DESOGESTREL-ETHINYL ESTRADIOL

Minor side effects (if these symptoms persist or worsen, inform your doctor)

• Nausea, vomiting, headache, bloating, breast tenderness, swelling of the ankles/feet (fluid retention), or weight change may occur. Vaginal bleeding between periods (spotting) or missed/irregular periods may occur, especially during the first few months of use. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. If you miss 2 periods in a row (or 1 period if the pill has not been used properly), contact your doctor for a pregnancy test.
• Increased blood pressure.

Serious side effects (inform your doctor immediately)

• Lumps in the breast, mental/mood changes (such as new/worsening depression), severe stomach/abdominal pain, unusual changes in vaginal bleeding (such as continuous spotting, sudden heavy bleeding, missed periods), dark urine, yellowing eyes/skin.
• Serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

• Rarely cause serious (sometimes fatal) problems from blood clots (such as deep vein thrombosis, heart attack, pulmonary embolism, stroke). Get medical help right away if any of these side effects occur: chest/jaw/left arm pain, confusion, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, slurred speech, sudden shortness of breath/rapid breathing, unusual headaches (including headaches with vision changes/lack of coordination, worsening of migraines, sudden/very severe headaches), unusual sweating, weakness on one side of the body, vision problems/changes (such as double vision, partial/complete blindness).

Precautions

• Inform your doctor.
  • Allergy to the medication or any allergies.
  • Medical History of blood clots (for example, in the legs, eyes, lungs), blood clotting disorders (such as protein C or protein S deficiency), high blood pressure, abnormal breast exam, cancer (especially endometrial or breast cancer), high cholesterol or triglyceride (blood fat) levels, depression, diabetes, family medical history (especially angioedema), gallbladder problems, severe headaches/migraines, heart problems (such as heart valve disease, irregular heartbeat, previous heart attack), history of yellowing eyes/skin (jaundice) during pregnancy or while using hormonal birth control (such as pills, patch), kidney disease, liver disease (including tumors), stroke, swelling (edema), thyroid problems, unexplained vaginal bleeding.
  • If you just had or will be having surgery or if you will be confined to a bed or chair for a long time (such as a long plane flight).
• This medication may cause blotchy, dark areas on your skin (melasma). Sunlight may worsen this effect. Avoid prolonged sun exposure, sunlamps, and tanning booths. Use a sunscreen, and wear protective clothing when outdoors.
• If you are nearsighted or wear contact lenses, you may develop vision problems or trouble wearing your contact lenses. Contact your eye doctor if these problems occur.
• It may take longer for you to become pregnant after you stop taking birth control pills.
• This medication should not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor right away. If you have just given birth or had a pregnancy loss/abortion after the first 3 months, talk with your doctor about reliable forms of birth control, and find out when it is safe to start using birth control that contains a form of estrogen, such as this medication.
• This medication may decrease breast milk production. A small amount passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.
• Do not use this medication if you smoke cigarettes/use tobacco and are over 35 years old. Smoking raises your risk of stroke, heart attack, blood clots, and high blood pressure from hormonal birth control (such as the pill, patch, ring). The risk of these serious problems increases with age and with the number of cigarettes you smoke. Do not smoke or use tobacco.

Interactions

Taking multiple drugs may affect how medications work and/or cause unwanted side effects. List down all the medications you are taking and inform your physician and pharmacist. Do not take, discontinue, or alter any dose of medications without prior approval of your physician.

• Products that may interact with this medication include:
  • aromatase inhibitors (such as anastrozole, exemestane), ospemifene, tamoxifen, tizanidine, tranexamic acid, a certain combination product used to treat chronic hepatitic C (ombitasvir/paritaprevir/ritonavir/dasabuvir).
• Some drugs may cause hormonal birth control to work less well by decreasing the amount of birth control hormones in your body. This effect can result in pregnancy.
  • griseofulvin, modafinil, rifamycins (such as rifampin, rifabutin), St. John’s wort, drugs used to treat seizures (such as barbiturates, carbamazepine, felbamate, phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir, nevirapine, ritonavir), among others.
• This medication may interfere with certain laboratory tests (such as blood clotting factors, thyroid), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this medication.

Overdose

If overdose is suspected, contact a poison control center or emergency room right away. Symptoms of overdose may include severe nausea and vomiting, sudden/unusual vaginal bleeding.

Keep all regular medical and laboratory appointments. You should have regular complete physical exams which include laboratory and medical tests (such as blood pressure, breast exam, pelvic exam, Pap smear) to monitor your progress and check for side effects.

Missed Dose: Refer to the product package information for advice on missed doses. You may need to use back-up birth control (such as condoms, spermicide) to prevent pregnancy. Ask your doctor or pharmacist if you have any questions.

If you often forget to take your pills as directed, contact your doctor to discuss switching to another form of birth control.

Storage:

• Store at room temperature away from light and moisture.
• Do not store in the bathroom.
• Keep all medications away from children and pets.
• Do not flush medications down the toilet or pour them into a drain unless instructed to do so.
• Properly discard this product when it is expired or no longer needed.

Brands

Also marketed as

• Cerazette [ Merck Sharp & Dohme ]
• Singapore Genebio Desogestrel [ Unicure ]