Generic Premarin (Conjugated Estrogens 0.625mg)

What are conjugated estrogens tablets?

CONJUGATED ESTROGENS (Premarin®, Cenestin™) contains a mixture of estrogen hormones. Estrogens are essential for maintaining normal female functions. Conjugated estrogens can help relieve symptoms of the menopause (hot flashes, night sweats, mood changes, and vaginal dryness and irritation), and also help to prevent osteoporosis (thin weak bones). Conjugated estrogens can also help improve female functions in women with hormonal imbalance or problems with their ovaries. This drug may also be given to patients with inoperable breast cancers (in men or women) or prostate cancer (men). Estrogens are occasionally prescribed for other purposes. Generic conjugated estrogen tablets are not yet available.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• asthma
• blood vessel disease, blood clotting disorder, or suffered a stroke
• breast, cervical, endometrial, ovarian or uterine cancer
• diabetes
• endometriosis
• fibroids in the womb
• heart disease
• high blood lipids or cholesterol
• high blood pressure
• high level of calcium in the blood
• low level of calcium in the blood
• hysterectomy
• kidney disease
• liver disease
• mental depression
• migraine
• porphyria
• systemic lupus erythematosus (SLE)
• thyroid disease
• tobacco smoker
• vaginal bleeding
• an unusual or allergic reaction to estrogens, other hormones, medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I take this medicine?

Take conjugated estrogen tablets by mouth. Follow the directions on the prescription label. Swallow the tablet with a drink of water. Take the tablets with food. Take your doses at regular intervals, at the same time each day. Do not take your medicine more often than directed.

• For all uses of this medicine:

Before starting this medication, read the paper on your prescription provided by your pharmacist or health care professional. This paper will tell you about the specific product you are taking. Make certain you understand the instructions.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What drug(s) may interact with conjugated estrogens?

• some antibiotics used to treat infections
• anastrozole
• barbiturates or benzodiazepines used for inducing sleep or treating seizures (convulsions)
• bromocriptine
• carbamazepine
• cimetidine
• cyclosporine
• dantrolene
• exemestane
• medications for diabetes
• methotrexate
• griseofulvin
• hydrocortisone, cortisone, or prednisolone
• isoniazid (INH)
• letrozole
• methotrexate
• mineral oil
• phenytoin
• raloxifene or tamoxifen
• rifabutin, rifampin, or rifapentine
• testolactone
• thyroid hormones
• topiramate
• tricyclic antidepressants
• warfarin

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What side effects may I notice from taking conjugated estrogens?

Side effects that you should report to your prescriber or health care professional as soon as possible:

• breakthrough bleeding and spotting
• breast enlargement, tenderness, unusual discharge or milk production
• chest pain
• confusion, forgetfulness
• leg, arm or groin pain
• nausea, vomiting
• severe headaches
• stomach pain (severe)
• sudden shortness of breath
• swelling of the hands, feet or ankles, or rapid weight gain
• vision or speech problems
• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):

• change in sexual desire
• mild stomach upset
• mood changes, anxiety, depression, frustration, anger, or emotional outbursts
• increased or decreased appetite
• skin rash, acne, or brown spots on the face
• tiredness
• urinary incontinence
• vaginal yeast infection (irritation and white discharge)
• weight gain

What should I watch for while taking conjugated estrogens?

Visit your prescriber or health care professional for regular checks on your progress. You should have a complete check-up every 6 months. You will need a regular breast and pelvic exam and 'Pap' smear while on conjugated estrogens therapy. You should also discuss the need for regular mammograms with your health care professional, and follow his or her guidelines for these tests.

Conjugated estrogens can make your body retain fluid, making your fingers, hands, or ankles swell. Your blood pressure can go up. Contact your prescriber or health care professional if you feel you are retaining fluid.

If you have any reason to think you are pregnant; stop taking conjugated estrogens at once and contact your prescriber or health care professional.

Tobacco smoking increases the risk of getting a blood clot or having a stroke while you are taking conjugated estrogens, especially if you are more than 35 years old. You are strongly advised not to smoke.

If you wear contact lenses and notice visual changes, or if the lenses begin to feel uncomfortable, consult your eye care specialist or health care professional.

In women who still have their uterus, estrogens increase the risk of developing a condition (endometrial hyperplasia) that may lead to cancer of the lining of the uterus. Taking progestins, another hormone drug, with estrogens lowers the risk of developing this condition. Therefore, if your uterus has not been removed (by a hysterectomy), your doctor may prescribe a progestin for you to take together with your estrogen. You should know, however, that taking estrogens with progestins may have additional health risks. You should discuss the use of estrogens and progestins with your health care professional to determine the benefits and risks for you.

If you are going to have elective surgery, you may need to stop taking your estrogens one month beforehand. Consult your health care professional for advice prior to scheduling the surgery.

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What is/are Premarin?

CONJUGATED ESTROGENS is an estrogen. It is mostly used as hormone replacement in menopausal women. It helps to treat hot flashes and prevent osteoporosis. It is also used to treat women with low hormone levels or in those who have had their ovaries removed. This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care providers before I take this medicine?

They need to know if you have any of these conditions:

abnormal vaginal bleeding blood vessel disease or blood clots breast, cervical, endometrial, ovarian, liver, or uterine cancer dementia diabetes endometriosis fibroids gallbladder disease heart disease or recent heart attack high blood pressure high cholesterol high level of calcium in the blood kidney disease liver disease mental depression migraine headaches stroke tobacco smoker an unusual or allergic reaction to estrogens, other medicines, foods, dyes, or preservatives pregnant or trying to get pregnant breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take your medicine at regular intervals, at the same time each day. Do not take your medicine more often than directed.

A patient information sheet for the product will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.

Talk to your pediatrician regarding the use of this medicine in children. This medicine is not approved for use in children.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

Note: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following:

aromatase inhibitors like aminoglutethimide, anastrozole, exemestane, letrozole, testolactone metyrapone

This medicine may also interact with the following:

barbiturates, such as phenobarbital carbamazepine clarithromycin erythromycin grapefruit juice medicines for fungal infections like ketoconazole and itraconazole phenytoin rifampin ritonavir St. John's Wort thyroid hormones

This list may not describe all possible interactions. Give your health care providers a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What side effects may I notice from this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue breast tissue changes or discharge changes in vision chest pain confusion, trouble speaking or understanding dark urine general ill feeling or flu-like symptoms light-colored stools nausea, vomiting pain, swelling, warmth in the leg right upper belly pain severe headaches shortness of breath sudden numbness or weakness of the face, arm or leg trouble walking, dizziness, loss of balance or coordination unusual vaginal bleeding yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

hair loss increased hunger or thirst increased urination symptoms of vaginal infection like itching, irritation or unusual discharge unusually weak or tired

This list may not describe all possible side effects.

What should I watch for while using this medicine?

Visit your health care professional for regular checks on your progress. You will need a regular breast and pelvic exam and Pap smear while on this medicine. You should also discuss the need for regular mammograms with your health care professional, and follow his or her guidelines for these tests.

This medicine can make your body retain fluid, making your fingers, hands, or ankles swell. Your blood pressure can go up. Contact your doctor or health care professional if you feel you are retaining fluid.

If you have any reason to think you are pregnant; stop taking this medicine at once and contact your doctor or health care professional.

Smoking increases the risk of getting a blood clot or having a stroke while you are taking this medicine, especially if you are more than 35 years old. You are strongly advised not to smoke.

If you wear contact lenses and notice visual changes, or if the lenses begin to feel uncomfortable, consult your eye care specialist.

This medicine can increase the risk of developing a condition (endometrial hyperplasia) that may lead to cancer of the lining of the uterus. Taking progestins, another hormone drug, with this medicine lowers the risk of developing this condition. Therefore, if your uterus has not been removed (by a hysterectomy), your doctor may prescribe a progestin for you to take together with your estrogen. You should know, however, that taking estrogens with progestins may have additional health risks. You should discuss the use of estrogens and progestins with your health care professional to determine the benefits and risks for you.

If you are going to have surgery, you may need to stop taking this medicine. Consult your health care professional for advice before you schedule the surgery.

Where should I keep this medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

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