What is ORTHO TRI-CYCLEN® LO?

What is the most important information I should know about ORTHO TRI-CYCLEN® LO?

Cigarette smoking increases the risk of serious cardiovascular Auvitra side effects from hormonal contraceptive use. This risk increases with age, with heavy smoking (15 or more cigarettes per day) and in women over 35 years of age. Women who use hormonal contraceptives are strongly advised not to smoke.

Who should not use ORTHO TRI-CYCLEN® LO?

You should not use ORTHO TRI-CYCLEN® LO if you are pregnant or think you may be pregnant or if you have any of the following conditions:

A history of heart attack or stroke, blood clots in the legs, lungs, or eyes, a history of blood clots in the deep veins of your legs, chest pain, known or suspected breast cancer or cancer of the lining of the uterus, cervix or vagina, unexplained vaginal bleeding (until your doctor reaches a diagnosis), yellowing of the whites of your eyes or of the skin (jaundice) during pregnancy or during previous use of hormonal contraceptives, liver tumor (benign or cancerous), or if you plan to have surgery with prolonged bed rest.

Tell your healthcare professional if you have ever had any of these conditions, he/she can recommend a safer method of birth control.

What are the possible side effects of ORTHO TRI-CYCLEN® LO?

Irregular vaginal bleeding or spotting. If bleeding occurs in more than one cycle or lasts for more than a few days call your healthcare professional
Problems wearing contact lenses such as change in vision or inability to wear your lenses. If these occur, contact your healthcare professional
Fluid retention with swelling of the fingers or ankles and may raise your blood pressure. Contact your healthcare professional if you experience fluid retention.
Spotty darkening of the skin (particularly the face). This may persist after you stop using ORTHO TRI-CYCLEN® LO
Other side effects include nausea and vomiting, change in appetite, headache, nervousness, depression, dizziness, loss of scalp hair, vaginal infections and allergic reactions.

Call your doctor immediately if you experience any of these side effects while you are using ORTHO TRI-CYCLEN® LO:
Sharp chest pain, coughing blood or sudden shortness of breath, pain in the calf, crushing chest pain or tightness in the chest, sudden, severe, headache or vomiting, dizziness or fainting, disturbances of vision or speech, weakness or numbness in an arm or leg, sudden or complete loss of vision, breast lumps, severe pain or tenderness in the stomach area, difficulty in sleeping, weakness, lack of energy, fatigue or change in mood, yellowing of the skin or whites of the eye along with fever, fatigue, loss of appetite, dark-colored urine or light-colored bowel movements.

What should I tell my healthcare professional before using ORTHO TRI-CYCLEN® LO?

Tell your healthcare professional if you: Smoke, are breast-feeding, or are taking any other medications.

Also, tell your healthcare professional if you have or have had: Breast nodules, fibrocystic disease of the breast, an abnormal breast x-ray or mammogram, a family history of breast cancer, diabetes, elevated cholesterol or triglycerides, high blood pressure, migraine or other headaches or epilepsy, depression, gallbladder, liver, heart or kidney disease, history of light or irregular menstrual periods.

Tell your healthcare professional about all of the medicines you are taking, before starting and while you are using ORTHO TRI-CYCLEN® LO including prescription and non-prescription medicines, vitamins, herbal and dietary supplements such as:

Barbiturates, bosentan, carbamazepine, phenybutazone, drugs used to treat HIV or AIDS, antibiotics, phenytoin, rifampin, topiramate, St. John’s Wort (a herbal supplement).

These medicines/herbal supplements may make your contraceptive less effective and you may need to use a barrier contraceptive when you take these drugs or products. ((NOTE: this paragraph MUST always appear underneath above paragraph. Cannot break to another page.))

Also, tell your healthcare professional if you take lamotrigine (LAMICTAL®), an anticonvulsant used for epilepsy. This may increase the risk of seizures so your healthcare professional may need to adjust the dose

Ask your healthcare provider if you are not sure if any of your medicines are listed above.

Ortho-Tri-Cyclen Lo Drug Description

ORTHO TRI-CYCLEN® Lo Tablets (norgestimate, ethinyl estradiol) is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. ORTHO TRI-CYCLEN® Lo Tablets (norgestimate, ethinyl estradiol)

Each white tablet contains 0.180 mg of the progestational compound, norgestimate (+)-13-Ethyl-17-hydroxy-18, 19-dinor-17α-pregn-4-en-20-yn-3-one oxime acetate (ester) and 0.025 mg of the estrogenic compound, ethinyl estradiol (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). Inactive ingredients include lactose, magnesium stearate, croscarmellose sodium, microcrystalline cellulose, carnauba wax, hypromellose, polyethylene glycol, titanium dioxide, and purified water.

Each light blue tablet contains 0.215 mg of the progestational compound norgestimate Viagra Jelly (+)-13-Ethyl-17-hydroxy-18, 19-dinor-17α-pregn-4-en-20-yn-3-one oxime acetate (ester) and 0.025 mg of the estrogenic compound, ethinyl estradiol (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). Inactive ingredients include FD & C Blue No. 2 Aluminum Lake, lactose, magnesium stearate, croscarmellose sodium, microcrystalline cellulose, carnauba wax, hypromellose, polyethylene glycol, titanium dioxide, and purified water.

Each dark blue tablet contains 0.250 mg of the progestational compound norgestimate (+)-13-Ethyl-17-hydroxy-18, 19-dinor-17α-pregn-4-en-20-yn-3-one oxime acetate (ester) and 0.025 mg of the estrogenic compound, ethinyl estradiol (19-nor-1717α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). Inactive ingredients include FD & C Blue No. 2 Aluminum Lake, lactose, magnesium stearate, croscarmellose sodium, microcrystalline cellulose, polysorbate 80, carnauba wax, hypromellose, polyethylene glycol, titanium dioxide, and purified water. Each dark green tablet contains only inert ingredients, as follows: FD & C Blue No. 2 Aluminum Lake, lactose, magnesium stearate, pregelatinized starch, ferric oxide, hypromellose, polyethylene glycol, titanium dioxide, talc and purified water.

SIDE EFFECTS:Nausea, vomiting, headache, stomach cramping/bloating, dizziness, vaginal discomfort/irritation, increased vaginal fluids, or breast tenderness/enlargement may occur. Acne may improve or get worse. 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, notify your doctor 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.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these serious side effects occur: changes in vaginal bleeding (e.g., continuous spotting, sudden heavy bleeding, missed periods), problem wearing contact lenses, dark patches on the skin (melasma), unwanted facial/body hair, swelling of the ankles/feet, weight changes (gain or loss).

This medication may rarely cause serious (sometimes fatal) problems from blood clots (e.g., pulmonary embolism, stroke, heart attack). Seek immediate medical attention if you experience: sudden shortness of breath, chest/jaw/left arm pain, confusion, coughing up blood, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, tingling/weakness/numbness in the arms/legs, headaches that are different from those you may have experienced in the past (e.g., headaches with other symptoms such as vision changes/lack of coordination, existing migraines becoming worse, sudden/very severe headaches), slurred speech, weakness on one side of the body, vision problems/changes.

Tell your doctor immediately if any of these rare but very serious side effects occur: lumps in the breast, severe stomach/abdominal/pelvic pain, mental/mood changes (e.g., depression, suicidal thoughts, persistent trouble sleeping), unusual tiredness, dark urine, yellowing eyes/skin.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS:See also Warning section.

Before using this medication, tell your doctor or pharmacist if you are allergic to any estrogens (e.g., ethinyl estradiol, mestranol) or any progestins (e.g., norethindrone, desogestrel); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this product, consult your doctor or pharmacist if you have: history of stroke or other blood clots (e.g., in the legs, eyes, lungs), severe high blood pressure, abnormal breast exam, cancer (especially endometrial or breast cancer), diabetes that has caused kidney/eye/nerve/blood vessel disease, severe headaches, history of heart disease (e.g., heart attack, chest pain), heart valve disease, liver problems (e.g., liver tumor, active liver disease), current or suspected pregnancy, recent major surgery, long periods of sitting or lying down (e.g., immobility such as being bedridden), history of yellowing eyes/skin (jaundice) during pregnancy or while using hormonal birth control (e.g., pills, patch), unexplained vaginal bleeding, heavy tobacco use (especially if 35 or over).

Before using this product, tell your doctor your medical history, especially of: high blood pressure, high cholesterol or triglyceride (blood fat) levels, depression, diabetes, swelling (edema), gallbladder problems, kidney disease, migraine, obesity, irregular/missed/very light periods, recent pregnancy, thyroid problems.

Do not smoke cigarettes or use tobacco. Hormonal birth control (e.g., pills, injections, devices) combined with smoking significantly increases your risk for stroke, blood clots, high blood pressure, and heart attacks, especially in women older than 35. For more details, ask your doctor or pharmacist, or consult the Patient Information Leaflet that comes with this product.

If you have diabetes, this medication may make it harder to control your blood sugar levels. Monitor your blood sugar regularly as directed by your doctor. Tell your doctor the results and any symptoms such as increased thirst/urination. Your anti-diabetic medication or diet may need to be adjusted.

Notify your doctor beforehand if you will be having surgery or will be confined to a chair/bed for a long time (e.g., a long plane flight). You may need to stop the medication for a time or take special precautions.

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. Consult your doctor.

This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor immediately. 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 passes into breast milk. This may affect milk production and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.