October 25, 2014
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Diane-35

(cyproterone - ethinyl estradiol)

DIN (Drug Identification Number)

02233542 DIANE-35 TABLET

What side effects are possible with Diane-35?

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 this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. 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
  • dizziness
  • headache
  • increased or decreased interest in sexual intercourse
  • nausea
  • 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 check with your doctor or seek medical attention.

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

  • 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)
  • 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)
  • increased blood pressure
  • symptoms of liver problems (e.g., swelling, pain, or tenderness 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 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

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 this medication.





Are there any other precautions or warnings for Diane-35?

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 this medication.

Birth control: This medication 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 this medication. Birth control pills should not be taken at the same time as cyproterone - ethinyl estradiol.

Blood clots: This medication 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). 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 this medication 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 this medication.

Diabetes: This medication can cause changes in blood sugars. If you have diabetes or a family history of diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, 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 this medication 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 this medication, contact your doctor as soon as possible.

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 this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. This medication 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 this medication. If you have this combination of medical conditions, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

This medication can cause fluid retention, which may worsen conditions such as high blood pressure, heart disease, or kidney disease.

Migraine: This medication 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 this medication 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 this medication. If you are scheduled for surgery, let all doctors involved in your care know that you are taking this medication.

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 this medication, contact your doctor.

Pregnancy: This medication should not be taken by pregnant women as it can cause harm to the developing baby. If you become or suspect that you may be pregnant while taking this medication, 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: This medication passes into breast milk and can reduce the amount and quality of breast-milk produced. This medication is not recommended for women who are breast-feeding.

What other drugs could interact with Diane-35?

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

  • alcohol
  • ampicillin
  • amiodarone
  • analgesics (painkillers; e.g., acetaminophen, codeine)
  • anastrozole
  • antacids
  • antihistamines (e.g., chlorpheniramine, loratidine)
  • antimigraine medications (e.g., dihydroergotamine)
  • antipsychotic medications (e.g., haloperidol, perphenazine, olanzapine)
  • antiseizure medications (e.g., carbamazepine, lamotrigine, phenobarbital, phenytoin, primidone, topiramate)
  • aprepitant
  • aripiprazole
  • "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)
  • certain benzodiazepines (e.g., alprazolam, bromazepam, clonazepam)
  • chloral hydrate
  • cholestyramine
  • clofibrate
  • clonidine
  • cobicistat
  • conivaptan
  • corticosteroids (e.g., dexamethasone, prednisone)
  • cotrimoxazole
  • cyclosporine
  • dabrafenib
  • dacarbazine
  • dasatinib
  • deferasirox
  • dehydroepiandrostenone
  • diabetes medications (e.g., glyburide, gliclazide)
  • dofetilide
  • dronedarone
  • duloxetine
  • estrogens (e.g., conjugated estrogen, estradiol, ethinyl estradiol)
  • exemestane
  • exenatide
  • felbamate
  • flutamide
  • griseofulvin
  • HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delaviridine, efavirenz, etravirine, nevirapine)
  • HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
  • hyaluronidase
  • imatinib
  • isoniazid
  • ivacaftor
  • levothyroxine
  • lidocaine
  • macrolide antibiotics (e.g., clarithromycin, erythromycin)
  • melatonin
  • meperidine
  • methyldopa
  • metronidazole
  • mexiletine
  • mifepristone
  • mirtazapine
  • modafinil
  • mycophenolate
  • nefazodone
  • nitrofurantoin
  • norfloxacin
  • penicillin
  • pimozide
  • phenylbutazone
  • prucalopride
  • rasagiline
  • retinoic acid (Vitamin A) derivatives
  • rifabutin
  • rifampin
  • 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
  • theophyllines (e.g., aminophylline, oxtriphylline, theophylline)
  • thyroid medications (e.g., levothyroxine, desiccated thyroid)
  • tipranavir
  • 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 this medication. 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.

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