NOLVO®

PLEASE READ THE PACKAGE INSERT CAREFULLY BEFORE USE.

Keep the package insert for reference. If you have any questions that are not addressed here, please consult your physician. This drug has been individually prescribed by your physician for personal use. Under no circumstances do not administer it to others, even if they appear with the same symptoms, it may harm them. If you notice any of the side effects stated in this package please notify your doctor or pharmacist immediately.

WHAT IS TAMOXIFEN CITRATE

Tamoxifen blocks the actions of estrogen, a female hormone. Certain types of breast cancer require estrogen to grow.

Tamoxifen is used to treat some types of breast cancer in men and women. It is also used to lower a woman’s chance of developing breast cancer if she has a high risk (such as a family history of breast cancer).

Tamoxifen may also be used for purposes not listed in this medication guide.

IMPORTANT INFORMATION

Do not use tamoxifen if you are pregnant. It could harm the unborn baby. Use a barrier form of birth control (such as a condom or diaphragm with spermicide) while you are using this medication and for at least 2 months after your treatment ends.

You should not use tamoxifen if you are allergic to it, or if you have a history of blood clots in your veins or your lungs, or if you are also taking a blood thinner such as warfarin (Coumadin).

Before using this medicine, tell your doctor if you have liver disease, high triglycerides (a type of fat in the blood), a history of cataract, or a history of stroke or blood clot.

HOW TO USE TAMOXIFEN CITRATE

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one. Tamoxifen can be taken with or without food. While using tamoxifen, you may need frequent blood tests.

If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are taking tamoxifen. Have regular physical exams and mammograms, and self-examine your breasts for lumps on a monthly basis while using this medicine.

Use tamoxifen regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely. You may need to keep using this medication for up to 5 years.

TAMOXIFEN CITRATE DOSING INFORMATION

Usual Adult Dose for Breast Cancer:
For the treatment of metastatic breast cancer in women and men: 20 to 40 mg orally Dosages greater than 20 mg should be given in divided doses (morning and evening).

For the treatment of women with Ductal Carcinoma in Situ, following breast surgery and radiation:
20 mg orally daily for 5 years.

To reduce the incidence of breast cancer in women at high risk for breast cancer:
20 mg orally daily for 5 years.

TAMOXIFEN CITRATE SIDE EFFECTS

Get emergency medical help if you have signs of an allergic reaction to tamoxifen: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Tamoxifen can increase your risk of stroke or blood clots. Call your doctor at once if you have:

• signs of a stroke – sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
• signs of a blood clot in the lung – chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
• signs of a blood clot in your leg – pain, swelling, warmth, or redness in one or both legs. Also call your doctor at once if you have:
• blurred vision, tunnel vision, eye pain, or seeing halos around lights;
• unusual vaginal bleeding or discharge;
• changes in your menstrual periods;
• pain or pressure in your pelvic area;
• a new breast lump;
• liver problems – nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• high levels of calcium in your blood – vomiting, constipation, increased thirst or urination, muscle weakness, bone pain, confusion, lack of energy, or tired feeling. Common tamoxifen ide effects may include:
• hot flashes;
• vaginal discharge; or
• weight loss.