How does this medication work? What will it do for me?

Ospemifene belongs to the class of medications called selective estrogen receptor modifiers (SERMs). It is used to treat postmenopausal women who have vaginal symptoms associated with decreased estrogen levels. Symptoms treated include vaginal dryness and pain during sexual intercourse.

SERMs are not hormones but they work by acting like estrogen in certain parts of the body.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Each white-to-off-white, oval, biconvex, film-coated tablet, engraved with "60" on one side contains 60 mg of ospemifene. Nonmedicinal ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, and triacetin.

How should I use this medication?

The recommended dose of ospemifene is 60 mg taken once daily with food,

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take this medication if you:

  • are allergic to ospemifene or any ingredients of the medication
  • have or may have a cancer that depends on estrogen for growth
  • have abnormal, undiagnosed vaginal bleeding
  • have or have had a blood clot in the legs or lungs
  • have or have a history of blood clots causing heart attack or stroke
  • have severely decreased liver function
  • are or may become pregnant

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • acne
  • diarrhea
  • hair growth on the face, chest, abdomen, or legs
  • headache
  • hot flushes
  • increased sweating
  • joint or muscle pain
  • muscle spasms (e.g., leg cramps)
  • red, itchy skin
  • stomach pain
  • urge to move legs, restless legs syndrome
  • vaginal discharge

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • breast lump, tenderness, or pain
  • signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
  • symptoms of an ovarian cyst (e.g., pelvic pain, bloating, abdominal swelling, frequent need to urinate, painful bowel movements or vaginal bleeding)
  • symptoms of a urinary tract infection (e.g., pain when urinating, urinating more often than usual, low back or flank pain)
  • symptoms of a vaginal infection (e.g., vaginal discharge, redness, swelling, burning sensation, or discomfort)
  • swelling of the hands or legs
  • unexplained vaginal bleeding

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • shortness of breath
  • signs of a blood clot in the arm or leg (tenderness, pain, swelling, warmth, or redness in the arm or leg) or lungs (difficulty breathing, sharp chest pain that is worst when breathing in, coughing, coughing up blood, sweating, or passing out)
  • signs of heart attack (e.g., sudden chest pain or pain radiating to back, down arm, jaw; sensation of fullness of the chest; nausea; vomiting; sweating; anxiety)
  • signs of stroke (e.g., sudden or severe headache; sudden loss of coordination; vision changes; sudden slurring of speech; or unexplained weakness, numbness, or pain in arm or leg)
  • signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
  • sudden partial or complete loss of vision

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Blood clots: Ospemifene may increase the risk of developing blood clots. These blood clots may form anywhere in the body, but are more noticeable when they occur in the legs, lung, brain (stroke), or heart (heart attack). If you experience pain in the chest or leg, unexplained shortness of breath, fast and irregular heartbeat, severe headache, blurred vision, or slurred speech, get immediate medical attention.

Breast cancer: The safety and effectiveness of ospemifene has not been determined for women with breast cancer. It should not be used for women with known or suspected breast cancer.

Endometrial cancer: Ospemifene works like estrogen in the uterus and vagina. There is a possibility of an increased risk of developing endometrial cancer (cancer of the lining of the uterus). If you experience unusual vaginal bleeding, contact your doctor as soon as possible.

Liver function: If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Surgery: Certain situations such as surgery and long-term bed confinement may increase the risk for blood clots. If you are scheduled for surgery, let all doctors involved in your care know that you are taking this medication.

Women who have not reached menopause: The safety and effectiveness of using ospemifene have not been established for women who have not reached menopause. This medication should not be used by premenopausal women.

Pregnancy: This medication is not intended to be used by women who are or may become pregnant.

Breast-feeding: It is not known if ospemifene passes into breast milk. If you are breast-feeding and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: This medication is not intended for use by children.

What other drugs could interact with this medication?

There may be an interaction between ospemifene and any of the following:

  • "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)
  • bazedoxifene
  • ceritinib
  • clarithromycin
  • clomiphene
  • cobicistat
  • estrogens (e.g., conjugated estrogen, estradiol, ethinyl estradiol)
  • HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
  • mifepristone
  • raloxifene
  • rifampin
  • tamoxifen
  • warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over the counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2022. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Osphena