FOSRENOL 500 MG CHEWABLE TABLETS

Pays: Israël

Langue: anglais

Source: Ministry of Health

Ingrédients actifs:

LANTHANUM AS CARBONATE HYDRATE

Disponible depuis:

TAKEDA ISRAEL LTD

Code ATC:

V03AE03

forme pharmaceutique:

CHEWABLE TABLETS

Composition:

LANTHANUM AS CARBONATE HYDRATE 500 MG

Mode d'administration:

PER OS

Type d'ordonnance:

Required

Fabriqué par:

SHIRE PHARMACEUTICAL CONTRACTS LTD, UK

Groupe thérapeutique:

LANTHANUM CARBONATE

Domaine thérapeutique:

LANTHANUM CARBONATE

indications thérapeutiques:

Fosrenol is indicated as a phosphate binding agent for use in the control of hyperphosphatemia in CRF patients on haemodyalisis or continuous ambulatory peritoneal dialysis (CAPD).Fosrenol is also indicated in adult patients with chronic kidney disease not on dialysis with serum phosphate levels > or = 1.78 mmol/L in whom a low phosphate diet alone is insufficient to control serum phosphate levels.

Date de l'autorisation:

2014-04-30

Notice patient

-
Regulations (Preparations)
Patient leaflet in accordance with the Pharmacists'
1986
This medicine is dispensed with physician’s prescription only
Fosrenol
®
500 mg chewable tablets
Fosrenol
®
750 mg chewable tablets
Fosrenol
®
1000 mg chewable tablets
Each chewable tablet contains 500 mg; 750 mg; 1000 mg of the active
ingredient
lanthanum (as carbonate hydrate), respectively.
Inactive ingredients and allergens: See section 2 "Important
information about some
of this medicine’s ingredients" and section 6 ("Additional
information") in this leaflet.
Read the entire leaflet carefully before you start using this
medicine. This leaflet
contains concise information about this medicine. If you have any
further questions,
consult your physician or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It
may harm them, even if it seems to you that their illness is similar
to yours.
This medicine is not intended for users under the age of 18. The
safety and efficacy of
Fosrenol in children below the age of 18 years has not been examined.
Attention: Do not swallow! You must chew the tablet completely.
It is important to take the medicine with or immediately after a meal.
Inform your physician if you need to undergo X-ray imaging, as use of
Fosrenol may
affect the results.
1. What is this medicine intended for?
The
medicine
is
indicated
for
reduction
of
high
blood
phosphate
levels
(hyperphosphataemia) in chronic renal failure patients on
haemodialysis or ambulatory
peritoneal dialysis. The medicine is also indicated for patients with
chronic kidney
disease not on dialysis with high serum phosphate levels (greater than
1.78 mmol/L),
which are not controlled by low phosphate diet alone.
Therapeutic activity: Fosrenol binds phosphate originating from food
in the intestine.
Phosphate bound in such manner cannot be absorbed in the body; thus,
Fosrenol
assists in reduction of blood phosphate level.
Therapeutic group: medicines for treatment of hyperkalaemia and
hyperphosphatemia.

Résumé des caractéristiques du produit

SUMMARY OF THE PRODUCT CHARACTERISTICS
1
N
AME OF THE
M
EDICINAL
P
RODUCT
Fosrenol 500 mg chewable tablets
Fosrenol 750 mg chewable tablets
Fosrenol 1000 mg chewable tablets
2
Q
UALITATIVE AND
Q
UANTITATIVE
C
OMPOSITION
Fosrenol 500 mg chewable tablets:
Each chewable tablet contains lanthanum carbonate hydrate
corresponding to 500 mg lanthanum.
Fosrenol 750 mg chewable tablets:
Each chewable tablet contains lanthanum carbonate hydrate
corresponding to 750 mg lanthanum
Fosrenol 1000 mg chewable tablets:
Each chewable tablet contains lanthanum carbonate hydrate
corresponding to 1000 mg lanthanum.
Excipient(s) with known effect
Fosrenol
500
mg chewable tablets:
Chewable tablets
also contain on average
1066 mg
of dextrates, containing glucose.
Fosrenol 750 mg chewable tablets:
Chewable tablets also contain on average 1599 mg of dextrates,
containing glucose.
Fosrenol 1000 mg chewable tablets:
Chewable tablets also contain on average 2132 mg of dextrates,
containing glucose.
For the full list of excipients, see section 6.1.
3
P
HARMACEUTICAL
F
ORM
Chewable tablet.
Fosrenol 500 mg chewable tablets:
White, round, 18mm, bevelled-edge flat tablets debossed with
‘S405/500’ on one side.
Fosrenol 750 mg chewable tablets:
White, round, 20mm, bevelled-edge flat tablets debossed with
‘S405/750’ on one side.
Fosrenol 1000 mg chewable tablets:
White, round, 22mm, bevelled-edge flat tablets debossed with
‘S405/1000’ on one side.
4
C
LINICAL
P
ARTICULARS
4.1
Therapeutic indications
Fosrenol is indicated as a phosphate binding agent for use in the
control of hyperphosphataemia in
chronic renal failure (CRF) patients on haemodialysis or continuous
ambulatory peritoneal dialysis
(CAPD). Fosrenol is also indicated in adult patients with chronic
kidney disease not on dialysis with
serum phosphate levels

1.78 mmol/L in whom a low phosphate diet alone is insufficient to
control
serum phosphate levels.
4.2
Posology and method of administration
Fosrenol is for oral administration.
The tablets must be chewed completely and no