Details for: NORLUTATE
Company: ERFA CANADA 2012 INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 00023760 | NORLUTATE | NORETHINDRONE ACETATE | 5 MG | TABLET | ORAL |
Summary Reports
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.
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.
| 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.