Fexeric
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
09-10-2019
Charakterystyka produktu
(SPC)
09-10-2019
Sprawozdanie z oceny publicznego
(PAR)
02-10-2015
Składnik aktywny:
ferric citrate coordination complex
Dostępny od:
Akebia Europe Limited
Kod ATC:
V03AE
INN (International Nazwa):
ferric citrate coordination complex
Grupa terapeutyczna:
Drugs for treatment of hyperkalaemia and hyperphosphataemia
Dziedzina terapeutyczna:
Hyperphosphatemia; Renal Dialysis
Wskazania:
Fexeric is indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease (CKD).
Podsumowanie produktu:
Revision: 2
Status autoryzacji:
Withdrawn
Data autoryzacji:
2015-09-23
Ulotka dla pacjenta
20
B. PACKAGE LEAFLET
21
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FEXERIC 1 G FILM-COATED TABLETS
ferric citrate coordination complex
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 Fexeric is and what it is used for
2.
What you need to know before you take Fexeric
3.
How to take Fexeric
4.
Possible side effects
5.
How to store Fexeric
6.
Contents of the pack and other information
1.
WHAT FEXERIC IS AND WHAT IT IS USED FOR
Fexeric
contains ferric citrate coordination complex as the active ingredient.
In adults with impaired
kidney function it is used to lower high blood phosphorus levels.
Phosphorus is contained in many foods. Patients with kidneys that do
not work properly are not able to
eliminate phosphorus from their body adequately. This can lead to high
phosphorus levels in the
blood. Keeping the phosphorus level normal is important to maintain
healthy bones and blood vessels
and to prevent itchy skin, red eyes, bone pain or bone fractures.
Fexeric
binds to the phosphorus from food in your digestive tract to prevent
it from being absorbed
into your blood. The Fexeric
-
bound phosphorus is then excreted from your body in faeces.
You may have been advised to follow a special diet to prevent the
phosphorus in your blood rising to
high levels. If this is the case, y
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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
Fexeric 1 g film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 1 g of ferric citrate coordination
complex (equivalent to 210 mg of
ferric iron).
Excipients with known effect:
Each film-coated tablet contains sunset yellow FCF (E110) (0.99 mg)
and Allura Red AC (E129)
(0.70 mg).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Peach-coloured, oval shaped, film-coated tablet, embossed with
“KX52”. Tablets are 19 mm long,
7.2 mm thick and 10 mm wide.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fexeric is indicated for the control of hyperphosphataemia in adult
patients with chronic kidney
disease (CKD).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Starting dose_
_ _
The recommended starting dose of Fexeric is 3 to 6 g (3 to 6 tablets)
per day based on serum
phosphorus levels.
CKD patients who are not on dialysis require the lower starting dose,
3 g (3 tablets) per day.
Fexeric must be taken in divided doses with or immediately after meals
of the day.
_ _
Patients previously on other phosphate binders who are switched to
Fexeric should start taking 3 to 6 g
(3 to 6 tablets) per day.
Patients receiving this medicine should adhere to their prescribed low
phosphate diets.
_Dose titration_
_ _
Serum phosphorus concentrations should be monitored within 2 to 4
weeks of starting or changing the
dose of Fexeric, and approximately every 2-3 months when stable. The
dose can be increased or
3
decreased by 1 to 2 g (1 to 2 tablets) per day at 2- to 4-week
intervals as needed to maintain serum
phosphorus at recommended target levels up to a maximum of 12 g (12
tablets) per day.
There are li
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