues (calcification). This
can result in stiffening of the blood vessels, making it harder for
the blood to be pumped around the
body. It may also lead to calcium deposits in soft tissues and bone
causing effects such as red eyes,
itchy skin and bone pain.
V

Fachinformation

OBJECT 1
VELPHORO 500 MG CHEWABLE TABLETS
Summary of Product Characteristics Updated 11-Apr-2018 | 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
Velphoro 500 mg chewable tablets
2. Qualitative and quantitative composition
Each chewable tablet contains 500 mg iron as sucroferric oxyhydroxide
also known as a mixture of
polynuclear iron(III)-oxyhydroxide, sucrose, and starches.
The active ingredient sucroferric oxyhydroxide contains 750 mg sucrose
and 700 mg starches.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Chewable tablet.
Brown, circular tablets embossed with PA500 on one side. Tablets have
a 20 mm diameter and a
thickness of 6.5 mm.
4. Clinical particulars
4.1 Therapeutic indications
Velphoro is indicated for the control of serum phosphorus levels in
adult chronic kidney disease (CKD)
patients on haemodialysis (HD) or peritoneal dialysis (PD).
Velphoro should be used within the context of a multiple therapeutic
approach, which could include
calcium supplement, 1,25-dihydroxy vitamin D3 or one of its analogues,
or calcimimetics to control the
development of renal bone disease.
4.2 Posology and method of administration
Posology
_Starting dose _
The recommended starting dose of Velphoro is 1,500 mg iron (3 tablets)
per day, divided across the meals
of the day. Velphoro is for oral administration only and must be taken
with meals.
Patients receiving Velphoro should adhere to their prescribed diets.
_Titration and maintenance _
Serum phosphorus levels must be monitored and the dose of Velphoro up
or down titrated in increments
of 500 mg iron (1 tablet) per day every 2-4 weeks until an acceptable
serum phosphorus level is reached,
with regular monitoring afterwards.
In clinical practice, treatment wil