Ogen 1.25: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

OGEN is used to treat menopausal or and postmenopausal symptoms.

OGEN should be used only under the supervision of a doctor, with regular follow-up at least once a year to identify side effects associated with its use. Your first follow-up visit should be within 3 to 6 months of starting treatment. Your visit may include a blood pressure check, a breast exam, a Pap smear and pelvic exam. You should have a mammogram before starting treatment and at regular intervals as recommended by your doctor. Your doctor may recommend some blood tests.

You should carefully discuss the risks and benefits of hormone replacement therapy (HRT) with your doctor. You should regularly talk with your doctor about whether you still need treatment with HRT.

What it does:

OGEN is a medicine that contains a manufactured estrogen hormone that is similar to the estrogen produced by a woman's ovaries. OGEN alleviates symptoms associated with menopause.

When it should not be used:

You should not take estrogen if you have or have had any of the following conditions:

• Certain cancers including cancer of the breast, cancer of

  uterus or of the endometrium (lining of the uterus)

• Endometrial hyperplasia (overgrowth of the uterus lining)

• If you have active thrombophlebitis (inflamed varicose

  veins) or you currently have a problem with abnormal blood clots forming in your blood vessels, or have ever had such a problem in the past. This may cause painful inflammation of the veins (thrombophlebitis) or blockage of a blood vessel in the legs (deep vein thrombosis), lungs (pulmonary embolism) or other organs.

• Stroke or heart attack
• Migraine headaches
• Heart disease
• Liver disease
• Unusual genital bleeding

• Pregnancy

  • Partial or complete loss of vision due to disease of the blood vessels in the eye
  • Known or suspected allergy to OGEN or to any of its ingredients

What the medicinal ingredient is:

estropipate.

What the nonmedicinal ingredients are:

alcohol, colloidal silicon dioxide, FD&C Yellow No. 10, FD&C Yellow No. 6 and FD&C Blue No. 2, hydrogenated vegetable oil wax, hydroxypropyl cellulose, lactose monohydrate and/or lactose anhydrous, magnesium stearate, microcrystalline cellulose, potassium phosphate dibasic, purified water, sodium starch glycolate, tromethamine.

OGEN 0 .75 mg also contains: FD&C Yellow No. 10 and FD&C Yellow No. 6. OGEN 1.5 mg also contains: FD&C Yellow No. 6. OGEN 3.0 mg also contains: FD&C Blue No. 2.

What dosage forms it comes in:

OGEN 0.75 mg (0 .75 mg estropipate, calculated as sodium estrone sulphate 0 .625 mg) is supplied as a yellow-coloured, oval tablet.

OGEN 1.5 mg (1.5 mg estropipate, calculated as sodium estrone sulphate 1.25 mg) is supplied as a peach-coloured, oval tablet. OGEN 3.0 mg (3.0 mg estropipate, calculated as sodium estrone sulphate 2.5 mg) is supplied as a blue-coloured, oval tablet. Each OGEN tablet contains 0.75 mg, 1.5 mg or 3.0 mg estropipate.

WARNINGS AND PRECAUTIONS

This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.

Serious Warnings and Precautions The Women’s Health Initiative (WHI) trial is a large clinical study that assessed the benefits and risks of oral combined estrogen plus progestin therapy and oral estrogen-alone therapy compared with placebo (a pill with no active ingredients) in postmenopausal women. The WHI trial indicated an increased risk of myocardial infarction (heart attack), stroke, breast cancer, pulmonary emboli (blood clots in the lungs) and deep vein thrombosis (blood clots in the large veins) in postmenopausal women taking oral combined estrogen plus progestin.

The WHI trial indicated an increased risk of stroke and deep vein thrombosis in postmenopausal women with prior hysterectomy (surgical removal of the uterus) taking oral estrogen-alone.

Therefore, you should highly consider the following:

• There is an increased risk of developing invasive breast cancer, heart attack, stroke and blood clots in both lungs and large veins with the use of estrogen plus progestin therapy.
• There is an increased risk of stroke and blood clots in the large veins with the use of estrogen-alone therapy.
• Estrogens with or without progestins should not be used for the prevention of heart disease or stroke.
• Estrogens with or without progestins should be used at the lowest effective dose and for the shortest period of time possible. Regular medical follow-up is advised.

Breast Cancer The results of the WHI trial indicated an increased risk of breast cancer in postmenopausal women taking combined estrogen plus progestin compared to women taking placebo.

The results of the WHI trial indicated no difference in the risk of breast cancer in post-menopausal women with prior hysterectomy taking estrogen-alone compared to women taking placebo.

Estrogens should not be taken by women who have a personal history of breast cancer.

In addition, women with a family history of breast cancer or women with a history of breast lumps, breast biopsies or abnormal mammograms (breast x-rays) should consult with their doctor before starting HRT.

Women should have a mammogram before starting HRT and at regular intervals during treatment as recommended by their doctor.

Regular breast examinations by a doctor and regular breast self-examinations are recommended for all women. You should review technique for breast self-examination with your doctor.

Overgrowth of the lining of the uterus and cancer of the uterus The use of estrogen-alone therapy by post menopausal women who still have a uterus increases the risk of developing endometrial hyperplasia (overgrowth of the lining of the uterus), which increases the risk of endometrial cancer (cancer of the lining of the

uterus).

If you still have your uterus, you should take a progestin medication (another hormone drug) regularly for a certain number of days of each month to reduce the risk of endometrial hyperplasia.

You should discuss progestin therapy and risk factors for endometrial hyperplasia and endometrial carcinoma with your doctor. You should also report any unexpected or unusual vaginal bleeding to your doctor.

If you have had your uterus removed, you are not at risk of developing endometrial hyperplasia or endometrial carcinoma.

Progestin therapy is therefore not generally required in women who have had a hysterectomy.

Ovarian Cancer In some studies, the use of estrogen-alone and estrogen plus progestin therapies for 5 or more years has been associated with an increased risk of ovarian cancer.

Heart Disease and Stroke The results of the WHI trial indicated an increased risk of stroke and coronary heart disease in post-menopausal women taking combined estrogen plus progestin compared to women taking placebo.

The results of the WHI trial indicated an increased risk of stroke, but no difference in the risk of coronary heart disease in post-menopausal women with prior hysterectomy taking estrogen alone compared to women taking placebo.

Abnormal Blood Clotting The results of the WHI trial indicated an increased risk of blood clots in the lungs and large veins in post-menopausal women taking combined estrogen plus progestin compared to women taking placebo.

The results of the WHI trial indicated an increased risk of blood clots in the large veins, but no difference in the risk of blood clots in the lungs in post-menopausal women with prior hysterectomy taking estrogen-alone compared to women taking placebo.

The risk of blood clots also increases with age, if you or a family member has had blood clots, if you smoke or if you are severely overweight. The risk of blood clots is also temporarily increased if you are immobilized for long periods of time and following major surgery. You should discuss risk factors for blood clots with your doctor since blood clots can be life threatening or cause serious disability.

Gallbladder Disease The use of estrogens by postmenopausal women has been associated with an increased risk of gallbladder disease requiring surgery.

Dementia The Women’s Health Initiative Memory Study (WHIMS) was a substudy of the WHI trial and indicated an increased risk of dementia (loss of memory and intellectual function) in postmenopausal women age 65 and over taking oral

combined estrogen plus progestin compared to women taking placebo.

The WHIMS indicated no difference in the risk of dementia in post-menopausal women age 65 and over with prior hysterectomy taking oral estrogen-alone compared to women taking placebo.

BEFORE you use OGEN talk to your doctor or pharmacist if you:

• have a history of allergy or intolerance to any medications or other substances
• have a personal history of breast disease (including breast lumps) and/or breast biopsies, or a family history of breast cancer
• have experienced any unusual or undiagnosed vaginal bleeding
• have a history of uterine fibroids or endometriosis
• have a history of liver disease, liver tumours or jaundice (yellowing of the eyes and/or skin) or itching related to estrogen use or during pregnancy
• have been told that you have a condition called hereditary angioedema or if you have had episodes of rapid swelling of the hands, feet, face, lips, eyes, tongue, throat (airway blockage), or digestive tract.
• have been diagnosed with lupus
• have been diagnosed with hearing loss due to otosclerosis
• have a history of migraine headache
• have a history of high blood pressure
• have a personal or family history of blood clots, or a personal history of heart disease or stroke
• have a history of kidney disease, asthma or epilepsy (seizures)
• have a history of bone disease (this includes certain metabolic conditions or cancers that can affect blood levels of calcium and phosphorus)
• have been diagnosed with diabetes
• have been diagnosed with porphyria (a disease of blood pigment)
• have a history of high cholesterol or high triglycerides
• are pregnant or may be pregnant
• have had a hysterectomy (surgical removal of the uterus)
• smoke

INTERACTIONS WITH THIS MEDICATION

Tell your doctor or pharmacist if you are taking any other medications, including prescription medications, over-the-counter medications, vitamins or herbal products (such as St-John’s wort). Some medications (such as medications for high blood pressure, diabetes, blood clots, sleeping, anxiety, seizures, pain-relief and tuberculosis) may affect how OGEN works. OGEN may also affect how other medicines work.

PROPER USE OF THIS MEDICATION

Usual dose:

• Take OGEN as directed by your doctor or pharmacist.
• Swallow the tablet whole, with some water.

• You and your doctor should discuss regularly, about every 3

  to 6 months, whether you still need to take OGEN for your symptoms.

  • The usual daily dose of OGEN is 0.75 mg to 3.0 mg estropipate. The dose of OGEN should be adjusted by your doctor depending on how well it works for you.

Missed dose:

Do not take a double dose to make up for a forgotten tablet. It is important that you take OGEN regularly at the same time each day. If you forget to take a dose, take it as soon as you remember, as long as it is within a few hours of the missed dose. If it is longer than that since the missed dose, or if you do not remember whether you took a dose or not, then skip that dose, and wait to take the next dose at the correct time.

Overdose:

Overdose with estrogen may cause nausea, breast discomfort, fluid retention bloating or vaginal bleeding in women. In case of overdose, call your doctor, hospital or poison control center immediately.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

As with most drugs, OGEN can cause some side effects.

The most common side effects are irregular vaginal spotting, headache, breast pain, water retention, bloating, stomach/abdominal cramps, bloating, changes in appetite, body weight, and libido.

Other side effects are high blood pressure, liver problems, high blood sugar, fluid retention, enlargement of benign tumours in the uterus (fibroids), irritability, vaginal yeast infections, acne, spotty darkening of the skin and hair loss.

If you notice any side effects not mentioned above, or any of the above-mentioned side effects persist or become bothersome, please contact your doctor or pharmacist.

For management of a suspected drug overdose, contact your regional Poison Control Centre.

This is not a complete list of side effects. For any unexpected effects while taking OGEN, contact your doctor or pharmacist.

HOW TO STORE IT

• Store between 15°C and 30°C, in the original package.

  Do not freeze.

• Always keep OGEN out of reach and sight of children.

REPORTING SUSPECTED SIDE EFFECTS

To monitor drug safety, Health Canada through the Canada Vigilance Program collects information on serious and unexpected side effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Ca nada Vigilance:

Online: www.healthcanada.gc.ca/medeffect

Toll-free phone: 1-866-234-2345

Toll-free fax: 1-866-1578-6789

Postage Paid Mail: Canada Vigilance Program Health Canada

AL 0701C

Ottawa, Ontario K1A OK9

Note: Should you require information related to the management of the side effect, please contact your health care provider. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full prescribing information, prepared for health professionals can be found at: http://www.pfizer.ca or by contacting the sponsor, Pfizer Canada Inc., at: 1-800-463-6001.

Kirkland, Quebec

H9J 2M5

Last revised: 25 May 2009