Before Using

Drug information provided by: Merative, Micromedex®

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Ospemifene is not indicated for use in the pediatric population.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ospemifene in the elderly.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Abiraterone Acetate
  • Amiodarone
  • Ceritinib
  • Eslicarbazepine Acetate
  • Fluconazole
  • Fluvoxamine
  • Ketoconazole
  • Piperaquine
  • Regorafenib

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Amobarbital
  • Aprobarbital
  • Bosentan
  • Butabarbital
  • Butalbital
  • Carbamazepine
  • Dexamethasone
  • Efavirenz
  • Enzalutamide
  • Etravirine
  • Fosphenytoin
  • Mephobarbital
  • Methohexital
  • Modafinil
  • Nafcillin
  • Nevirapine
  • Oxcarbazepine
  • Pentobarbital
  • Phenobarbital
  • Phenytoin
  • Prednisone
  • Primidone
  • Rifabutin
  • Rifampin
  • Rifapentine
  • Secobarbital
  • St John's Wort
  • Thiopental

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Abnormal or unusual vaginal bleeding or
  • Blood clots, active or history of or
  • Breast cancer, known or suspected, or a history of or
  • Deep vein thrombosis (blood clot in the leg), active or history of or
  • Heart attack, active or history of or
  • Liver disease, severe or
  • Pulmonary embolism (blood clot in the lung), active or history of or
  • Stroke, active or history of or
  • Tumors (estrogen-dependent), known or suspected—Should not be used in patients with these conditions.
  • Diabetes or
  • Heart disease or
  • Hypercholesterolemia (high cholesterol or fats in the blood) or
  • Hypertension (high blood pressure) or
  • Obesity, or history of or
  • Systemic lupus erythematosus—Use with caution. May cause side effects to become worse.