Norgestrel tablets

What are norgestrel tablets?

NORGESTREL (Ovrette®) is a birth-control pill (to prevent an unwanted pregnancy). Norgestrel acts like the natural hormone progesterone. Natural progesterone is essential to normal functioning of the womb and reproductive system. Generic norgestrel tablets are not yet available.

NOTE: This drug is discontinued in the United States.

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

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

• blood vessel disease, blood clotting disorder, or suffered a stroke

• breast, uterine, vaginal or cervical cancer

• diabetes

• heart, kidney or liver disease

• high blood lipids or cholesterol

• incomplete abortion, or ectopic pregnancy

• mental depression

• migraine

• seizures (convulsions)

• vaginal bleeding

• an unusual or allergic reaction to norgestrel, other hormones, medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I take this medicine?

Take norgestrel tablets by mouth. Follow the directions on the prescription label. Before you start taking these pills decide what is a suitable time of day and always take them at the same time of day. Norgestrel tablets should be taken every day, without breaks between packs. Swallow the tablet with a drink of water. Take your doses at regular intervals. Do not take your medicine more often than directed.

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 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 norgestrel?

• aprepitant, a medicine used for chemotherapy-induced nausea and vomiting

• barbiturate medicines for inducing sleep or treating seizures (convulsions)

• bosentan

• carbamazepine

• griseofulvin

• modafinil

• oxcarbazepine

• phenytoin

• rifabutin

• rifampin

• rifapentine

• St. John's wort

• topiramate

• troglitazone or pioglitazone

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional 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 with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking norgestrel?

Visit your prescriber or health care professional for regular checks on your progress. 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 norgestrel as a contraceptive, 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 norgestrel at once and contact your prescriber or health care professional.

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.

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

What side effects may I notice from taking norgestrel?

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

• heavy vaginal bleeding

• breast pain 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

• swelling of the hands, feet or ankles, or rapid weight gain

• unusual weakness or tiredness

• vision or speech problems

• yellowing of skin or eyes

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

• breakthrough bleeding, spotting, irregular menstrual cycle, or no menstruation

• facial hair growth

• loss of appetite or increase in appetite

• mood changes, anxiety, depression, frustration, anger, or emotional outbursts

• nausea, vomiting, or stomach discomfort

• skin rash

• vaginal yeast infection (irritation and white discharge)

• weight change

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 degrees C (59 and 86 degrees F). Keep container tightly closed. Throw away any unused medicine after the expiration date.