Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets)

1. Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) © All Contraceptives

2. Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) © All Contraceptives

3. Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) Diane-35 Tablets (Ethinyl Estradiol and Cyproterone Acetate Tablets) is used in the treatment of signs of androgenisation in women, such as severe acne (involving inflammation or nodularity or risk of scarring) where prolonged oral antibiotics or local treatment alone has not been successful, or idiopathic hirsutism of mild to moderate degree. Diane-35 will also provide effective oral contraception in this patient group. It should not be used in combination with other hormonal contraceptives. Diane-35 should not be prescribed for the purpose of contraception alone. © All Contraceptives

4. Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) Active Ingredients The active pharmaceutical ingredients contained in Diane-35 tablets are Cyproterone Acetate and Ethinyl Estradiol. Each Diane-35 tablet contains 2 mg of Cyproterone Acetate and 35 micrograms of Ethinyl Estradiol. © All Contraceptives

5. Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) Chemical Structure - Cyproterone Acetate © All Contraceptives

6. Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) Chemical Structure - Ethinyl Estradiol © All Contraceptives

7. Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) Diane-35 Tablets Diane-35 Tablets are marketed by Bayer Zydus Pharma Private Limited, India and manufactured by Bayer AG, Berlin, Germany. The blister pack of Diane 35 has 21 active pills. These 21 active or hormone containing tablets are beige in color. (Website: https://www.bayer.com/en/ https://www.bayer.com/en/) URL: URL: https://www.allcontraceptives.com/diane-35-pills.html https://www.allcontraceptives.com/diane-35-pills.html © All Contraceptives

8. Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) Uses of Diane-35 Tablets Diane-35 tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) are used for the treatment of signs of physical male characteristics caused by the male sex hormone, androgen, produced by in women in small amounts (androgenisation), such as: severe acne where other treatments have not been successful and for excessive growth of facial or body hair (known as hirsutism) of a mild to moderate degree, where no underlying cause has been found. Diane-35 tablets can also be used as a contraceptive to prevent pregnancy in women who are taking it for the treatment of signs of physical male characteristics as described above. Diane-35 ED contains a progestogen and an oestrogen hormone, and therefore works similarly to the combined oral contraceptive birth control pill, also known as 'the Pill'. It should not be used in combination with another hormonal contraceptive. URL: URL: https://www.allcontraceptives.com/diane-35-pills.html https://www.allcontraceptives.com/diane-35-pills.html © All Contraceptives

9. Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) Recommended Dosage The dosage of Diane-35 tablets Diane-35 tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) is given below: First Treatment course: First Treatment course: One tablet daily for 21 days following the arrows, starting on the first day of the menstrual cycle (the first day of menstruation counting as day 1). Subsequent Courses: Subsequent Courses: Each subsequent course is started after 7 tablet- free days have followed the preceding course. When the contraceptive action of Diane-35 tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) is also to be employed, it is essential that the above instructions be rigidly adhered to. Should bleeding fail to occur during the tablet-free interval, the possibility of pregnancy must be excluded before the next pack is started. URL: URL: https://www.allcontraceptives.com/diane-35-pills.html https://www.allcontraceptives.com/diane-35-pills.html © All Contraceptives

10. Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) Recommended Dosage The dosage of Diane-35 tablets Diane-35 tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) is given below: Changing from 21-Day Combined Oral Contraceptives (COCs): Changing from 21-Day Combined Oral Contraceptives (COCs): The first tablet of Diane 35 should be taken on the first day immediately after the end of the previous COC course. Additional contraceptive precautions are not required. Changing from a Combined Every Day Pill (28 day tablets): Changing from a Combined Every Day Pill (28 day tablets): Diane 35 should be started after taking the last hormone containing tablet from the Every Day Pill pack. The first tablet of Diane 35 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 Diane 35 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 POPs should be discarded. URL: URL: https://www.allcontraceptives.com/diane-35-pills.html https://www.allcontraceptives.com/diane-35-pills.html © All Contraceptives

11. Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) Contraindications Diane-35 tablets are contraindicated in patients with a hypersensitivity to Cyproterone Acetate, Ethinyl Estradiol or any other component of this medication. They are also contraindicated in the following cases: They are also contraindicated in the following cases: History of or actual thrombophlebitis or thromboembolic disorders; History of or actual cerebrovascular disorders; History of or actual myocardial infarction or coronary arterial disease; Active liver disease; Previous or existing liver tumours (benign or malignant); History of cholestatic jaundice; Use with the Hepatitis C virus combination drug regimen Ombitasvir, Paritaprevir, Ritonavir, with or without Dasabuvir; URL: URL: https://www.allcontraceptives.com/diane-35-pills.html https://www.allcontraceptives.com/diane-35-pills.html © All Contraceptives

12. Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) Contraindications They are also contraindicated in the following cases: They are also contraindicated in the following cases: Known or suspected carcinoma of the breast; Known or suspected estrogen-dependent neoplasia; Undiagnosed abnormal vaginal bleeding; Any ocular lesion arising from ophthalmic vascular disease, such as partial or complete loss of vision or defect in visual fields; Concomitant use with other estrogen/progestogen combinations or estrogens or progestogens alone; When pregnancy is suspected or diagnosed; Severe diabetes with vascular changes; A history of otosclerosis with deterioration during pregnancy; URL: URL: https://www.allcontraceptives.com/diane-35-pills.html https://www.allcontraceptives.com/diane-35-pills.html © All Contraceptives

13. Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) Storage Instructions Diane-35 Tablets (Cyproterone Acetate 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.allcontraceptives.com/diane-35-pills.html https://www.allcontraceptives.com/diane-35-pills.html © All Contraceptives

14. Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) Warnings Diane-35, as with all estrogen/progestogen combinations, is contraindicated in women with thrombophlebitis, thromboembolic disorders, or a history of these conditions. Diane-35 users appear to have an elevated risk of venous thromboembolic events compared to users of levonorgestrel-containing combined oral contraceptives. Diane-35 should not be prescribed for the purpose of contraception alone. Estrogens or progestogens should not be taken during treatment with Diane-35. The need to continue treatment with Diane-35 should be evaluated periodically by the treating physician. Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels from the use of Diane-35. This risk increases with age and heavy smoking. URL: URL: https://www.allcontraceptives.com/diane-35-pills.html https://www.allcontraceptives.com/diane-35-pills.html © All Contraceptives

15. Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) Warnings Discontinue Medication at the Earliest Manifestation of the Following: Thromboembolic and Cardiovascular Disorders such as thrombophlebitis, pulmonary embolism, cerebrovascular disorders, myocardial ischemia, mesenteric thrombosis, and retinal thrombosis. Conditions that predispose to Venous Stasis and to Vascular Thrombosis (eg, immobilization after accidents or confinement to bed during long-term illness). Non- hormonal treatment for acne should be used until regular activities are resumed. Visual Defects - Partial or Complete Papilledema, or Ophthalmic Vascular Lesions Severe Headache of Unknown Etiology, or Worsening of Pre-existing Migraine Headache Onset of Jaundice or Hepatitis Itching of the Whole Body Significant Rise in Blood Pressure Onset of Severe Depression Severe Upper Abdominal Pain or Liver Enlargement A liver tumor should be considered in the differential diagnosis when severe upper abdominal pain, liver enlargement, or signs of intra-abdominal hemorrhage occur in women taking estrogen/progestogen combinations. URL: URL: https://www.allcontraceptives.com/diane-35-pills.html https://www.allcontraceptives.com/diane-35-pills.html © All Contraceptives

16. Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) Warnings Like many other steroids, Cyproterone Acetate and Ethinyl Estradiol tablets when given in very high doses and for the majority of the animal's life-span, has been found to cause an increase in the incidence of tumours, including carcinoma, in the liver of rats. The relevance of this finding to humans is unknown. A meta-analysis from 54 epidemiological studies reported that there is a slightly increased relative risk (RR = 1.24) of having breast cancer diagnosed in women who are currently using COCs. Women with hypertriglyceridaemia, or a family history thereof, may be at an increased risk of pancreatitis when using COCs or CPA+EE. Hypertension is a risk factor for stroke and myocardial infarction. Although small increases in blood pressure have been reported in many women taking COCs or oestrogen/progestogen combinations like CPA+EE, clinically relevant increases are rare. Acute or chronic disturbances of liver function may necessitate the discontinuation of COC or CPA+EE use until markers of liver function return to normal. All diabetics are at an increased risk of arterial disease and this should be considered when prescribing COCs or CPA+EE. Diabetics with existing vascular disease are contraindicated from using CPA+EE. Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation whilst taking CPA+EE. © All Contraceptives

17. Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) Diane-35 Tablets Side Effects The most common side effects (1% or more) reported in patients treated with Diane-35 Tablets are nausea, abdominal pain, weight increased, headache,depressed mood, mood altered, breast pain, breast tenderness. The uncommon side effects (Occuring in 1 per thousand or more and less than 1 in 100) are vomiting, diarrhea, fluid retention, migrane, libido decreased, breast hypertrophy, Rash, and urticaria. The rare side effects include contact lens intolerance, hypersensitivity, weight decreased, libido increased, vaginal discharge, breast discharge, Erythema nodosum and erythema multiforme. URL: URL: https://www.allcontraceptives.com/diane-35-pills.html https://www.allcontraceptives.com/diane-35-pills.html © All Contraceptives

18. Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) Overdose There have been no reports of overdose with Diane-35 (Cyproterone Acetate and Ethinyl Estradiol). Overdose may cause nausea, vomiting and, in females, withdrawal bleeding. Withdrawal bleeding may even occur in girls before their menarche, if they accidentally take the medicinal product. There are no specific antidotes and further treatment should be symptomatic. URL: URL: https://www.allcontraceptives.com/diane-35-pills.html https://www.allcontraceptives.com/diane-35-pills.html © All Contraceptives

19. Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) Diane-35 Tablets During Pregnancy Cyproterone Acetate and Ethinyl Estradiol Tablets (Diane-35 Tablets) has been classified by the US FDA as Pregnancy Category X. You should NOT use Diane-35 if you are pregnant or think that you may be pregnant. It will not prevent the pregnancy from continuing. It may interfere with the normal development of your baby. If you become pregnant while taking Diane-35, stop taking it immediately and contact your doctor. Animal studies have revealed that feminization of male foetuses may occur if CPA is administered during the phase of embryogenesis at which differentiation of the external genitalia occurs. Although the results of these tests are not necessarily relevant to humans, the possibility must be considered that administration of CPA+EE to women after the 45th day of pregnancy could cause feminization of male foetuses. © All Contraceptives

20. Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) Diane-35 tablets Diane-35 tablets (Cyproterone Acetate and Ethinyl Estradiol tablets) are manufactured by Bayer AG, Berlin, Germany and marketed by Bayer Zydus Pharma Private Limited, India. URL: URL: https://www.allcontraceptives.com/diane-35-pills.html https://www.allcontraceptives.com/diane-35-pills.html © All Contraceptives