Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets)

1. Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets) © Clearsky Pharmacy ( www.clearskypharmacy.biz )

2. Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets) © Clearsky Pharmacy ( www.clearskypharmacy.biz )

3. Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets) Ovral-L (Levonorgestrel and Ethinyl Estradiol Tablets) is a combination hormone medicine which is indicated for use by females of reproductive potential for prevention of 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 is also used for the treatment of moderate acne vulgaris in women more than 14 years of age who, have no known contraindications to oral contraceptive therapy, desire contraception, and have achieved menarche. © Clearsky Pharmacy ( www.clearskypharmacy.biz )

4. Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets) Active Ingredients The active ingredients present in Ovral-L tablets are Levonorgestrel and Ethinyl Estradiol. Each Ovral-L Contraceptive Tablets contains 150 mcg of Levonorgestrel and 30 mcg of Ethinyl Estradiol. © Clearsky Pharmacy ( www.clearskypharmacy.biz )

5. Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets) Chemical Structure The structure of Levonorgestrel is given below: © Clearsky Pharmacy ( www.clearskypharmacy.biz )

6. Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets) Chemical Structure The structure of Ethinyl Estradiol is given below: © Clearsky Pharmacy ( www.clearskypharmacy.biz )

7. Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets) Ovral-L Tablets are manufactured by Pfizer Limited, India. (Website: https://www.pfizerindia.com/ https://www.pfizerindia.com/ ) URL: URL: https://www.clearskypharmacy.biz/generic-alesse-ovral-l-by-wyeth.html https://www.clearskypharmacy.biz/generic-alesse-ovral-l-by-wyeth.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

8. Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets) Levonorgestrel and Ethinyl Estradiol Tablets – Brand Names Levonorgestrel and Ethinyl Estradiol tablets are available under various Drug trade names that include Alesse, Aviane, Ovral-L, Choice, Combee, Loette, Enpresse, Lessina, Levlen, Levlite, Levora, Lutera, Lybrel, Microgynon 30, Nordette, Portia, Sronyx, Tri-Levlen, Triphasil, Trivora, Ovilow and Triquilar. URL: URL: https://www.clearskypharmacy.biz/generic-alesse-ovral-l-by-wyeth.html https://www.clearskypharmacy.biz/generic-alesse-ovral-l-by-wyeth.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

9. Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets) Uses of Ovral-L Tablets Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets or LNG/EE Tablets) is a combination of Levonorgestrel, a progestin, and Ethinyl Estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. It contains 2 hormones: a progestin and an estrogen. 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 for treatment of moderate acne vulgaris in women 14 years of age or more who, have no known contraindications to oral contraceptive therapy, desire contraception, and have achieved menarche. URL: URL: https://www.clearskypharmacy.biz/generic-alesse-ovral-l-by-wyeth.html https://www.clearskypharmacy.biz/generic-alesse-ovral-l-by-wyeth.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

10. Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets) Ovral-L Dosage Ovral-L tablets (Generic Levonorgestrel and Ethinyl Estradiol tablets) is given below: The dosage of is one Ovral-L tablet daily for 21 consecutive days. Tablets should be taken exactly as directed and at intervals not exceeding 24 hours. The next pack should start 7 days after the last active tablet was taken. The patient should be told to start taking Ovral-L on Day 1 of menstruation. Switching from another hormonal method of contraception: When the patient is switching from a 21-day regimen of tablets, she should wait 7 days after her last tablet before she starts Ovral-L tablets. URL: URL: https://www.clearskypharmacy.biz/generic-alesse-ovral-l-by-wyeth.html https://www.clearskypharmacy.biz/generic-alesse-ovral-l-by-wyeth.html The dosage of Ovral-L tablets © Clearsky Pharmacy ( www.clearskypharmacy.biz )

11. Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets) Ovral-L Dosage The dosage of Ovral-L tablets Ovral-L tablets (Generic Levonorgestrel and Ethinyl Estradiol tablets) is given below: When the patient is switching from a 28-day regimen of tablets, she should start her first pack of Ovral-L on the day after her last tablet. She should not wait any days between packs. The patient may switch any day from a progestin-only pill and should begin Ovral- L the next day. If switching from an implant or injection, the patient must start Ovral-L on the day of implant removal or, if using an injection, the day the next injection would be due. In switching from a progestin-only pill, injection, or implant, the patient must be advised to use a nonhormonal back-up method of birth control for the first 7 days of tablet-taking. Withdrawal bleeding should usually occur within 3 days following discontinuation of pink tablets and may not have finished before the next pack is started. If spotting or breakthrough bleeding occur, the patient is instructed to continue on the same regimen. This type of bleeding is usually transient and without significance; however, if the bleeding is persistent or prolonged, the patient is advised to consult her physician. URL: URL: https://www.clearskypharmacy.biz/generic-alesse-ovral-l-by-wyeth.html https://www.clearskypharmacy.biz/generic-alesse-ovral-l-by-wyeth.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

12. Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets) Missed Dose Instructions The following instructions are an alternative for the management of missed tablets: If one active tablet is missed, it should be taken as soon as it is remembered. Subsequent tablets should be taken at the usual time. If two consecutive active tablets are missed during week 1 or week 2, two tablets should be taken on both the day remembered and the following day. Subsequent tablets should be taken at the usual time. A non-hormonal back-up method of birth control must be used for the next 7 days. URL: URL: https://www.clearskypharmacy.biz/generic-alesse-ovral-l-by-wyeth.html https://www.clearskypharmacy.biz/generic-alesse-ovral-l-by-wyeth.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

13. Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets) Missed Dose Instructions If two consecutive active tablets are missed during week 3 or if three or more consecutive active tablets are missed during weeks 1-3, the following apply: Day 1 starters should discard any tablets remaining in the current pack and start a new pack the same day. URL: URL: https://www.clearskypharmacy.biz/generic-alesse-ovral-l-by-wyeth.html https://www.clearskypharmacy.biz/generic-alesse-ovral-l-by-wyeth.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

14. Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets) Advice In Case Of Vomiting And/ Or Diarrhea If vomiting or diarrhea occurs within 4 hours after tablet taking, absorption may be incomplete. Use of tablets from a back-up pack is required, as outlined below. Refer to recommendations for management of missed dose. URL: URL: https://www.clearskypharmacy.biz/generic-alesse-ovral-l-by-wyeth.html https://www.clearskypharmacy.biz/generic-alesse-ovral-l-by-wyeth.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

15. Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets) Ovral-L Tablets Contraindications Ovral-L tablets are contraindicated in persons with a hypersensitivity (allergy) to Ethinyl Estradiol, Levonorgestrel or any of the other ingredients of this medicine. Combination oral contraceptives should not be used in women with any of the following conditions: Thrombophlebitis or thromboembolic disorders A history of deep-vein thrombophlebitis or thromboembolic disorders Cerebrovascular or coronary artery disease (current or past history) Valvular heart disease with thrombogenic complications Thrombogenic rhythm disorders Hereditary or acquired thrombophilias Major surgery with prolonged immobilization Diabetes with vascular involvement Headaches with focal neurological symptoms Uncontrolled hypertension URL: URL: https://www.clearskypharmacy.biz/generic-alesse-ovral-l-by-wyeth.html https://www.clearskypharmacy.biz/generic-alesse-ovral-l-by-wyeth.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

16. Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets) Ovral-L Tablets Contraindications Combination oral contraceptives should not be used in women with any of the following conditions: Known or suspected carcinoma of the breast or personal history of breast cancer Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia Undiagnosed abnormal genital bleeding Cholestatic jaundice of pregnancy or jaundice with prior pill use Hepatic adenomas or carcinomas, or active liver disease Known or suspected pregnancy URL: URL: https://www.clearskypharmacy.biz/generic-alesse-ovral-l-by-wyeth.html https://www.clearskypharmacy.biz/generic-alesse-ovral-l-by-wyeth.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

17. Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets) Storage Instructions Ovral-L Tablets (Generic Levonorgestrel 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.clearskypharmacy.biz/generic-alesse-ovral-l-by-wyeth.html https://www.clearskypharmacy.biz/generic-alesse-ovral-l-by-wyeth.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

18. Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets) Warnings Cigarette smoking increases the risk of serious cardiovascular side effects from oral-contraceptive use. This risk increases with age and with the extent of smoking and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke. Vascular Events: Stop Combined oral contraceptives (COCs) such as Ovral-L (Ethinyl Estradiol and Levonorgestrel Tablets) if an arterial or deep venous thrombotic event occurs. Although use of COCs increases the risk of venous thromboembolism, pregnancy increases the risk of venous thromboembolism as much or more than the use of COCs. URL: URL: https://www.clearskypharmacy.biz/generic-alesse-ovral-l-by-wyeth.html https://www.clearskypharmacy.biz/generic-alesse-ovral-l-by-wyeth.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

19. Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets) Warnings Carcinoma of the Breast and Cervix: Women who currently have or have had breast cancer should not use COCs because breast cancer may be hormonally sensitive. Liver Disease: Stop using COCs if jaundice develops. Steroid hormones may be poorly metabolized in patients with impaired liver function. Risk of Liver Enzyme Elevations with Concomitant Hepatitis C Treatment: During clinical trials with the Hepatitis C combination drug regimen that contains Obmitasvir / Paritaprevir / Ritonavir, with or without Dasabuvir, ALT elevations greater than 5 times the upper limit of normal (ULN), including some cases greater than 20 times the ULN, were significantly more frequent in women using Ethinyl Estradiol-containing medications, such as COCs. Discontinue Ovral-L (Ethinyl Estradiol and Levonorgestrel Tablets) prior to starting therapy with the combination medicine regimen. URL: URL: https://www.clearskypharmacy.biz/generic-alesse-ovral-l-by-wyeth.html https://www.clearskypharmacy.biz/generic-alesse-ovral-l-by-wyeth.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

20. Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets) Warnings High Blood Pressure: For women with well-controlled hypertension, monitor blood pressure and stop COCs if blood pressure rises significantly. Women with uncontrolled hypertension or hypertension with vascular disease should not use COCs Gallbladder Disease: Studies suggest a small increased relative risk of developing gallbladder disease among COC users. Carbohydrate and Lipid Metabolic Effects:Carefully monitor prediabetic and diabetic women who are taking COCs. COCs may decrease glucose tolerance in a dose-related fashion. Headache:If a woman taking Combined oral contraceptives develops new headaches that are recurrent, persistent, or severe, evaluate the cause as well as significant change in headaches and discontinue COCs if indicated. Bleeding Irregularities: Unscheduled (breakthrough) bleeding and spotting sometimes occur in patients on Combined oral contraceptives, especially during the first 3 months of use. If bleeding persists, check for causes such as pregnancy or malignancy. If pathology and pregnancy are excluded, bleeding irregularities may resolve over time or with a change to a different Combined oral contraceptive medicine. © Clearsky Pharmacy ( www.clearskypharmacy.biz )

21. Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets) Warnings Interference with Laboratory Tests: The use of Combined oral contraceptives could change the results of some laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins. Monitoring: A woman who is taking Combined oral contraceptives should have a yearly visit with her healthcare provider for a blood pressure check and for other indicated healthcare. Uterine bleeding: Evaluate irregular bleeding or amenorrhea. URL: URL: https://www.clearskypharmacy.biz/generic-alesse-ovral-l-by-wyeth.html https://www.clearskypharmacy.biz/generic-alesse-ovral-l-by-wyeth.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

22. Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets) Ovral-L Tablets Side Effects Common Side effects of Levonorgestrel and Ethinyl Estradiol Tablets (Ovral-L ) in 5% or more of women during clinical trials were: headaches (33%); irregular and/or heavy uterine bleeding (13%), dysmenorrhea (11%), nausea and/or vomiting (11%), back pain (8%). Other side effects include: vulvovaginal candidiasis, breakthrough bleeding, decreased glucose tolerance, increased blood pressure, migraine, spotty menstruation, vaginitis, dizziness, abdominal cramps, abdominal distention, acne vulgaris, breast tension and breast changes. URL: URL: https://www.clearskypharmacy.biz/generic-alesse-ovral-l-by-wyeth.html https://www.clearskypharmacy.biz/generic-alesse-ovral-l-by-wyeth.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

23. Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets) Overdose There have been no reports of serious adverse effects from overdose, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea. There is no specific antidote for Ovral-L overdosage and further treatment of overdose, if necessary, is directed to the symptoms. URL: URL: https://www.clearskypharmacy.biz/generic-alesse-ovral-l-by-wyeth.html https://www.clearskypharmacy.biz/generic-alesse-ovral-l-by-wyeth.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

24. Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets) Ovral-L Tablets During Pregnancy Levonorgestrel and Ethinyl Estradiol Tablets (Ovral-L) is classified by the US FDA as Pregnancy Category X. There is little or no increased risk of birth defects in women who inadvertently use Combined oral contraceptives 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 Combined oral contraceptives prior to conception or during early pregnancy. URL: URL: https://www.clearskypharmacy.biz/generic-alesse-ovral-l-by-wyeth.html https://www.clearskypharmacy.biz/generic-alesse-ovral-l-by-wyeth.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

25. Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets) Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets) is manufactured by Pfizer Limited, India. URL: URL: https://www.clearskypharmacy.biz/generic-alesse-ovral-l-by-wyeth.html https://www.clearskypharmacy.biz/generic-alesse-ovral-l-by-wyeth.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )