- Patient Information
- What Is Amabelz?
- Amabelz Is Used After Menopause To:
- Who Should Not Take Amabelz?
- Do Not Take Amabelz If You:
- Before You Take Amabelz, Tell Your Healthcare Provider If You:
- How Should I Take Amabelz?
- Follow The Instructions Below To Use Your Amabelz Wallet Pack:
- What Are The Possible Side Effects Of Amabelz?
- Serious, But Less Common Side Effects Include:
- Call Your Healthcare Provider Right Away If You Get Any Of The Following Warning Signs Or Any Other Unusual Symptoms That Concern You:
- Less Serious, But Common Side Effects Include:
- What Can I Do To Lower My Chances Of A Serious Side Effect With Amabelz?
- Active Ingredients:
- Inactive Ingredients:
- Manufactured For:
- Manufactured By:
- Pouch Pack:
- Carton Pack:
- 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).
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.
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
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
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.
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
AMABELZ
estradiol and norethindrone acetate tablet
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-830 Route of Administration ORAL
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ESTRADIOL(UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E) ESTRADIOL 1 mg NORETHINDRONE(UNII: T18F433X4S) (NORETHINDRONE - UNII:T18F433X4S) NORETHINDRONE 0.5 mg
Inactive Ingredients Ingredient Name Strength COPOVIDONE(UNII: D9C330MD8B) HYPROMELLOSES(UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X) MAGNESIUM STEARATE(UNII: 70097M6I30) STARCH, CORN(UNII: O8232NY3SJ) TRIACETIN(UNII: XHX3C3X673)
Product Characteristics Color WHITE (white to off-white) Score no score Shape ROUND Size 6mm Flavor Imprint Code M54;LU Contains
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68180-830-13 3 in 1 CARTON 10/21/2016 1 NDC:68180-830-11 1 in 1 POUCH 1 28 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA203339 10/21/2016
AMABELZ
estradiol and norethindrone acetate tablet
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-829 Route of Administration ORAL
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ESTRADIOL(UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E) ESTRADIOL 0.5 mg NORETHINDRONE(UNII: T18F433X4S) (NORETHINDRONE - UNII:T18F433X4S) NORETHINDRONE 0.1 mg
Inactive Ingredients Ingredient Name Strength COPOVIDONE(UNII: D9C330MD8B) HYPROMELLOSES(UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X) MAGNESIUM STEARATE(UNII: 70097M6I30) STARCH, CORN(UNII: O8232NY3SJ) TRIACETIN(UNII: XHX3C3X673)
Product Characteristics Color WHITE (white to off-white) Score no score Shape ROUND Size 6mm Flavor Imprint Code M53;LU Contains
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68180-829-13 3 in 1 CARTON 10/21/2016 1 NDC:68180-829-11 1 in 1 POUCH 1 28 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA203339 10/21/2016
Labeler -Lupin Pharmaceuticals, Inc. (089153071)
Registrant -LUPIN LIMITED (675923163)
Establishment Name Address ID/FEI Business Operations LUPIN LIMITED 650582310 manufacture(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.