Yasmin Tablets (Drospirenone and Ethinyl Estradiol Tablets)

1. Yasmin Tablets (Drospirenone and Ethinyl Estradiol Tablets) © The Swiss Pharmacy

2. Yasmin Tablets (Drospirenone and Ethinyl Estradiol Tablets) Yasmin (Drospirenone and Ethinyl Estradiol Tablets) is a estrogen/progestin combined oral contraceptive indicated for use by women to prevent pregnancy. The decision to prescribe Yasmin should take into consideration the individual woman's current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Yasmin compares with other combined hormonal contraceptives (CHCs). © The Swiss Pharmacy

3. Yasmin Tablets (Drospirenone and Ethinyl Estradiol Tablets) Yasmin Tablets are manufactured by Bayer AG, Berlin Germany and marketed by Bayer Zydus Pharma Private Limited, India in the strength of 3 mg of Drospirenone and 0.03 mg of Ethinyl Estradiol. © The Swiss Pharmacy

4. Yasmin Tablets (Drospirenone and Ethinyl Estradiol Tablets) Chemical Structure - Drospirenone © The Swiss Pharmacy

5. Yasmin Tablets (Drospirenone and Ethinyl Estradiol Tablets) Chemical Structure - Ethinyl Estradiol © The Swiss Pharmacy

6. Yasmin Tablets (Drospirenone and Ethinyl Estradiol Tablets) The active ingredients contained in Yasmin tablets are Drospirenone and Ethinyl Estradiol. Each Yasmin tablet contains 3 mg of Drospirenone and 0.03 mg of Ethinyl Estradiol. © The Swiss Pharmacy

7. Yasmin Tablets (Drospirenone and Ethinyl Estradiol Tablets) Uses of Yasmin (Drospirenone 3mg & Ethinyl Estradiol 0.03mg) tablets: Drospirenone and Ethinyl Estradiol combination (Yasmin Tablets) is used to prevent pregnancy. It is a birth control pill that contains two types of hormones, Ethinyl Estradiol and Drospirenone, 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 (pregnancy) is prevented. It also makes vaginal fluid thicker to help prevent sperm from reaching an egg (fertilization) and changes the lining of the uterus (womb) to prevent attachment of a fertilized egg. If a fertilized egg does not attach to the uterus, it passes out of the body. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9761_Yasmin-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9761_Yasmin-Pills.html © The Swiss Pharmacy

8. Yasmin Tablets (Drospirenone and Ethinyl Estradiol Tablets) Uses of Yasmin (Drospirenone 3mg & Ethinyl Estradiol 0.03mg) tablets: Besides preventing pregnancy, birth control pills may make your periods more regular, decrease blood loss and painful periods, and decrease your risk of ovarian cysts. This medicine 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9761_Yasmin-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9761_Yasmin-Pills.html © The Swiss Pharmacy

9. Yasmin Tablets (Drospirenone and Ethinyl Estradiol Tablets) Recommended Adult Dosage Yasmin Tablets Yasmin Tablets (Drospirenone and Ethinyl Estradiol Tablets) Should be administered as given below: Take one tablet by mouth at the same time every day. The 21 yellow tablets, each containing 3 mg Drospirenone (DRSP) and 0.03 mg Ethinyl Estradiol (EE), should be taken first, one tablet a day followed by seven tablet free days. The failure rate may increase when pills are missed or taken incorrectly. To achieve maximum contraceptive effectiveness, Yasmin must be taken as directed, in the order directed on the blister pack. Single missed pills should be taken as soon as remembered. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9761_Yasmin-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9761_Yasmin-Pills.html © The Swiss Pharmacy

10. Yasmin Tablets (Drospirenone and Ethinyl Estradiol Tablets) How to Start Yasmin Tablets Instruct the patient to begin taking Yasmin 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: Day 1 Start: During the first cycle of Yasmin use, instruct the patient to take one yellow Yasmin daily, beginning on Day 1 of her menstrual cycle. (The first day of menstruation is Day 1.) She should take one yellow Yasmin daily for 21 consecutive days, followed by 7 pill free days on Days 22 through 28. If Yasmin is first taken later than the first day of the menstrual cycle, Yasmin 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9761_Yasmin-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9761_Yasmin-Pills.html © The Swiss Pharmacy

11. Yasmin Tablets (Drospirenone and Ethinyl Estradiol Tablets) How to Start Yasmin Tablets Sunday Start: Sunday Start: During the first cycle of Yasmin use, instruct the patient to take one yellow Yasmin daily, beginning on the first Sunday after the onset of her menstrual period. She should take one yellow Yasmin daily for 21 consecutive days, followed by 7 pill free days on Days 22 through 28. Yasmin 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9761_Yasmin-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9761_Yasmin-Pills.html © The Swiss Pharmacy

12. Yasmin Tablets (Drospirenone and Ethinyl Estradiol Tablets) Yasmin Tablets – Missed Pill Instructions If You Miss 1 Pill: If You Miss 1 Pill: Take the tablet as soon as you remember. Take the next pill at your regular time. This means you may take two pills in one day. If You Miss 2 Pills In A Row In Week 1 Or Week 2 Of Your Pack: Take two pills on the day you remember and two pills the next day.Then take one pill a day until you finish the pack. You MUST use another birth control method (such as condoms or spermicides) as a back-up for 7 days after restarting your tablets. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9761_Yasmin-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9761_Yasmin-Pills.html © The Swiss Pharmacy

13. Yasmin Tablets (Drospirenone and Ethinyl Estradiol Tablets) Yasmin Tablets – Missed Pill Instructions If You Miss 2 Pills In A Row In Week 3 Or Week 4 Of Your Pack: If You Miss 2 Pills In A Row In Week 3 Or Week 4 Of Your Pack: If you are a Day 1 Starter: Throw out the rest of the pill pack and start a new pack that same day. If you are a Sunday Starter: Keep taking one pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack of pills that same day. You could become pregnant if you have sex in the 7 days after you restart your pills. You must use another birth control method (such as a condom and spermicide) as a back-up for those 7 days. You may not have your period this month but this is expected. However, if you miss your period two months in a row, call your healthcare provider because you might be pregnant. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9761_Yasmin-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9761_Yasmin-Pills.html © The Swiss Pharmacy

14. Yasmin Tablets (Drospirenone and Ethinyl Estradiol Tablets) Yasmin Tablets – Missed Pill Instructions If You Miss 3 Or More Pills In A Row During Any Week: If You Miss 3 Or More Pills In A Row During Any Week: If you are a Day 1 Starter: Throw out the rest of the pill pack and start a new pack that same day. If you are a Sunday Starter: Keep taking 1 pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack of pills that same day. You could become pregnant if you have sex in the 7 days after you restart your pills. You must use another birth control method (such as condoms and spermicides) as a back-up for those 7 days. You may not have your period this month but this is expected. However, if you miss your period two months in a row, call your healthcare provider because you might be pregnant. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9761_Yasmin-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9761_Yasmin-Pills.html © The Swiss Pharmacy

15. Yasmin Tablets (Drospirenone and Ethinyl Estradiol Tablets) Contraindications ➔Yasmin is contraindicated in patients with a known hypersensitivity to Drospirenone, Ethinyl Estradiol or any component of the tablet. ➔Renal impairment ➔Adrenal insufficiency ➔A high risk of arterial or venous thrombotic diseases ➔Have cerebrovascular disease ➔Have coronary artery disease ➔Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation). URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9761_Yasmin-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9761_Yasmin-Pills.html © The Swiss Pharmacy

16. Yasmin Tablets (Drospirenone and Ethinyl Estradiol Tablets) Contraindications ➔Have inherited or acquired hypercoagulopathies ➔Have uncontrolled hypertension ➔Have diabetes mellitus with vascular disease ➔Have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35. ➔Undiagnosed abnormal uterine bleeding ➔Breast cancer or other estrogen- or progestin-sensitive cancer ➔Liver tumors or liver disease ➔Pregnancy, because there is no reason to use COCs during pregnancy ➔Co-administration with Hepatitis C drug combinations Containing Ombitasvir, Paritaprevir / Ritonavir, with or without Dasabuvir due to the potential for ALT elevations URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9761_Yasmin-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9761_Yasmin-Pills.html © The Swiss Pharmacy

17. Yasmin Tablets (Drospirenone and Ethinyl Estradiol Tablets) Storage Instructions Yasmin Tablets (Drospirenone and Ethinyl Estradiol Tablets) ) have to be stored at controlled room temperature i.e. from 20°C to 25°C (68°F to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). Keep this as well as all other medicines away from children and pets. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9761_Yasmin-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9761_Yasmin-Pills.html © The Swiss Pharmacy

18. Yasmin Tablets (Drospirenone and Ethinyl Estradiol Tablets) Warnings Women over 35 years old who smoke should not use Drospirenone and Ethinyl Estradiol tablets (Yasmin tablets). Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. Vascular risks: Stop Drospirenone and Ethinyl Estradiol tablets if a thrombotic event occurs. Stop at least 4 weeks before and through 2 weeks after major surgery. Start no earlier than 4 weeks after delivery, in women who are not breastfeeding. COCs containing DRSP may be associated with a higher risk of venous thromboembolism (VTE) than COCs containing Levonorgestrel or some other progestins. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9761_Yasmin-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9761_Yasmin-Pills.html © The Swiss Pharmacy

19. Yasmin Tablets (Drospirenone and Ethinyl Estradiol Tablets) Warnings Before initiating Drospirenone and Ethinyl Estradiol tablets in a new COC user or a woman who is switching from a contraceptive that does not contain DRSP, consider the risks and benefits of a DRSP-containing COC in light of her risk of a VTE. Hyperkalemia: DRSP has anti-mineralocorticoid activity. Do not use in patients predisposed to hyperkalemia. Check serum potassium concentration during the first treatment cycle in women on long-term treatment with medications that may increase serum potassium concentration. Liver disease: Discontinue drospirenone and Ethinyl Estradiol tablets if jaundice occurs. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9761_Yasmin-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9761_Yasmin-Pills.html © The Swiss Pharmacy

20. Yasmin Tablets (Drospirenone and Ethinyl Estradiol Tablets) Warnings High blood pressure: Do not prescribe Drospirenone and Ethinyl Estradiol tablets for women with uncontrolled hypertension or hypertension with vascular disease. Carbohydrate and lipid metabolic effects: Monitor prediabetic and diabetic women taking Drospirenone and Ethinyl Estradiol tablets. Consider an alternate contraceptive method for women with uncontrolled dyslipidemia. Headache: Evaluate significant change in headaches and discontinue Drospirenone and Ethinyl Estradiol tablets if indicated. Uterine bleeding: Evaluate irregular bleeding or amenorrhea. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9761_Yasmin-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9761_Yasmin-Pills.html © The Swiss Pharmacy

21. Yasmin Tablets (Drospirenone and Ethinyl Estradiol Tablets) Possible Side Effects Most common Drospirenone and Ethinyl Estradiol (Yasmin tablets) side effects with an incidence rate of greater than or equal to 2% are premenstrual syndrome (13.2%), headache /migraine (10.7%), breast pain/tenderness/discomfort (8.3%), nausea/vomiting (4.5%), abdominal pain/tenderness/discomfort (2.3%), mood changes (2.3%). Serious side effects associated with the use of COCs are: Serious cardiovascular events and stroke Vascular events and Liver disease. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9761_Yasmin-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9761_Yasmin-Pills.html © The Swiss Pharmacy

22. Yasmin Tablets (Drospirenone and Ethinyl Estradiol Tablets) Possible Side Effects The following side effects have been identified during post-approval use of Yasmin. Vascular disorders: Venous and arterial thromboembolic events (including pulmonary emboli, deep vein thrombosis, intracardiac thrombosis, intracranial venous sinus thrombosis, sagittal sinus thrombosis, retinal vein occlusion, myocardial infarction and stroke), hypertension Hepatobiliary disorders: Gallbladder disease Immune system disorders: Hypersensitivity Metabolism and nutrition disorders: Hyperkalemia Skin and subcutaneous tissue disorders: Chloasma URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9761_Yasmin-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9761_Yasmin-Pills.html © The Swiss Pharmacy

23. Yasmin Tablets (Drospirenone and Ethinyl Estradiol Tablets) Yasmin Tablets Overdosage There have been no reports of serious ill effects from Drospirenone and Ethinyl Estradiol (Yasmin tablets) overdose, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea. Drospirenone is a spironolactone analogue which has anti- mineralocorticoid properties. Serum concentration of potassium and sodium, and evidence of metabolic acidosis, should be monitored in cases of overdose. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9761_Yasmin-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9761_Yasmin-Pills.html © The Swiss Pharmacy

24. Yasmin Tablets (Drospirenone and Ethinyl Estradiol Tablets) Yasmin Tablets During Pregnancy Drospirenone and Ethinyl Estradiol Tablets (Yasmin Tablets) have Drospirenone and Ethinyl Estradiol Tablets (Yasmin Tablets) have been classified by the US FDA as Pregnancy Category X. been classified by the US FDA as Pregnancy Category X. Estrogens and progestins should not be used during pregnancy. There is little or no increased risk of birth defects in women who inadvertently use COCs during early pregnancy. Epidemiologic studies and meta- analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to low dose COCs prior to conception or during early pregnancy. The administration of COCs to induce withdrawal bleeding should not be used as a test for pregnancy. COCs should not be used during pregnancy to treat threatened or habitual abortion URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9761_Yasmin-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9761_Yasmin-Pills.html © The Swiss Pharmacy

25. Yasmin Tablets (Drospirenone and Ethinyl Estradiol Tablets) Yasmin Tablets Yasmin Tablets (Drospirenone and Ethinyl Estradiol Tablets) are manufactured by Bayer AG, Berlin, Germany and marketed by Bayer Zydus Pharma Private Limited, India. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9761_Yasmin-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9761_Yasmin-Pills.html © The Swiss Pharmacy