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Premarin Vaginal Cream

(conjugated estrogens vaginal cream)

In this factsheet:
• How does Premarin Vaginal Cream work? What will it do for me?
• How should I use Premarin Vaginal Cream?
• What form(s) does Premarin Vaginal Cream come in?
• Who should NOT take Premarin Vaginal Cream?
• What side effects are possible with Premarin Vaginal Cream?
• Are there any other precautions or warnings for Premarin Vaginal Cream?
• What other drugs could interact with Premarin Vaginal Cream?

DIN (Drug Identification Number)

What side effects are possible with Premarin Vaginal Cream?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abdominal cramps, bloating
• abdominal or back pain
• breast tenderness
• hair loss
• headache
• nausea or vomiting

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• breast pain
• itching of the vagina or genitals
• stinging or redness in the genital area
• thick, white vaginal discharge without odour or with a mild odour
• unusual or unexpected uterine bleeding or spotting

Stop taking the medication and seek immediate medical attention if any of the following occur:

• migraine
• severe leg pain or numbness affecting any part of the body
• shortness of breath
• sudden vision changes
• tightness of the chest

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for Premarin Vaginal Cream?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Note the following important information about estrogen replacement therapy: The Women's Health Initiative (WHI) study results indicated an increased risk of heart attack, stroke, breast cancer, blood clots in the lungs, and blood clots in the leg veins in postmenopausal women during 5 years of treatment with 0.625 mg conjugated equine estrogens and 2.5 mg medroxyprogesterone compared to women receiving sugar tablets. Other combinations of estrogen and progestins were not studied. However, until additional data are available, the risks should be assumed to be similar for other hormone replacement products. Therefore,

• estrogen with or without progestins should be used at the lowest dose that relieves your menopausal symptoms for the shortest time period possible, as directed by your doctor.
• estrogen with or without progestins should not be used to prevent heart disease, heart attacks, or strokes.

Blood clotting disorders: Estrogen with or without progestins are associated with an increased risk of blood clots in the lungs and legs. This risk also increases with age, a personal or family history of blood clots, smoking, and obesity. The risk of blood clots is also increased if you are immobilized for prolonged periods and with major surgery. If possible, this medication should be stopped 4 to 6 weeks before major surgery. Talk about the risk of blood clots with your doctor.

Breast cancer: Some studies have found an association between a modest increase in the risk of developing breast cancer and the use of hormone replacement therapy after menopause. Women who have history of breast cancer should not use estrogens. If you have a family history of breast cancer, breast nodules, fibrocystic disease of the breast, or abnormal mammograms, you should be closely monitored by your doctor if you use estrogens. Women using estrogens should have regular breast examinations and should be taught how to do a breast self-examination. Your doctor may also recommend regular mammograms, depending on your age, risk factors, and previous mammogram results. This medication must not be applied to the breasts, as it may have harmful effects on the breast tissue. Discuss the benefits and risks with your doctor so that you can make an informed choice about using this medication.

Condoms, diaphragms, or cervical caps: Conjugated estrogens vaginal cream may weaken the latex rubber of condoms, diaphragms, and cervical caps. Therefore, they may not be effective in preventing pregnancy for women who use the cream.

Dementia: Women over age 65 receiving combined estrogen and progestin replacement therapy may be at increased risk of developing dementia (loss of memory and intellectual function). If you are over 65 years of age, your doctor should closely monitor you for loss of memory and intellectual function.

Diabetes: People with diabetes should monitor their blood glucose closely to detect any changes in blood glucose control that sometimes occurs with use of estrogens. If you have risk factors for diabetes, your doctor will monitor your blood glucose regularly while taking this medication.

Endometrial cancer: Several studies suggest that estrogen replacement therapy increases the risk of cancer of the endometrium (uterus). Taking a progestin along with the estrogen reduces the risk to the same level as that of a woman not using estrogens. For this reason, all women who have not had their uterus removed should also take a progestin if they are using estrogens.

Fibroids: This medication may worsen fibroids, causing sudden enlargement, pain, or tenderness. If you notice these effects, contact your doctor.

Gallbladder: An increased risk of gallbladder disease has been reported by postmenopausal women who take oral estrogens.

Heart disease and stroke: Studies indicate an increased risk of heart disease and stroke with estrogen (with or without progestins) for postmenopausal women. If you experience symptoms of a heart attack (chest pain, tightness or pressure, sweating, nausea, feeling of impending doom) or stroke (sudden dizziness, headache, loss of speech, changes in vision, weakness or numbness in the arms and legs) while taking this medication, get immediate medical attention.

High cholesterol or triglycerides: Estrogen may increase triglyceride (a type of fat found in the blood) levels, especially in those who already have high levels of triglycerides. Your doctor will monitor your triglyceride levels closely while you are using this medication.

Kidney disease: People with kidney disease should be monitored by their doctor while using estrogen.

Liver disease: If you have or have had liver problems, you may require special monitoring by your doctor while you use this medication. Make sure to tell your doctor if you have ever had liver problems.

Water retention: Estrogen may cause sodium (salt) and water retention; therefore, people with epilepsy, asthma, or kidney or heart dysfunction should be closely monitored by their doctor while using this medication.

Pregnancy: Estrogen should not be used during pregnancy. If you become pregnant while using this medication, contact your doctor immediately.

Breast-feeding: Estrogen passes into breast milk. If you are a breast-feeding mother and are using this medication, it may affect your baby. This medication is not recommended for breast-feeding mothers.

Children: The safety and effectiveness of this medication have not been established for children.

What other drugs could interact with Premarin Vaginal Cream?

There may be an interaction between conjugated estrogens vaginal cream and any of the following:

antidiabetic medications (e.g., insulin, glyburide) barbiturates (e.g., phenobarbital) blood-pressure-lowering medications (e.g., propranolol, enalapril, diltiazem) carbamazepine cimetidine clarithromycin corticosteroids (hydrocortisone, prednisolone, prednisone) cyclosporine dexamethasone grapefruit juice

itraconazole ketoconazole meprobamate morphine phenylbutazone phenytoin rifampin ritonavir St. John's wort temazepam theophylline topiramate warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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