Brand Name(s): Aygestin, Camila, Errin, Jolivette, Micronor, Nor-QD

Generic Name Norethindrone Oral

What are norethindrone tablets?

NORETHINDRONE (Ortho-Micronor^® or Errin™ or Jolivette™, Nor-QD^® or Camila™, Norlutin^®, Aygestin^®) is used as a birth-control pill (to prevent an unwanted pregnancy) or a hormone treatment, depending on the brand you have been prescribed. Norethindrone acts like the natural hormone progesterone. Natural progesterone is essential to normal functioning of the female reproductive system. Norethindrone also helps to treat an irregular menstrual cycle, lack of menstrual periods, or abnormal uterine bleeding caused by a hormonal imbalance. Norethindrone tablets are available from several pharmaceutical manufacturers; however, not all brands are substitutable for one another.

What should my health care professional know before I take norethindrone?

They need to know if you have any of these conditions:

• blood vessel disease, blood clotting disorder, or suffered a stroke
• breast, cervical, or vaginal cancer
• diabetes
• heart, kidney or liver disease
• high blood lipids or cholesterol
• mental depression
• migraine
• seizures (convulsions)
• vaginal bleeding
• an unusual or allergic reaction to norethindrone, other hormones, medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I take this medicine?

Take norethindrone tablets by mouth. Follow the directions on the prescription label. Swallow the tablets with a drink of water. Take your doses at regular intervals. Do not take your medicine more often than directed.

For treating absent or irregular menses or for controlling unusual bleeding: Take norethindrone from day 5 to day 25 of the cycle.

For treating endometriosis: Before you start taking these pills decide what is a suitable time of day and always take them at the same time of day. Your doctor may instruct you to take norethindrone every day for 2 weeks, and from there may increase your dosage to get the proper effect. You will probably take the medication every day for 6 to 9 months.

As a contraceptive (birth control method): Before you start taking these pills decide what is a suitable time of day and always take them at the same time of day. Norethindrone birth control tablets should be taken every day, without breaks between packs.

For all uses of this medicine:

Read the paper on your prescription provided by your health care provider or pharmacist. This paper will tell you about the specific product you are taking. Make certain you understand the instructions.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

For general use: If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

For contraceptive use: Every time you miss a dose, or take a dose late by > 3 hours, your chance of getting pregnant increases. Try not to miss a dose. When one pill is missed (even if only 3 hours late), take the missed pill as soon as possible and continue taking a pill each day at the regular time (a backup method of birth control, like a condom or spermicide, should be used for the next 48 hours). Whenever > 1 dose is missed, additional contraception should be used for the rest of your pill pack until menses occurs. You should also contact your health care professional for instruction whenever more than 1 dose has been missed.

What drug(s) may interact with norethindrone?

• antibiotics or medicines for infections, especially rifampin, rifabutin, rifapentine, and griseofulvin
• aprepitant, a medicine used for chemotherapy-induced nausea and vomiting
• barbiturate medicines for inducing sleep or treating seizures (convulsions)
• bosentan
• carbamazepine
• modafinil
• phenytoin
• St. John's Wort
• topiramate
• troglitazone or pioglitazone

Tell your doctor or pharmacist: about all other medicines you are taking, including non-prescription medicines; if you are a frequent user of drinks with caffeine or alcohol; if you smoke; or if you use illegal drugs. These may affect the way your medicine works. Check before stopping or starting any of your medicines.

What side effects may I notice from taking norethindrone?

Side effects that you should report to your prescriber or health care professional as soon as possible:

• breast tenderness or discharge
• numbness or pain in the arm or leg
• pain in the chest, groin or leg
• severe headache
• stomach pain
• sudden shortness of breath
• unusual weakness or tiredness
• vision or speech problems
• yellowing of skin or eyes

Call your doctor as soon as you can if you get any of these side effects.

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):

• changes in sexual desire or ability
• changes in vaginal bleeding
• facial hair growth
• fluid retention and swelling
• headache
• increased sweating or hot flashes
• loss of appetite or increase in appetite
• mood changes, anxiety, depression, frustration, anger, or emotional outbursts
• nausea, vomiting
• skin rash
• stomach discomfort
• weight gain or weight loss
• vaginal yeast infection (irritation and white discharge)

Let your doctor know about these side effects if they do not go away or if they annoy you.

What should I watch for while taking norethindrone?

You should have a complete check-up every 6 to 12 months. If you have any unusual bleeding contact your prescriber or health care professional for advice. If you are taking norethindrone as a contraceptive (birth control), use an additional form of contraception during the first 2 weeks of the first cycle (first pack).

If you have any reason to think you are pregnant, stop taking norethindrone at once and contact your doctor.

Tobacco smoking increases the risk of getting a blood clot or having a stroke while you are taking norgestrel, especially if you are more than 35 years old. You are strongly advised not to smoke.

If you wear contact lenses and notice visual changes, or if the lenses begin to feel uncomfortable, consult your eye prescriber or health care professional.

Progestins may cause swelling, tenderness, or bleeding of the gums; be careful when brushing and flossing teeth, and visit your dentist regularly.

Norethindrone tablets do not protect you against HIV infection (AIDS) or other sexually transmitted diseases.

Where can I keep my medicine?

Keep out of the reach of children in a container that small children cannot open.

Store at room temperature between 15 and 30 °C (59 and 86 °F). Keep container tightly closed. Throw away any unused medicine after the expiration date.