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Triphasil (Levonorgestrel/Ethinyl Estradiol) – 28 Generic Tablet

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Disp Pack

Chemical Name: LEVONORGESTREL (LEE-voe-nor-jess-trel) and ETHINYL ESTRADIOL
(ETH-in-il ess-tra-DYE-ole)

Common uses

This medicine is an estrogen and progestin combination contraceptive pill used
to prevent pregnancy. It may also be used to regulate the menstrual cycle, treat
symptoms of menopause, or treat other conditions as determined by your doctor.

Before using

WARNING: Smoking cigarettes while using this medicine increases your chance of
having heart problems. Do not smoke while using this medicine. Women greater
than 35 years of age and women who smoke 15 or more cigarettes per day are at a
greater risk for heart problems. Some medicines or medical conditions may
interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all
prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS
MEDICINE if you are also taking azole antifungal medicines such as ketoconazole
or itraconazole, acitretin, aprepitant, bosetan, barbiturates, griseofulvin,
carbamazepine, topiramate, tetracycline antibiotics, hydantoins such as
phenytoin, St. John’s wort, or rifampin without talking with your doctor. An
increased risk of pregnancy has been identified when taking these medicines with
birth-control pills. Check with your doctor or pharmacist for more information.
ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking
benzodiazepines, corticosteroids, felbamate, HIV protease inhibitors, nevirapine,
modafinil, beta-blockers such as metoprolol or carvedilol, lamotrigine,
pioglitazone, penicillin antibiotics, theophylline, troglitazone, troleandomycin,
or medicine for seizures. DO NOT START OR STOP any medicine without doctor or
pharmacist approval. Inform your doctor of any other medical conditions
including cancer, diabetes, headaches or migraines, high triglyceride level in
the blood, high blood pressure, recent surgery, allergies, pregnancy, or
breast-feeding. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have a history of
problems with the blood vessels in the brain or heart, heart valve problems,
heart attack, uncontrolled high blood pressure, abnormal or undiagnosed vaginal
bleeding, certain cancers including breast cancer, serious liver problems, blood
clots, certain blood disorders such as porphyria, stroke, or smoking. Contact
your doctor or pharmacist if you have any questions or concerns about taking
this medicine.

Directions

Follow the directions for using this medicine provided by your doctor. THIS
MEDICINE COMES with a patient information leaflet. Read it carefully. Ask your
doctor, nurse, or pharmacist any questions that you may have before using this
medicine. TRY TO TAKE THIS MEDICINE at the same time every day, not more than 24
hours apart. STORE THIS MEDICINE at room temperature, away from heat and light.
IF YOU MISS A DOSE OF THIS MEDICINE, take it as soon as you remember. Take your
next dose at the regular time. This means you may take 2 doses on the same day.
IF YOU MISS MORE THAN 1 DOSE OF THIS MEDICINE, refer to the patient information
that came with this medicine. If you have any questions, contact your doctor,
nurse, or pharmacist.

Cautions

DO NOT TAKE THIS MEDICINE if you have had an allergic reaction to it or are
allergic to any ingredient in this product. KEEP ALL DOCTOR AND LABORATORY
APPOINTMENTS while you are taking this medicine. You should have a complete
physical examination, including blood pressure measurements, breast and pelvic
examinations, and a PAP test (for vaginal cancer), at least once a year. Follow
your doctor’s instructions for examining your own breasts, and report any lumps
immediately. This medicine may affect certain lab test results. Make sure
laboratory personnel and your doctors know you use this medicine. If you will be
having surgery or will be confined to a chair or bed for a long period of time
(such as a long plane flight), notify your doctor 3 to 4 weeks beforehand.
Special precautions may need to be taken in these circumstances while you are
taking this medicine. IF YOU MISS YOUR PERIOD during the week of inactive pills,
call your doctor immediately. A missed period may indicate that you are
pregnant. BLEEDING OR SPOTTING may occur while taking this medicine. DO NOT STOP
taking this medicine if this occurs. If bleeding or spotting continues for more
than 7 days or is heavy, contact your doctor. SMOKING CIGARETTES while using
this medicine may increase your risk of stroke, heart attack, blood clots, high
blood pressure, or other diseases of the heart and blood vessels. TAKING CERTAIN
ANTIBIOTICS or anticonvulsants while you are using this medicine may decrease
the effectiveness of this medicine. To prevent pregnancy, use an additional form
of birth control until your next period. If you have any questions, contact your
doctor, nurse, or pharmacist. IF YOU WEAR CONTACT LENSES and you develop
problems with them, contact your doctor. THIS MEDICINE MAY CAUSE dark skin
patches on your face. Exposure to the sun may make these patches darker. If
patches develop, use a sunscreen or protective clothing when exposed to the sun,
sunlamps, or tanning booths. USE OF THIS MEDICINE WILL NOT PREVENT the spread of
sexually transmitted diseases (STDs). DO NOT USE THIS MEDICINE if you are
pregnant. IF YOU SUSPECT THAT YOU COULD BE PREGNANT, contact your doctor
immediately. THIS MEDICINE IS EXCRETED IN BREAST MILK. DO NOT BREAST-FEED while
you are taking this medicine.

Possible side
effects

SIDE EFFECTS, that may go away during treatment, include nausea, vomiting,
bleeding between menstrual periods, breast tenderness, or weight change. If they
continue or are bothersome, check with your doctor. CHECK WITH YOUR DOCTOR AS
SOON AS POSSIBLE if you experience persistent or recurrent abnormal vaginal
bleeding, a missed menstrual period, dizziness or fainting, swelling of fingers
or ankles, headache, or difficulty wearing contact lenses. CONTACT YOUR DOCTOR
IMMEDIATELY if you experience calf/leg pain or swelling, trouble breathing or
shortness of breath, chest pain, one-sided weakness, slurred speech, lumps in
the breast, sudden severe headache, sharp or crushing chest pain, sudden
shortness of breath, yellowing skin or eyes, changes in vision, numbness of an
arm or leg, or severe stomach pain. AN ALLERGIC REACTION to this medicine is
unlikely, but seek immediate medical attention if it occurs. Symptoms of an
allergic reaction include rash, itching, swelling, dizziness, or trouble
breathing. If you notice other effects not listed above, contact your doctor,
nurse, or pharmacist.

If you take too
much

If overdose is suspected, contact your local poison control center or emergency
room immediately. Symptoms of overdose may include nausea, vomiting, and vaginal
bleeding.

Additional
information

DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT
USE THIS MEDICINE for other health conditions. KEEP THIS MEDICINE out of the
reach of children. IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain
refills before your supply runs out.
 

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