Soltamox SolutionGeneric Name: Tamoxifen
Women taking Soltamox Solution to decrease the risk of developing breast cancer have developed cancer of the uterus, stroke, and blood clots in the lung. Some of these events have been fatal. Contact your doctor right away if you develop any of the following: unusual vaginal bleeding or discharge; abnormal menstrual period; groin pressure or pain; chest pain; shortness of breath; coughing up blood; confusion; one-sided weakness; vision or speech problems.
Women at high risk of breast cancer or with ductal carcinoma in situ (DCIS) should discuss the use of Soltamox Solution with their doctor. Decide if the possible benefits (reducing the risk of breast cancer) outweigh the risk of these events. The benefits of Soltamox Solution outweigh the risks in women who already have breast cancer.
Soltamox Solution is used for:
Treating breast cancer that has spread to other sites in the body.It is also used along with other medicines to treat other types of breast cancer. It is used in women who are at high risk for breast cancer and in women with DCIS (after surgery and radiation) to decrease the risk of developing breast cancer. It may also be used for other conditions as determined by your doctor.
Soltamox Solution is an antiestrogen. It works by blocking the effect of estrogen on certain tumors. This may prevent the growth of tumors that are activated by estrogen.
Do NOT use Soltamox Solution if:
- you are allergic to any ingredient in Soltamox Solution
- you are using Soltamox Solution to reduce your risk of breast cancer and you have a history of blood clots in the lung or leg
- you are using Soltamox Solution to reduce your risk of breast cancer and you also take certain anticoagulants (eg, warfarin)
- you are taking anastrozole
Contact your doctor or health care provider right away if any of these apply to you.
Before using Soltamox Solution:
Some medical conditions may interact with Soltamox Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of blood clots in the legs or lungs
- if you have high levels of calcium in your blood, a weakened immune system, or low levels of white blood cells or platelets in your blood
- if you have high cholesterol or lipid levels
- if you have cataracts or other vision problems
- if you are using cytotoxic cancer medicines
- if you are confined to a bed or chair
Some MEDICINES MAY INTERACT with Soltamox Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Anticoagulants (eg, warfarin) because the risk of bleeding may be increased
- Cytotoxic cancer medicines (eg, cisplatin) because the risk of developing blood clots may be increased
- Rifampin because it may decrease Soltamox Solution's effectiveness
- Fluorouracil or mitomycin C because they may increase the risk of Soltamox Solution's side effects
- Aromatase inhibitors (eg, anastrozole, letrozole) because their effectiveness may be decreased by Soltamox Solution
This may not be a complete list of all interactions that may occur. Ask your health care provider if Soltamox Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Soltamox Solution:
Use Soltamox Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Soltamox Solution comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Soltamox Solution refilled.
- Soltamox Solution may be taken by mouth with or without food.
- Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
- Continue to take Soltamox Solution even if you feel well. Do not miss any doses. Taking Soltamox Solution at the same time each day will help you to remember to take it.
- If you miss a dose of Soltamox Solution, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Soltamox Solution.
Important safety information:
- Soltamox Solution may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Soltamox Solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Soltamox Solution may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
- Soltamox Solution may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
- New tumors have occurred in body sites other than the uterus in patients taking Soltamox Solution. It is unknown if Soltamox Solution may be the cause. Discuss any questions or concerns with your doctor.
- Women who take Soltamox Solution to reduce the risk of breast cancer should have a breast exam, mammogram, and gynecological exam before starting and during treatment with Soltamox Solution.
- Women who may become pregnant should begin taking Soltamox Solution during a menstrual period. Women who have irregular menstrual periods should have a pregnancy test immediately before starting Soltamox Solution. Talk to your doctor if you have any questions about how to begin taking Soltamox Solution.
- Women who may become pregnant must use effective nonhormonal birth control (eg, condoms, diaphragm) during sexual intercourse while they are taking Soltamox Solution and for 2 months after they stop taking it. Do not use hormonal birth control (eg, birth control pills); it may not work as well while you are taking Soltamox Solution. Discuss any questions about effective nonhormonal birth control with your doctor.
- Soltamox Solution will not prevent you from becoming pregnant.
- Lab tests, including breast exams, mammograms, gynecologic exams,complete blood counts, and liver function tests, may be performed while you use Soltamox Solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Soltamox Solution should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Soltamox Solution may cause harm to the fetus. Do not become pregnant while you are using it and for 2 months after you stop using it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Soltamox Solution while you are pregnant. It is not known if Soltamox Solution is found in breast milk. Do not breast-feed while taking Soltamox Solution.
Possible side effects of Soltamox Solution:
All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Bone pain; constipation; coughing; hot flashes; muscle pain; nausea; tiredness; vaginal discharge; weight loss.Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unexplained hoarseness); abnormal menstrual periods; abnormal vaginal bleeding or bloody discharge; chest pain; coughing up blood; dark urine; decreased sexual desire or ability; depression; fever, chills, or persistent sore throat; groin or pelvic pain or pressure; loss of appetite; loss of balance or coordination; missed menstrual period; new or increased breast tumor or pain; new or unusual lumps; one-sided weakness; pain or swelling in one or both legs; red, swollen, blistered, or peeling skin; severe or persistent tiredness or weakness; shortness of breath; skin changes; stomach pain; sudden severe headache; swelling of the arms or the legs; unusual bleeding or bruising; vision or speech problems; yellowing of the eyes or skin.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include exaggerated reflexes; seizures; severe or persistent dizziness; tremor; trouble breathing; trouble walking.Proper storage of Soltamox Solution:
Store Soltamox Solution at room temperature, below 77 degrees F (25 degrees C), in the original container. Do NOT refrigerate or freeze. Store away from moisture, heat, and light. Do not store in the bathroom. Throw away any unused medicine 3 months after the bottle is opened. Keep Soltamox Solution out of the reach of children and away from pets.
- If you have any questions about Soltamox Solution, please talk with your doctor, pharmacist, or other health care provider.
- Soltamox Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
This information is a summary only. It does not contain all information about Soltamox Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
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