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Details for: NORLUTATE

Company: ERFA CANADA 2012 INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
00023760NORLUTATENORETHINDRONE ACETATE5 MGTABLETORAL
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Summary Reports

Summary Safety Review - Hormone Replacement Therapy (Estrogenic and Progestogenic Agents) and Selective Estrogen Receptor Modulators (SERMs) - Assessing the Potential Risk of Ovarian Cancer
Summary Safety Review - Hormonal Birth Control Products (excluding Emergency Birth Control Products) - Assessing the Potential Risk of Suicidal Thoughts and Behaviours (suicidality)

Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

Norlutate is indicated in:

  • lack of menstruation (amenorrhea)
  • abnormal bleeding of the uterus (womb) due to hormonal imbalance (if you don’t have other diseases and if you don’t have cancer of the uterus)
  • endometriosis.

Norlutate should be prescribed only to women with intact uteri.

Norlutate 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. Your doctor may recommend some blood tests.

Norlutate is not intended for use as hormone replacement therapy (HRT) for treating menopausal and post-menopausal symptoms.

What it does

NORLUTATE is similar to the progesterone hormones naturally produced by the body.

When it should not be used

Do not take NORLUTATE if:

  • You have hypersensitivity to this drug or any of its components.
  • You have or have had problems such as stroke, heart attack, or coronary heart disease.
  • You have liver disease and liver function tests have failed to return to normal.
  • You have known or suspected endometrial cancer or any other cancer which is sensitive to estrogens or progestins.
  • You have known, suspected or history of breast cancer.
  • You have undiagnosed genital bleeding.
  • You have a known or suspected pregnancy
  • You had or have confirmed venous thromboembolism (blood clots) or active thrombophlebitis (inflammation of the veins).
  • You had partial or complete loss of vision due to blood vessel disease in the eye.
  • You suffer from missed abortion (an abortion in which the fetus dies but is retained within the uterus).
What the medicinal ingredient is

Norethindrone acetate

What the non-medicinal ingredients are

Acacia, cornstarch, FD&C Red No. 3, FD&C Yellow No. 10, lactose, magnesium stearate, sugar and talc

What dosage form it comes in

Each cylindrical, flat, salmon-coloured tablet, beveled, scored on one side contains : Norethindrone Acetate 5 mg.
Each grooved, salmon-coloured, slightly mottled tablet, debossed “PD” on one side contains: Norethindrone Acetate 5 mg.

Warnings and precautions

Serious Warnings and Precautions

Discontinue medication and consult your physician immediately if there is a sudden partial or complete loss of vision or if there is sudden onset of proptosis (bulging of the eye), diplopia (double vision), or migraine.

You might have an increase risk of having thrombophlebitis and pulmonary embolism while taking this medication

Breast Cancer

Some epidemiological studies of oral contraceptive users have reported an increased relative risk of developing breast cancer, particularly at a younger age and apparently related to duration of use. These studies have predominately involved combined oral contraceptives and there is insufficient data to determine whether the use of progestin-only pills like Norlutate similarily increases the risk. If you have or had breast cancer you should not use Norlutate before discussing with your physician since the role of this pill in breast cancer has not been fully determined.

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

Overgrowth of the lining of the uterus and cancer of the uterus

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

It is unclear from the literature if progestin alone increases the risk of having cardiovascular diseases.

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.

Available data indicate that use of progestin by postmenopausal women is associated with an increased risk of developing blood clots.

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

It is unclear from the literature if progestin alone increases the risk of having dementia

BEFORE you use NORLUTATE 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 high blood pressure
  • have a personal or family history of blood clots, or a personal history of heart disease or stroke
  • have 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 diabetes
  • have porphyria (a disease of blood pigment)
  • have high cholesterol or high triglycerides
  • are pregnant or may be pregnant
  • have had a hysterectomy (surgical removal of the uterus)
  • smoke
  • have lupus
  • have or have had a history of depression
  • have or have had problems with your gallbladder
  • are breastfeeding
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.

Drugs that may interact with Norlutate include:

  • drugs used for the treatment of epilepsy
  • drugs used for the treatment of infection
  • drugs used for the treatment of pulmonary hypertension (bosentan)
  • sedative and hypnotics (bezodiazepines, barbiturates)
  • cyclosporin
Proper use of this medication

Usual dose

NORLUTATE is taken by mouth with food or after a meal to prevent stomach upset.

Follow your doctor`s orders or the directions on the label.

This dosage schedule assumes that the interval between your menstrual periods is 28 days.

Amenorrhea or Abnormal uterine bleeding:
2.5 to 10 mg starting with the fifth day of your menstrual cycle and ending on the 25th day.

Endometriosis:
Initial daily dose: 5 mg for 2 weeks with increments of 2.5 mg/day every 2 weeks until 15 mg/day is reached. The treatment may continue for 6 to 9 months or until breakthrough bleeding stops.

Overdose

If you take too much NORLUTATE you could have depressed mood, tiredness, acne and hirsutism.

In case of a suspected drug overdose, contact your health care practitioners, or your regional Poison Control Center.

Missed Dose

If you missed a dose, you should take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule.
Do not double the dose to catch up.

Side effects and what to do about them

Side effects include swelling of ankles or feet, absent menstrual period and mild headache. These effects should disappear as your body adjusts to the medication. If they persist, become bothersome or increase in severity, inform your doctor. If an absent menstrual period persists please consult your doctor.

Serious side effects, how often they happen and what to do about them
Symptom/possible side effect Talk with your doctor or pharmacist Only if severe Talk with your doctor or pharmacist In all cases Stop taking drug and call your doctor or pharmacist
Common
Abdominal pain, nausea or vomiting    
Headache    
Persistent sad mood    
Breakthrough bleeding, Change in menstrual flow, spotting or unexpected vaginal bleeding    
Changes in weight (increase or decrease), fluid retention    
Uncommon
Changes in skin pigmentation, Itching, Rash    
sleeplessness, or irritability    
Yellowing of the skin or eyes (jaundice)    
Crushing chest pain or chest heaviness    
Pain or swelling in the leg    
Breast lump    
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    

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

How to store

Store at controlled room temperature (15 - 30°C).
Keep out of reach of children.

Reporting 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:

  • 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.

More information

This document plus the full product monograph prepared for health professionals can be found at http://www.erfa.net or by contacting the sponsor, ERFA Canada Inc. at 1-888-922-3133.

This leaflet was prepared by ERFA Canada Inc.

Last revised: November 29, 2010.

Date modified: