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

1. Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets) © All Contraceptives

2. Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets) © All Contraceptives

3. Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets) Ovral-L (Generic Levonorgestrel and Ethinyl Estradiol Tablets) is a combination of Levonorgestrel, a progestin, and Ethinyl Estradiol, an estrogen which is indicated for use by females of reproductive potential for prevention of pregnancy. 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. © All Contraceptives

4. Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets) Active Ingredients The active pharmaceutical ingredients contained in Ovral-L tablets are Ethinyl Estradiol and Levonorgestrel. Each uncoated Ovral-L Contraceptive tablet contains 0.15 mg (150 mcg) Levonorgestrel and 0.03 mg (30 mcg) Ethinyl Estradiol. © All Contraceptives

5. Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets) Chemical Structure - Levonorgestrel © All Contraceptives

6. Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets) Chemical Structure – Ethinyl Estradiol © All Contraceptives

7. Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets) Ovral-L Tablets Ovral-L Tablets are manufactured by Pfizer Limited, India. Ovral-L is available as uncoated tablets containing 0.15 mg (150 mcg) Levonorgestrel and 0.03 mg (30 mcg) Ethinyl Estradiol. (Website: https://www.pfizerindia.com/ https://www.pfizerindia.com/ ) URL: URL: https://www.allcontraceptives.com/ovral-l-tablets.html https://www.allcontraceptives.com/ovral-l-tablets.html © All Contraceptives

8. Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets) Uses of Ovral-L Tablets Levonorgestrel and Ethinyl Estradiol combination (Ovral-L tablets) is used to prevent 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. Besides preventing pregnancy, birth control pills may make your periods more regular, decrease blood loss and painful periods, decrease your risk of ovarian cysts, and also treat acne. This medicine will not prevent HIV infection or other sexually transmitted diseases. It will not help as emergency contraception, such as after unprotected sexual contact. URL: URL: https://www.allcontraceptives.com/ovral-l-tablets.html https://www.allcontraceptives.com/ovral-l-tablets.html © All Contraceptives

9. Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets) Uses of Ovral-L Tablets The decision to prescribe Ovral-L (Generic Ethinyl Estradiol and Levonorgestrel Tablets) should take into consideration the individual woman's current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Ovral-L tablets compares with other combined hormonal contraceptives (CHCs). URL: URL: https://www.allcontraceptives.com/ovral-l-tablets.html https://www.allcontraceptives.com/ovral-l-tablets.html © All Contraceptives

10. Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets) Recommended 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. Tablets must be taken orally in the order directed on the blister package at about the same time every day, with some liquid if necessary. First treatment cycle: First treatment cycle: 1 tablet daily for 21 days, starting on the first day of the menstrual cycle. Contraceptive protection begins immediately. URL: URL: https://www.allcontraceptives.com/ovral-l-tablets.html https://www.allcontraceptives.com/ovral-l-tablets.html The dosage of Ovral-L tablets © All Contraceptives

11. Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets) Recommended Dosage Ovral-L tablets (Generic Ethinyl Estradiol and Levonorgestrel Tablets) is given below: Subsequent cycles: Subsequent cycles: Tablet-taking from the next pack of Ovral-L is continued after a 7-day tablet-free interval, beginning on the same day of the week as the first pack. A withdrawal bleed usually occurs during the tablet-free interval. Changing from 21-day combined oral contraceptives: Changing from 21-day combined oral contraceptives: The first tablet of Ovral-L should be taken on the first day immediately after the end of the previous oral contraceptive course. Additional contraceptive precautions are not required. The dosage of Ovral-L tablets URL: URL: https://www.allcontraceptives.com/ovral-l-tablets.html https://www.allcontraceptives.com/ovral-l-tablets.html © All Contraceptives

12. Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets) Recommended Dosage Ovral-L tablets (Generic Ethinyl Estradiol and Levonorgestrel Tablets) is given below: Changing from a combined Every Day pill (28 -day tablets): Changing from a combined Every Day pill (28 -day tablets): Ovral-L should be started after taking the last active tablet from the Every Day Pill pack. The first Ovral-L tablet is taken the next day. Additional contraceptive precautions are not then required. Changing from a progestogen-only pill (POP): Changing from a progestogen-only pill (POP): The first tablet of Ovral-L should be taken on the first day of bleeding, even if a POP has already been taken on that day. Additional contraceptive precautions are not then required. The remaining progestogen-only pills should be discarded. URL: URL: https://www.allcontraceptives.com/ovral-l-tablets.html https://www.allcontraceptives.com/ovral-l-tablets.html The dosage of Ovral-L tablets © All Contraceptives

13. 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.allcontraceptives.com/ovral-l-tablets.html https://www.allcontraceptives.com/ovral-l-tablets.html © All Contraceptives

14. 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.allcontraceptives.com/ovral-l-tablets.html https://www.allcontraceptives.com/ovral-l-tablets.html © All Contraceptives

15. 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.allcontraceptives.com/ovral-l-tablets.html https://www.allcontraceptives.com/ovral-l-tablets.html © All Contraceptives

16. Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol 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 Combination oral contraceptives should not be used in women with any of the following conditions: 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 URL: URL: https://www.allcontraceptives.com/ovral-l-tablets.html https://www.allcontraceptives.com/ovral-l-tablets.html © All Contraceptives

17. Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets) Contraindications Combination oral contraceptives should not be used in women with Combination oral contraceptives should not be used in women with any of the following conditions: any of the following conditions: Hereditary or acquired thrombophilias Major surgery with prolonged immobilization Diabetes with vascular involvement Headaches with focal neurological symptoms Uncontrolled hypertension 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. URL: URL: https://www.allcontraceptives.com/ovral-l-tablets.html https://www.allcontraceptives.com/ovral-l-tablets.html © All Contraceptives

18. Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets) Contraindications Combination oral contraceptives should not be used in Combination oral contraceptives should not be used in women with any of the following conditions: women with any of the following conditions: 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.allcontraceptives.com/ovral-l-tablets.html https://www.allcontraceptives.com/ovral-l-tablets.html © All Contraceptives

19. Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets) Storage Instructions Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets 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.allcontraceptives.com/ovral-l-tablets.html https://www.allcontraceptives.com/ovral-l-tablets.html © All Contraceptives

20. 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. 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. URL: URL: https://www.allcontraceptives.com/ovral-l-tablets.html https://www.allcontraceptives.com/ovral-l-tablets.html © All Contraceptives

21. Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets) Warnings 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. 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. © All Contraceptives

22. Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets) Warnings 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. © All Contraceptives

23. 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.allcontraceptives.com/ovral-l-tablets.html https://www.allcontraceptives.com/ovral-l-tablets.html © All Contraceptives

24. Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets) Ovral-L Tablets Side Effects Common Side effects of Levonorgestrel and Ethinyl Estradiol Tablets 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.allcontraceptives.com/ovral-l-tablets.html https://www.allcontraceptives.com/ovral-l-tablets.html © All Contraceptives

25. Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets) Overdose There have been no reports of serious adverse effects from Levonorgestrel and Ethinyl Estradiol tablets 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.allcontraceptives.com/ovral-l-tablets.html https://www.allcontraceptives.com/ovral-l-tablets.html © All Contraceptives

26. Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets) Ovral-L Tablets During Pregnancy Levonorgestrel and Ethinyl Estradiol tablets (Ovral-L ) are 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. Do not administer COCs to induce withdrawal bleeding as a test for pregnancy. Do not use COCs during pregnancy to treat threatened or habitual abortion. URL: URL: https://www.allcontraceptives.com/ovral-l-tablets.html https://www.allcontraceptives.com/ovral-l-tablets.html © All Contraceptives

27. Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets) Ovral-L Tablets Ovral-L Tablets (Generic Levonorgestrel and Ethinyl Estradiol Tablets) by Pfizer Limited, India. URL: URL: https://www.allcontraceptives.com/ovral-l-tablets.html https://www.allcontraceptives.com/ovral-l-tablets.html © All Contraceptives