Yaz Plus (Drospirenone/Ethinylestradiol/Levomefolate Calcium)

Usual dose:

How to Take YAZ PLUS:

1. READ THESE DIRECTIONS
   • before you start taking your pills, and
   • any time you are not sure what to do.
2. LOOK AT YOUR PILL PACK, it has 28 pills.
3. The YAZ PLUS pill pack has 24 hormone-containing pink “active” pills to be taken for 24 days, followed by 4 hormone-free light-orange pills to be taken for four days. It is important to take the light-orange pills because they contain folate.
4. ALSO CHECK the pill pack for: 1) where to start, and 2) direction to take pills in (follow the arrows).
5. You should use a second method of birth control (e.g., latex or polyurethane condoms and spermicidal foam or gel) for the first seven days of the first cycle of pill use. This will provide a back-up in case pills are forgotten while you are getting used to taking them.
6. When receiving any medical treatment, be sure to tell your doctor that you are using birth control pills.
7. IF YOU EXPERIENCE VOMITING OR DIARRHEA, OR IF YOU TAKE CERTAIN MEDICINES, such as antibiotics, your pills may not work as well. Use a back-up method, such as latex or polyurethane condoms and spermicidal foam or gel, until you can check with your doctor or clinic.
8. Visit your doctor three months or sooner after the initial examination. Afterward, visit your doctor at least once a year.
9. Take the pills only on the advice of your doctor and carefully follow all directions given to you. You must take the pills exactly as prescribed. Otherwise, you may become pregnant.
10. Your doctor will advise you of the appropriate time to start the use of birth control pills after childbirth, miscarriage, or therapeutic abortion.
11. THERE IS NO NEED TO STOP TAKING BIRTH CONTROL PILLS FOR A REST PERIOD.
12. IF YOUR QUESTIONS ARE NOT ANSWERED HERE, CALL YOUR DOCTOR OR CLINIC.

When to Start the First Pack of Pills:

BE SURE TO READ THESE INSTRUCTIONS:

• before you start taking your pills, and
• any time you are not sure what to do.

Decide with your doctor or clinic what is the best day for you to start taking your first pack of pills. Pick a time of day which will be easy to remember.

1. THE FIRST DAY OF YOUR MENSTRUAL PERIOD (BLEEDING) IS DAY 1 OF YOUR CYCLE. Your doctor may advise you to start taking the pills on Day 1 or on the first Sunday after your period begins. If your period starts on Sunday, start that same day.
2. Take one pill at approximately the same time every day for 28 days. Begin a new pack the next day, NOT MISSING ANY DAYS. Your period should occur during the last four days of using that pill pack.

What to Do During the Month:

1. TAKE A PILL AT APPROXIMATELY THE SAME TIME EVERY DAY UNTIL THE PACK IS EMPTY.
   • Try to associate taking your pill with some regular activity, such as eating a meal or going to bed.
   • Do not skip pills even if you have bleeding between monthly periods or feel sick to your stomach (nausea).
   • Do not skip pills even if you do not have sex very often.
2. WHEN YOU FINISH A PACK
3. Start the next pack on the day after your last hormone-free light-orange pill. Take one pill every day. It is important to take the light-orange pills because they contain folate. Do not wait any days between packs.

Overdose:

Symptoms of overdose may include nausea, vomiting, or vaginal bleeding. Available information from cases of accidental ingestion of oral contraceptives by children indicates no serious effects.

In case of drug overdose, contact a health care practitioner, hospital emergency department, or regional Poison Control Center immediately, even if there are no symptoms.

Missed dose:

MISSING PILLS CAN CAUSE SOME SPOTTING OR LIGHT BLEEDING, even if you make up the missed pills. You also could feel a little sick to your stomach on the days you take two pills to make up for missed pills.

IF YOU MISS PILLS AT ANY TIME, YOU COULD GET PREGNANT. THE GREATEST RISKS FOR PREGNANCY ARE:

• when you start a pack late, or

• when you miss pills at the beginning or at the very end of the pack.

What to Do if You Miss Pills:

The following chart outlines the actions you should take if you miss one or more of your birth control pills. Match the number of pills missed with the appropriate starting time for your type of pill pack.

The following side effects have been observed in studies of women taking YAZ PLUS which may or may not be drug related:

Most side effects when using the birth control pill are not serious. The most common side effects are nausea, vomiting, bleeding or spotting between menstrual periods, breast pain, acne, itching, migraine, dizziness, emotional lability (sudden changes in emotional state without a reason), dysmenorrhea (painful menstrual cramps), headache, vaginal yeast infection, depression, back pain, abdominal pain, nervousness, rash.

Other side effects can occur such as gastrointestinal symptoms (abdominal cramps and bloating), darkening of the skin (particularly on the face), change in appetite, change in libido (sex drive), hair loss, change in weight (increase or decrease), swelling, breast changes (tenderness, enlargement, discharge), temporary infertility after discontinuation of treatment.

If you experience new onset of high blood pressure or worsening of high blood pressure, contact your doctor or pharmacist.

The following additional symptoms have been reported in women taking hormonal contraceptives in general:

• difficulty wearing contact lenses
• vaginal irritation or infections
• urinary tract infections or inflammation
• upper respiratory tract infections (colds, bronchitis, runny or stuffy nose, sore throat, etc)
• severe headaches
• depression, insomnia, nervousness
• amenorrhea (lack of a period or breakthrough bleeding)
• back pain
• abdominal pain
• flu-like symptoms
• allergy, fatigue, fever
• diarrhea, flatulence
• rash

Many women have spotting or light bleeding, or may feel sick to their stomach during the first three months on the pill. If you do feel sick, do not stop taking the pill. The problem will usually go away. If it does not go away, check with your doctor or clinic.

Serious Warnings and Precautions

Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels. This risk increases with age and becomes significant in hormonal contraceptive users older than 35 years of age, and with the number of cigarettes smoked. For this reason, combination oral contraceptives, including YAZ PLUS, should not be used by women who are over 35 years of age and smoke. Women should not smoke.

Birth control pills DO NOT PROTECT against sexually transmitted infections (STIs), including HIV/AIDS.

For protection against STIs, it is advisable to use latex or polyurethane condoms IN COMBINATION WITH birth control pills.

YAZ PLUS is a birth control pill containing estrogen and progestin and a vitamin (levomefolate calcium). The progestin in YAZ PLUS is known as drospirenone and it may increase the levels of potassium in your blood. Therefore, you should not take YAZ PLUS if you have kidney, liver, or adrenal disease (a disease that may alter the body's fluid and mineral balance) because this could cause serious heart and health problems. Other drugs may also increase potassium (see Before you use YAZ PLUS, talk to your doctor or pharmacist if you:). During the first month that you take YAZ PLUS, you should have a blood test to check your potassium level.

It has been reported that drospirenone, the progestin in YAZ PLUS, may carry a higher risk of blood clots than some other progestins (including levonorgestrel). You should talk to your doctor about the available options.

BEFORE you use YAZ PLUS, talk to your doctor or pharmacist if you:

• smoke
• are overweight
• have a history of breast disease (e.g., breast lumps) or a family history of breast cancer
• have high blood pressure
• have high cholesterol
• have diabetes
• have heart or kidney disease
• have a history of seizures/epilepsy
• have a history of depression
• have a history of liver disease or jaundice
• wear contact lenses
• have uterine fibroids (benign tumors of the uterus)
• may be pregnant or are breastfeeding
• have systemic lupus erythematosus
• have inflammatory bowel disease such as Crohn's disease or ulcerative colitis
• have haemolytic uremic syndrome
• have sickle cell disease
• have any problems with the valves in your heart and/or have an irregular heart rhythm
• if you suffer from vitamin B12 deficiency (for example due to a reduced B12 diet such as a strict vegetarian diet, due to a history of gastrointestinal surgery or certain types of gastritis) tell your doctor that you use YAZ PLUS because folates may hide vitamin B12 deficiency
• have been told that you have a condition called hereditary angioedema or if you have had episodes of swelling in body parts such as hands, feet, face, or airway passages
• you are currently on daily, long-term treatment for a chronic condition with any of the medications listed below:
  • Non steroidal anti-inflammatory drugs (NSAIDs) when taken long-term and for treatment of arthritis or other problems (e.g., ibuprofen, naproxen, or others)
  • Potassium-sparing diuretics (spironolactone and others)
  • Potassium supplements
  • ACE inhibitors and Angiotensin-II receptor antagonists for the treatment of high blood pressure (e.g., captopril, enalapril, lisinopril, losartan, valsartan, irbesartan, or others)
  • Heparin

You should also inform your doctor about a family history of blood clots, heart attacks, or strokes.

Inform your doctor if you are taking daily folate supplements.

YAZ PLUS contains the equivalent of 0.4 mg of folic acid.

If you see a different doctor, inform him or her that you are using YAZ PLUS.

Tell your doctor if you are scheduled for any laboratory tests since certain blood tests may be affected by hormonal contraceptives.

Also tell your doctor if you are scheduled for MAJOR surgery. You should consult your doctor about stopping the use of YAZ PLUS four weeks before surgery and not using YAZ PLUS for a time period after surgery or during bed rest.

YAZ PLUS should be used only under the supervision of a doctor, with regular follow-up to identify side effects associated with its use. Your visits may include a blood pressure check, a breast exam, an abdominal exam and a pelvic exam, including a Pap smear. Visit your doctor three months or sooner after the initial examination. Afterward, visit your doctor at least once a year. Use YAZ PLUS only on the advice of your doctor and carefully follow all directions given to you. You must use the birth control pill exactly as prescribed. Otherwise, you may become pregnant.

If you and your doctor decide that, for you, the benefits of YAZ PLUS outweigh the risks, you should be aware of the following:

The Risks of Using YAZ PLUS:

1. Circulatory disorders (including blood clot in legs, lungs, heart, eyes, or brain)
2. Women who use hormonal contraceptives have a higher incidence of blood clots. Blood clots are the most common serious side effects of birth control pills. The risk of developing blood clots is especially high during the first year a woman ever uses a hormonal contraceptive or restarts the same or a different hormonal contraceptive. Clots can occur in many parts of the body.
3. Be alert for the following symptoms and signs of serious adverse effects. Call your doctor immediately if they occur:
   • sharp pain in the chest which may increase with deep breathing; coughing blood; sudden shortness of breath or rapid breathing; sense of anxiety; severe light headedness or dizziness; rapid or irregular heartbeat. These symptoms could indicate a possible blood clot in the lung.
   • pain and/or swelling in the calf or along a vein in the leg; pain or tenderness in the leg which may be felt only when standing or walking, increased warmth in the affected leg; red or discoloured skin on the leg. These symptoms could indicate a possible blood clot in the leg.
   • crushing chest pain, discomfort, pressure, heaviness, sensation of squeezing or fullness in the chest, arm, or below the breastbone; discomfort radiating to the back, jaw, throat, arm, stomach; fullness, indigestion or choking feeling; sweating, nausea, vomiting or dizziness; extreme weakness, anxiety, or shortness of breath; rapid or irregular heartbeats. These symptoms could indicate a possible heart attack.
   • sudden severe or worsening headache or vomiting; sudden trouble walking, dizziness, loss of balance or coordination; loss of consciousness or fainting with or without seizure; sudden confusion, disturbances of vision, speech or understanding; sudden weakness or numbness of the face, arm or leg. These symptoms could indicate a possible stroke.
   • sudden partial or complete loss of vision. This symptom could indicate a blood clot in the eye.
   • other signs of a blood clot can include sudden pain, swelling and slight blue discoloration of an extremity; acute abdomen.
4. Any of these conditions can cause death or disability. Clots also occur rarely in the blood vessels of the eye, resulting in blindness or impaired vision or in a blood vessel leading to an arm or leg, resulting in damage to or loss of a limb.
5. The risk of clotting seems to increase with higher estrogen doses. It is important, therefore, to use as low a dosage of estrogen as possible.
6. Cancer of the breast, cervix, or liver may be life threatening or may result in death.
7. Breast cancer
8. The most significant risk factors for breast cancer are increasing age and a strong history of breast cancer in the family (mother or sister). Other established risk factors include obesity, never having children, and having your first full-term pregnancy at a late age.
9. Some women who use hormonal contraceptives may be at increased risk of developing breast cancer before menopause, which occurs around age 50. These women may be long-term users of birth control pills (more than eight years) or women who start using birth control pills at an early age. In a few women, the use of birth control pills may accelerate the growth of an existing but undiagnosed breast cancer. Early diagnosis, however, can reduce the effect of breast cancer on a woman's life expectancy. The potential risks related to birth control pills seem to be small, however. A yearly breast examination by a health care professional is recommended for all women.
10. ASK YOUR DOCTOR FOR ADVICE AND INSTRUCTIONS ON REGULAR SELF-EXAMINATION OF YOUR BREASTS.
11. Cervical cancer
12. Some studies have found an increase of cancer of the cervix in women who use hormonal contraceptives, although this finding may be related to factors other than the use of oral contraceptives. However, there is insufficient evidence to rule out the possibility that oral contraceptives may cause such cancers.
13. Liver tumors
14. The short and long-term use of birth control pills have also been linked with the growth of liver tumors. Such tumors are extremely rare.
15. Contact your doctor immediately if you experience severe pain or a lump in the abdomen.
16. Gallbladder disease
17. Users of birth control pills have a greater risk of developing gallbladder disease requiring surgery within the first year of use. The risk may double after four or five years of use.
18. Use in pregnancy
19. Birth control pills should not be taken by pregnant women. There is no evidence, however, that the birth control pill can damage a developing child. You should check with your doctor about risks to your unborn child from any medication taken during pregnancy. Also, check with your doctor about appropriate folate supplementation if you stop taking YAZ PLUS, are pregnant, or plan on becoming pregnant.
20. Use after pregnancy, miscarriage or an abortion
21. Your doctor will advise you of the appropriate time to start the use of YAZ PLUS after childbirth, miscarriage, or therapeutic abortion.
22. Pregnancy after stopping YAZ PLUS
23. You will have a menstrual period when you stop using YAZ PLUS. You should delay pregnancy until another menstrual period occurs within four to six weeks. In this way the pregnancy can be more accurately dated. Contact your doctor for recommendations on alternate methods of contraception during this time.
24. Use while breastfeeding
25. If you are breastfeeding, consult your doctor before starting the birth control pill. The hormones in birth control pills are known to appear in breast milk. These hormones may decrease the flow of breast milk. If birth control pills are not resumed until nursing is established, however, the quantity and quality of breast milk does not seem to be affected. Adverse effects on the child have been reported, including yellowing of the skin (jaundice) and breast enlargement. You should use another method of contraception and only consider starting the birth control pill once you have weaned your child completely.

Certain drugs may interact with birth-control pills to make them less effective in preventing pregnancy or cause an increase in breakthrough bleeding. Please inform your doctor or pharmacist if you are taking or have recently taken any other drugs or herbal products, even those without a prescription. Also tell any other doctor or dentist (or the dispensing pharmacist) who prescribes another drug that you use YAZ PLUS. They can tell you if you need to use an additional method of contraception and if so, for how long.

Drugs that may interact with YAZ PLUS include:

• drugs used for the treatment of epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate, phenobarbital, valproic acid); tuberculosis (e.g., rifampin, rifabutin), HIV infections (e.g., ritonavir, nevirapine), and Hepatitis C Virus infections (e.g., boceprevir, telaprevir)
• antibiotics (e.g., penicillins, tetracyclines, clarithromycin, erythromycin) for infectious diseases
• cyclosporine
• antifungals (e.g., griseofulvin, fluconazole, itraconazole, ketoconazole, voriconazole)
• cholesterol-lowering drugs (e.g., clofibrate)
• drugs used for the treatment of certain heart diseases or high blood pressure (e.g., diltiazem, verapamil)
• antidiabetic drugs and insulin (for diabetes)
• prednisone
• sedatives and hypnotics (e.g., benzodiazepines, barbiturates, chloral hydrate, glutethimide, meprobamate)
• pain medication (meperidine)
• antidepressants (e.g., clomipramine)
• tizanidine (drug used for multiple sclerosis [MS])
• theophylline (drug used for asthma)
• some nutritional supplements (e.g., Vit. B12, folic acid)
• antacids (use 2 hours before or after taking YAZ PLUS)
• drugs that may decrease folate levels (e.g., methotrexate, trimethoprim, sulfasalazine, triamterene, cholestyramine, and antiepileptic drugs listed above)

YAZ PLUS may also interfere with the working of other drugs.

Herbal or food products that may interact with YAZ PLUS include:

• the herbal remedy St. John’s wort (primarily used for the treatment of depressive moods)
• grapefruit juice

This is not a complete list of possible drug interactions with YAZ PLUS. Talk to your doctor for more information about drug interactions.