Apo-Tamox 10mg tablets

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

tamoxifen (tamoxifen citrate)

Available from:

Apotex Inc.

ATC code:

L02BA

INN (International Name):

tamoxifen (tamoxifen citrate)

Dosage:

10mg

Pharmaceutical form:

tablets

Units in package:

(100) plastic container

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2015-05-15

Patient Information leaflet

Page 13 of 36
INFORMATION FOR THE CONSUMER
APO-TAMOX
TAMOXIFEN CITRATE TABLETS, BP
10 MG AND 20 MG
DESCRIPTION
APO-TAMOX is a medicine that blocks the effects of the hormone
estrogen in the body. It is used
to treat breast cancer.
The exact way that tamoxifen works against cancer is not known, but it
may be related to the way
it blocks the effects of estrogen on the body.
APO-TAMOX is available only with your doctor’s prescription.
WHAT DOES APO-TAMOX CONTAIN?
In addition to the active ingredient tamoxifen citrate, each tablet
contains the following inactive
ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose
monohydrate,
magnesium stearate, and microcrystalline cellulose.
BEFORE USING THIS MEDICATION
In deciding to use a medicine, the risks of taking the medicine must
be weighed against the good
it will do. This is a decision you and your doctor will make.
Before taking tamoxifen, tell your doctor if any of the following
apply to you:

If you have ever had any unusual or allergic reaction to APO-TAMOX or
to any
one of its ingredients (See WHAT DOES APO-TAMOX CONTAIN?).

If you intend to become pregnant. It is best to use some kind of birth
control while you are
taking APO-TAMOX and for about two months after you stop taking it.
Please see your
doctor for advice on what contraceptive precautions you should take,
as some may be
affected by APO-TAMOX. Tell your doctor right away if you think you
have become
pregnant while taking tamoxifen or within two months of having stopped
it.
Page 14 of 36

It is important that you tell your doctor immediately if you have any
unusual vaginal
bleeding or other gynaecological symptoms (such as pelvic pain or
pressure) when you are
taking APO-TAMOX or anytime afterwards. This is because a number of
changes to the
lining of the womb (the endometrium) may occur, some of which may be
serious and could
include cancer.

If you are breastfeeding or intend to breastfeed.

If you are taking or have recently taken any other prescription,
including antid

Summary of Product characteristics

Page 1 of 36
PRODUCT MONOGRAPH
APO-TAMOX
TAMOXIFEN CITRATE TABLETS, BP
10 MG AND 20 MG
(TAMOXIFEN AS TAMOXIFEN CITRATE)
ANTINEOPLASTIC AGENT
APOTEX INC.
DATE OF PREPARATION:
150 SIGNET DRIVE
October 17, 1989
TORONTO, ONTARIO
DATE OF REVISION:
M9L 1T9
FEBRUARY 19, 2018
Control Number: 201525
Page 2 of 36
PRODUCT MONOGRAPH
APO-TAMOX
Tamoxifen Citrate Tablets, BP
10 mg and 20 mg
THERAPEUTIC CLASSIFICATION
Antineoplastic Agent (non-steroidal antiestrogen)
TAMOXIFEN CITRATE THERAPY WAS ASSOCIATED WITH SERIOUS AND
LIFE-THREATENING EVENTS
INCLUDING UTERINE MALIGNANCIES, STROKE, PULMONARY EMBOLISM, AND DEEP
VEIN
THROMBOSIS IN THE NSABP P-1 TRIAL FOR THE PREVENTION OF BREAST CANCER.
THE USE OF
TAMOXIFEN CITRATE FOR BREAST CANCER PREVENTION IS NOT AN APPROVED
INDICATION IN CANADA.
IN THE NSABP P-1 TRIAL, THE RELATIVE RISK OF TAMOXIFEN CITRATE
COMPARED TO PLACEBO WAS
3.1 FOR ENDOMETRIAL CANCER, 4.0 FOR UTERINE SARCOMAS, 1.6 FOR STROKE,
3.0 FOR PULMONARY
EMBOLISM, AND 1.6 FOR DEEP VEIN THROMBOSIS. THESE EVENTS WERE FATAL IN
SOME PATIENTS.
HEALTH CARE PROVIDERS SHOULD BE AWARE OF THE POSSIBLE RISKS ASSOCIATED
WITH APO-
TAMOX THERAPY AND SHOULD DISCUSS THEM WITH THEIR PATIENTS.
THE BENEFITS OF TAMOXIFEN CITRATE THERAPY OUTWEIGH THE RISKS IN THE
MAJORITY OF WOMEN BEING TREATED ACCORDING TO THE APPROVED CANADIAN
INDICATION FOR THE TREATMENT OF BREAST CANCER.
ACTIONS AND CLINICAL PHARMACOLOGY
Tamoxifen citrate, the active ingredient, is a non-steroidal agent
which has demonstrated
potent antiestrogenic properties in animal test systems. The
antiestrogenic effects are related
to its ability to compete with estrogen for binding sites in target
tissues such as breast and
uterus. Tamoxifen citrate inhibits the induction of rat mammary
carcinoma induced by
dimethylbenzanthracene (DMBA) and causes the regression of already
established DMBA-
induced tumours. In this rat model, tamoxifen citrate appears to exert
its antitumour effects by
binding to estrogen receptors.
In cytosols derived from human endometrium and human breast and
uterin