Apo-Norethindrone: Uses, Side Effects and Dosage

What is APO-NORETHINDRONE used for?

APO-NORETHINDRONE is used only in adult women with an intact womb (uterus) to treat:

• the absence of menstrual periods (amenorrhea).
• abnormal bleeding of the uterus due to a hormonal imbalance. For these patients, the bleeding is not caused by other diseases such as benign growths in the uterus (called fibroids) or uterine cancer.
• endometriosis, a condition in which the tissue that forms the lining of the uterus (endometrium) grows in other parts of the body. This can cause pain when you have your period, during other times of the month or during sex.

APO-NORETHINDRONE is not intended for use as hormone replacement therapy (HRT) for treating symptoms of menopause or post-menopause.

How does APO-NORETHINDRONE work?

APO-NORETHINDRONE is a type of hormone called progestin. It is similar to the progesterone hormone that is naturally produced by your body. It works by:

• stopping the normal growth of the endometrium during the menstrual cycle. This helps to treat endometriosis by shrinking endometrium-like tissue found outside the uterus.

Serious Warnings and Precautions

• signaling hormone changes in the uterus to restore normal menstrual periods. This helps to treat the absence of periods or abnormal bleeding of the womb due to a hormonal imbalance.

What are the ingredients in APO-NORETHINDRONE?

Medicinal ingredients: Norethindrone acetate

Non-medicinal ingredients: Acacia, cornstarch, FD&C Red No. 3, FD&C Yellow No. 10, lactose, magnesium stearate, sugar and talc

APO-NORETHINDRONE comes in the following dosage forms:

Tablets; 5 mg.

Do not use APO-NORETHINDRONE if:

• you are allergic to norethindrone acetate or to any other ingredients in APO-NORETHINDRONE.
• you have or have had blood clots in the legs, lungs, eyes or any other part of the body, or currently suffer from inflammation of the veins (thrombophlebitis).
• you have or have had a stroke, heart attack, or coronary artery disease.
• you have liver disease and liver function tests have failed to return to normal.
• you have or think you may have a tumour associated with the use of estrogen or progestin containing products (e.g., cancer of the lining of the uterus or the ovaries).
• you have, have had or think you may have breast cancer.
• you have unusual vaginal bleeding without a known reason.
• you have partial or complete loss of vision due to a blood vessel disease of the eye.
• you are pregnant or think you might be pregnant.
• you suffer from a missed abortion (also known as a missed miscarriage). It is a miscarriage in which the fetus is no longer alive, but the body does not recognize the pregnancy loss or expel the pregnancy tissue.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take APO-NORETHINDRONE. Talk about any health conditions or problems you may have, including if you:

• have risk factors for breast cancer such as:

  • you have never given birth to a child.
  • you are overweight.
  • you had your first period at an early age.
  • you had your first child later in life.
  • you are in menopause (you haven’t experienced a period for a year).
• are in post-menopause (you haven’t experienced a period for more than a year).
• have heart disease.
• have high blood pressure.
• have diabetes or have high blood sugar levels as APO-NORETHINDRONE may worsen your tolerance to glucose (sugar).
• have high blood cholesterol or triglyceride levels, including if you have familial hyperlipidemia (a disorder where high levels of fat in the blood are passed down through families).
• have porphyria (a rare blood disorder passed down through families). APO-NORETHINDRONE can bring about a porphyria attack.
• have kidney problems.
• have bone problems (e.g., osteoporosis, bone tumours), or other conditions that can affect blood calcium and phosphorus levels.
• have thyroid problems.

• have one of the following rare hereditary conditions as APO-NORETHINDRONE contains lactose:

  • galactose intolerance
  • lactase deficiency
  • glucose-galactose malabsorption
• have benign growths in your uterus (called fibroids).

• have a family history, or have risk factors for blood clots (venous thromboembolism) such as:

  • you are severely overweight (body mass index greater than 30).
  • your blood forms clots easily (thrombophilia).
  • you have heart or blood vessel problems.
  • you have lupus (an autoimmune disease).
  • you had prolonged bed rest, or immobility.
  • your age.
  • you are a smoker.
• have liver or gallbladder problems.
• have a history of migraines.
• have dementia.
• have epilepsy (seizures). APO-NORETHINDRONE may worsen your condition.
• have or have a history of depression.
• have asthma.
• are breastfeeding or are planning to breastfeed.

Other warnings you should know about:

Check-ups and testing: APO-NORETHINDRONE should only be used under the supervision of a healthcare professional, with regular check-ups to identify side effects related to its use. Before you start taking APO-NORETHINDRONE, your healthcare professional will ask you some questions about your personal health history and that of your close relatives. They will also conduct a complete physical exam, which includes:

• A blood pressure check.
• A breast exam, including a mammography.
• A pelvic exam, including a Pap smear.
• A biopsy of the lining of the uterus, if necessary.

• Blood tests to monitor:

  • Your blood glucose (sugar) levels
  • Your blood cholesterol and triglyceride levels (types of fats)
  • Your blood calcium levels
  • The health of your thyroid or liver, if necessary

The first follow-up exam should be done 3 to 6 months after starting treatment with APO-NORETHINDRONE. After this, exams should be done at least once a year.

Breast cancer: Some studies have shown that the risk of breast cancer increases in women taking birth control pills, especially at a younger age. The risk was also linked to how long the birth control pills were taken. These studies mainly involved birth control pills containing both estrogen and progestin. It is not known whether the use of progestin-only pills, such as APO-NORETHINDRONE, may have similar risks.

Talk to your healthcare professional for advice and instructions on how to self-examine your breasts. Check your breasts often while you are taking APO-NORETHINDRONE. See your healthcare professional right away if you notice any changes such as:

• Dimpling or sinking of the skin
• Changes in the nipple
• Any lumps you can see or feel

If you detect any new masses on your breasts while taking APO-NORETHINDRONE, you should also talk to your healthcare professional. Your healthcare professional should do a breast exam at least once per year.

Ovarian cancer: Some studies have shown that the risk of ovarian cancer increases in women receiving hormone replacement therapy (HRT), especially for 5 or more years. These studies included estrogen-only and estrogen plus progestin therapies.

Your healthcare professional should do a pelvic exam at least once a year. When ovarian cancer first develops, it might not cause any noticeable symptoms. If you experience some of the following symptoms, tell your healthcare professional right away:

• Abdominal bloating or swelling
• Quickly feeling full when eating
• Weight loss
• Discomfort in the pelvic area
• Lack of energy
• Back pain
• Changes in bowel movements
• Frequent need to urinate

Unusual vaginal bleeding: Tell your healthcare professional right away if you ever have unusual vaginal bleeding while taking APO-NORETHINDRONE. This includes:

• Irregular bleeding or spotting (unexpected bleeding that can happen between your normal menstrual periods)
• Longer or heavier than usual menstrual periods

These may be signs of benign growths in your uterus (called fibroids) or cancer of the uterus.

You should discuss progestin therapy and risk factors for overgrowth of the lining of the uterus and cancer of the uterus with your healthcare professional. If you have had your uterus removed, you are not at risk of developing these conditions. Progestin therapy, such as APO-NORETHINDRONE, is usually not needed in women who have had a hysterectomy (surgery to remove the uterus).

Heart disease and stroke: It is unclear if the use of progestin-only pills, such as APO-NORETHINDRONE, increases the risk of heart disease and stroke. However, if you develop vision changes, migraines or worsening of migraines, temporary speech problems, loss of muscle function (paralysis) or fainting, stop taking APO-NORETHINDRONE and tell your healthcare professional right away. These may be signs that your brain is not getting enough blood flow or that you are having a stroke.

Gallbladder problems: APO-NORETHINDRONE may cause gallbladder problems such as gallstones and biliary motility issues (gallbladder isn’t contracting and ejecting bile as it should).

Dementia: It is unclear if progestin alone, such as APO-NORETHINDRONE, increases the risk of having dementia.

Pregnancy: You should not take APO-NORETHINDRONE during pregnancy. There may be an increased risk of birth defects in children whose mothers have taken this medicine during the first 4 months of pregnancy. If you discover that you are pregnant while taking APO-NORETHINDRONE, tell your healthcare professional right away. They will discuss with you the potential risks to your unborn baby.

Breastfeeding: APO-NORETHINDRONE passes into breastmilk. It is not known if it can harm a breastfed baby. Therefore, it is not recommended to breastfeed while taking APO-NORETHINDRONE. Talk to your healthcare professional about the best way to feed your baby during this time.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with APO-NORETHINDRONE:

• Other medications containing norethindrone (or also called norethisterone)
• Medicines known as “corticosteroids”, used to treat inflammation
• Medicines used to treat HIV/AIDS (e.g., ritonavir, nelfinavir, nevirapine, efavirenz)

• Medicines that may cause fluid retention such as:

  • Non-steroidal inflammatory drugs (NSAIDs), used to treat pain, inflammation and fever (e.g., ibuprofen, naproxen, acetylsalicylic acid)
  • Medicines that open your blood vessels, used to treat high blood pressure, chest pain and other heart conditions
• Medicines used to treat seizures (e.g., carbamazepine, ethosuximide, phenobarbital, phenytoin, primidone, lamotrigine)
• Medicines used to treat fungal infections (e.g., griseofulvin)
• Medicines used to treat bacterial infections (e.g., rifampicin, rifabutin, tetracyclines, ampicillin, oxacillin, trimethoprim/sulfamethoxazole, linezolid)
• Medicines that may enhance drowsiness or are used to help with sleeping such as sedatives and hypnotics (e.g., benzodiazepines, barbiturates, chloral hydrate, glutethimide, meprobamate)
• Cytotoxic medicines, used during chemotherapy in the treatment of cancer
• Cyclosporine, used to suppress the immune system
• Bosentan, used to treat high blood pressure in the lungs
• Smoking
• Certain herbal and natural products such as St. John’s wort

How to take APO-NORETHINDRONE:

• APO-NORETHINDRONE is taken by mouth with food or after a meal to prevent stomach upset.

• Take APO-NORETHINDRONE exactly as your healthcare professional has told you.

Usual dose:

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

• To treat the absence of menstrual periods or abnormal bleeding from the uterus:

  2.5 to 10 mg per day starting with the fifth day of your menstrual cycle and ending on the 25th day.

• To treat endometriosis:

  The starting dose is 5 mg per day for the first 2 weeks of treatment. Your daily dose will be increased by 2.5 mg every 2 weeks until you reach a daily dose of 15 mg. The treatment may continue for 6 to 9 months or until breakthrough bleeding (spotting) stops.

Overdose:

If you take too much APO-NORETHINDRONE you may experience:

• a depressed mood
• tiredness
• acne
• excessive hair growth on certain parts of your body

Missed Dose:

If you missed a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your next scheduled dose. Do not double the dose to make up for a forgotten dose.

What are possible side effects from using APO-NORETHINDRONE?

These are not all the possible side effects you may have when taking APO-NORETHINDRONE. If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

• Nausea or vomiting
• Stomach cramps, pressure, pain or bloating
• Lack of energy
• Changes in appetite and/or weight
• Changes in sex drive
• Pain in the leg
• Headaches or worsening of migraines
• Feeling dizzy
• Feeling nervous or irritable, mood swings
• Burning or painful urination
• Bladder infection
• Swollen or tender breasts
• Painful menstrual period
• Vaginal itching or discharge
• Genital pain during or after intercourse
• Absence of menstrual period
• Facial pigmentation
• Hair loss on the scalp or excessive hair growth on certain parts of your body
• Acne
• Breast milk drying up

The side effects listed above should disappear as your body adjusts to APO-NORETHINDRONE. If they continue, become bothersome or severe, tell your healthcare professional.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

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

If you want more information about APO-NORETHINDRONE:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website http://www.apotex.ca/products, or by calling 1-800-667-4708.