Generic Nolvadex (Tamoxifen)
Nolvadex
Nolvadex is able to cause ovulation in women. In men with oligospermia it increases concentration of hormones. Cancer treatment.
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Product Description

MEDICATION: tamoxifen citrate (Brand names include Nolvadex, Nolvadex-D, Novo-Tamoxifen, Istubal, Valodex and Tamofen.)

DESCRIPTION
Tamoxifen (Nolvadex) (tamoxifen citrate) Tablets, a nonsteroidal antiestrogen, are for oral administration. Tamoxifen (Nolvadex) tablets are available as:
10 mg Tablets. Each tablet contains 15.2 mg of tamoxifen citrate which is equivalent to 10 mg of tamoxifen.
20 mg Tablets. Each tablet contains 30.4 mg of tamoxifen citrate which is equivalent to 20 mg of tamoxifen.

What are the most important things I should know about Tamoxifen (Nolvadex)?
Tamoxifen (Nolvadex) has been shown to help women with advanced breast cancer and in clinical trials of over 30,000 women with early breast cancer it has been shown to reduce the risk of recurrence. Also in a trial of 13,000 women at high risk of breast cancer, Tamoxifen (Nolvadex) reduced the risk of developing the disease.
Like all medicines, Tamoxifen (Nolvadex) has some side effects. Most are mild and relate to its hormonal mode of action. For all women Tamoxifen (Nolvadex) can, however, also increase the risk of some serious and potentially life-threatening events, including uterine cancer, blood clots, and stroke. Some of these events have caused death. Tamoxifen (Nolvadex) can also increase the risk of getting cataracts or of needing cataract surgery. If you experience symptoms of any of these, tell your doctor immediately.
If you are a woman at high risk for breast cancer or a woman with DCIS considering Tamoxifen (Nolvadex) to reduce your risk of developing breast cancer, you should discuss the potential benefits versus the potential risks of these serious events with your health care provider.

What is Tamoxifen (Nolvadex)?
Tamoxifen (Nolvadex) is a non-steroid anti-estrogen which competitively inhibits estrogen receptors in the target organs and tumors in them. Mechanism of its action is not completely investigated though it is known that a complex of Tamoxifen (Nolvadex) with the receptor and cofactor appears and than it is transferred to the cell nucleus preventing hypertrophy of the cells which depend on regulation by estrogen. The effect of the medication can last several weeks after a single dose. Tamoxifen (Nolvadex) is able to cause ovulation in women, stimulation production of gonadotropic hormones of hypophysis. In men with oligospermia it increases concentration of luteinizing hormone and follicle-stimulating hormone, testosterone and estrogen in the blood serum. Tamoxifen (Nolvadex) is used to treat breast cancer in women and in men (especially after castration) and also when it has spread to other parts of the body, kidney cancer, melanomas and sarcomas of the soft tissues with estrogen receptors, cancer of the ovary.


How does Tamoxifen (Nolvadex) work?
Tamoxifen (Nolvadex) belongs to a group of medicines called antiestrogens. Antiestrogens work by blocking the effects of the hormone estrogen in the body. Estrogen may cause the growth of some types of breast tumors. Tamoxifen (Nolvadex) may block the growth of tumors that respond to estrogen.

Who should not take Tamoxifen (Nolvadex)?
• You should not take Tamoxifen (Nolvadex) to reduce the risk of getting breast cancer if you have ever had blood clots or if you develop blood clots that require medical treatment. However, if you are taking Tamoxifen (Nolvadex) for treatment of early or advanced breast cancer, the benefits of Tamoxifen (Nolvadex) may outweigh the risks associated with developing new blood clots. Your health care professional can assist you in deciding whether Tamoxifen (Nolvadex) is right for you.
• You should not take Tamoxifen (Nolvadex) to reduce the risk of getting breast cancer if you are taking medicines to thin your blood (anticoagulants) like warfarin (Coumadin®).
• You should not take Tamoxifen (Nolvadex) if you plan to become pregnant while taking Tamoxifen (Nolvadex) or during the two months after you stop taking it because Tamoxifen (Nolvadex) may harm your unborn child. You should see your doctor immediately and stop taking Tamoxifen (Nolvadex) if you become pregnant while taking the drug. Please talk with your doctor about birth control recommendations. If you are capable of becoming pregnant, you should start Tamoxifen (Nolvadex) during a menstrual period or if you have irregular periods have a negative pregnancy test before beginning to take Tamoxifen (Nolvadex). Tamoxifen (Nolvadex) does not prevent pregnancy, even in the presence of menstrual irregularity.
• You should not take Tamoxifen (Nolvadex) if you are breast feeding.
• You should not take Tamoxifen (Nolvadex) if you have ever had an allergic reaction to Tamoxifen (Nolvadex) or tamoxifen citrate (the chemical name) or any of its ingredients.
• Tamoxifen (Nolvadex) is not known to reduce the risk of breast cancer in women with changes in breast cancer genes (BRCA1 or BRCA2).
• You should not take Tamoxifen (Nolvadex) to decrease the chance of getting breast cancer if you are less than age 35 because Tamoxifen (Nolvadex) has not been tested in younger women.
• You should not take Tamoxifen (Nolvadex) to reduce the risk of breast cancer unless you are at high risk of getting breast cancer. Certain conditions put women at high risk and it is possible to calculate this risk for any woman. Breast cancer risk assessment tools to help calculate your risk of breast cancer have been developed and are available to your health care professional. You should discuss your risks with your health care professional.
• Children should not take Tamoxifen (Nolvadex) because treatment for them has not been sufficiently studied.

How should I take Tamoxifen (Nolvadex)?
• Follow your doctor’s instructions about when and how to take Tamoxifen (Nolvadex). Read the label on the container. If you are unsure or have questions, ask your doctor or pharmacist.
• You will take Tamoxifen (Nolvadex) differently, depending on your diagnosis.
• For reduction of the risk of breast cancer, the usual dose is 20 mg a day, for five years.
• For treatment of breast cancer in adult women and men, the usual dose is 20-40 mg a day. Take the tablets once or twice a day depending on the tablet strength prescribed. If your doctor has prescribed a different dose, do not change it unless he or she tells you to do so. For women with early breast cancer, Tamoxifen (Nolvadex) should be taken for 5 years. For women with advanced cancer, Tamoxifen (Nolvadex) should be taken until your doctor feels it is no longer indicated.
• Take your medicine each day. You may find it easier to remember to take your medicine if you take it at the same time each day. If you forget to take a dose, take it as soon as you remember and then take the next dose as usual.
• Swallow the tablets whole with a drink of water.
• You can take Tamoxifen (Nolvadex) with or without food.
• Do not stop taking your tablets unless your doctor tells you to do so.

Are there other important factors to consider before taking Tamoxifen (Nolvadex)?
• Tell your doctor if you have ever had blood clots that required medical treatment.
• Because Tamoxifen (Nolvadex) may affect how other medicines work, always tell your doctor if you are taking any other prescription or non-prescription (over-thecounter) medications, particularly if you are taking warfarin to thin your blood.
• You should not become pregnant when taking Tamoxifen (Nolvadex) or during the two months after you stop taking it as Tamoxifen (Nolvadex) may harm your unborn child. Please contact your doctor for birth control recommendations. Tamoxifen (Nolvadex) does not prevent pregnancy, even in the presence of menstrual irregularity. You should see your doctor immediately if you think you may have become pregnant after starting to take Tamoxifen (Nolvadex).

What should I avoid or do while taking Tamoxifen (Nolvadex)?
• You should contact your doctor immediately if you notice any of the following symptoms. Some of these symptoms may suggest that you are experiencing a rare but serious side effect associated with Tamoxifen (Nolvadex).
- new breast lumps
- swelling or tenderness in your calf
- vaginal bleeding
- unexplained breathlessness (shortness of breath)
- changes in your menstrual cycle
- sudden chest pain
- changes in vaginal discharge
- coughing up blood
- pelvic pain or pressure
- changes in your vision
If you see a health care professional who is new to you (an emergency room doctor, another doctor in the practice), tell him or her that you take Tamoxifen (Nolvadex) or have previously taken Tamoxifen (Nolvadex).
• Because Tamoxifen (Nolvadex) may affect how other medicines work, always tell your doctor if you are taking any other prescription or non-prescription (over-thecounter) medicines. Be sure to tell your doctor if you are taking warfarin (Coumadin) to thin your blood.
• You should not become pregnant when taking Tamoxifen (Nolvadex) or during the 2 months after you stop taking it because Tamoxifen (Nolvadex) may harm your unborn child. You should see your doctor immediately if you think you may have become pregnant after starting to take Tamoxifen (Nolvadex). Please talk with your doctor about birth control recommendations. If you are taking Tamoxifen (Nolvadex) to reduce your risk of getting breast cancer, and you are sexually active, Tamoxifen (Nolvadex) should be started during your menstrual period. If you have irregular periods, you should have a negative pregnancy test before you start Tamoxifen (Nolvadex). Tamoxifen (Nolvadex) does not prevent pregnancy, even in the presence of menstrual irregularity.
• If you are taking Tamoxifen (Nolvadex) to reduce your risk of getting breast cancer, you should know that Tamoxifen (Nolvadex) does not prevent all breast cancers. While you are taking Tamoxifen (Nolvadex) and after you stop taking Tamoxifen (Nolvadex) and in keeping with your doctor’s recommendation, you should have annual gynecological check-ups which should include breast exams and mammograms. If breast cancer occurs, there is no guarantee that it will be detected at an early stage. That is why it is important to continue with regular check-ups.

Drug Interactions
• Tamoxifen may interact with some drugs, including bromocriptine, estrogens, aminoglutethimide, warfarin, and certain anticancer drugs. Tell all prescribers what drugs you are taking.

What are the possible side effects of Tamoxifen (Nolvadex)?
Like many medicines, Tamoxifen (Nolvadex) causes side effects in most patients. The majority of the side effects seen with Tamoxifen (Nolvadex) have been mild and do not usually cause breast cancer patients to stop taking the medication. In women with breast cancer, withdrawal from Tamoxifen (Nolvadex) therapy is about 5%. Approximately 15% of women who took Tamoxifen (Nolvadex) to reduce the chance of getting breast cancer stopped treatment because of side effects.
The most common side effects reported with Tamoxifen (Nolvadex) are: hot flashes; vaginal discharge or bleeding; and menstrual irregularities (these side effects may be mild or may be a sign of a more serious side effect). Women may experience hair loss, skin rashes (itching or peeling skin) or headaches; or inflammation of the lungs, which may have the same symptoms as pneumonia, such as breathlessness and cough; however, hair loss is uncommon and is usually mild.
A rare but serious side effect of Tamoxifen (Nolvadex) is a blood clot in the veins. Blood clots stop the flow of blood and can cause serious medical problems, disability, or death. Women who take Tamoxifen (Nolvadex) are at increased risk for developing blood clots in the lungs and legs. Some women may develop more than one blood clot, even if Tamoxifen (Nolvadex) is stopped. Women may also have complications from treating the clot, such as bleeding from thinning the blood too much. Symptoms of a blood clot in the lungs may include sudden chest pain, shortness of breath or coughing up blood. Symptoms of a blood clot in the legs are pain or swelling in the calves. A blood clot in the legs may move to the lungs. If you experience any of these symptoms of a blood clot, contact your doctor immediately.
Tamoxifen (Nolvadex) increases the chance of having a stroke, which can cause serious medical problems, disability, or death. If you experience any symptoms of stroke, such as weakness, difficulty walking or talking, or numbness, contact your doctor immediately.
Tamoxifen (Nolvadex) increases the chance of changes occurring in the lining (endometrium) or body of your uterus which can be serious and could include cancer. If you have not had a hysterectomy (removal of the uterus), it is important for you to contact your doctor immediately if you experience any unusual vaginal discharge, vaginal bleeding, or menstrual irregularities; or pain or pressure in the pelvis (lower stomach). These may be caused by changes to the lining (endometrium) or body of your uterus. It is important to bring them to your doctor’s attention without delay as they can occasionally indicate the start of something more serious and even life-threatening.
Tamoxifen (Nolvadex) may cause cataracts or changes to parts of the eye known as the cornea or retina. Tamoxifen (Nolvadex) can increase the chance of needing cataract surgery, and can cause blood clots in the veins of the eye. Tamoxifen (Nolvadex) can result in difficulty in distinguishing different colors. If you experience any changes in your vision, tell your doctor immediately.
Rare side effects, which may be serious, include certain liver problems such as jaundice (which may be seen as yellowing of the whites of the eyes) or hypertriglyceridemia (increased levels of fats in the blood) sometimes with pancreatitis (pain or tenderness in the upper abdomen). Stop taking Tamoxifen (Nolvadex) and contact your doctor immediately if you develop angioedema (swelling of the face, lips, tongue and/or throat) even if you have been taking Tamoxifen (Nolvadex) for a long time.
If you are a woman receiving Tamoxifen (Nolvadex) for treatment of advanced breast cancer, and you experience excessive nausea, vomiting or thirst, tell your doctor immediately. This may mean that there are changes in the amount of calcium in your blood (hypercalcemia). Your doctor will evaluate this.
In patients with breast cancer, a temporary increase in the size of the tumor may occur and sometimes results in muscle aches/bone pain and skin redness. This condition may occur shortly after starting Tamoxifen (Nolvadex) and may be associated with a good response to treatment.
Many of these side effects happen only rarely. However, you should contact your doctor if you think you have any of these or any other problems with your Tamoxifen (Nolvadex). Some side effects of Tamoxifen (Nolvadex) may become apparent soon after starting the drug, but others may first appear at any time during therapy.
This summary does not include all possible side effects with Tamoxifen (Nolvadex). It is important to talk to your health care professional about possible side effects. If you want to read more, ask your doctor or pharmacist to give you the professional labeling.

How should I store Tamoxifen (Nolvadex)?
Tamoxifen (Nolvadex) Tablets should be stored at room temperature 20-25 C (68-77°F). Keep in a well-closed, light-resistant container. Keep out of the reach of children.
Do not take your tablets after the expiration date on the container. Be sure that any discarded tablets are out of the reach of children.

Dosage
Take it exactly as recommended by your physician as the dosage depends on your condition. Long treatment (about 2 years) is advised. Take this medication with food and a big glass of water as a single dose or divide it in two (taken in the morning and the evening), do not chew or crush them.
For patients with breast cancer, the recommended daily dose is 20-40 mg. Dosages greater than 20 mg per day should be given in divided doses (morning and evening).
Ductal Carcinoma in Situ (DCIS): The recommended dose is Tamoxifen (Nolvadex) 20 mg daily for 5 years.
Reduction in Breast Cancer Incidence in High Risk Women: The recommended dose is Tamoxifen (Nolvadex) 20 mg daily for 5 years. There are no data to support the use of Tamoxifen (Nolvadex) other than for 5 years

Missed dose
If you forgot to take your dose in time, please do it as soon as you remember. But do not take if it is too late or almost time for your next dose. Do not take double or extra doses. Take your usually dose next day in the same regularly time.

Overdose
Acute overdosage in humans has not been reported. In patients with metastatic cancer treated with the maximally tolerated doses of Tamoxifen (Nolvadex) side acute neurotoxicity manifested by tremor, hyperreflexia, unsteady gait and dizziness were observed. If you supposes that took too much of this medication look for immediate medical help and contact your doctor.
 
Disclaimer
We provide only general information about medications which does not cover all directions, possible drug integrations, or precautions. Information at the site cannot be used for self-treatment and self-diagnosis. Any specific instructions for a particular patient should be agreed with your health care adviser or doctor in charge of the case. We disclaim reliability of this information and mistakes it could contain. We are not responsible for any direct, indirect, special or other indirect damage as a result of any use of the information on this site and also for consequences of self-treatment.

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