Ospemifene Oral Tablet (OSPEMIFENE - ORAL)

Instructions

Take the medicine with food.

This medicine will work best if you take it at about the same time every day.

Store at room temperature away from heat, light, and moisture. Do not keep in the bathroom.

If you forget to take a dose on time, take it as soon as you remember. If it is almost time for the next dose, do not take the missed dose. Return to your normal schedule. Do not take 2 doses at one time.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Tell your doctor if symptoms do not get better or if they get worse.

Keep all appointments for medical exams and tests while on this medicine.

Do not take the medicine more than once during 24 hours.

Brand Name(s): Osphena

Generic Name: Ospemifene

Cautions

This medicine is not approved for use in men.

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

Some patients taking this medicine have experienced serious side effects. Please speak with your doctor to understand the risks and benefits associated with this medicine.

This medicine may increase the risk of some types of cancer in women. Please speak with your doctor about the risks and benefits of using this medicine.

This medicine is associated with an increased risk of serious heart problems, heart attack, and stroke. Please speak with your doctor about the risks and benefits of using this medicine. Contact your doctor immediately if you experience chest pain or difficulty breathing.

This medicine is associated with an increased risk for serious blood clots. Speak with your doctor about the benefits and risks from using this medicine.

Do not use the medication any more than instructed.

Avoid smoking while on this medicine. Smoking may increase your risk for stroke, heart attack, blood clots, high blood pressure, and other diseases of the heart and blood vessels.

Ask your doctor how to do a breast self-exam. Check monthly. Report any changes to your doctor.

Talk to your doctor about getting a complete physical exam every year while on this medicine.

Tell the doctor or pharmacist if you are pregnant, planning to be pregnant, or breastfeeding.

Do not use this medicine if you are pregnant. If you become pregnant, contact your doctor immediately.

Women who are pregnant or in their childbearing years should not touch or handle this medicine. This medicine can be absorbed through the woman's skin and harm the unborn baby.

Do not share this medicine with anyone who has not been prescribed this medicine.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

  • feeling of heat or flushing
  • muscle cramps
  • sweating

Call your doctor or get medical help right away if you notice any of these more serious side effects:

  • breast lumps
  • chest pain
  • dizziness
  • fainting
  • severe or persistent headache
  • sudden leg pain, swelling, warmth or redness
  • shortness of breath
  • severe stomach or bowel pain
  • symptoms of stroke (such as one-sided weakness, slurred speech, confusion)
  • cramping of the uterus or bleeding from the vagina
  • vaginal itching or discharge
  • blurring or changes of vision

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.

Please speak with your doctor, nurse, or pharmacist if you have any questions about this medicine.

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