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

1. Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) © The Swiss Pharmacy

2. Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) Diane-35 (Cyproterone Acetate and Ethinyl Estradiol tablets) is used for 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. Effective oral contraception in this group of women requiring treatment for these androgen-dependent diseases is an indication for treatment with Diane-35 tablets. © The Swiss Pharmacy

3. Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) © The Swiss Pharmacy

4. Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) Diane 35 Tablets are manufactured by Bayer AG, Berlin, Germany in the strength of 2.035mg (2 mg of Cyproterone Acetate and 0.035 mg of Ethinyl Estradiol). They are marketed by Bayer Zydus Pharma Private Limited, India. © The Swiss Pharmacy

5. Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) Chemical Structure - Cyproterone Acetate © The Swiss Pharmacy

6. Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) Chemical Structure-Ethinyl Estradiol © The Swiss Pharmacy

7. Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) The active ingredients contained in Diane-35 tablets are Cyproterone Acetate and Ethinyl Estradiol. Each film-coated Diane-35 tablet contains 2 mg of Cyproterone Acetate and 0.035 mg of Ethinylestradiol. © The Swiss Pharmacy

8. Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) Uses of Diane-35 tablets: Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) is used for treatment of women with severe acne, especially pronounced forms of acne that may be accompanied by inflammation or formation of nodes (acne nodulocystica, acne papulopustulosa), with associated symptoms of androgenization, including seborrhea and mild hirsutism and/or androgenic alopecia. Diane-35 should be used only when acne is unresponsive to topical therapy and oral antibiotic treatments. Oral contraception in women requiring treatment for these androgen- dependent diseases is an indication for treatment with Diane-35. However, Diane-35 is not recommended in women solely for contraception. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9760_Diane-35-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9760_Diane-35-Pills.html © The Swiss Pharmacy

9. Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) Uses of Diane-35 tablets: It should not be used in combination with other hormonal contraceptives. Diane-35 is also used for the relief of symptoms of polycystic ovary syndrome. However, when taken as recommended, Diane-35 will provide reliable contraception in patients treated for the above clinical conditions. If patient compliance is uncertain and contraception is necessary, then a supplementary non-hormonal contraceptive method should be considered. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9760_Diane-35-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9760_Diane-35-Pills.html © The Swiss Pharmacy

10. Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) Recommended Adult Dosage Diane-35 Tablets Diane-35 Tablets (Ethinylestradiol and Cyproterone Acetate tablets) inhibits ovulation and, thereby, prevents conception. Patients who are using Diane-35 should not, therefore, use an additional hormonal contraceptive, as this will expose the patient to an excessive dose of hormones and is not necessary for effective contraception. 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: Each subsequent course is started after 7 tablet-free days have followed the preceding course. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9760_Diane-35-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9760_Diane-35-Pills.html © The Swiss Pharmacy

11. Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) Recommended Adult Dosage When the contraceptive action of Diane-35 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. When changing from an oral contraceptive and relying on the contraceptive action of Diane-35, follow the instructions given below. 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): 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9760_Diane-35-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9760_Diane-35-Pills.html © The Swiss Pharmacy

12. Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) Recommended Adult Dosage Postpartum and Post-abortum Use: After pregnancy, Diane-35 can be started 21 days after a vaginal delivery, provided that the patient is fully ambulant and there are no puerperal complications. Additional contraceptive precautions will be required for the first 7 days of tablet taking. Since the first postpartum ovulation may precede the first bleeding, another method of contraception should be used in the interval between childbirth and the first course of tablets. Lactation is contraindicated with Diane-35. After a first trimester abortion, Diane-35 may be started immediately, in which case no additional contraceptive precautions are required. Duration of Use: Time to relief of symptoms is at least three months. The need to continue treatment should be evaluated periodically by the treating physician. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9760_Diane-35-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9760_Diane-35-Pills.html © The Swiss Pharmacy

13. Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) Contraindications ➔Diane-35 is contraindicated in patients with a known hypersensitivity to Ethinylestradiol, Cyproterone Acetate or any component of the tablet. ➔Presence or a history of a cerebrovascular accident or venous or arterial thrombotic/thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) ➔Presence or history of prodromi for a thrombosis (e.g. angina pectoris, transient ischaemic attack) ➔The presence of a severe or multiple risk factor(s) for venous or arterial thrombosis may also constitute a contraindication ➔Diabetes mellitus with vascular involvement URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9760_Diane-35-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9760_Diane-35-Pills.html © The Swiss Pharmacy

14. Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) Contraindications ➔History of epilepsy ➔Presence or history of liver tumours (benign or malignant) ➔Known or suspected sex-steroid influenced malignancies (e.g. of the breasts or the genital organs) ➔History of migraine with focal neurological symptoms ➔Presence or history of severe hepatic disease as long as liver function values have not returned to normal ➔Pancreatitis or a history of pancreatitis if associated with severe hypertriglyceridemia URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9760_Diane-35-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9760_Diane-35-Pills.html © The Swiss Pharmacy

15. Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) Contraindications ➔Undiagnosed vaginal bleeding. ➔Concomitant use with another hormonal contraceptive. ➔Known or suspected pregnancy. ➔Lactation. ➔Meningioma or a history of meningioma. ➔Diane-35 is contraindicated for use with the Hepatitis C combination drug regimen Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir with or without Ribavirin. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9760_Diane-35-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9760_Diane-35-Pills.html © The Swiss Pharmacy

16. 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.theswisspharmacy.com/product_info.php?info=p9760_Diane-35-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9760_Diane-35-Pills.html © The Swiss Pharmacy

17. Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) Warnings Time to relief of symptoms is at least 3 months. The need to continue treatment should be evaluated periodically by the treating physician. Women should be advised that Ethinylestradiol and Cyproterone Acetate does not protect against HIV infection (AIDS) and other sexually transmitted diseases. Assessment of women prior to starting oral contraceptives (and at regular intervals thereafter) should include a personal and family medical history of each woman. Physical examination should be guided by this and by the contraindications and warnings for this product. The likelihood of pregnancy should be excluded before starting treatment. Undiagnosed vaginal bleeding that is suspicious for underlying conditions should be investigated. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9760_Diane-35-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9760_Diane-35-Pills.html © The Swiss Pharmacy

18. Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) Warnings Conditions That Require Strict Medical Supervision: If any of the conditions / risk factors mentioned below is present, the benefits of the use of Cyproterone Acetate and Ethinylestradiol (CPA+EE) should be weighed against the possible risks for each individual woman and discussed with the woman before she decides to start using CPA+EE. In the event of aggravation, exacerbation or first appearance of any of these conditions or risk factors, the woman should contact her physician. Diabetes mellitus, with mild vascular disease or mild nephropathy, retinopathy or neuropathy, Hypertension that is adequately controlled, i.e. systolic greater than 140 to 159 mmHg or diastolic greater than 90 to 94 mmHg, Porphyria, Clinical depression, Obesity, Migraine, Cardiovascular diseases, Chloasma. Patients with a history of depression or any condition mentioned above should be monitored during treatment with CPA+EE. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9760_Diane-35-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9760_Diane-35-Pills.html © The Swiss Pharmacy

19. Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) Warnings 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 Bayer Schering Pharma Germany. The need to continue treatment with Diane 35 should be evaluated periodically by the treating physician. Diane 35 should be discontinued 3 to 4 cycles after signs have completely resolved. 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 (15 or more cigarettes per day) and is more marked in women over 35 years of age. Women who use this medication should not smoke. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9760_Diane-35-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9760_Diane-35-Pills.html © The Swiss Pharmacy

20. Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) Warnings Discontinue Medication at the Earliest Manifestation of the Following: Thromboembolic and Cardiovascular Disorderssuch asthrombophlebitis, 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 URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9760_Diane-35-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9760_Diane-35-Pills.html © The Swiss Pharmacy

21. Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) Warnings Discontinue Medication at the Earliest Manifestation of the Following: 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.theswisspharmacy.com/product_info.php?info=p9760_Diane-35-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9760_Diane-35-Pills.html © The Swiss Pharmacy

22. Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) Warnings Carcinogenesis and Mutagenesis: Malignancies may be life-threatening or may have a fatal outcome. Breast Cancer: Increasing age and a strong family history are the most significant risk factors for the development of breast cancer. Other established risk factors include obesity, nulliparity, and late age for first full- term pregnancy. The identified groups of women that may be at increased risk of developing breast cancer before menopause are long-term users of estrogen / progestogen combinations (more than eight years) and starters at early age. Cervical Cancer: The most important risk factor for cervical cancer is persistent HPV infection. Some epidemiological studies have indicated that long-term use of COCs may further contribute to this increased risk but there continues to be controversy about the extent to which this finding is attributable to confounding effects, e.g., cervical screening and sexual behaviour including use of barrier contraceptives. © The Swiss Pharmacy

23. Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) Warnings Patients with fibroids (leiomyomata) should be carefully observed. Sudden enlargement, pain, or tenderness requires discontinuation of the use of the medication. Persistent irregular vaginal bleeding requires special diagnostic judgement to exclude the possibility of pregnancy or neoplasm Epidemiological studies have suggested an association between the use of estrogen/progestogen combinations and an increased risk of arterial and venous thrombotic and thromboembolic diseases such as myocardial infarction, deep venous thrombosis, pulmonary embolism, and of cerebrovascular accidents. These events occur rarely. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9760_Diane-35-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9760_Diane-35-Pills.html © The Swiss Pharmacy

24. Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) Warnings Diane-35 must be discontinued prior to starting therapy with the Hepatitis C virus (HCV) combination drug regiment Ombitasvir, Paritaprevir, Ritonavir, with or without Dasabuvier If there is a clear-cut history of cholestatic jaundice, especially if it occurred during pregnancy, other methods of treatment should be prescribed. The development of severe generalized pruritus or icterus requires that the medication be withdrawn until the problem is resolved. Exogenous estrogens may induce or exacerbate symptoms of angioedema, in particular in women with hereditary angioedema. Discontinuation of this medication should be considered. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9760_Diane-35-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9760_Diane-35-Pills.html © The Swiss Pharmacy

25. Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) Warnings The use of estrogen / progestogen combinations in some women has been associated with positive lupus erythematous cell tests and with clinical lupus erythematosus. In some instances exacerbation of rheumatoid arthritis and synovitis have been observed. The onset or exacerbation of migraine or the development of headache of a new pattern that is recurrent, persistent, or severe, requires discontinuation of medication and evaluation of the cause. Progressive astigmatic error, possibly leading to keratoconus, has been noted in some myopic women receiving drugs of the estrogen/progestogen class. There is an increased risk of thromboembolic complications in estrogen / progestogen combination users after major surgery. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9760_Diane-35-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9760_Diane-35-Pills.html © The Swiss Pharmacy

26. Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) Warnings Patients with a history of emotional disturbances, especially the depressive type, are more prone to have a recurrence of depression while taking estrogen / progestogen combinations. Diane-35 may cause fluid retention. Conditions such as epilepsy, asthma, and cardiac or renal dysfunction require careful observation. Women having a history of oligomenorrhea, secondary amenorrhea, or irregular cycles may remain anovulatory or become amenorrheic following discontinuation of estrogen / progestogen combination therapy. Amenorrhea, especially if associated with breast secretion, that continues for 6 months or more after withdrawal, warrants a careful assessment of hypothalamic- pituitary function. After discontinuing therapy, the patient should delay pregnancy until at least one normal spontaneous cycle has occurred in order to date the pregnancy. The patient should be instructed to use a non-hormonal method of contraception during this time period. © The Swiss Pharmacy

27. Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) Diane-35 and Alcohol Alcohol doesn’t affect the overall effectiveness of your birth control. But alcohol consumption can affect your behavior and judgment, increasing the likelihood of contraceptive failure. Alcohol doesn’t have a direct effect on how your birth control works. However, the effects of alcohol can increase your risk of birth control failure. First, if you’re drinking heavily or become intoxicated, the odds that you’ll forget to take your medicine on time increase. You’re more likely to forget to take your birth control pill if you started drinking before the time you normally take it. The hormones in birth control may affect your body water distribution which can change the rate the alcohol you drink is eliminated. This could lead to higher blood alcohol levels and may increase your level of intoxication if you’re on the pill. In other words, you may become intoxicated more quickly than you did before you started the pill. This may also increase your likelihood of missing a dose or forgetting to use protection if you choose to have sex. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9760_Diane-35-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9760_Diane-35-Pills.html © The Swiss Pharmacy

28. Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) Possible Side Effects Most common Cyproterone Acetate and Ethinyl Estradiol tablets (Diane-35) side effects reported during clinical trials with an incidence rate of greater than or equal to 1% are nausea, abdominal pain, increased weight, headache, depressed mood, altered mood, breast pain, breast tenderness. The Uncommon Diane-35 side effects included Vomiting, Diarrhoea, Fluid retention, Migraine, Libido decreased, Breast hypertrophy, Rash and Urticaria. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9760_Diane-35-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9760_Diane-35-Pills.html © The Swiss Pharmacy

29. Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) Possible Side Effects The rare Diane-35 side effects included Contact lens intolerance, Hypersensitivity, Weight decreased, Libido increased, Vaginal discharge, breast discharge, Erythema nodosum, Erythema multiforme and Thromboembolism. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9760_Diane-35-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9760_Diane-35-Pills.html © The Swiss Pharmacy

30. Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) Diane-35 Tablets Overdosage Diane-35 Overdose may cause nausea, vomiting and 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.theswisspharmacy.com/product_info.php?info=p9760_Diane-35-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9760_Diane-35-Pills.html © The Swiss Pharmacy

31. Diane-35 Tablets (Cyproterone Acetate and Ethinyl Estradiol Tablets) Diane-35 Tablets During Pregnancy Cyproterone Acetate and Ethinyl Estradiol tablets (Diane-35) has been classified by the US FDA as Pregnancy Category X. Administration of Diane-35 ( Cyproterone Acetate and Ethinyl Estradiol Tablets) is contraindicated in pregnancy. If pregnancy occurs during treatment with Diane-35 tablets, use is to be stopped immediately. Estrogen/progestogen combinations must not be taken by pregnant women. Rule out pregnancy before treatment is begun. Because of the antiandrogenic action of Diane-35, feminization of male fetuses has occurred in animal studies and may possibly occur in humans. Fetal abnormalities have been reported to occur in the offspring of women who have taken estrogen / progestogen combinations in early pregnancy. Rule out pregnancy as soon as it is suspected. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9760_Diane-35-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9760_Diane-35-Pills.html © The Swiss Pharmacy

32. 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.theswisspharmacy.com/product_info.php?info=p9760_Diane-35-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9760_Diane-35-Pills.html © The Swiss Pharmacy