Download What key warnings do I need to know about before giving this drug

Ethinyl Estradiol and Norgestrel
(ETH in il es tra DYE ole & nor
JES trel)
Brand Names: U.S.
Cryselle® 28; Lo/Ovral®-28; Low-Ogestrel®; Ogestrel®
Brand Names: Canada
Lo-Femenal 21; Ovral®
What key warnings do I need to know about before giving this drug to my
child?
• Do not smoke while taking birth control pills. Cigarette smoking raises the chance of very bad
heart and blood-related side effects. This chance is higher with heavy smoking (15 or more
cigarettes per day). Birth control pills do not stop the spread of diseases caused by having sex.
• Sometimes drugs are not safe when you take them with certain other drugs. Taking them
together can cause bad side effects. This is one of those drugs. Be sure to talk to your doctor
about all the drugs you take.
Is it safe for my child to take this drug?
• If you have an allergy to ethinyl estradiol, norgestrel, or any other part of this drug.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your
doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath;
wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Blood clots, breast cancer, diseased arteries in the brain,
disease of a heart valve with problems, endometrial cancer, heart disease, high blood pressure,
liver disease, liver tumor, very bad headache, tumor where estrogen makes it grow, or vaginal
bleeding.
• If you have surgery and need bed rest.
• If you have not started your period.
• If you turned yellow during pregnancy or with estrogen-based or hormone contraceptive use.
• If you are pregnant or may be pregnant. Do not take this drug if you are pregnant.
Why does my child need this drug?
• It is used to control monthly period (menstrual) cycle.
• It is used to ease painful period (menstrual) cycles.
• It is used to treat hormonal imbalance.
• It is used to treat endometriosis.
• It is used to stop pregnancy.
• It is used to treat pimples (acne).
How is this drug given?
• Follow how to use as you have been told by your doctor or read the package insert.
• Take this drug at the same time of day.
• Take with or without food. Take with food if it causes an upset stomach.
• If you are taking this drug to stop pregnancy, and miss 2 periods in a row, take a pregnancy test
before starting a new dosing cycle.
How long does this drug take to work?
• For birth control, it will take 1 week to see the full effect.
• For other uses, it may take a few months to see the full effect.
What do I do if my child misses a dose?
• Take a missed dose as soon as you think about it and go back to your normal time.
• Missed dosing facts may be found in the package insert or call your doctor to find out what to do.
What safety measures do I need to take when my child is using this drug?
• If you have a family history of blood clots, talk with your doctor.
• If you have heart disease, talk with your doctor.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• If you have migraine headaches, talk with your doctor.
• Have your blood pressure and heart rate checked often. Talk with your doctor.
• If you are taking a blood thinner, have your blood work checked. Talk with your doctor.
• Have an eye exam every year.
• Check all drugs you are taking with your doctor. This drug may not mix well with some other drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to
your doctor.
• Tell dentists, surgeons, and other doctors that you use this drug.
• Take good care of your teeth. See a dentist often.
• Do not take St John's wort, dong quai, black cohosh, saw palmetto, red clover, or ginseng with this
drug.
• If you drink grapefruit juice or eat grapefruit often, talk with your doctor.
• If you are taking this drug and have high blood pressure, talk with your doctor before using OTC
products that may raise blood pressure. These include cough or cold drugs, diet pills, stimulants,
ibuprofen or like products, and some natural products or aids.
• Avoid cigarette smoking. People smoking more than 15 cigarettes per day have more chance for
heart disease.
• This drug does not stop the spread of diseases like HIV or hepatitis that are passed through blood
or having sex. Do not have any kind of sex without using a condom. Do not share needles or other
things like toothbrushes or razors. Talk with your doctor.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
What are some side effects of this drug?
• Headache.
• Belly pain.
• Upset stomach or throwing up. Many small meals, good mouth care, sucking hard, sugar-free
candy, or chewing sugar-free gum may help.
• Period (menstrual) changes. These include spotting between cycles or very light periods.
• Mood changes.
• Swelling.
• Enlarged breasts.
• Vaginal yeast infection. Report itching or discharge.
• Blood clots may rarely happen.
When do I need to call my child's doctor?
• If you think there has been an overdose, call your poison control center or get medical care right
away. Be ready to tell or show what was taken, how much, and when it happened.
• If your child shows signs of a very bad reaction, call your child's doctor or the ER right away. These
include wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; swelling of
face, lips, tongue, or throat; or if your child is not acting normal.
• Chest pain or pressure.
• Trouble breathing.
• Swelling, warmth, or pain in the leg or arm.
• Very bad headache.
• Very bad belly pain.
• Very upset stomach or throwing up.
• Not able to eat.
• Dark urine or yellow skin or eyes.
• Change in how contact lenses feel in the eyes.
• Sudden change in eyesight, eye pain, or irritation.
• A lump in the breast or breast soreness.
• If you get pregnant while taking this drug.
• Any rash.
• Side effect or health problem is not better or you are feeling worse.
How do I store and/or throw out this drug?
• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
General drug facts
• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep all drugs out of the reach of children and pets.
• Some drugs may have another patient information leaflet. If you have any questions about this drug,
please talk with your doctor, pharmacist, or other health care provider.
• In Canada, take any unused drugs to the pharmacy. Also, visit
http://www.hc-sc.gc.ca/hl-vs/iyhvsv/med/disposal-defaire-eng.php#th to learn about the right way to get rid of unused drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to
your doctor.
• These are not all of the side effects that may occur. If you have questions about side effects, call
your doctor. Call your doctor for medical advice about side effects.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or
vitamins.
• Read the package insert for more details.
• If you do not use a drug the right way, it may not be safe. Follow what your child’s doctor tells you.
Disclaimer
This information should not be used to decide whether or not to take this medicine or any other
medicine. Only your healthcare provider has the knowledge and training to decide which medicines
are right for you. This information does not endorse any medicine as safe, effective, or approved for
treating any patient or health condition. This is only a brief summary of general information about this
medicine. It does NOT include all information about the possible uses, directions, warnings,
precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is
not specific medical advice and does not replace information you receive from your healthcare
provider. You must talk with your healthcare provider for complete information about the risks and
benefits of using this medicine.
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