Zymoplex

Uses

What is Zymoplex® (tamoxifen citrate, nolvadex) used for?

Zymoplex® is commonly used for treatment 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).

This drug is also effective in these following cases:

• Ovarian cancer
• Kidney cancer
• Endometrial cancer
• Prostate cancer
• Melanoma and sarcoma of soft tissues

How should I take Zymoplex® (tamoxifen citrate, nolvadex)?

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, regular physical exams and mammograms, and self-examine your breasts for lumps on a monthly basis.

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.

How do I store Zymoplex® (tamoxifen citrate, nolvadex)?

Zymoplex® is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Zymoplex® in the bathroom or the freezer. There may be different brands of Zymoplex® that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Zymoplex® down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Zymoplex® (tamoxifen citrate, nolvadex)?

Before using this drug, there is some important information that you may notice:

• 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).
• If you are taking tamoxifen to reduce your risk of breast cancer, you may need to take your first dose while you are having a menstrual period.
• You may also need to have a pregnancy test before you start taking this medicine, to make sure you are not pregnant.
• To make sure this medication is not causing harmful effects, your doctor may want you to have mammograms and to perform routine breast self-exams on a regular basis. Your liver function may also need to be tested. Visit your doctor regularly.
• Taking tamoxifen may increase your risk of uterine cancer, stroke, or a blood clot in the lung, which can be fatal. Talk with your doctor about your specific risks in taking this medication.

Is it safe during pregnancy or breastfeeding?

Pregnancy

There are no adequate studies in women for determining risk when using Zymoplex® during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Zymoplex®. This Zymoplex® is pregnancy risk category D, according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

• A=No risk
• B=No risk in some studies
• C=There may be some risk
• D=Positive evidence of risk
• X=Contraindicated
• N=Unknown

Breastfeeding

It is not known whether tamoxifen passes into breast milk or if it could harm a nursing baby. This medicine may slow breast milk production. You should not breastfeed while taking tamoxifen.

Side effects

What side effects can occur from Zymoplex® (tamoxifen citrate, nolvadex)?

These common side effects may include:

• Hot flashes
• Vaginal discharge
• Weight loss

Get emergency medical help if you have signs of an allergic reaction to tamoxifen such as hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Also, call your doctor at once if you have:

• Signs of a stroke including 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 including chest pain, sudden cough, wheezing, rapid breathing, coughing up blood
• Signs of a blood clot in your leg such as pain, swelling, warmth, or redness in one or both legs
• 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 such as nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes)
• High levels of calcium in your blood – vomiting, constipation, increased thirst or urination, muscle weakness, bone pain, confusion, lack of energy, or tired feeling

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Zymoplex® (tamoxifen citrate, nolvadex)?

Zymoplex® may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs, and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Zymoplex® (tamoxifen citrate, nolvadex)?

Zymoplex® may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Zymoplex® (tamoxifen citrate, nolvadex)?

Zymoplex® may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

These health conditions may include:

• A history of stroke or blood clot
• Liver disease
• High cholesterol or triglycerides (a type of fat in the blood)
• A history of cataracts
• Chemotherapy or radiation

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using Zymoplex® (tamoxifen citrate, nolvadex).

What is the dose of Zymoplex® (tamoxifen citrate, nolvadex) for an adult?

Breast cancer

The recommended dose is 20 to 40 mg daily for 5 years, orally.

General advice

Divide dosages greater than 20 mg/day (morning and evening).

What is the dose of Zymoplex® (tamoxifen citrate, nolvadex) for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Zymoplex® (tamoxifen citrate, nolvadex) available?

Zymoplex® is available in the following dosage forms and strengths:

• Tablets, oral 10 mg
• Tablets, oral 20 mg

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Zymoplex®, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.