TAMOSIN tamoxifen 20mg (as citrate) tablet

Quốc gia: Úc

Ngôn ngữ: Tiếng Anh

Nguồn: Department of Health (Therapeutic Goods Administration)

Thành phần hoạt chất:

tamoxifen citrate, Quantity: 30.4 mg (Equivalent: tamoxifen, Qty 20 mg)

Sẵn có từ:

Orion Pharma (AUS) Pty Limited

Dạng dược phẩm:

Tablet, uncoated

Thành phần:

Excipient Ingredients: lactose monohydrate; magnesium stearate; sodium starch glycollate; povidone; maize starch

Tuyến hành chính:

Oral

Các đơn vị trong gói:

60 tablets, 30 tablets

Loại thuốc theo toa:

(S4) Prescription Only Medicine

Chỉ dẫn điều trị:

Palliative treatment of breast cancer.

Tóm tắt sản phẩm:

Visual Identification: White, round, convex tablet debossed 20 on one side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Tình trạng ủy quyền:

Registered

Ngày ủy quyền:

1994-02-02

Tờ rơi thông tin

TAMOSIN (tamoxifen) – Consumer Medicine Information
1
TAMOSIN TABLETS
_Tamoxifen (as tamoxifen citrate) _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about TAMOSIN. It does
not contain all of the available
information.
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 TAMOSIN
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT TAMOSIN IS
USED FOR
TAMOSIN contains the active
ingredient tamoxifen (as tamoxifen
citrate). Tamoxifen is an anti-
oestrogen medicine and is used to
counteract the actions of the naturally
occurring female sex hormone,
oestrogen.
TAMOSIN is used in the treatment
of breast cancer.
TAMOSIN blocks the actions of
oestrogen. In some types of breast
cancer, oestrogen can help the cancer
cells to grow.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY TAMOSIN
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is only available with
a doctor’s prescription.
TAMOSIN is not addictive.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE TAMOSIN IF YOU HAVE
EVER HAD AN ALLERGIC REACTION TO:
•
tamoxifen
•
lactose. This product contains
sugars as lactose.
•
any of the other ingredients listed
at the end of this leaflet.
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.
DO NOT TAKE TAMOSIN IF YOU ARE
PREGNANT.
It may affect your developing baby.
DO NOT TAKE TAMOSIN AFTER THE
EXPIRY DATE PRINTED ON THE PACK.
DO NOT TAKE TAMOSIN IF THE
PACKAGING IS TORN OR SHOWS SIGNS OF
TAMPERING OR IF THE TABLETS DO NOT
LOOK QUITE RIGHT.
_BEFORE YOU START TO TAKE IT _
TELL YOUR DO

Đặc tính sản phẩm

PI – TAMOSIN (tamoxifen)
Page 1 of 11
AAUSTRALIAN PRODUCT INFORMATION
TAMOSIN (TAMOXIFEN CITRATE)
1. NAME OF THE MEDICINE
Tamoxifen citrate.
2. QUALITATIVE AND QUANTITATIVE
Each TAMOSIN
tablet contains tamoxifen citrate equivalent to 20 mg of tamoxifen.
Excipients with known effect: Sugars as lactose
For full list of excipients, see _section 6.1 List of excipients_.
3. PHARMACEUTICAL FORM
Tablet
TAMOSIN is a white, round, convex tablet, 9 mm in diameter with 20
debossed on one side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Palliative treatment of breast cancer.
4.2 DOSE AND METHOD OF ADMINISTRATION
The recommended daily dose of TAMOSIN is 20 mg. A dose of 40 mg may be
used in patients
with advanced breast cancer in which no response is seen with the
minimal dose.
Response is usually not achieved until after a treatment period of 2
to 3 months.
The current recommended treatment duration is five years; however the
optimum duration has
not been established.
OLDER PEOPLE
Similar dosing regimens of tamoxifen have been used in older people
with breast cancer and in
some of these patients it has been used as sole therapy.
TAMOSIN is not indicated for use in children.
METHOD OF ADMINISTRATION
For administration by the oral route.
4.3 CONTRAINDICATIONS
Tamoxifen must not be given during pregnancy. Premenopausal patients
must be carefully
examined before treatment for breast cancer to exclude the possibility
of pregnancy.
Tamoxifen is contraindicated in patients hypersensitive to it.
PI – TAMOSIN (tamoxifen)
Page 2 of 11
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
AN
INCREASED
INCIDENCE
OF
ENDOMETRIAL
CHANGES
INCLUDING
HYPERPLASIA,
ENDOMETRIAL
POLYPS, CANCER AND UTERINE SARCOMA (MOSTLY MALIGNANT MIXED MULLERIAN
TUMOURS) HAVE
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 PREVIOUSLY RECEIVED
TAMOXIFEN WHO REPORT
ABNORMAL GYNAECOLOGICA