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AMABELZ- estradiol and norethindrone acetate tablet


  1. Patient Information
  2. What Is Amabelz?
  3. Amabelz Is Used After Menopause To:
  4. Who Should Not Take Amabelz?
  5. Do Not Take Amabelz If You:
  6. Before You Take Amabelz, Tell Your Healthcare Provider If You:
  7. How Should I Take Amabelz?
  8. Follow The Instructions Below To Use Your Amabelz Wallet Pack:
  9. What Are The Possible Side Effects Of Amabelz?
  10. Serious, But Less Common Side Effects Include:
  11. Call Your Healthcare Provider Right Away If You Get Any Of The Following Warning Signs Or Any Other Unusual Symptoms That Concern You:
  12. Less Serious, But Common Side Effects Include:
  13. What Can I Do To Lower My Chances Of A Serious Side Effect With Amabelz?
  14. Active Ingredients:
  15. Inactive Ingredients:
  16. Manufactured For:
  17. Manufactured By:
  18. Pouch Pack:
  19. Carton Pack:
  20. Revised: 5/2017document Id:

Patient Information 

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 Amabelz.

What Is Amabelz? 

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

Amabelz 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 Amabelz.

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 Amabelz 1 mg/0.5 mg to treat these problems. If you use Amabelz 1 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 Amabelz 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 Amabelz.

Who Should Not Take Amabelz? 

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

Amabelz 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 Amabelz.

Do Not Take Amabelz 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 Amabelz.

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 Amabelz or any of its ingredients

Before You Take Amabelz, 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 Amabelz.

are breast feeding

The hormones in Amabelz 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 Amabelz works. Amabelz 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 Amabelz? 

Take Amabelz exactly as your healthcare provider tells you to take it.

Take 1 Amabelz 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 Amabelz.

Follow The Instructions Below To Use Your Amabelz Wallet Pack: 

1. Set The Day Reminder

Each wallet has been preprinted with the days of the week, starting with Sunday, to facilitate a Sunday-Start regimen.

Six different day label strips of the week have been provided with this pack in order to accommodate beginning any day of the week.

Pick the day label strip that starts with the current day of the week. Place this day label strip over the area that has the days of the week (starting with Sunday) pre-printed on the wallet (Refer figure below).

wallet image

2. How to take the first tablet.

Remove tablet "1" by pushing down on the tablet. The tablet will come out through a hole in the back of the strip.

The patient should wait 24 hours to take the next tablet. Moving across each row of the wallet, continue taking tablet daily until all tablets have been taken.

When your wallet is empty, you will start a new wallet on the day after tablet "28." The first tablet in every refill will always be taken on the same day of the week, no matter when the patient takes the next tablet.

What Are The Possible Side Effects Of Amabelz? 

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 Amabelz. 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 Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or to FDA at 1-800-FDA-1088.

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

Talk with your healthcare provider regularly about whether you should continue taking Amabelz.

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 Amabelz at room temperature between 68 F to 77 F (20 C to 25 C).

Store Amabelz in a dry place protected from light.

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

General information about the safe and effective use of Amabelz.

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

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

For more information, you can call our toll free number 1-800-399-2561 or you can visit the Lupin website at www.lupinpharmaceuticals.com.

Active Ingredients: 

estradiol and norethindrone acetate

Inactive Ingredients: 

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

Amabelz 1 mg/0.5 mg or Amabelz 0.5 mg/0.1 mg is supplied in a wallet pack enclosed in a pouch with the desiccants containing 28 tablets.

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

Amabelz is a trademark of Lupin Pharmaceuticals, Inc.

Manufactured For: 

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States

Manufactured By: 

Lupin Limited

Pithampur (M.P.) 454 775

India

June 2016 ID: # 244731

AMABELZ (estradiol and norethindrone acetate tablets USP) - 1 mg/0.5 mg

Pouch Pack: 

NDC: 681810-830-11

1 Wallet of 28 Tablets

Rx only

Pharmacist: Each unit contains information intended for the patients. See enclosed information for the patient including boxed warning. This informational piece is to be provided to the patient with each prescription.

pouch - 1mg-0.5mg

AMABELZ (estradiol and norethindrone acetate tablets USP) - 1 mg/0.5 mg

28 Day Regimen

Wallet Pack: NDC: 681810-830-11

28 Tablets

Rx only

wallet - 1mg-0.5mg

AMABELZ (estradiol and norethindrone acetate tablets USP) - 0.5 mg / 0.1 mg

Carton Pack: 

NDC: 681810-829-13

3 Pouches of 28 Tablets Each

Rx only

carton 0.5 mg-0.1 mg

AMABELZ (estradiol and norethindrone acetate tablets USP) - 0.5 mg / 0.1 mg

Pouch Pack: NDC: 681810-829-11

1 Wallet of 28 Tablets

Rx only

Pharmacist: Each unit contains information intended for the patients. See enclosed information for the patient including boxed warning. This informational piece is to be provided to the patient with each prescription.

pouch 0.5mg-0.1mg

AMABELZ (estradiol and norethindrone acetate tablets USP) - 0.5 mg / 0.1 mg

28 Day Regimen

Wallet Pack: NDC: 681810-829-11

28 Tablets

Rx only

wallet 0.5 mg-0.1 mg
AMABELZ
estradiol and norethindrone acetate tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68180-830
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ESTRADIOL(UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E)ESTRADIOL1 mg
NORETHINDRONE(UNII: T18F433X4S) (NORETHINDRONE - UNII:T18F433X4S)NORETHINDRONE0.5 mg
Inactive Ingredients
Ingredient NameStrength
COPOVIDONE(UNII: D9C330MD8B)
HYPROMELLOSES(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
STARCH, CORN(UNII: O8232NY3SJ)
TRIACETIN(UNII: XHX3C3X673)
Product Characteristics
ColorWHITE (white to off-white)Scoreno score
ShapeROUNDSize6mm
FlavorImprint CodeM54;LU
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68180-830-133 in 1 CARTON10/21/2016
1NDC:68180-830-111 in 1 POUCH
128 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20333910/21/2016
AMABELZ
estradiol and norethindrone acetate tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68180-829
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ESTRADIOL(UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E)ESTRADIOL0.5 mg
NORETHINDRONE(UNII: T18F433X4S) (NORETHINDRONE - UNII:T18F433X4S)NORETHINDRONE0.1 mg
Inactive Ingredients
Ingredient NameStrength
COPOVIDONE(UNII: D9C330MD8B)
HYPROMELLOSES(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
STARCH, CORN(UNII: O8232NY3SJ)
TRIACETIN(UNII: XHX3C3X673)
Product Characteristics
ColorWHITE (white to off-white)Scoreno score
ShapeROUNDSize6mm
FlavorImprint CodeM53;LU
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68180-829-133 in 1 CARTON10/21/2016
1NDC:68180-829-111 in 1 POUCH
128 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20333910/21/2016
Labeler -Lupin Pharmaceuticals, Inc. (089153071)
Registrant -LUPIN LIMITED (675923163)
Establishment
NameAddressID/FEIBusiness Operations
LUPIN LIMITED650582310manufacture(68180-829, 68180-830) , pack(68180-829, 68180-830)

Revised: 5/2017document Id: 

32c2d4a8-73e7-4415-9464-6a71ef763246Set id: 3b8a7426-6f1c-470a-ac36-b8465b8679cdVersion: 5Effective Time: 20170501Lupin Pharmaceuticals, Inc.



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