Lanthanum carbonate 750 mg Chewable tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

LANTHANUM

Available from:

Mylan Ireland Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

ATC code:

V03AE03

INN (International Name):

LANTHANUM 750 mg

Pharmaceutical form:

CHEWABLE TABLET

Composition:

LANTHANUM 750 mg

Prescription type:

POM

Therapeutic area:

ALL OTHER THERAPEUTIC PRODUCTS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2020-12-17

Patient Information leaflet

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LANTHANUM CARBONATE 750 MG CHEWABLE TABLETS
lanthanum
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, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Lanthanum carbonate is and what it is used for
2.
What you need to know before you take Lanthanum carbonate
3.
How to take Lanthanum carbonate
4.
Possible side effects
5.
How to store Lanthanum carbonate
6.
Contents of the pack and other information
1.
WHAT LANTHANUM CARBONATE IS AND WHAT IT IS USED FOR
Lanthanum carbonate is used to lower the phosphate level in the blood
of adult patients with chronic kidney
disease.
Patients who have kidneys that do not work properly are not able to
control the level of phosphate in the
blood. The amount of phosphate in the blood then rises (your doctor
may call this hyperphosphataemia).
Lanthanum carbonate is a medicine which reduces the body's absorption
of phosphate from food by binding
with it in your digestive tract. Phosphate which have bonded to
lanthanum carbonate cannot be absorbed
through the intestinal wall.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LANTHANUM CARBONATE
DO NOT TAKE LANTHANUM CARBONATE:
-
if you are allergic to lanthanum carbonate or any of the other
ingredients of this medicine (listed in
section 6).
-
if you have too little phosphate in your blood (hypophosphataemia).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Lanthanum carbonate if
you know that you have, or have
had, any of the following conditions:
•
stomach or intestinal cancer,
•
in

Summary of Product characteristics

Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Lanthanum carbonate 750 mg Chewable tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 750 mg chewable tablet contains lanthanum carbonate octahydrate
equivalent to 750 mg lanthanum.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Chewable tablet.
750 mg chewable tablets:
White to off-white, round, flat-faced, bevelled-edge tablet, debossed
with ‘M’ on one side of the tablet and
‘
LC
’ over ‘
750
’ on the other side. Each tablet has approximately 17 mm of
diameter.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lanthanum carbonate is indicated in adult patients as a phosphate
binding agent for use in the control of
hyperphosphataemia in chronic renal failure patients on haemodialysis
or continuous ambulatory peritoneal
dialysis (CAPD).
Lanthanum carbonate 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
POSOLOGY
Lanthanum carbonate is for oral administration.
The tablets must be chewed completely and not swallowed whole. To aid
with chewing the tablets may be
crushed.
Other dosage forms are available in the market for patients who have
difficulty chewing the tablets.
_Adults, including elderly (> 65 years) _
Lanthanum carbonate should be taken with food or immediately after,
with the daily dose divided between
meals. Patients should adhere to recommended diets in order to control
phosphate and fluid intake.
Lanthanum carbonate is presented as a chewable tablet therefore
avoiding the need to take additional fluid.
Serum phosphate levels should be monitored and the dose of lanthanum
carbonate titrated every 2-3 weeks
until an acceptable serum phosphate levels is reached, with regular
monitoring thereafter.
Control of serum phosphate level has been demonstrated at doses
starting from 750 mg p