Generic Name/API: tamoxifen citrate

Manufacturer: AstraZeneca

Dosage Forms & Strength & Pack Size:
Tablets 20 mg, 30’s

 Store at room temperature (15 to 30°C). Protect from light.
 Keep out of reach and sight of children.


What is NOLVADEX used for?
NOLVADEX is used in women to treat:

Early-stage breast cancer after surgery, radiation or chemotherapy in patients with tumours that are estrogen receptor positive.

Breast cancer that is called hormone responsive locally advanced or metastatic.
NOLVADEX should only be used for the conditions listed above.

Do not use NOLVADEX-D if:
 you are allergic to tamoxifen citrate, or to any other ingredients in this medicine or part of the
 you are pregnant.
 you are under 18 years of age.
 you have had a stroke in the past.
 you have had a pulmonary embolism in the past which is when a blood vessel in your lungs
is blocked.
 you have had blood clots in the past, including deep vein thrombosis which is when blood
clots form in deep veins like the legs.
 you are taking medicines called anticoagulants used to prevent blood clots, like warfarin.
 you have been told by your healthcare professional that you have an increased risk of
developing cancer of the endometrium.
To help avoid side effects and ensure proper use, talk to your healthcare professional
before you take NOLVADEX-D. Talk about any health conditions or problems you may
have, including if you:
 are breastfeeding or intend to breastfeed.
 are taking or have recently taken antidepressant medicines such as paroxetine used to
improve mood or symptoms of hot flushes.
 have cataracts or other eye problems.
 have decreased white blood cells or platelets in your blood.
 are taking medicines called aromatase inhibitors used for endocrine therapy, such as
anastrozole, letrozole or exemestane.
 are taking medicines called cytotoxic agents used to destroy cancer cells.
 have metastatic bone disease or elevated calcium levels (hypercalcemia).
 have a history of hereditary angioedema. This is an inherited condition where fluid builds up
outside of the blood vessels. Taking NOLVADEX-D may cause symptoms of hereditary
angioedema or make them worse.
Other warnings you should know about:
Tell your healthcare professional if you are planning to become pregnant or if you think you
might have become pregnant. You must not take NOLVADEX-D if you are pregnant. This is
because it may harm your unborn baby. You must use effective birth control while you are
taking NOLVADEX-D and for nine months after you stop taking it. Talk to your healthcare
professional about effective methods of birth control.
Breast reconstruction surgery:
Tell your healthcare professional if you are planning to have breast reconstruction surgery
called microvascular breast reconstruction. This is where your own tissue is used to make a
new breast. It can occur weeks to years after your primary cancer surgery. Taking
NOLVADEX-D when you have microvascular breast reconstruction surgery can increase your
risk of complications.
Endometrial and uterine cancer and fibroids:
Taking NOLVADEX-D can increase your risk of getting endometrial or uterine cancer or uterine
fibroids (non-cancerous tumours in your uterus). Tell your healthcare professional right away if
you have any unusual vaginal bleeding or pelvic pain or pressure when you are taking NOLVADEX-D or anytime afterwards. This is because a number of changes to the lining of the
endometrium and uterus may occur, some of which may be serious and could include cancer.
If you go into the hospital, let medical staff know you are taking NOLVADEX-D.
Driving and using machines:
NOLVADEX-D may make you tired and weak. This may affect your ability to drive and use
machines. Before driving or using machines, wait until you are feeling well again.
Tell your healthcare professional about all the medicines you take, including any drugs,
vitamins, minerals, natural supplements or alternative medicines.
The following may interact with NOLVADEX-D:
 Medicines called Selective Serotonin Reuptake Inhibitors (SSRIs) used to treat depression
such as paroxetine, a known CYP2D6 inhibitor.
 Medicines used to prevent blood clots such as warfarin.
 Cytotoxic agents.
 Medicines called aromatase inhibitors, which are used to treat breast cancer and include
anastrozole, letrozole or exemestane.
How to take NOLVADEX-D:
 Take NOLVADEX-D exactly as your healthcare professional tells you to.
 It is important to keep taking NOLVADEX-D even if you start to feel ill. Do not change your
dose or stop taking this medicine without talking to your healthcare professional.
 Stay under your healthcare professional’s care while taking NOLVADEX-D.
Usual dose:
The recommended daily dose of NOLVADEX-D is 20 to 40 mg in a single dose or in two
divided doses. The lowest effective dose should be used. Your healthcare professional will tell
you how much NOLVADEX-D to take and when to take it.
If you think you, or a person you are caring for, have taken too much NOLVADEX-D, contact
a healthcare professional, hospital emergency department, or regional poison control centre
immediately, even if there are no symptoms.
Missed Dose:
If you miss a dose, take the dose as soon as you remember. Do not take two doses at the
same time to make up for a missed dose.
What are possible side effects from using NOLVADEX-D?
These are not all the possible side effects you may feel when taking NOLVADEX-D. If you
experience any side effects not listed here, contact your healthcare professional.
 Hot flushes
 Itching around the vagina
 Vaginal discharge
 Nausea, vomiting, diarrhea and constipation
 Bad taste in the mouth, loss of taste or distaste to food
 Headaches

 Light-headedness
 Sensory changes (including taste disorder and numbness or tingling in the skin)
 Hair loss
 Leg cramps
 Tingling, numbness or prickling of the skin
 Muscle pain
 Tiredness and weakness
 Disturbances of menstrual function, irregular or missed menstrual periods
 Increased levels of fats in the blood, sometimes with pain or tenderness in the upper

If you have a troublesome symptom or side effect that is not listed here or becomes bad
enough to interfere with your daily activities, tell your healthcare professional.


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