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ACTIVELLA- estradiol and norethindrone acetate tablet, film coated


  1. (a Combination Of Estrogen And Progestin)?
  2. What Is Activella?
  3. Activella Is Used After Menopause To:
  4. Who Should Not Take Activella?
  5. Do Not Take Activella If You:
  6. Before You Take Activella, Tell Your Healthcare Provider If You:
  7. How Should I Take Activella?
  8. What Are The Possible Side Effects Of Activella?
  9. Serious, But Less Common Side Effects Include:
  10. Call Your Healthcare Provider Right Away If You Get Any Of The Following Warning Signs Or Any Other Unusual Symptoms That Concern You:
  11. Less Serious, But Common Side Effects Include:
  12. What Can I Do To Lower My Chances Of A Serious Side Effect With Activella?
  13. Active Ingredients:
  14. Inactive Ingredients:
  15. Manufactured By:
  16. Patient Information
  17. Distributed By:

(a Combination Of Estrogen And Progestin)? 

  • Do not use estrogens with progestins to prevent heart disease, heart attacks, strokes, or dementia (decline of brain function).
  • Taking estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots.
  • Taking estrogens with progestins may increase your chance of getting dementia, based on a study of women 65 years of age or older.
  • Do not use estrogen-alone to prevent heart disease, heart attacks, strokes or dementia.
  • Taking estrogen-alone may increase your chance of getting cancer of the uterus (womb).
  • Taking estrogen-alone may increase your chances of getting strokes or blood clots.
  • Taking estrogen-alone may increase your chance of getting dementia, based on a study of women 65 years of age or older.
  • You and your healthcare provider should talk regularly about whether you still need treatment with Activella.

What Is Activella? 

Activella is a prescription medicine that contains two kinds of hormones, an estrogen and a progestin.

Activella Is Used After Menopause To: 

  • reduce moderate to severe hot flushes

Estrogens are hormones made by a woman s ovaries. The ovaries normally stop making estrogens when a woman is between 45 and 55 yrs old. This drop in body estrogen levels causes the change of life or menopause, the end of monthly menstrual periods. Sometimes both ovaries are removed during an operation before natural menopause takes place. The sudden drop in estrogen levels causes surgical menopause.

When the estrogen levels begin dropping, some women get very uncomfortable symptoms, such as feelings of warmth in the face, neck, and chest, or sudden, intense episodes of heat and sweating ( hot flashes or hot flushes ). In some women, the symptoms are mild, and they will not need to take estrogens. In other women, symptoms can be more severe. You and your healthcare provider should talk regularly about whether or not you still need treatment with Activella.

  • treat moderate to severe menopausal changes in and around the vagina

You and your healthcare provider should talk regularly about whether you still need treatment with Activella 1.0 mg/0.5 mg to treat these problems. If you use Activella 1.0 mg/0.5 mg only to treat your menopausal changes in and around your vagina, talk with your healthcare provider about whether a topical vaginal product would be better for you.

  • help reduce your chances of getting osteoporosis (thin weak bones)

If you use Activella only to prevent osteoporosis from menopause, talk to your healthcare provider about whether a different treatment or medicine without estrogens might be better for you.

You and your healthcare provider should talk regularly about whether you still need treatment with Activella.

Who Should Not Take Activella? 

Do not take Activella if you have had your uterus (womb) removed (hysterectomy).

Activella contains a progestin to decrease the chance of getting cancer of the uterus. If you do not have a uterus, you do not need a progestin and you should not take Activella.

Do Not Take Activella If You: 

  • have unusual vaginal bleeding

Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.

  • currently have or have had certain cancers

Estrogens may increase the chance of getting certain types of cancers, including cancer of the breast or uterus. If you have or have had cancer, talk with your healthcare provider about whether you should take Activella.

  • had a stroke or heart attack
  • currently have or have had blood clots
  • currently have or have had liver problems
  • have been diagnosed with a bleeding disorder
  • are allergic to Activella or any of its ingredients

Before You Take Activella, Tell Your Healthcare Provider If You: 

  • have any unusual vaginal bleeding

Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.

  • have any other medical conditions

Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), diabetes, migraine, endometriosis, lupus, angioedema (swelling of face and tongue), or problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.

  • are going to have surgery or will be on bed rest

Your healthcare provider will let you know if you need to stop taking Activella.

  • are breast feeding

The hormones in Activella can pass into your breast milk.

Tell your healthcare provider about all the medicines you take,including prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how Activella works. Activella may also affect how your other medicines work. Keep a list of your medicines and show them to your healthcare provider and pharmacist when you get a new medicine.

How Should I Take Activella? 

  • Take Activella exactly as your healthcare provider tells you to take it.
  • Take 1 Activella at the same time each day.
  • You and your healthcare provider should talk regularly (every 3 to 6 months) about the dose you are taking and whether you still need treatment with Activella.

Follow the instructions below to use your Activella Dispenser.

How to use the ACTIVELLA Dispenser

What Are The Possible Side Effects Of Activella? 

Side effects are grouped by how serious they are and how often they happen when you are treated.

Serious, But Less Common Side Effects Include: 

  • heart attack
  • stroke
  • blood clots
  • dementia
  • breast cancer
  • cancer of the lining of the uterus (womb)
  • cancer of the ovary
  • high blood pressure
  • high blood sugar
  • gallbladder disease
  • liver problems
  • changes in your thyroid hormone levels
  • enlargement of benign tumors ( fibroids )

Call Your Healthcare Provider Right Away If You Get Any Of The Following Warning Signs Or Any Other Unusual Symptoms That Concern You: 

  • new breast lumps
  • unusual vaginal bleeding
  • changes in vision or speech
  • sudden new severe headaches
  • severe pains in your chest or legs with or without shortness of breath, weakness and fatigue

Less Serious, But Common Side Effects Include: 

  • headache
  • breast pain
  • irregular vaginal bleeding or spotting
  • stomach or abdominal cramps, bloating
  • nausea and vomiting
  • hair loss
  • fluid retention
  • vaginal yeast infection

These are not all the possible side effects of Activella. For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider if you have any side effect that bothers you or does not go away. You may report side effects to Gemini Laboratories, LLC at (855) 346-8326 or to FDA at 1-800-FDA-1088.

What Can I Do To Lower My Chances Of A Serious Side Effect With Activella? 

  • Talk with your healthcare provider regularly about whether you should continue taking Activella.
  • If you have a uterus, talk with your healthcare provider about whether the addition of a progestin is right for you.
  • The addition of a progestin is generally recommended for a woman with a uterus to reduce the chance of getting cancer of the uterus (womb).
    • Store Activella at room temperature between 68 F to 77 F (20 C to 25 C).
    • Store Activella in a dry place protected from light.

    KEEP ACTIVELLA and all medicines out of the reach of children.

    General information about the safe and effective use of Activella.

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

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

    For more information go towww.activella.comor call 1-855-346-8326.

Active Ingredients: 

estradiol and norethindrone acetate

Inactive Ingredients: 

lactose monohydrate, starch (corn), copovidone, talc, magnesium stearate, hypromellose, and triacetin.

The 0.5 mg/0.1 mg tablet also contains hydroxypropylcellulose.

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

Activellais a registered trademark owned by Novo Nordisk FemCare AG

The embossed (Apis) bull symbol on the tablets is a trademark of Novo Nordisk A/S.

2000-2015 Novo Nordisk

Novo Nordisk Inc.

Gemini Laboratories, LLC

Bridgewater, NJ 08807, USA

www.gemini-labs.com

Manufactured By: 

Novo Nordisk A/S

2880 Bagsvaerd,

Denmark

Patient Information 

See FDA-approved patient labeling (Patient Information)

17.1 Abnormal Vaginal Bleeding

Inform postmenopausal women of the importance of reporting abnormal vaginal bleeding to their healthcare provider as soon as possible[see Warnings and Precautions (5.2)].

17.2 Possible Serious Adverse Reactions with Estrogen Plus Progestin Therapy

Inform postmenopausal women of possible serious adverse reactions of estrogen plus progestin therapy including Cardiovascular Disorders, Malignant Neoplasms, and Probable Dementia[see Warnings and Precautions (5.1,5.2,5.3)].

17.3 Possible Less Serious but Common Adverse Reactions with Estrogen Plus Progestin Therapy

Inform postmenopausal women of possible less serious but common adverse reactions of estrogen plus progestin therapy such as headache, breast pain and tenderness, nausea and vomiting.

Date of Issue: 10/2017

Rx Only

Distributed By: 

Gemini Laboratories, LLC

Bridgewater, NJ 08807 USA

www.gemini-labs.com



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