Onsenal
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
06-04-2011
Charakterystyka produktu
(SPC)
06-04-2011
Sprawozdanie z oceny publicznego
(PAR)
06-04-2011
Składnik aktywny:
Celecoxib
Dostępny od:
Pfizer Limited
Kod ATC:
L01XX33
INN (International Nazwa):
celecoxib
Grupa terapeutyczna:
Antineoplastic agents
Dziedzina terapeutyczna:
Adenomatous Polyposis Coli
Wskazania:
Onsenal is indicated for the reduction of the number of adenomatous intestinal polyps in familial adenomatous polyposis (FAP), as an adjunct to surgery and further endoscopic surveillance (see section 4.4).The effect of Onsenal-induced reduction of polyp burden on the risk of intestinal cancer has not been demonstrated (see sections 4.4 and 5.1)
Podsumowanie produktu:
Revision: 13
Status autoryzacji:
Withdrawn
Data autoryzacji:
2003-10-17
Ulotka dla pacjenta
43
B. PACKAGE LEAFLET
Medicinal product no longer authorised
44
PACKAGE LEAFLET: INFORMATION FOR THE USER
ONSENAL 200 MG HARD CAPSULES
CELECOXIB
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
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. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET
:
1.
What Onsenal is and what it is used for
2.
Before you take Onsenal
3.
How to take Onsenal
4.
Possible side effects
5.
How to store Onsenal
6.
Further information
1.
WHAT ONSENAL IS AND WHAT IT IS USED FOR
Onsenal belongs to a group of medicines called cyclo-oxygenase-2
(COX-2) inhibitors.
Cyclo-oxygenase-2 is an enzyme that increases at inflammatory sites
and in abnormally growing cells.
Onsenal works by inhibiting COX-2, to which such dividing cells are
sensitive. As a consequence the
cells die.
Onsenal is used to reduce the number of gastrointestinal polyps in
patients with Familial Adenomatous
Polyposis (FAP). FAP is an inherited disorder in which the rectum and
colon are covered with many
polyps that might develop colorectal cancer. Onsenal should be used
along with the usual care for FAP
patients such as surgery and endoscopic surveillance.
2.
BEFORE YOU TAKE ONSENAL
DO NOT TAKE ONSENAL
-
if you have had an allergic reaction to any of the ingredients of
Onsenal
-
if you have had an allergic reaction to a group of medicines called
“sulphfonamides”. These
include some antibiotics (Bactrim and Septra used in combination of
sulfamethoxazole and
trimethoprim), which can be used to treat infections
-
if you have a stomach or duodenal ulcer, or bleeding in the stomach or
intestines
-
if after taking aspirin or another anti-inflammatory
medicine you have had nasal polyps or
severe n
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Charakterystyka produktu
1
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Onsenal 200 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 200 mg of celecoxib.
Excipients: Lactose Monohydrate 49.8 mg For a full list of excipients,
see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
White, opaque capsules with two gold bands marked 7767 and 200.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Onsenal is indicated for the reduction of the number of adenomatous
intestinal polyps in familial
adenomatous polyposis (FAP), as an adjunct to surgery and further
endoscopic surveillance (see
section 4.4).
The effect of Onsenal-induced reduction of polyp burden on the risk of
intestinal cancer has not been
demonstrated (see sections 4.4 and 5.1)
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The recommended oral dose is two 200 mg capsules twice per day, taken
with food (see section 5.2).
Usual medical care for FAP patients should be continued while on
celecoxib. The maximum
recommended daily dose is 800 mg.
_Hepatic impairment_
: In patients with moderate hepatic impairment (serum albumin of 25-35
g/l), the
daily recommended dose of celecoxib should be reduced by 50% (see
sections 4.3 and 5.2). Caution
should be used as there is no experience in such patients at doses
higher than 200 mg.
_ _
_Renal impairment:_
Experience with celecoxib in patients with mild or moderate renal
impairment is
limited, therefore such patients should be treated with caution (see
sections 4.3, 4.4 and 5.2).
_ _
_Paediatric patients:_
Experience with celecoxib in FAP patients below the age of 18 years is
limited to
a single pilot study in a very small population, in which patients
were treated with celecoxib at doses
up to 16 mg/kg daily, which corresponds to the recommended adult FAP
dose of 800 mg daily (see
section 5.1).
_CYP2C9 Poor Metabolizers:_
Patients who are known or suspected to be CYP2C9 poor
metabolizers based on genotyping or previous history/experience w
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