Foznol 1000 mg Oral Powder

Country: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

Lanthanum carbonate hydrate

থেকে পাওয়া:

Takeda Pharmaceuticals International AG Ireland Branch

এটিসি কোড:

V03AE; V03AE03

INN (International Name):

Lanthanum carbonate hydrate

ডোজ:

1000 milligram(s)

ফার্মাসিউটিকাল ফর্ম:

Oral powder

Therapeutic area:

Drugs for treatment of hyperkalemia and hyperphosphatemia; lanthanum carbonate

অনুমোদন অবস্থা:

Not marketed

অনুমোদন তারিখ:

2012-05-11

তথ্য লিফলেট

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FOZNOL 750 MG ORAL POWDER
FOZNOL 1000 MG ORAL POWDER
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Foznol is and what it is used for
2.
What you need to know before you take Foznol
3.
How to take Foznol
4.
Possible side effects
5.
How to store Foznol
6.
Contents of the pack and other information
1.
WHAT FOZNOL IS AND WHAT IT IS USED FOR
Foznol 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).
Foznol is a medicine which reduces the body's absorption of phosphate
from food by binding with it in
your digestive tract. Phosphate which has bonded to Foznol cannot be
absorbed through the intestinal
wall.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FOZNOL
DO NOT TAKE FOZNOL
•
if you are allergic to lanthanum carbonate hydrate 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 Foznol if you know
that you have or have had any of
the following:
•
stomach or intestinal cancer
•
inflammatory bowel disease including ulcerative colitis or Crohn’s
disease
•
abdominal surgery, or infection or inflammation of the abdomen/bowel
(perito

পণ্য বৈশিষ্ট্য

Health Products Regulatory Authority
06 October 2023
CRN00D8S6
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Foznol 1000 mg Oral Powder
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains 750 mg lanthanum (as lanthanum carbonate
hydrate).
Each sachet contains 1000 mg lanthanum (as lanthanum carbonate
hydrate).
Excipient with known effect
750 mg: Each sachet also contains 641.7 mg dextrates, containing
glucose.
1000 mg: Each sachet also contains 855.6 mg dextrates, containing
glucose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral powder.
White to off-white powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Foznol 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). Foznol is also indicated in adult
patients with chronic kidney disease not on dialysis with serum
phosphate levels ³ 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
Foznol is for oral administration.
Foznol oral powder is intended to be mixed with a small quantity of
soft food (e.g., applesauce or other similar food product)
and consumed immediately (within 15 minutes). The sachet must not be
opened until ready to use. Once mixed with food,
Foznol oral powder must not be stored for future use. Foznol oral
powder is insoluble and must not be dissolved in liquid for
administration.
_Adults, including elderly (> 65 years)_
Foznol should be taken with or immediately after food, with the daily
dose divided between meals. Patients should adhere to
recommended diets in order to control phosphate and fluid intake.
Foznol is presented as an oral powder intended to be
mixed with soft food, therefore avoiding the need to take additional
fluid. Serum phosphate levels should be monitored and
the dose of Foznol titrated every 2 to 3 weeks u