Drospirenone and Ethinyl Estradiol Tablets USP: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

• To prevent pregnancy
• To treat moderate acne vulgaris in women 14 years of age and older who are able to use birth control pills and have achieved menarche. Your first menstrual period is referred to as menarche.

What it does:

Drospirenone and Ethinyl Estradiol Tablets USP is a birth control pill (oral contraceptive) that contains two female sex hormones, the progestin drospirenone (3 mg) and a low dose of the estrogen ethinyl estradiol (0.02 mg). Both hormones are synthetic and similar to those that occur naturally in your body. The Drospirenone and Ethinyl Estradiol Tablets USP pill pack has 24 hormone-containing brown to reddish brown “active” pills to be taken for 24 days, followed by 4 hormone-free white to off-white “reminder” pills to be taken for four days. It has been shown to be highly effective in preventing pregnancy when taken as prescribed by your doctor. Pregnancy is always more risky than taking birth control pills, except in smokers older than age 35.

Birth control pills work in two ways:

1. 1. They inhibit the monthly release of an egg by the ovaries.
2. 2. They change the mucus produced by the cervix. This slows the movement of the sperm through the mucus and through the uterus (womb).

Drospirenone in Drospirenone and Ethinyl Estradiol Tablets USP helps with androgen- (male sex hormone) related skin problems. Androgen circulates naturally within the female body. Androgens can cause glands in the skin to over-produce oil. This results in acne. Drospirenone and Ethinyl Estradiol Tablets USP works by lowering androgen levels in the body and by blocking the effects of androgens at the gland. As a result, a reduction in the number of acne breakouts is associated with Drospirenone and Ethinyl Estradiol Tablets USP treatment.

Effectiveness of Birth Control Pills

Combination birth control pills are more than 99 percent effective in preventing pregnancy when:

• the pill is TAKEN AS DIRECTED, and
• the amount of estrogen is 20 micrograms or more.

A 99 percent effectiveness rate means that if 100 women used birth control pills for one year, one woman in the group would get pregnant.

The chance of becoming pregnant increases with incorrect use.

Other Ways to Prevent Pregnancy

Other methods of birth control are available to you. They are usually less effective than birth control pills. When used properly, however, other methods of birth control are effective enough for many women.

The following table gives reported pregnancy rates for various forms of birth control, including no birth control. The reported rates represent the number of women out of 100 who would become pregnant in one year.

Reported Pregnancies per 100 Women per Year:

Combination pill less than 1 to 2

Intrauterine device (IUD) less than 1 to 6

Condom with spermicidal foam or gel 1 to 6

Mini-pill 3 to 6

Condom 2 to 12

Diaphragm with spermicidal foam or gel 3 to 18

Spermicide 3 to 21

Sponge with spermicide 3 to 28

Cervical cap with spermicide 5 to 18

Periodic abstinence (rhythm), all types 2 to 20

No birth control 60 to 85

Pregnancy rates vary widely because people differ in how carefully and regularly they use each method. (This does not apply to IUDs since they are implanted in the uterus.). Regular users may achieve pregnancy rates in the lower ranges. Others may expect pregnancy rates more in the middle ranges.

The effective use of birth control methods other than birth control pills and IUDs requires more effort than taking a single pill every day. It is an effort that many couples undertake successfully.

When it should not be used:

The birth control pill is not suitable for every woman. In a small number of women, serious side effects may occur. Your doctor can advise you if you have any conditions that would pose a risk to you. The use of the birth control pill always should be supervised by your doctor.

You should not use Drospirenone and Ethinyl Estradiol Tablets USP if you have or have had any of the following conditions:

• blood clots in the legs, lungs, eyes, or elsewhere, or thrombophlebitis (inflammation or swelling of the veins)
• stroke, heart attack, or coronary artery disease (eg, angina pectoris), or a condition that may be a first sign of a stroke (such as a transient ischemic attack or small reversible stroke)
• disease of the heart valves with complications
• known abnormalities of the blood clotting system that increases your risk for developing blood clots
• severe high blood pressure
• diabetes with complications
• very high blood cholesterol or triglyceride levels
• you smoke and are over age 35
• migraine headache
• you are scheduled for major surgery
• prolonged bed rest
• you are taking ombitasvir, paritaprevir, ritonavir, with or without dasabuvir for the treatment of Hepatitis C
• jaundice (yellowing of the eyes or skin), liver disease or liver tumor
• known or suspected cancer of the breast or uterus (womb) or other estrogen-dependent cancer
• unusual vaginal bleeding without a known reason
• loss of vision due to blood vessel disease of the eye
• you are pregnant or suspect you may be pregnant
• pancreatitis (inflammation of the pancreas) associated with high levels of fatty substances in your blood
• allergy (hypersensitivity) to ethinyl estradiol, drospirenone, or to any of the other ingredients in Drospirenone and Ethinyl Estradiol Tablets USP (see What the medicinal ingredients are and What the nonmedicinal ingredients are)

In addition, you should not use Drospirenone and Ethinyl Estradiol Tablets USP if you have any of the following conditions:

• Kidney disease
• Liver disease
• Adrenal disease

Tell your doctor if you have ever had any of the above conditions (your doctor can recommend another method of birth control).

What the medicinal ingredients are:

drospirenone and ethinyl estradiol

What the nonmedicinal ingredients are:

Non-medicinal ingredients for the hormone-containing tablets: lactose monohydrate, corn starch, crospovidone, povidone, magnesium stearate, talc, hypromellose, titanium dioxide, and iron oxide red.

Non-medicinal ingredients for the hormone-free tablets: lactose monohydrate, lactose anhydrous, microcrystalline cellulose, hypromellose, polacrilin potassium, magnesium stearate, titanium dioxide, polyethylene glycol and polysorbate.

What dosage forms it comes in:

Drospirenone and Ethinyl Estradiol Tablets USP is available in a 28-day regimen.

Each blister pack contains 24 hormone-containing brown to reddish brown tablets and 4 hormone-free white to off-white tablets.

Description of the hormone-containing tablets: Brown to reddish brown, round, biconvex, film coated tablets debossed with ‘E3’ on one side

Description of the hormone-free tablets: White to off-white, round, biconvex, film coated tablets debossed with ‘E6’ on one side.

Each hormone-containing tablet contains 3 mg Drospirenone and 0.02 mg Ethinyl Estradiol.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

Drospirenone and Ethinyl Estradiol Tablets USP is a birth control pill containing estrogen and progestin. The progestin in Drospirenone and Ethinyl Estradiol Tablets USP is known as drospirenone and it may increase the levels of potassium in your blood. Therefore, you should not take Drospirenone and Ethinyl Estradiol Tablets USP 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 Drospirenone and Ethinyl Estradiol Tablets USP, talk to your doctor or pharmacist if you). During the first month that you take Drospirenone and Ethinyl Estradiol Tablets USP, you should have a blood test to check your potassium level.

Do not use Drospirenone and Ethinyl Estradiol Tablets USP if you are taking ombitasvir, paritaprevir, ritonavir, with or without dasabuvir for the treatment of Hepatitis C. Using these drugs at the same time as Drospirenone and Ethinyl Estradiol Tablets USP has the potential to cause liver problems, such as an increase in the ALT liver enzyme. You can usually start Drospirenone and Ethinyl Estradiol Tablets USP about 2 weeks after finishing treatment with this combination of drugs used for Hepatitis C, but always consult with your doctor or pharmacist.

It has been reported that drospirenone, the progestin in Drospirenone and Ethinyl Estradiol Tablets USP, 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 Drospirenone and Ethinyl Estradiol Tablets USP, talk to your doctor or pharmacist if you:

• smoke
• are overweight
• have a history of breast disease (eg, 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 breast feeding
• 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
• 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:

  • Nonsteroidal anti-inflammatory drugs (NSAIDs) when taken long-term and for treatment of arthritis or other problems (eg, 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 (eg, 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.

If you see a different doctor, inform him or her that you are using Drospirenone and Ethinyl Estradiol Tablets USP.

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 Drospirenone and Ethinyl Estradiol Tablets USP four weeks before surgery and not using Drospirenone and Ethinyl Estradiol Tablets USP for a time period after surgery or during bed rest.

Drospirenone and Ethinyl Estradiol Tablets USP 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 Drospirenone and Ethinyl Estradiol Tablets USP 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 Drospirenone and Ethinyl Estradiol Tablets USP outweigh the risks, you should be aware of the following:

THE RISKS OF USING DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS USP

1. 1. Circulatory disorders (including blood clot in legs, lungs, heart, eyes, or brain)

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.

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.

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.

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.

Cancer of the breast, cervix, or liver may be life-threatening or may result in death.

1. 2. Breast cancer

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.

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.

ASK YOUR DOCTOR FOR ADVICE AND INSTRUCTIONS ON REGULAR SELF-EXAMINATION OF YOUR BREASTS.

1. 3. Cervical cancer

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.

1. 4. Liver tumors

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.

Contact your doctor immediately if you experience severe pain or a lump in the abdomen.

1. 5. Gallbladder disease

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.

1. 6. Use in pregnancy

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.

1. 7. Use after pregnancy, miscarriage, or an abortion

Your doctor will advise you of the appropriate time to start the use of Drospirenone and Ethinyl Estradiol Tablets USP after childbirth, miscarriage, or therapeutic abortion.

1. 8.

   Pregnancy after stopping Drospirenone and Ethinyl Estradiol Tablets USP

   You will have a menstrual period when you stop using Drospirenone and Ethinyl Estradiol Tablets USP. 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.

   1. 9. Use while breastfeeding

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.

INTERACTIONS WITH THIS MEDICATION

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 Drospirenone and Ethinyl Estradiol Tablets USP. 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 Drospirenone and Ethinyl Estradiol Tablets USP include:

• drugs used for the treatment of epilepsy (eg, primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate); tuberculosis (eg, rifampin, rifabutin), HIV infections (eg, ritonavir, nevirapine) and Hepatitis C Virus infections (eg boceprevir, telaprevir)
• antibiotics (eg, penicillins, tetracyclines, clarithromycin, erythromycin) for infectious diseases
• cyclosporine
• ombitasvir, paritaprevir, ritonavir, with or without dasabuvir (used to treat Hepatitis C)
• antifungals (eg, griseofulvin, fluconazole, itraconazole, ketoconazole, voriconazole)
• cholesterol-lowering drugs (eg, clofibrate)

• drugs used for the treatment of certain heart diseases or high blood pressure (eg, diltiazem, verapamil)
• antidiabetic drugs and insulin (for diabetes)
• prednisone
• sedatives and hypnotics (eg, benzodiazepines, barbiturates, chloral hydrate, glutethimide, meprobamate)
• pain medication (meperidine)
• antidepressants (eg, clomipramine)
• tizanidine (drug used for multiple sclerosis [MS])
• theophylline (drug used for asthma)
• some nutritional supplements (eg, Vit. B12, folic acid)
• antacids (use 2 hours before or after taking Drospirenone and Ethinyl Estradiol Tablets USP)

Drospirenone and Ethinyl Estradiol Tablets USP may also interfere with the working of other drugs.

Herbal or food products that may interfere with Drospirenone and Ethinyl Estradiol Tablets USP 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 Drospirenone and Ethinyl Estradiol Tablets USP. Talk to your doctor for more information about drug interactions.

PROPER USE OF THIS MEDICATION

Usual dose:

HOW TO TAKE DROSPIRENONE AND

ETHINYL ESTRADIOL TABLETS USP

1. 1.

   READ THESE DIRECTIONS

   • before you start taking your pills, and
   • any time you are not sure what to do.
2. 2.

   LOOK AT YOUR PILL PACK, it has 28 pills;

   The Drospirenone and Ethinyl Estradiol Tablets USP pill pack has 24 hormone-containing brown to reddish brown “active” pills to be taken for 24 days, followed by 4 hormone-free white to off-white “reminder” pills to be taken for four days.

   ALSO CHECK the pill pack for: 1) where to start and 2) direction to take pills in (follow the arrows).

   1. 3. You should use a second method of birth control (eg, 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 backup in case pills are forgotten while you are getting used to taking them.
   2. 4. When receiving any medical treatment, be sure to tell your doctor that you are using birth control pills.
   3. 5. 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.
   4. 6. Visit your doctor three months or sooner after the initial examination. Afterward, visit your doctor at least once a year.
   5. 7. 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.
   6. 8. Your doctor will advise you of the appropriate time to start the use of birth control pills after childbirth, miscarriage, or therapeutic abortion.
   7. 9. THERE IS NO NEED TO STOP TAKING BIRTH CONTROL PILLS FOR A REST PERIOD.
   8. 10. 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. 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. 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. 1. TAKE A PILL AT APPROXIMATELY THE SAME TIME EVERY DAY UNTIL THE PACK IS EMPTY.
2. • Try to associate taking your pill with some regular activity, such as eating a meal or going to bed.
3. • Do not skip pills even if you have bleeding between monthly periods or feel sick to your stomach (nausea).
4. • Do not skip pills even if you do not have sex very often.
5. 2. WHEN YOU FINISH A PACK

Start the next pack on the day after your last hormone-free white to off-white “reminder” pill. Take one pill every day. Do not wait any days between packs.

Overdose:

Symptoms of overdose may include nausea, vomiting, or vaginal bleeding. Even girls who have not yet had their first menstrual period but have accidentally taken this medicine may experience such bleeding. Available information from cases of accidental ingestion of oral contraceptives by children indicates no serious effects.

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.

NOTE: If you forget any of the four hormone-free white to off-white “reminder” pills in Week 4, just safely dispose of the pills you missed. Then keep taking one pill each day until the pack is empty. You do not need to use a back-up method.

Always be sure you have on hand

• a backup method of birth control (such as latex or polyurethane condoms and spermicidal foam or

  • gel) in case you miss pills, and an extra, full pack of pills.

IF YOU FORGET MORE THAN ONE PILL TWO

MONTHS IN A ROW, TALK TO YOUR DOCTOR OR CLINIC about ways to make pill-taking easier or about using another method of birth control.

Noncontraceptive Benefits of Birth Control Pills

Several health advantages have been linked to the use of birth control pills:

• Combination estrogen and progestin birth control pills reduce the incidence of cancer of the uterus and ovaries.
• Birth control pills reduce the likelihood of developing benign (noncancerous) breast disease and ovarian cysts.
• Users of birth control pills lose less menstrual blood and have more regular cycles. The risk of developing iron-deficiency anemia is thus reduced.
• There may be a decrease in painful menstruation and in premenstrual syndrome (PMS).
• Acne, excessive hair growth, and male hormone-related disorders also may be improved.
• Ectopic (tubal) pregnancy may occur less frequently.
• Acute pelvic inflammatory disease may occur less frequently.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

The following side effects have been observed in studies of women taking Drospirenone and Ethinyl Estradiol Tablets USP 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.

This is not a complete list of side effects. For any unexpected effects while taking Drospirenone and Ethinyl Estradiol Tablets USP, contact your doctor or pharmacist.

HOW TO STORE IT

Store in original packaging between 15ºC and 30ºC. Keep out of reach of children and pets.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Reporting Side Effects:

If you want more information about Drospirenone and Ethinyl Estradiol Tablets USP:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp); or by calling 1-844-801-7468.

Glenmark Pharmaceuticals Canada Inc.

1600 Steeles Ave. West, Suite 407

Concord, Ontario

L4K 4M2

Last Revised: April 09, 2021

MORE INFORMATION