Femhrt: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

• To relieve menopausal and postmenopausal symptoms such

  as hot flushes and night sweats

• To treat vulvar and vaginal atrophy due to lower estrogen

  levels related to menopause. Symptoms include itching. burning, dryness, and pain while having sex. If you use femHRT or femHRT Lo only to treat symptoms of vulvar and vaginal atrophy related to menopause, talk with your healthcare provider about whether a vaginal (topical) treatment might be better for you.

• To prevent thinning of the bones (osteoporosis). If you use

  femHRT or femHRT Lo only to prevent osteoporosis associate with menopause, talk to your healthcare provider about whether a different treatment or medicine without estrogen may be better for you. Weight-bearing exercise, like walking or running, cessation of smoking, adequate diet, and taking calcium and vitamin D supplements may also lower your chances of getting postmenopausal osteoporosis. It is important to talk about exercise and supplements with your healthcare provider before starting them.

femHRT and femHRT Lo should only be used in women with an intact uterus.

femHRT and femHRT Lo 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

femHRT and femHRT Lo replace the estrogen in your body which decreases at menopause. Estrogen therapy can help to reduce your menopausal symptoms and to prevent thinning of bones related to menopause. The progestin hormone in femHRT and fernHRT Lo will help to reduce the risk of endometrial hyperplasia (stimulation of growth of the lining of the uterus). which could lead to cancer of the lining of the uterus (womb).

When it should not be used

You should not take femHRT or femHRT Lo:

• In the presence of liver disease

• If you currently have or have had certain cancers.

  Estrogens increase the risk of certain types of cancers including cancer of the breast and uterus. If you have or had cancer, talk with your doctor about whether you should take femHRT or femHRT Lo.

• If you have endometrial hyperplasia (overgrowth of the uterus lining)
• If you have undiagnosed or abnormal vaginal bleeding

• If you are pregnant or may be pregnant

• If you are breastfeeding
• If you have had or have any blood circulation problems including blood clots
• If you have a history of heart attack, heart disease or stroke
• If you have migraine headaches
• If you have had any loss of vision due to blood vessel disease in the eye
• If you have had a hysterectomy (uterus removed)
• If you have had an allergic response to estrogen or progestin treatment

What the medicinal ingredients are

Ethinyl estradiol (estrogen) and norethindrone acetate (progestin)

What the non-medicinal ingredients are

femHRT and femHRT Lo tablets also contain calcium stearate, cornstarch, lactose monohydrate, and microcrystalline cellulose.

What dosage form it comes in

femHRT Lo is supplied in an oval, white pill, which contains 0.5 milligram of norethindrone acetate (which is the progesterone portion of the pill, and is called a “progestin”) and 2.5 micrograms of ethinyl estradiol (the estrogen portion of the pill).

femHRT is supplied in a D-shaped white pill, which contains 1 milligram of norethindrone acetate (which is the progesterone portion of the pill, and is called a “progestin”) and 5 micrograms of ethinyl estradiol (the estrogen portion of the pill).

WARNINGS AND PRECAUTIONS

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 post-menopausal 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 postmenopausal women with prior hysterectomy taking estrogen-alone compared to women taking placebo. Estrogens with or without progestins 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). The purpose of adding a progestin medication to estrogen therapy (as in femHRT and femHRT Lo) is to reduce the risk of endometrial hyperplasia..

  • Ovarian Cancer – In some studies, the use of estrogen/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 femHRT or femHRT Lo, 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, jaundice (yellowing of the

  eyes and/or skin) or itching related to estrogen use or during pregnancy

• 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)
• are breastfeeding
• have problems with your thyroid
• have been diagnosed with hearing loss due to otosclerosis

• have been told that you have a condition called hereditary

  hemangioma, or if you have had episodes of rapid swelling of the hands, feet, lips, eyes, tongue, throat (airway blockage) or digestive tract

• have been diagnosed with lupus
• smoke

INTERACTIONS WITH THIS MEDICATION

Some drugs may affect the activity of femHRT and femHRT Lo, and it is important that your doctor or pharmacist knows all of the medications, which you are taking. Consult your doctor or pharmacist before taking any other medication, including non-prescription drugs and herbal remedies.

PROPER USE OF THIS MEDICATION

Usual Dose

femHRT and femHRT Lo must only be taken under the supervision of your doctor. femHRT and femHRT Lo are each very simple to take – one pill by mouth, once a day, every day. You can take femHRT or femHRT Lo any time of day, with or without food. However, it’s usually easier to plan to take it at the same time each day; for example, just after brushing your teeth or before you go to bed.

Overdose

Symptoms: Overdosage with estrogen or progestin containing products may cause nausea, breast discomfort, fluid retention, bloating, vaginal bleeding, depressed mood, tiredness, acne and hirsutism (abnormal or excessive hair growth).

Treatment: In case of overdose call your doctor, hospital, or poison control centre immediately, even if there are no symptoms.

Missed Dose

If you forget to take your pill at the usual time, take it as soon as you remember. If it is almost time for your next pill, skip the missed pill and take the next one in the pack. Do not take two pills at once.

HOW TO STORE IT

femHRT and femHRT Lo should be stored at controlled room temperature, 15-25° C.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

The following side effects have been reported with femHRT or femHRT Lo and are similar to reports with other HRT products. Speak to your doctor if you experience:

• Nausea and vomiting
• Breast tenderness or enlargement

• Enlargement of uterine fibroids (benign growths in the

  uterus)

• Headache
• Retention of extra fluid (edema)
• Spotty darkening of the skin
• Abdominal pain (cramps, bloating)
• Dyspepsia
• Diarrhea
• Nervousness
• Urinary Tract Infection

This is not a complete list of side effects. For any unexpected effects while taking femHRT or femHRT Lo, contact your doctor or pharmacist. For more information, talk to your healthcare provider.

Will I have a monthly menstrual period?

No, but you may notice some light bleeding or spotting for the first few months when taking femHRT or femHRT Lo. This is normal and occurs because the endometrium (lining of the uterus) is adjusting to the hormones. With femHRT and femHRT Lo, bleeding normally stops during the first 3 to 6 months of therapy. If you experience vaginal bleeding while taking femHRT or femHRT Lo, discuss your bleeding pattern with your doctor. Any undiagnosed or unusual vaginal bleeding should be investigated by your doctor.

Will I gain weight with femHRT or femHRT Lo? In clinical studies, women on femHRT or femHRT Lo did not gain any more weight than women who were not on femHRT or femHRT Lo.

MORE INFORMATION

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

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• Report online at www.healthcanada.gc.ca/medeffect
• Call toll-free at 1-866-234-2345

• Complete a Canada Vigilance Reporting Form and:

  • Fax toll-free to 1-866-678-6789, or

  • Mail to: Canada Vigilance Program

    Health Canada

    Postal Locator 0701D Ottawa, Ontario K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at

www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

This document plus the full product monograph, prepared for health professionals is available by contacting Warner Chilcott Canada Co. at: 1-800-565-0814.

Last revised: March 4, 2011