Genox

국가: 뉴질랜드

언어: 영어

출처: Medsafe (Medicines Safety Authority)

유효 성분:

Tamoxifen citrate 30.4mg equivalent to tamoxifen 20 mg;  

제공처:

Viatris Limited

INN (International Name):

Tamoxifen citrate 30.4 mg (=tamoxifen 20 mg)

복용량:

20 mg

약제 형태:

Tablet

구성:

Active: Tamoxifen citrate 30.4mg equivalent to tamoxifen 20 mg   Excipient: Croscarmellose sodium Magnesium stearate Maize starch Mannitol

패키지 단위:

Blister pack, 30 tablets

수업:

Prescription

처방전 유형:

Prescription

Manufactured by:

Olon SpA

치료 징후:

Indicated for the treatment of breast cancer

제품 요약:

Package - Contents - Shelf Life: Blister pack, PVC/Al (white opaque) - 30 tablets - 60 months from date of manufacture stored at or below 25°C protect from light - Blister pack, Al/PVC (transparent green) - 30 tablets - 60 months from date of manufacture stored at or below 25°C protect from light - Blister pack, PVC/Al (white opaque) - 60 tablets - 60 months from date of manufacture stored at or below 25°C protect from light - Blister pack, Al/PVC (transparent green) - 60 tablets - 60 months from date of manufacture stored at or below 25°C protect from light - Blister pack, PVC/Al (white opaque) - 100 tablets - 60 months from date of manufacture stored at or below 25°C protect from light - Blister pack, Al/PVC (transparent green) - 100 tablets - 60 months from date of manufacture stored at or below 25°C protect from light

승인 날짜:

1985-07-18

환자 정보 전단

Page 1 of 4
NEW ZEALAND CONSUMER MEDICINE INFORMATION
GENOX
_TAMOXIFEN (AS CITRATE) TABLETS 20 MG_
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking GENOX.
This leaflet answers some common
questions about GENOX.
It does not contain all the
information available on this
medicine. It does not take the place
of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking GENOX
against the benefits it is expected it
will have for you.
IF YOU HAVE CONCERNS ABOUT USING
THIS MEDICINE ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE. You may need to read it
again.
WHAT GENOX IS
USED FOR AND HOW IT
WORKS
GENOX is used to treat breast
cancer.
GENOX tablets contain the active
ingredient tamoxifen which works by
blocking the actions of oestrogen, a
female sex hormone. It belongs to
a group of medicines known as non-
steroidal anti-oestrogens.
Your doctor, however, may have
prescribed GENOX for another
reason. Ask your doctor if you have
any questions about why GENOX
has been prescribed for you.
GENOX is not approved for use in
children.
This medicine is only available with
a doctor’s prescription.
There is no evidence that GENOX
is addictive.
BEFORE YOU TAKE
GENOX
_WHEN YOU MUST NOT TAKE _
_IT_
Do not use GENOX if:

You are allergic to tamoxifen or
any of the other ingredients
listed at the end of this leaflet.

You are pregnant.
_BEFORE YOU TAKE IT_
Tell your doctor if:

You have had an allergic
reaction to any medicine that
you have taken previously to
treat your current condition.

You think you might be pregnant
or plan to become pregnant.

You are breast feeding.
Some of the symptoms of an
allergic reaction may include:
shortness of breath; wheezing or
difficulty breathing; swelling of the
face, lips, tongue or other parts of
the body; rash, itching or hives on
the skin.
GENOX should not be used during
pregnancy as birth defects can
result. A nine month interval is
recommended between stop

제품 특성 요약

Page 1 of 8
NEW ZEALAND DATA SHEET
GENOX
1. PRODUCT NAME
GENOX, 10 mg and 20 mg, tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg or 20 mg of tamoxifen (as citrate).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Each GENOX 10 tablet contains 10 mg of tamoxifen (as tamoxifen
citrate). GENOX 10 is presented
as white, biconvex, tablets, marked “TN” over “10” on one side
and G on the reverse.
Each GENOX 20 tablet contains 20 mg of tamoxifen (as tamoxifen
citrate). GENOX 20 is presented
as white, biconvex tablets, marked “TN” above a score and “20”
below the score on one side and G
on the reverse.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
GENOX is indicated for the treatment of breast cancer.
_4.2_
_DOSE AND METHOD OF ADMINISTRATION_
ADULTS
The initial dose is 20 mg once daily. In advanced breast cancer, if no
response is seen, dosage may
be increased to 40 mg once daily.
CHILDREN
GENOX is not indicated for use in children.
_4.3_
_CONTRAINDICATIONS_
GENOX must not be given during pregnancy. Premenopausal patients must
be carefully examined
before treatment for breast cancer to exclude the possibility of
pregnancy.
GENOX should not be given to patients who have experienced
hypersensitivity to the product or any
of its excipients listed in section 6.1.
_4.4_
_SPECIAL WARNINGS AND PRECAUTIONS FOR USE_
An increased incidence of endometrial changes including hyperplasia,
polyps, cancer and uterine
sarcoma (mostly malignant mixed Mullerian tumours) has been reported
in association with
tamoxifen treatment. The incidence and pattern of this increase
suggest that the underlying
mechanism is related to the oestrogenic properties of tamoxifen. Any
patients receiving or having
Page 2 of 8
previously received tamoxifen, who report abnormal gynaecological
symptoms, especially vaginal
bleeding, should be promptly investigated.
In a large randomized trial in Sweden of adjuvant tamoxifen 40 mg/day
for 2-5 years, an increased
incidence of uterine