Safyral (28 Day)

Safyral (28 Day) is a combination medicine used to prevent pregnancy as a contraceptive. The Beyaz brand of Safyral (28 Day) is also used to treat moderate acne in women who are at least 14 years old, have started their menstrual periods, and want to use birth control pills.

Beyaz is also used to help with symptoms of premenstrual dysphoric disorder (PMDD), which can include anxiety, depression, irritability, trouble concentrating, low energy, changes in sleep or appetite, breast tenderness, joint or muscle pain, headaches, and weight gain.

Safyral (28 Day) may also be used for other reasons not mentioned in this medication guide.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended. Take your first pill on the first day of your period or on the first Sunday after your period begins. You may need to use back-up birth control, such as condoms with spermicide, when you first start using this medication.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You could get pregnant if you do not take one pill daily.

You must take the pills in the correct order for this medicine to work in preventing pregnancy. Follow the arrows shown on each row of pills in your blister pack. The last few pills you will take contain only levomefolate and not the contraceptive (birth control) medicines.

Use back-up birth control if you are sick with severe vomiting or diarrhea.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

If you need major surgery or will be on long-term bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using this medicine.

Store at room temperature away from moisture and heat.

Do not use if you are pregnant or if you recently had a baby.

You should not take this medicine if you have: an adrenal gland disorder, kidney disease, uncontrolled high blood pressure, heart disease, coronary artery disease, circulation problems (especially with diabetes), undiagnosed vaginal bleeding, liver disease or liver cancer, severe migraine headaches, if you also take certain hepatitis C medication, if you will have major surgery, if you smoke and are over 35, or if you have ever had a heart attack, a stroke, a blood clot, jaundice caused by pregnancy or birth control pills, or cancer of the breast, uterus/cervix, or vagina.

Taking this medicine can increase your risk of blood clots, stroke, or heart attack.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. You should not take this medicine if you smoke and are over 35 years old.

Taking this medicine can raise your chances of getting blood clots, having a stroke, or having a heart attack. Your risk is higher if you have high blood pressure, diabetes, high cholesterol, or if you are overweight. The risk of stroke or blood clot is highest during your first year of using this medicine. Your risk is also high if you start this medicine again after not taking it for 4 weeks or more.

Smoking can significantly increase your risk of blood clots, stroke, or heart attack. Your risk goes up as you get older and the more you smoke. You should not take this medicine if you smoke and are over 35 years old.

Do not use this medicine if you are pregnant. Stop using this medicine and contact your doctor immediately if you become pregnant or if you miss 2 menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking this medicine.

You should not take this medicine if you have:

• an adrenal gland disorder;
• kidney disease;
• untreated or uncontrolled high blood pressure;
• heart disease (coronary artery disease, history of heart attack, stroke, or blood clot);
• a higher risk of having blood clots due to a heart problem or a genetic blood disorder;
• circulation issues (especially if caused by diabetes);
• a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina;
• unusual vaginal bleeding that has not been evaluated by a doctor;
• liver disease or liver cancer;
• severe migraine headaches (with aura, numbness, weakness, or vision changes), especially if you are older than 35;
• a history of jaundice caused by pregnancy or birth control pills;
• if you smoke and are over 35 years old; or
• if you take any hepatitis C medication that includes ombitasvir/paritaprevir/ritonavir (Technivie).

To ensure this medicine is safe for you, inform your doctor if you have ever had:

• heart problems, high blood pressure, or if you are prone to blood clots;
• high potassium levels in your blood;
• high cholesterol or triglycerides, or if you are overweight;
• depression;
• liver or kidney disease;
• an underactive thyroid, diabetes, gallbladder disease; or
• a migraine headache.

The hormones in this medicine can pass into breast milk and may harm a nursing baby. This medicine may also reduce breast milk production. Do not use if you are breastfeeding.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

This medicine may cause serious side effects. Stop using this medicine and call your doctor right away if you have:

• signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
• signs of a blood clot--sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;
• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• liver problems--loss of appetite, upper stomach pain, tiredness, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• increased blood pressure--severe headache, blurred vision, pounding in your neck or ears;
• swelling in your hands, ankles, or feet;
• a change in the pattern or severity of migraine headaches; or
• symptoms of depression--sleep problems, weakness, tired feeling, mood changes.

Common side effects of Safyral (28 Day) may include:

• nausea;
• breast tenderness;
• headache; or
• breakthrough bleeding.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

Follow the patient instructions that come with your medicine. Ask your doctor or pharmacist if you do not understand these instructions. Missing a pill increases your risk of becoming pregnant. If you miss 1 pill during Week 1, 2, or 3, take 2 pills on the day you remember. Then take 1 pill each day for the rest of the pack.

If you miss 2 pills in a row in Week 1 or 2, take 2 pills each day for 2 days in a row. Then take 1 pill each day for the rest of the pack. Use back-up birth control for at least 7 days after missing the pills.

If you miss 2 pills in a row in Week 3, throw away the rest of the pack and start a new pack the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw away the rest of the pack and start a new pack that day.

If you miss 3 pills in a row in Week 1, 2, or 3, throw away the rest of the pack and start a new pack on the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw away the rest of the pack and start a new pack that day.

If you miss two or more pills, you may not have a period during the month. If you miss a period for two months in a row, call your doctor because you might be pregnant.

If you miss a levomefolate pill in Week 4, throw the pill away and keep taking 1 pill each day until the pack is empty.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222. Taking too much may cause nausea or vaginal bleeding.

Do not smoke while using this medicine, especially if you are over 35 years old.

This medicine will not protect you from sexually transmitted diseases, including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Other drugs may interact with Safyral (28 Day), including prescription and over-the-counter medicines, vitamins, and herbal products. Some drugs can make this medicine less effective, which may lead to pregnancy. Inform your doctor about all your current medicines and any medicines you begin or stop using.