What Prometrium is used for and how to use it
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Prometrium - Consumer Medicine Information

Manufacture: Merck
Country: Canada
Condition: Amenorrhea, Endometrial Hyperplasia, Prophylaxis, Perimenopausal Symptoms, Progesterone Insufficiency, Premature Labor, Uterine Bleeding
Class: Progestins
Form: Tablets
Ingredients: micronized progesterone, sunflower oil, gelatin, glycerin, soya lecithin (may contain traces of medium chain triglycerides), titanium dioxide

PROMETRIUM

Progesterone capsules

About this Medication

What the medication is used for

PROMETRIUM (micronized progesterone) is approved for use in the following situation:

  • In women with an intact uterus (have not had surgery to remove the uterus) who are using estrogen replacement therapy for menopause

Progesterone, as in PROMETRIUM capsules, has a strong influence on the inner lining of the uterus and is used with estrogen therapy during and after menopause. The purpose of using progesterone is to protect the inner lining of the uterus from overgrowth caused by estrogen therapy.

PROMETRIUM 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

The active ingredient in PROMETRIUM capsules is progesterone, a natural female hormone. In healthy women of childbearing age, progesterone is produced by the ovaries each month during the second part of the menstrual cycle. Progesterone plays a role in the monthly shedding of the inner lining of the uterus (endometrium) and the menstrual bleeding that follows.

When it should not be used

Do not use PROMETRIUM (micronized progesterone) if you:

  • Have an allergic or an unusual reaction to progesterone, soya, peanut or to any of the ingredients in PROMETRIUM;
  • have liver disease;
  • have or have had cancer or abnormalities of the breast or uterus;
  • have overgrowth of the lining of the uterus;
  • have undiagnosed or unexpected vaginal bleeding;
  • are pregnant or suspect you may be pregnant;
  • have a history of heart disease (including heart attack) or stroke;
  • have migraine headaches;
  • have or have had abnormal increase in blood clotting;
  • have partially or completely lost vision due to blood vessel disease of the eye.

What the medicinal ingredient is

Micronized progesterone

What the nonmedicinal ingredients are

Non-medicinal ingredients: sunflower oil, gelatin, glycerin, soya lecithin (may contain traces of medium chain triglycerides), titanium dioxide.

What dosage form it comes in

Capsules. Each capsule contains 100 mg (milligrams) of micronized progesterone.

Warnings and Precautions

Serious Warnings and Precautions

The Women’s Health Initiative (WHI) trial assessed the health benefits and risks of oral combined estrogen plus progestin therapy and estrogen-alone therapy in postmenopausal women.

The estrogen plus progestin arm of the WHI trial indicated increased risk of myocardial infarction (heart attack), stroke, invasive breast cancer, pulmonary emboli (blood clots in the lungs) and deep vein thrombosis (blood clots in the large veins) in postmenopausal women receiving treatment with conjugated equine estrogens (an estrogen medication) and medroxyprogesterone acetate (a progestin medication).

The estrogen-alone arm of the WHI trial indicated increased risk of stroke and deep vein thrombosis in postmenopausal women with prior hysterectomy (surgical removal of the uterus) receiving treatment with conjugated equine estrogens.

The Women’s Health Initiative Memory Study (WHIMS) estrogen plus progestin ancillary study of the WHI reported an increased risk of probable dementia (madness) in postmenopausal women 65 years of age or older.

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 or dementia.
  • 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

In the estrogen plus progestin arm of the WHI trial, among 10,000 women over a one-year period there were:

  • 8 more cases of invasive breast cancer.

In the estrogen-alone arm of the WHI trial of women with prior hysterectomy, among 10,000 women over a one-year period there was:

  • no meaningful difference in the rate of invasive breast cancer.

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 hormone replacement therapy.

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.

Stroke and Cardiac Disease

In the estrogen plus progestin arm of the WHI trial, among 10,000 women over a one-year period there were:

  • 8 more cases of stroke
  • 7 more cases of coronary heart disease.

In the estrogen-alone arm of the WHI trial of women with prior hysterectomy, among 10,000 women over a one-year period, there were/was:

  • 12 more cases of stroke
  • no meaningful difference in the rate of coronary heart disease.

Abnormal Blood Clotting

In the estrogen plus progestin arm of the WHI trial, among 10,000 women over a one-year period there were:

  • 18 more cases of blood clots in the lungs and large veins.

In the estrogen-alone arm of the WHI trial of women with prior hysterectomy, among 10,000 women over a one-year period, there were:

  • 7 more cases of blood clots in the lungs and large veins.

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.

Dementia

The Women’s Health Initiative Memory Study (WHIMS) was a substudy of the WHI trial involving women aged 65 and older.

In the estrogen plus progestin arm of the WHIMS, among 10,000 women over a one-year period there were:

  • 23 more cases of probable dementia (loss of memory and intellectual function).

In the estrogen-alone arm of the WHIMS involving women with prior hysterectomy, among 10,000 women over a one-year period there was:

  • no meaningful difference in the rate of probable dementia.

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

  • have a history of allergy or intolerance to PROMETRIUM or any of its ingredients (see What the medicinal ingredient is / What the important nonmedicinal ingredients are), or are allergic to soya or peanut or to any other substances or medications;
  • have a history of liver disease or jaundice (yellowing of the eyes and/or skin) or itching related to estrogen use or during pregnancy;
  • have a personal history of breast disease (including breast lumps) and/or breast biopsies, or a family history of breast cancer);
  • have experienced undiagnosed or abnormal vaginal bleeding;
  • have experienced pressure or pain in your abdomen or pelvis;
  • have a history of heart attack, heart disease or stroke;
  • have a history of migraine headache;
  • have a personal or family history of blood clots or a personal history of active thrombophlebitis (inflammation of the veins);
  • have a partial or complete loss of vision due to blood vessel disease of the eye;
  • are pregnant or may be pregnant;
  • smoke;
  • have a history of high blood pressure;
  • have a history of kidney disease, epilepsy (seizures) or asthma;
  • 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;
  • have a history of depression;
  • have had a hysterectomy (surgical removal of the uterus).

PROMETRIUM may cause some people to feel dizzy or sleepy, 1–4 hours after ingestion of the capsules. Therefore, before you drive or do anything else that requires alertness, make sure you are not experiencing these side effects.

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. Some medications (such as certain anti-seizure medications or antibiotics) may affect how PROMETRIUM Capsules work. PROMETRIUM Capsules may also affect how your other medicines work.

Proper Use of this Medication

Usual Dose

Take PROMETRIUM (micronized progesterone) only as directed by your doctor or pharmacist.

Hormone Replacement Therapy for Menopause.

The recommended dose is 2 capsules (200 mg) of PROMETRIUM per day for the last 14 days of estrogen treatment each cycle or 3 capsules per day (300 mg) for the last 12–14 days of estrogen treatment each cycle. If you are being treated with 2 capsules (200 mg) a day you should take them both at bedtime. If you are being treated with 3 capsules (300 mg) a day, you should split the daily dose in two parts by taking one capsule in the morning and two at bedtime. PROMETRIUM® should be started on the first estrogen cycle. The length of time that you will take PROMETRIUM will depend of the length of time that you are treated with estrogen. PROMETRIUM should be taken as long as you take estrogen and you have an intact uterus (have not had surgery to remove the uterus).

A few days after completing a PROMETRIUM course of 3 capsules daily, the inner lining of the uterus will usually shed. This is accompanied by vaginal bleeding (resembling a normal monthly period). With a dosage of 2 capsules daily, many women will not have such vaginal bleedings, although the lining of the uterus will also be protected against overgrowth.

Overdose

When someone accidentally takes too much PROMETRIUM (micronized progesterone), the following symptoms may arise: nausea, vomiting, sleepiness, dizziness, depressive mood, tiredness, acne and hairiness.

If someone has accidentally taken PROMETRIUM or has taken several capsules at once, consult a doctor.

In case of overdose, contact your doctor or pharmacist, emergency department of the nearest hospital, a poison control centre immediately

Missed Dose

If you are being treated with 2 capsules a day (total dose at bedtime) and you forget to take this dose, you should take one capsule the following morning and continue taking the rest of the capsules as prescribed. If you are being treated with 3 capsules a day and you forget to take a morning or evening dose, you should not take the missed dose.

GENERAL THINGS TO REMEMBER

  1. Keep all medication out of the reach of children.
  2. This medication has been prescribed only for your current medical condition. Do not use it for other medical problems.
  3. Do not allow other people to use your medications and do not use medications meant for other people.
  4. Tell any doctor treating you what medications you are taking. Always carry a medical information card stating which medications you are using. This can be very important in case you are involved in an accident.
  5. Return unused medications to the pharmacy for safe disposal.
  6. Make sure that other people you live with or who look after you read this information.

Side Effects and what to do about them

Depending on the dosage of PROMETRIUM (micronized progesterone) and the sensitivity of the patient, the following side effects are possible: genital bleeding or spotting (minor vaginal bleeding) in between the normal periods (mainly during the first two months); irregular menstrual periods; dizziness or vertigo; sleepiness; abdominal discomfort (cramps, pressure, pain); nausea (urge to vomit); fatigue (tiredness); aggravation of migraine headaches, headaches or depressive mood; lightheadedness (feeling faint); breast tenderness/swelling; liver disease.

Side effects observed in women taking progestins in general: a severe allergic reaction which may include hives, itchiness, skin redness, swelling, wheezing, increase heart rate and difficulty breathing; rash with or without itching; rare cases of loss of consciousness; hot flashes; impaired concentration; confusion; swelling; and difficulty with speech.

Other side effects that have been observed with estrogen and progestin combinations in general, but not necessarily with PROMETRIUM treatment are:

  • water retention (bloating, swelling);
  • overgrowth of the lining of the uterus;
  • gallbladder disorder, impaired liver function, jaundice (yellowing of the eyes or skin);
  • menstrual cramps;
  • vaginal itching/discharge;
  • pain during sexual intercourse;
  • pain on urination or difficulty urinating;
  • premenstrual syndrome (PMS);
  • inflammation of the bladder;
  • brown, blotchy spots on exposed skin (pregnancy mask);
  • skin rash, tender red lumps or nodules or other skin reactions;
  • loss of hair, hairiness;
  • acne;
  • palpitations (unpleasant sensation of irregular and/or forceful beating of the heart);
  • pain, swelling or redness of the calf or leg which may indicate a blood clot;
  • chest pain or shortness of breath which may indicate a blood clot;
  • increase in blood pressure;
  • depression;
  • nervousness;
  • irritability;
  • visual disturbances, intolerance to contact lenses;
  • changes in appetite and body weight;
  • change in sexual drive;
  • pain in the joints and muscles, usually lasting only 3–6 weeks.

During your first 2–4 months of HRT, you may experience minor unscheduled vaginal bleeding (at times other than when you would expect a normal period). This is a normal response of your body as it adjusts to the return of estrogen and progesterone to the levels that were seen before menopause. Should unscheduled vaginal bleeding persist, you should consult your doctor.

Serious Side Effects, how often they Happen and what to do about them

FrequencySymptom / EffectTalk with your
doctor or
pharmacist
Stop taking
drug and call
your doctor or
pharmacist
Only if
severe
In all
cases
At any frequency Abdominal pain,
nausea or vomiting
Breast lump
Crushing chest pain or chest heaviness
Pain or swelling in the
leg
Persistent sad mood
Sharp pain in the chest, coughing blood or sudden shortness of breath
Sudden partial or complete loss of vision
Sudden severe headache or worsening of headache, vomiting, dizziness, fainting, disturbance of vision or speech or weakness or numbness in an arm or leg (any of these, alone or in combination)
Unexpected vaginal bleeding
Yellowing of the skin or eyes (jaundice)

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

How to Store it

The capsules should be stored at controlled room temperature between 15°C and 30°C (59°F and 86°F). The date the capsules should be used by is printed on the strip after the term “Exp.” (expiry date). Protect from light.

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 ways:

  • 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, ON 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.


    or at Merck Canada Inc. by one of the following 2 ways:

    • Call toll-free at 1-800-567-2594
    • Complete a Canada Vigilance Reporting Form and:
      • Fax toll-free to 1-800-369-3090, or
      • Mail to: Merck Canada Inc.
        Pharmacovigilance
        P.O. Box 1005
        Pointe-Claire–Dorval, QC H9R 4P8

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.

More Information

This document plus the full product monograph, prepared for health professionals can be found at:

http://www.merck.ca

or by contacting the sponsor, Merck Canada Inc., at:

1-800-567-2594