CAPTERO 150 TABLET

Χώρα: Νότια Αφρική

Γλώσσα: Αγγλικά

Πηγή: South African Health Products Regulatory Authority (SAHPRA)

Διαθέσιμο από:

Hetero Drugs South Africa (Pty) Ltd

Δοσολογία:

See ingredients

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

EACH TABLET CONTAINS CAPECITABINE 150,0 mg

Καθεστώς αδειοδότησης:

Registered

Φύλλο οδηγιών χρήσης

_Applicant/PHRC: HETERO DRUGS SOUTH AFRICA (PTY) LTD _
_ _
_Product proprietary name: CAPTERO _
_ _
_Dosage form and strength: EACH FILM COATED TABLET CONTAINS 150 MG AND
500 MG CAPECITABINE RESPECTIVELY_
Initial
01 September 2020 Page 1 of 14
APPROVED PATIENT INFORMATION LEAFLET FOR CAPTERO
WARNING
If you are taking warfarin (medicine used to treat and prevent blood
clots) along with CAPTERO
your doctor will monitor your prothrombin time (blood test that
measures the time it takes your
blood to clot) regularly and based on the blood test results, your
doctor may adjust the warfarin
dose.
SCHEDULING STATUS: S4
CAPTERO 150 film-coated tablets
CAPTERO 500 film-coated tablets
CAPECITABINE
Contains sugar (lactose)
CAPTERO 150: Each film-coated tablet contains 15,6 mg lactose.
CAPTERO 500: Each film-coated tablet contains 52 mg lactose.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU TAKE CAPTERO
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other health care
provider.
•
CAPTERO has been prescribed for you personally and you should not
share your medicine with
other people. It may harm them, even if their symptoms are the same as
yours.
WHAT IS IN THIS LEAFLET:
_Applicant/PHRC: HETERO DRUGS SOUTH AFRICA (PTY) LTD _
_ _
_Product proprietary name: CAPTERO _
_ _
_Dosage form and strength: EACH FILM COATED TABLET CONTAINS 150 MG AND
500 MG CAPECITABINE RESPECTIVELY_
Initial
01 September 2020 Page 2 of 14
1.
What CAPTERO is and what it is used for
2.
What you need to know before you take CAPTERO
3.
How to take CAPTERO
4.
Possible side effects
5.
How to store CAPTERO
6.
Contents of the pack and other information
1.
WHAT CAPTERO IS AND WHAT IT IS USED FOR
CAPTERO belongs to the group of medicines called cytostatic medicines,
which stop the growth of
cancer cells. CAPTERO contains capecitabine, which is not a cytostatic
medicine in itself. Only after
being absorbed in the body (more in tumour tissue than in normal
tissue) is it changed int

Αρχείο Π.Χ.Π.

_Applicant/PHRC: HETERO DRUGS SOUTH AFRICA (PTY) LTD _
_ _
_Product proprietary name: CAPTERO _
_ _
_Dosage form and strength: EACH FILM COATED TABLET CONTAINS 150 MG AND
500 MG CAPECITABINE RESPECTIVELY_
Initial
01 September 2020 Page 1 of 46
APPROVED PROFESSIONAL INFORMATION FOR CAPTERO
WARNING
CAPTERO-Warfarin interaction: Patients receiving concomitant
capecitabine and oral coumarin-
derivative anticoagulant therapy should have their anticoagulant
response (INR or prothrombin time)
monitored frequently in order to adjust the anticoagulant dose
accordingly. A clinically important
CAPTERO-Warfarin interaction was demonstrated in a clinical
pharmacology trail. Altered
coagulation parameters and/or bleeding, including death, have been
reported in patients taking
CAPTERO concomitantly with warfarin. Post-marketing reports have shown
clinically significant
increases in prothrombin time (PT) and INR in patients who were
stabilised on anticoagulants at the
time CAPTERO was introduced. These events occurred with several days
and up to several months
after initiating CAPTERO therapy and, in few cases, within one month
after stopping CAPTERO.
These events occurred in patients with and without liver metastases.
Age greater than 60 and a
diagnosis of cancer independently predispose patients to an increased
risk of coagulopathy.
SCHEDULING STATUS
S4
1.
NAME OF THE MEDICINE
CAPTERO 150 film-coated tablets
CAPTERO 500 film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
CAPTERO 150: Each film-coated tablet contains 150 mg capecitabine.
_Applicant/PHRC: HETERO DRUGS SOUTH AFRICA (PTY) LTD _
_ _
_Product proprietary name: CAPTERO _
_ _
_Dosage form and strength: EACH FILM COATED TABLET CONTAINS 150 MG AND
500 MG CAPECITABINE RESPECTIVELY_
Initial
01 September 2020 Page 2 of 46
CAPTERO 500: Each film-coated tablet contains 500 mg capecitabine.
_Excipient with known effect: _
Contains sugar (lactose)
CAPTERO 150: Each film-coated tablet contains 15,6 mg lactose.
CAPTERO 500: Each film-coated tablet contains 52 mg lact