PATIENT INFORMATION
(Norethindrone Acetate and Ethinyl Estradiol Tablets)
Read this Patient Information before you start using Jinteli and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your menopausal symptoms or your treatment.
What is the most important information I should know about Jinteli (a combination of estrogen and progestogen)?
- Do not use estrogens with or without progestogens to prevent heart disease, heart attacks, strokes or dementia (decline of brain function).
- Using estrogens with progestogens may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots.
- Using estrogens with progestogens may increase your chance of getting dementia, based on a study of women 65 years of age and older.
- Using estrogen-alone may increase your chance of getting cancer of the uterus (womb).
- Do not use estrogen-alone to prevent heart disease, heart attacks, strokes or dementia (decline of brain function).
- Using estrogen-alone may increase your chances of getting strokes or blood clots.
- Using estrogen-alone may increase your chance of getting dementia, based on a study of women 65 years of age and older.
- Only one estrogen with progestogen product and dose have been shown to increase your chances of getting heart attacks, strokes, breast cancer, blood clots, and dementia. Only one estrogen-alone product and dose have been shown to increase your chances of getting strokes, blood clots, and dementia. Because other products and doses have not been studied in the same way, it is not known how the use of norethindrone acetate and ethinyl estradiol tablets will affect your chances of these conditions. You and your healthcare provider should talk regularly about whether you still need treatment with Jinteli.
What is Jinteli?
Jinteli is a prescription medicine that contains two kinds of hormones, an estrogen and a progestogen.
What is Jinteli used for?
Jinteli is used after menopause to:
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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 years 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 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.
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Help reduce your chances of getting osteoporosis (thin weak bones)
If you use Jinteli only to prevent osteoporosis from menopause, talk with 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 Jinteli.
Who should not use Jinteli?
Do not use Jinteli if you have had your uterus (womb) removed (hysterectomy).
Jinteli contains a progestogen to decrease the chance of getting cancer of the uterus (womb). If you do not have a uterus, you do not need a progestogen and you should not use Jinteli.
Do not start using Jinteli if you:
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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 been diagnosed with a bleeding disorder.
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currently have or have had certain cancers.
Estrogens may increase the chances of getting certain types of cancers, including cancer of the breast or uterus (womb). If you have or have had cancer, talk with your healthcare provider about whether you should use Jinteli.
- had a stroke or heart attack
- currently have or have had blood clots
- currently have or have had liver problems
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are allergic to Jinteli or any of its ingredients.
See the list of ingredients in Jinteli at the end of this leaflet.
Before you use Jinteli, tell your healthcare provider about all of your medical conditions, including if you:
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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.
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have any other medical conditions that may become worse while you are using norethindrone acetate and ethinyl estradiol tablets.
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.
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are going to have surgery or will be on bed rest
Your healthcare provider will let you know if you need to stop using Jinteli.
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are pregnant or think you may be pregnant.
Jinteli is not for pregnant women.
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are breastfeeding
The hormones in Jinteli can pass into your breast milk.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines may affect how Jinteli works. Some other medicines and food products may increase or decrease the concentrations of the hormones in Jinteli in the blood. Jinteli may also affect how your other medicines work. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get new medicine.
How should I use Jinteli?
- Take Jinteli exactly as your healthcare provider tells you to take it.
- Take 1 Jinteli tablet 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 or not you still need treatment with Jinteli.
What are the possible side effects of Jinteli?
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:
- Changes in vision
- High levels of fat in your blood
- Breast cancer
- Liver problems
- Cancer of the lining of the uterus (womb)
- Changes in your thyroid hormone levels
- Cancer of the ovary
- Swelling or fluid retention
- Dementia
- Cancer changes of endometriosis
- Gallbladder disease
- Enlargement of benign tumors of the uterus (“fibroids”)
- High or low blood calcium levels
- Worsening swelling of face or tongue (angioedema) in women who have a history of angioedema
- Changes in laboratory test results such as bleeding time and high blood sugar levels
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
Common side effects of Jinteli include:
- headache
- stomach or abdominal cramps, bloating
- breast pain
- hair loss
- irregular vaginal bleeding or spotting
- fluid retention
- vaginal yeast infection
These are not all the possible side effects of Jinteli. For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider if you have any side effects that bother you or do not go away.
You may report side effects to Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088.
What can I do to lower my chances of a serious side effect with Jinteli ?
- Talk with your healthcare provider regularly about whether you should continue using Jinteli.
- If you have a uterus, talk with your healthcare provider about whether Jinteli is right for you.
- In general, the addition of a progestogen is recommended for a woman with a uterus to reduce the chance of getting cancer of the uterus (womb).
- See your healthcare provider right away if you get vaginal bleeding while using Jinteli.
- 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 for getting heart disease.
Ask your healthcare provider for ways to lower your chances of getting heart disease.
How should I store Jinteli?
- Store Jinteli at room temperature between 68°F to 77°F (20°C to 25°C).
Keep Jinteli out of the reach of children.
General information about the safe and effective use of Jinteli .
Medicines are sometimes prescribed for conditions that are not mentioned in a Patient Information leaflet. Do not use Jinteli for conditions for which it was not prescribed. Do not give Jinteli to other people, even if they have the same symptoms you have. It may harm them.
You can ask your pharmacist or healthcare provider for information about Jinteli that is written for health professionals.
For more information call 1-888-838-2872.
What are the ingredients in Jinteli ?
Active Ingredients: norethindrone acetate and ethinyl estradiol
Inactive Ingredients: calcium stearate, lactose monohydrate, microcrystalline cellulose, pregelatinized corn starch, and sodium starch glycolate
This Patient Information has been approved by the U.S Food and Drug Administration.
Manufactured For:
Teva Pharmaceuticals
Parsippany, NJ 07054
Rev. D 11/2023