Diane 35 contains a combination of two ingredients: Cyproterone and ethinyl Estradiol. Cyproterone belongs to a group of medications known as antiandrogens. Ethinyl estradiol belongs to a group of medications known as estrogens. Together, they are used to treat certain severe types of Acne in women that have not been successfully treated with antibiotics and other treatments. Diane 35 works by regulating hormones that affect the skin.

Diane 35 may be available under multiple brand names and/or in several different forms. Any specific brand name of Diane 35 may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of Diane 35 may not be used for all of the conditions discussed here.

Your doctor may have suggested Diane 35 for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking Diane 35, speak to your doctor. Do not stop taking Diane 35 without consulting your doctor.

Do not give Diane 35 to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take Diane 35 if their doctor has not prescribed it.

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Diane 35 is taken in 28-day cycles consisting of 1 tablet daily for 21 days, followed by a 7-day interval without medication (i.e., 3 weeks on, 1 week off). Tablets should be taken at the same time each day. Treatment is usually started on the first day of menstrual bleeding. Often, several months of treatment are needed before improvement is seen. Once the acne has completely resolved, Diane 35 is usually continued for another 3 or 4 cycles and then stopped. Diane 35 may be restarted if your acne returns.

If spotting or breakthrough bleeding occurs during the 3 weeks during which Diane 35 is being taken, continue taking Diane 35. The spotting or breakthrough bleeding is usually temporary. If bleeding is persistent or lasts a long time, contact your doctor.

If your menstrual period fails to occur during the 7-day tablet-free interval, do not start the next medication cycle and contact your doctor.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

It is important to take Diane 35 exactly as prescribed by your doctor. The medication will be less effective if you miss doses. If you miss a dose of Diane 35, and you remember within 12 hours, take the missed dose. If more than 12 hours have passed, discard the missed tablet and continue to take the remaining tablets in the pack at the usual time. An additional non-hormonal method of birth control (e.g., condoms) should be used until the pack is empty. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Diane 35 at room temperature and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Diane 35. If you are concerned about side effects, discuss the risks and benefits of Diane 35 with your doctor.

The following side effects have been reported by at least 1% of people taking Diane 35. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• breast pain, tenderness, or swelling
• brown, blotchy spots on exposed skin
• discomfort wearing contact lenses
• dizziness
• excess hair growth on face, chest, legs
• hair loss
• headache
• increased or decreased interest in sexual intercourse
• irritability
• menstrual pain
• mood changes
• nausea
• nervousness
• rash or reddish lumps under the skin
• runny or stuffy nose
• swelling of ankles and feet
• unusual tiredness or weakness
• vomiting
• weight gain or loss

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• abnormal, uncontrollable movements of the arms or legs
• changes in the uterine bleeding pattern during or between menstrual periods (such as decreased bleeding, breakthrough bleeding or spotting between periods, prolonged bleeding, complete stopping of menstrual bleeding that occurs over several months in a row, or stopping of menstrual bleeding that only occurs sometimes)
• decreased blood flow to the extremities (Raynaud’s syndrome)
• signs of Depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
• for women with diabetes: mild increase of blood sugar, faintness, nausea, pale skin, or sweating
• for women with a history of breast disease: lumps in breast
• Headaches or migraines (although headaches may lessen for many users, they may increase in number or become worse for others)
• hearing changes
• increased blood pressure (e.g., headache, nausea, vomiting, vision change)
• signs of kidney problems (e.g., increased urination at night, decreased urine production, blood in the urine)
• symptoms of gall stones (e.g., pain in the upper abdomen, nausea, vomiting)
• symptoms of liver problems (e.g., swelling, pain, or tenderness or lump in upper abdominal area, yellowing of eyes or skin, skin itching)
• vaginal infection with vaginal itching or irritation, or thick, white, or curd-like discharge
• vision changes

Stop taking the medication and seek immediate medical attention if any of the following occur:

• abdominal or stomach pain (sudden, severe, or continuing)
• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• signs of Blood Clots (e.g., coughing up blood; pains in chest, groin, or leg – especially in calf of leg)
• signs of heart attack (e.g., sudden chest pain or pain radiating to back, down arm, jaw; sensation of fullness of the chest; nausea; vomiting; sweating; anxiety)
• signs of stroke (e.g., sudden or severe headache; sudden loss of coordination; vision changes; sudden slurring of speech; or unexplained weakness, numbness, or pain in arm or leg)
• shortness of breath
• swelling of the face, hands, feet, or airways

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Diane 35.

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Each beige, round, biconvex, sugar-coated tablet contains 2 mg of cyproterone acetate and 0.035 mg of ethinyl estradiol. Nonmedicinal ingredients: cornstarch, lactose, magnesium stearate, povidone, and talc; tablet coating: calcium carbonate, ferric oxide yellow, glycerol, polyethylene glycol, povidone, sucrose, talc, titanium dioxide, and wax.

Do not take cyproterone - ethinyl estradiol if you:

• are allergic to cyproterone, estradiol, or any ingredients of the medication
• are or may be pregnant
• have a history of cholestatic jaundice (yellowing of the skin, whites of the eyes caused by problems with bile flow)
• have active liver disease
• have any eye problems caused by blood vessel disease in the eye (such as partial or complete loss of vision or other vision changes)
• have or have had a blood vessel or blood clotting disorder (including deep vein thrombosis, pulmonary Embolism, Thrombophlebitis, cerebrovascular disease such as Stroke, Heart Attack, and Coronary Artery Disease)
• have had otosclerosis (abnormal bone growth in the ear) that worsened during pregnancy
• have known or suspected Breast Cancer
• have known or suspected tumours dependent on estrogen
• have or have had liver tumours
• have severe Diabetes with blood vessel changes
• have undiagnosed abnormal vaginal bleeding
• are taking another estrogen/progestogen combination or estrogens or progestogens alone
• have a hereditary condition called angioedema (a condition which causes swelling of the hands, feet, face, or airways)

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There may be an interaction between cyproterone - ethinyl estradiol and any of the following:

• Abiraterone
• alcohol
• ampicillin
• analgesics (painkillers; e.g., Acetaminophen, Codeine)
• Anastrozole
• antacids
• antihistamines (e.g., Chlorpheniramine, loratidine)
• antimigraine medications (e.g., Dihydroergotamine)
• antipsychotic medications (e.g., Chlorpromazine, Clozapine, Haloperidol, olanzepine, Quetiapine, Risperidone)
• antiseizure medications (e.g., Carbamazepine, Lamotrigine, Phenobarbital, Phenytoin, primidone, Topiramate)
• Apixaban
• Aprepitant
• "azole" antifungals (e.g., fluconazole, ketoconazole, Voriconazole)
• barbiturates (e.g., pentobarbital, secobarbital)
• beta-blockers (e.g., Metoprolol, Atenolol)
• boceprevir
• Bosentan
• caffeine
• calcium channel blockers (e.g., Diltiazem, Nifedipine, Verapamil)
• Celecoxib
• certain benzodiazepines (e.g., Alprazolam, Bromazepam, Clonazepam)
• chloral hydrate
• Cholestyramine
• clofibrate
• Clonidine
• Cobicistat
• Colesevelam
• conivaptan
• corticosteroids (e.g., Dexamethasone, Prednisone)
• cotrimoxazole
• Cyclosporine
• Dacarbazine
• Deferasirox
• dehydroepiandrostenone
• diabetes medications (e.g., Glyburide, Gliclazide)
• dofetilide
• Dronedarone
• elvitegravir
• estrogens (e.g., conjugated estrogen, estradiol, ethinyl estradiol)
• Exemestane
• Exenatide
• Flutamide
• grapefruit juice
• griseofulvin
• Heparin
• Hepatitis C antiviral combinations (e.g., ombitasvir - paritaprevir - ritonavir - dasabuvir, ombitasvir - paritaprevir - ritonavir)
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delavirdine, efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• hyaluronidase
• isoniazid
• Ivacaftor
• Lenalidomide
• lidocaine
• low-molecular-weight heparins (e.g., Dalteparin, Enoxaparin, Tinzaparin)
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• melatonin
• Meperidine
• methyldopa
• Metronidazole
• Mexiletine
• mifepristone
• Mirtazapine
• Modafinil
• mycophenolate
• nefazodone
• Nitrofurantoin
• Norfloxacin
• penicillin
• Pimozide
• phenylbutazone
• protein kinase inhibitors (e.g., Bosutinib, Dasatinib, imatinib, Nilotinib)
• Prucalopride
• Rasagiline
• retinoic acid (Vitamin A) derivatives (e.g., etretinate, Isotretinoin)
• rifabutin
• rifampin
• Rivaroxaban
• Ropinirole
• Rufinamide
• St. John's wort
• selective serotonin reuptake inhibitors (e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• Selegiline
• simeprevir
• "statins" (e.g., Atorvastatin, Pravastatin, Simvastatin)
• telaprevir
• Tetracycline
• thalidomide
• theophyllines (e.g., Aminophylline, Oxtriphylline, Theophylline)
• Thyroid medications (e.g., Levothyroxine, desiccated thyroid)
• tipranavir
• Tizanidine
• Tocilizumab
• Tranexamic acid
• tricyclic antidepressants (e.g., Amitriptyline, Desipramine)
• Ulipristal
• Ursodiol
• Warfarin
• vitamin C (ascorbic acid)

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Diane 35. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin taking a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should take Diane 35.

Birth control: Diane 35 should not be used only for the purpose of birth control. Women should use a non-hormonal method of birth control (such as condoms) while taking Diane 35. Birth control pills should not be taken at the same time as cyproterone - ethinyl estradiol.

Blood clots: Diane 35 appears to increase the risk of developing blood clots. This risk may be greater than that which occurs with birth control pills. These blood clots may form anywhere in the body, but are more noticeable when they occur in the large muscles, lung, brain (stroke), or heart (heart attack). This risk of developing blood clots is increased in women over 35 years of age. If you experience pain in the chest or leg, unexplained shortness of breath, fast and irregular heartbeat, severe headache, blurred vision, or slurred speech, get immediate medical attention. 

Breast cancer: All women who take Diane 35 should practice breast self-examination. Ask your doctor to teach you how to do this. If you have a family history of breast cancer, you should be closely monitored by your doctor while taking Diane 35.

Diabetes: Diane 35 can cause changes in blood sugars. If you have diabetes or a family history of diabetes, discuss with your doctor how Diane 35 may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Diane 35, and whether any special monitoring is needed.

Depression: Hormones, such as cyproterone - ethinyl estradiol have been known to cause mood swings and symptoms of depression. If you have depression or a history of depression, discuss with your doctor how Diane 35 may affect your medical condition and whether any special monitoring is needed.

If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, decreased interest in activities, or notice them in a family member who is taking Diane 35, contact your doctor as soon as possible.

Blood pressure: You should not take Diane 35 if you have high blood pressure that is not controlled by medication. If you have high blood pressure, discuss with your doctor how Diane 35 may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Diane 35, and whether any special monitoring is needed.

Liver function: Like other hormones, cyproterone - ethinyl estradiol can cause decreased liver function and liver disease. If you have decreased liver function or liver disease, discuss with your doctor how Diane 35 may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Diane 35, and whether any special monitoring is needed. Diane 35 should not be taken by women with severe liver disease.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Medical conditions: The combination of Obesity, high blood pressure, and diabetes greatly increases the risk of side effects from Diane 35. If you have this combination of medical conditions, discuss with your doctor how Diane 35 may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Diane 35, and whether any special monitoring is needed.

Diane 35 can cause fluid retention, which may worsen conditions such as high blood pressure, heart disease, or Kidney Disease.

Migraine: Diane 35 may cause migraine headaches to occur. If you experience a new pattern of headaches that is severe, persistent, or recurrent, contact your doctor as soon as possible. Cyproterone - ethinyl estradiol is not recommended for people who experience migraine headaches with aura.

Smoking: Smoking increases the risk of serious side effects on the heart and blood vessels. This risk increases with age and heavy smoking (15 or more cigarettes per day) and is even more serious for women over 35 years of age. Women who use Diane 35 should not smoke.

Surgery: Certain situations such as long-term bed confinement may make blood clots more likely. Discuss with your doctor the risks and benefits of temporarily stopping Diane 35. If you are scheduled for surgery, let all doctors involved in your care know that you are taking Diane 35.

Vaginal bleeding: Report any unusual vaginal bleeding to your doctor.

Vision and contact lenses: Like other hormones, cyproterone - ethinyl estradiol may cause changes to the shape of the eye. If your contact lenses do not seem to fit as well as they used to, consult your doctor or eye care professional. You may need to stop wearing them or be fitted for a different pair. If you experience any vision changes while taking Diane 35, contact your doctor.

Pregnancy: Diane 35 should not be taken by pregnant women as it can cause harm to the developing baby. If you become pregnant or suspect that you may be pregnant while taking Diane 35, contact your doctor immediately. After stopping treatment, you should wait until at least one normal menstrual cycle has occurred before trying to get pregnant.

Breast-feeding: Diane 35 passes into breast milk and can reduce the amount and quality of breast-milk produced. Diane 35 is not recommended for women who are breast-feeding.

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