Premplus®		Premplus pricing
	Brand Premplus manufactured by: WYETH-AYERST
	Chemical name: Conjugated Estrogens/Medroxyprogesterone

Estrogenic Hormones--Progestin

In the US, Prempro is manufactured as 1 combination tablet (Conjugated Estrogens / Medroxyprogesterone), but in Canada, the equivalent product (Premplus) is manufactured as two tablets: 1 Conjugated Estrogens tablet and 1 Medroxyprogesterone Acetate tablet (shown above)

Premplus Information | How to take Premplus | Premplus Precautions | Premplus Side Effects

Premplus Common Use: The relief of menopausal and postmenopausal symptoms, the prevention of osteoporosis (brittle bones), and to treat vulvar and vaginal atrophy.

IMPORTANT NOTE: The following information is intended to heighten awareness of health information and does not suggest diagnosis or treatment. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.

Premplus information: When taking Premplus women are using a combination of 2 hormones, an estrogen (i.e., conjugated estrogens tablets), and a progestin (i.e., medroxyprogesterone acetate tablets). Premplus replaces the hormones in your body which naturally decrease at menopause. Premplus has been shown to provide the benefits of estrogen replacement therapy while lowering the frequency of a possible precancerous condition of the uterine lining with the addition of the progestin. This therapy is not intended for women who have had a hysterectomy (surgical removal of the uterus).

This section describes when and how to use Premplus. Please read it carefully. If you want to know more or have any questions, please ask your doctor or pharmacist.

Uses of Premplus Tablets:

1) To Relieve Menopausal and Postmenopausal Symptoms: Estrogens are hormones produced by the ovaries. When a women is between the ages of 45 and 55, the ovaries normally stop making estrogens. This leads to a drop in body estrogen levels and marks the beginning of menopause (the end of monthly menstrual periods). A sudden drop in estrogen levels also occurs if both ovaries are removed during an operation before natural menopause takes place. This is referred to as “surgical menopause”. When the estrogen levels begin dropping, some women develop very uncomfortable symptoms, such as feelings of warmth in the face, neck and chest, or sudden intense episodes of heat and sweating (“hot flashes”). In some women the symptoms are mild; in others they can be severe. These symptoms may last only a few months or longer. Taking Premplus can alleviate these symptoms.

2) To Prevent Osteoporosis (brittle bones): After menopause, some women develop osteoporosis. This is a thinning of the bones that makes them weaker and allows them to break more easily often leading to fractures of the vertebrae, hip, and wrist bones. Using Premplus tablets in addition to taking adequate calcium (1000 to 1500 mg per day) and regular exercise slows down bone thinning and may prevent bones from breaking. Use of Premplus tablets for the prevention of osteoporosis should be confined to women who appear to be susceptible to this condition.

3)To Treat Vulvar and Vaginal Atrophy (itching, burning, dryness in or around the vagina, difficulty or burning on urination) associated with menopause.

Precautions: Premplus tablets contain estrogens and a progestin. If you take any drug that contains estrogens you should be aware that in some situations their use may not be appropriate.

• The use of estrogens has been reported to increase the risk of cancer of the lining of the uterus (endometrial cancer) in women after the menopause. This risk is significantly reduced when estrogen is used along with a progestin.
• Most studies have not shown a higher risk of breast cancer in women who have ever used estrogens. Some studies, however, have documented an association between a modest increase in the risk of developing breast cancer and the use of hormone replacement therapy in menopause when given for periods exceeding 5 years. Therefore, women with a family history of breast cancer, or with breast nodules, fibrocystic breast disease (lumps), or abnormal mammograms should consult with their doctor before starting hormone replacement therapy. Regular breast examinations by a physician and self-examinations are recommended for all women.
• The use of oral estrogens after menopause has been reported to increase the risk of gallbladder disease requiring surgery.
• Women on estrogen replacement therapy, taken alone or in combination with a progestin, have been reported in some studies to have an increased risk of thrombophlebitis (inflammation of the veins), and/or thromboembolic disease (blood clots).

Who should not use Premplus tablets? Certain medical conditions may be aggravated by estrogens, which is one of the components of Premplus tablets. Therefore, Premplus tablets should either not be used at all or should be used with precaution under these conditions:

• Premplus tablets should not be used during pregnancy. Since pregnancy may be possible early in the premenopause while you are still having spontaneous periods, the use of nonhormonal birth control should be discussed with your physician at this time. If you accidentally take estrogen during pregnancy, there is a small risk of your unborn child having birth defects.
• Premplus tablets should not be used if you are breast-feeding.
• You should not use Premplus if you have any unusual reaction to its ingredients.

Important details to tell your doctor:
Before using Premplus be sure to tell your doctor if you have any of the following medical problems as Premplus should not be used under these conditions:

• cancer of the breast or uterus,
• unexpected or unusual vaginal bleeding,
• abnormal blood clotting condition,
• serious liver disease,
• active phlebitis (inflamed veins),
• hysterectomy (surgical removal of the uterus).

To help your doctor decide whether you should use Premplus and what precautions should be taken during use, tell your doctor:

• what other prescription and non-prescription medicines, if any, you are taking. There are some medicines which interfere with the effects of estrogens and progestins;
• about your allergies or sensitivities to medicines or any other substances you may have;
• if you have ever had any of the following:
  • high triglyceride levels;
  • high blood pressure;
  • heart, kidney, or liver disease;
  • asthma;
  • epilepsy or other neurological disorders;
  • depression;
  • abnormalities of the breast or uterus including cancer;
  • breast disease, breast biopsies;
  • uterine fibroids;
  • phlebitis (inflamed veins);
  • stroke, heart attack or blood clot;
  • migraine headache.

Premplus side effects: Check with your doctor if these symptoms become troublesome. The following effects have been reported in women taking estrogens and/or progestins, the 2 components of Premplus tablets:

• nausea;
• retention of fluid;
• migraine headaches;
• localized darkening of the skin;
• breast tenderness and excessive vaginal secretions;
• persistent upper abdominal pain, vomiting, tender abdomen (may be signs of gallbladder disease);
• excessive nose bleeds, excessive heavy periods;
• lower abdominal pain or swelling, painful and/or heavy periods (may be signs of growth of fibroids in the uterus);
• yellowing of the eyes or skin (may be signs of jaundice).

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

• irregular vaginal bleeding;
• intolerable breast tenderness;
• breast enlargement or lumps;
• pain or heaviness in the legs or chest;
• severe headaches;
• dizziness;
• changes in vision;
• persistent or severe skin irritation;
• fluid retention or bloating persisting for more than 6 weeks.

Check with your doctor immediately if you experience:

• shortness of breath;
• tightness of the chest;
• severe pain in one or both legs or very marked numbness suddenly affecting one side or one part of the body;
• sudden change in vision;
• first migraine;
• any other unusual symptom.

Contact your physician or local Poison Control Center in case of accidental ingestion of high doses of Premplus tablets

Overdosage with Premplus may cause nausea and vomiting, and withdrawal bleeding may occur.

Overdosage may result in a period of amenorrhea (lack of menses) of a variable length and may be followed by irregular menses for several cycles. No cases of overdosage in male patients have been reported.

Medicinal Ingredients of Premplus Tablets: Each Conjugated Estrogens tablet contains 0.625 mg conjugated estrogens, a mixture obtained exclusively from natural sources, and each Medroxyprogesterone Acetate tablet contains 2.5 mg or 5.0 mg of medroxyprogesterone acetate.

Nonmedicinal Ingredients of Premplus Tablets: Each Conjugated Estrogens tablet contains the following inactive ingredients: lactose, methylcellulose, magnesium stearate, polysorbate 60, propylparaben, microcrystalline cellulose, carnauba wax, shellac, polyethylene glycol, glyceryl monooleate, calcium sulfate, sucrose, edible ink, titanium dioxide, FD&C Blue #2, FD&C Yellow #6 and FD&C Red #3.

Each Medroxyprogesterone Acetate tablet contains the following inactive ingredients: lactose, microcrystalline cellulose, methylcellulose and magnesium stearate. In addition, each Medroxyprogesterone Acetate 5.0 mg tablet contains D&C Blue #1 aluminum lake and D&C Red #30 aluminum lake.

How Supplied: Premplus is available in 2 strengths as follows: 0.625 mg/2.5 mg -2 identical blister cards in a carton totalling 56 tablets. Each card contains 14 oval, maroon Conjugated Estrogens (CE) 0.625 mg tablets imprinted “PREMARIN” on one side in white ink, and 14 oval, white Medroxyprogesterone Acetate (MPA) 2.5 mg tablets, scored on one side; debossed with 2 opposing “C”s on the other side.

0.625 mg/5.0 mg -2 identical blister cards in a carton totalling 56 tablets. Each card contains 14 oval, maroon Conjugated Estrogens (CE) 0.625 mg Tablets imprinted PREMARIN” on one side in white ink, and 14 oval, purple Medroxyprogesterone Acetate (MPA) 5.0 mg tablets, scored on one side; debossed with two opposing C”s on the other side.

Storage Conditions: Store at 15 to 25°C.

Keep out of reach of children.

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