hot flushes or flashes
vaginal discharge
muscle spasms
increased sweating
These are not all the possible side effects of OSPHENA. For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider about any side effects that bother you or does not go away.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What can I do to lower my chances of a serious side effect with OSPHENA?

Talk with your healthcare provider regularly about whether you should continue taking OSPHENA.
If you have a uterus, talk with your healthcare provider about whether the addition of a progestin is right for you.
See your healthcare provider right away if you develop vaginal bleeding while taking OSPHENA.
Have a pelvic exam, breast exam and mammogram (breast x-ray) every year unless your healthcare provider tells you something else.
If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram (breast x-ray), you may need to have breast exams more often.
If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or use tobacco, you may have a higher chance of getting heart disease.
Ask your healthcare provider for ways to lower your chances of getting heart disease.

How should I store OSPHENA?

Store OSPHENA at room temperature between 68°F to 77°F (20°C to 25°C).
Keep OSPHENA and all medicines out of the reach of children.

General information about the safe and effective use of OSPHENA.

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not take OSPHENA for conditions for which it was not prescribed. Do not give OSPHENA to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about OSPHENA. If you would like more information, talk with your healthcare provider or pharmacist. You can ask your healthcare provider or pharmacist for more information about OSPHENA that is written for health professionals.

For more information, go to www.osphena.com or call Shionogi Inc. at 1-855-OSPHENA (1-855-677-4362).

What are the ingredients in OSPHENA?

Active Ingredient: ospemifene

Inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, and triacetin.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Manufactured for:
Shionogi Inc.
Florham Park, NJ 07932

Manufactured by:
Penn Pharmaceutical Services Ltd.
23-24 Tafarnauback Industrial Estate
Tredegar, Gwent, South Wales
NP22 3AA, United Kingdom

Made in UK

Approved: February 2013
Principal Display Panel

NDC 5960-580-00

Penn Pharmaceutical Services Ltd.
23-24 Tafarnaubach Industrial Estate
Tredegar, Gwent, South Wales NP22 3AA UK

Product: Ospemifene 60 mg Tablets

Quantity: 600 blisters/carton, 36 carton