Yaz 28 20 mcg + 3 mg, 28 tabs
Generic Name: Ethinylestradiol + Drospirenone
What is Yaz?
Yaz combination is used to prevent pregnancy. It is a birth control pill that contains two types of hormones, ethinyl estradiol and Drospirenone (Yaz), and when taken properly, prevents pregnancy. It works by stopping a woman’s egg from fully developing each month. The egg can no longer accept a sperm and fertilization is prevented.
Yaz is also used to treat premenstrual dysphoric disorder (PMDD) and acne in women at least 14 years of age. PMDD is a severe form of premenstrual syndrome (PMS). Patients with PMDD may have severe emotional and physical symptoms 10 to 14 days before their menstrual flow starts.
No contraceptive method is 100 percent effective. Birth control methods such as having surgery to become sterile or not having sex are more effective than birth control pills. Discuss your options for birth control with your doctor.
Yaz does not prevent AIDS or other sexually transmitted diseases. It will not help as emergency contraception, such as after unprotected sexual contact.
Yaz is available only with your doctor’s prescription.
Yaz® is indicated for use by women to prevent pregnancy.
Premenstrual Dysphoric Disorder (PMDD)
Yaz is also indicated for the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive as their method of contraception. The effectiveness of Yaz for PMDD when used for more than three menstrual cycles has not been evaluated.
The essential features of PMDD according to the Diagnostic and Statistical Manual-4th edition (DSM-IV) include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in usual activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. In this disorder, these symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school, or with usual social activities and relationships with others. Diagnosis is made by healthcare providers according to DSM-IV criteria, with symptomatology assessed prospectively over at least two menstrual cycles. In making the diagnosis, care should be taken to rule out other cyclical mood disorders.
Yaz has not been evaluated for the treatment of premenstrual syndrome (PMS).
Yaz is indicated for the treatment of moderate acne vulgaris in women at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Yaz should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control.
Yaz is indicated in women who choose to use an oral contraceptive as their method of contraception, to raise folate levels for the purpose of reducing the risk of a neural tube defect in a pregnancy conceived while taking the product or shortly after discontinuing the product.
How should I use Yaz?
Use Yaz as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Yaz. Talk to your pharmacist if you have questions about this information.
- Take Yaz by mouth with or without food. It is preferable to take Yaz after the evening meal or at bedtime with liquid.
- Talk with your doctor about how you should start to take your first pack of Yaz. If you begin to take Yaz during the first 24 hours of your period, you do not need to use an extra form of birth control. If you begin to take Yaz on the Sunday after your period starts, you will need to use an extra form of birth control for 7 days after you start taking Yaz.
- If you are switching from another birth control pill to Yaz, start Yaz on the same day that you would have started a new pack of your previous birth control pills. If you are switching to Yaz from another type of hormonal birth control (eg, patch, vaginal ring), ask your doctor or pharmacist about when to start taking Yaz.
- Take Yaz at the same time each day. After taking the last pill in the pack, start taking the first pill from the new pack the very next day.
- Severe vomiting or diarrhea may decrease Yaz’s effectiveness. Talk with your doctor about what to do if severe vomiting or diarrhea occurs while you take Yaz. If you vomit within 3 to 4 hours after you take Yaz, this should be considered a missed dose.
- For Yaz to be effective, it must be taken every day. Do not skip doses even if you do not have sex very often. Do not skip pills if you are spotting, bleeding, or nauseated. If you have these side effects and they do not go away, check with your doctor.
- If you miss 1 dose of Yaz, take it as soon as possible. Take your next dose at the regular time. This means you may take 2 doses on the same day. You do not need to use a backup form of birth control if you only miss 1 pill. If you miss more than 1 dose, read the extra patient leaflet that comes with Yaz or contact your doctor for instructions. You must use a backup form of birth control (eg, condom, spermicide) if you miss more than 1 dose. If you are not sure how to handle missed doses, use an extra form of birth control (eg, condoms) and talk with your doctor.
Ask your health care provider any questions you may have about how to use Yaz.
Each pink active film-coated tablet contains Drospirenone (Yaz) 3 mg and Yaz 20 mcg as active substances. The white film-coated tablets do not contain active substances. It also contains the following ingredients: Pink active film-coated tablets: Tablet Core: Lactose monohydrate, pregelatinized starch (maize), povidone, croscarmellose sodium, polysorbate 80, magnesium stearate. Coating: Partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172). White film-coated tablets: Tablet Core: Anhydrous lactose, povidone, magnesium stearate. Coating: Partially hydrolized polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.
Each blister contains 28 tablets, 24 pink, active film-coated tablets in the 1st, 2nd, 3rd and 4th rows of the strip and 4 white placebo film-coated tablets in row 4. The core of the tablet is coated.
Each of the 24 active tablet contains a small quantity of 2 different female hormones, called Drospirenone (Yaz) (a progestogen) and Yaz (an estrogen). Due to the small quantity of the hormones, Yaz is considered a low-dose oral contraceptive. Since all tablets in the pack combine the same hormones in the same dose, it is considered a monophasic combined oral contraceptive.
The 4 tablets do not contain active ingredients and are called placebo tablets.
How to Take Yaz
Take one tablet by mouth at the same time every day. The failure rate may increase when pills are missed or taken incorrectly.
To achieve maximum contraceptive effectiveness, Yaz must be taken as directed, in the order directed on the blister pack. Single missed pills should be taken as soon as remembered.
How to Start Yaz
Instruct the patient to begin taking Yaz either on the first day of her menstrual period (Day 1 Start) or on the first Sunday after the onset of her menstrual period (Sunday Start).
Day 1 Start
During the first cycle of Yaz use, instruct the patient to take one blue Yaz daily, beginning on Day 1 of her menstrual cycle. (The first day of menstruation is Day 1.) She should take one blue Yaz daily for 21 consecutive days, followed by one peach tablet daily on Days 22 through 28. Yaz should be taken in the order directed on the package at the same time each day, preferably after the evening meal or at bedtime with some liquid, as needed. Yaz can be taken without regard to meals. If Yaz is first taken later than the first day of the menstrual cycle, Yaz should not be considered effective as a contraceptive until after the first 7 consecutive days of product administration. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.
During the first cycle of Yaz use, instruct the patient to take one blue Yaz daily, beginning on the first Sunday after the onset of her menstrual period. She should take one blue Yaz daily for 21 consecutive days, followed by one peach tablet daily on Days 22 through 28. Yaz should be taken in the order directed on the package at the same time each day, preferably after the evening meal or at bedtime with some liquid, as needed. Yaz can be taken without regard to meals. Yaz should not be considered effective as a contraceptive until after the first 7 consecutive days of product administration. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.
The patient should begin her next and all subsequent 28-day regimens of Yaz on the same day of the week that she began her first regimen, following the same schedule. She should begin taking her blue tablets on the next day after ingestion of the last peach tablet, regardless of whether or not a menstrual period has occurred or is still in progress. Anytime a subsequent cycle of Yaz is started later than the day following administration of the last peach tablet, the patient should use another method of contraception until she has taken a blue Yaz daily for seven consecutive days.
When switching from a different birth control pill
When switching from another birth control pill, Yaz should be started on the same day that a new pack of the previous oral contraceptive would have been started.
When switching from a method other than a birth control pill
When switching from a transdermal patch or vaginal ring, Yaz should be started when the next application would have been due. When switching from an injection, Yaz should be started when the next dose would have been due. When switching from an intrauterine contraceptive or an implant, Yaz should be started on the day of removal.
Withdrawal bleeding usually occurs within 3 days following the last blue tablet. If spotting or breakthrough bleeding occurs while taking Yaz, instruct the patient to continue taking Yaz by the regimen described above. Counsel her that this type of bleeding is usually transient and without significance; however, advise her that if the bleeding is persistent or prolonged, she should consult her healthcare provider.
Although the occurrence of pregnancy is low if Yaz is taken according to directions, if withdrawal bleeding does not occur, consider the possibility of pregnancy. If the patient has not adhered to the prescribed dosing schedule (missed one or more active tablets or started taking them on a day later than she should have), consider the possibility of pregnancy at the time of the first missed period and take appropriate diagnostic measures. If the patient has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy. Discontinue Yaz if pregnancy is confirmed.
The risk of pregnancy increases with each active blue tablet missed. For additional patient instructions regarding missed pills, see the “WHAT TO DO IF YOU MISS PILLS” section in the FDA-Approved Patient Labeling. If breakthrough bleeding occurs following missed tablets, it will usually be transient and of no consequence. If the patient misses one or more peach tablets, she should still be protected against pregnancy provided she begins taking a new cycle of blue tablets on the proper day.
For postpartum women who do not breastfeed or after a second trimester abortion, start Yaz no earlier than 4 weeks postpartum due to the increased risk of thromboembolism. If the patient starts Yaz postpartum and has not yet had a period, evaluate for possible pregnancy, and instruct her to use an additional method of contraception until she has taken Yaz for 7 consecutive days.
Advice in Case of Gastrointestinal Disturbances
In case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken. If vomiting occurs within 3-4 hours after tablet-taking, this can be regarded as a missed tablet.
Always inform the prescriber about the medications or herbal preparations the patient are taking. Also inform any other health professional that has prescribed other medication (or the pharmacist) that the patient is taking Yaz. The healthcare professional may inform the patient the need to use additional contraceptives (eg, condom) and inform the patient the duration.
Some medicine can cause Yaz to lose its contraceptive effect or can cause unexpected bleeding. This applies to medicines used to treat epilepsy (eg, primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine) and tuberculosis (eg, rifampicin), HIV (ritonavir), other infectious disease (griseofulvin, ampicillin, tetracyclines) and the medicinal herb St. John’s wort.
If the patient wants to use herbal preparations which contain St. John’s wort while taking Yaz, she should consult the doctor beforehand. Yaz can affect other medicines eg, those which contain ciclosporin or the anticonvulsant drug lamotrigine (this can increase the frequency of convulsions).
Consult the doctor or pharmacist before taking any medicine. Inform the doctor or pharmacist if the patient is taking or have recently taken any other medicines, including medicines obtained without a prescription.
Taking Yaz with Food and Drink: Take Yaz tablet everyday with some water if needed. The patient can take the tablets with or without food, but should take Yaz approximately at the same time everyday.
Laboratory Tests: If the patient need a blood analysis, inform the doctor or laboratory staff that the patient is taking a contraceptive, as oral contraceptives can affect the results of some test.
Yaz side effects
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Contraception And Acne Clinical Trials
The data provided reflect the experience with the use of Yaz in the adequate and well-controlled studies for contraception (N=1,056) and for moderate acne vulgaris (N=536).
For contraception, a Phase 3, multicenter, multinational, open-label study was conducted to evaluate safety and efficacy up to one year in 1,027 women aged 17 – 36 who took at least one dose of Yaz. A second Phase 3 study was a single center, open-label, active-controlled study to evaluate the effect of 7 28-day cycles of Yaz on carbohydrate metabolism, lipids and hemostasis in 29 women aged 18-35. For acne, two multicenter, double-blind, randomized, placebo-controlled studies, in 536 women aged 14-45 with moderate acne vulgaris who took at least one dose of Yaz, evaluated the safety and efficacy during up to 6 cycles.
The adverse reactions seen across the 2 indications overlapped, and are reported using the frequencies from the pooled dataset. The most common adverse reactions ( ≥ 2% of users) were: headache/migraine (6.7%), menstrual irregularities (including vaginal hemorrhage [primarily spotting] and metrorrhagia (4.7%), nausea/vomiting (4.2%), breast pain/tenderness (4%) and mood changes (mood swings, depression, depressed mood and affect lability) (2.2%).
PMDD Clinical Trials
Safety data from trials for the indication of PMDD are reported separately due to differences in study design and setting in the Contraception and Acne studies as compared to the PMDD clinical program.
Two (one parallel and one crossover designed) multicenter, double-blind, randomized, placebocontrolled trials for the secondary indication of treating the symptoms of PMDD evaluated safety and efficacy of Yaz during up to 3 cycles among 285 women aged 18-42, diagnosed with PMDD and who took at least one dose of Yaz.
Common adverse reactions ( ≥ 2% of users) were: menstrual irregularities (including vaginal hemorrhage [primarily spotting] and metrorrhagia) (24.9%), nausea (15.8%), headache (13.0%), breast tenderness (10.5%), fatigue (4.2%), irritability (2.8%), decreased libido (2.8%), increased weight (2.5%), and affect lability (2.1%).
Adverse Reactions ( ≥ 1%) Leading To Study Discontinuation Contraception Clinical Trials
Of 1,056 women, 6.6% discontinued from the clinical trials due to an adverse reaction; the most frequent adverse reactions leading to discontinuation were headache/migraine (1.6%) and nausea/vomiting (1.0%).
Acne Clinical Trials
Of 536 women, 5.4% discontinued from the clinical trials due to an adverse reaction; the most frequent adverse reaction leading to discontinuation was menstrual irregularities (including menometrorrhagia, menorrhagia, metrorrhagia and vaginal hemorrhage) (2.2%).
PMDD Clinical Trials
Of 285 women, 11.6% discontinued from the clinical trials due to an adverse reaction; the most frequent adverse reactions leading to discontinuation were: nausea/vomiting (4.6%), menstrual irregularity (including vaginal hemorrhage, menorrhagia, menstrual disorder, menstruation irregular and metrorrhagia) (4.2%), fatigue (1.8%), breast tenderness (1.4%), depression (1.4%), headache (1.1%), and irritability (1.1%).
Serious Adverse Reactions
none reported in the clinical trials
PMDD Clinical Trials
The following adverse reactions have been identified during post approval use of Yaz. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Adverse reactions are grouped into System Organ Classes, and ordered by frequency.
Vascular disorders: Venous and arterial thromboembolic events (including pulmonary emboli, deep vein thrombosis, cerebral thrombosis, retinal thrombosis, myocardial infarction and stroke), hypertension (including hypertensive crisis)
Hepatobiliary disorders: Gallbladder disease, liver function disturbances, liver tumors
Immune system disorders: Hypersensitivity (including anaphylactic reaction)
Metabolism and nutrition disorders: Hyperkalemia, hypertriglyceridemia, changes in glucose tolerance or effect on peripheral insulin resistance (including diabetes mellitus)
Skin and subcutaneous tissue disorders: Chloasma, angioedema, erythema nodosum, erythema multiforme
Gastrointestinal disorders: Inflammatory bowel disease
Musculoskeletal and connective tissue disorders: Systemic lupus erythematosus
Hypersensitivity to Drospirenone (Yaz) or Yaz or any other ingredient in Yaz. This could cause itching, a rash or inflammation.
Patients that have (or have had in the past) blood clots (thrombosis) in a blood vessel of the leg, lungs (embolsim) or other organs; a heart attack or stroke; any illness which could lead to a heart attack (eg, angina pectoris which causes serious pain in the chest) or a stroke (eg, a temporary or minor stroke without residual effects); certain form of migraine (focal neurological symptoms); inflammation of the pancreas (pancreatitis); liver illness and hepatic function have not yet normalized; kidneys do not work well (kidney failure); liver tumor; suspect breast cancer or cancer of the sexual organs.
Any illness which could increase the risk of developing artery thrombosis eg, diabetes with damaged blood vessels, very high blood pressure, very high fat levels in the blood (cholesterol or triglycerides); disturbance of blood clotting (eg, protein C deficiency); vaginal bleeding and the cause is unknown.
Use in pregnancy: If the patient is pregnant, do not take Yaz. If the patient is pregnant when taking Yaz, stop taking it immediately and contact the doctor.
Consult the doctor or pharmacist before taking any medicine.
Active ingredient matches for Yaz:
Drospirenone/Ethinylestradiol in Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Costa Rica, Croatia (Hrvatska), Czech Republic, Denmark, Dominican Republic, Ecuador, Estonia, Finland, France, Georgia, Germany, Guatemala, Honduras, Hong Kong, Indonesia, Ireland, Israel, Italy, Latvia, Lithuania, Malta, Netherlands, New Zealand, Nicaragua, Norway, Panama, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United States.