Visanne

The recommended dose of Visanne (Dienogest) is 2 mg taken by mouth once daily. Visanne (Dienogest) should be taken at the same time every day, if possible.

Take the medication continuously (every day) even if you are on your period. Once you have completed a pack of tablets, begin the new package on the next day. Visanne (Dienogest) is not intended to be used as birth control. Do not take a break from the medication.

Take Visanne (Dienogest) with some liquid as needed. Visanne (Dienogest) may be taken with food or without food.

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 taking the medication without consulting your doctor.

It is important that Visanne (Dienogest) be taken exactly as prescribed by your doctor.

If you miss a dose or if you vomit or have Diarrhea within 3 to 4 hours of taking a tablet, take a dose as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. 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 Visanne (Dienogest) at room temperature, protect it from light and moisture, 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.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause headaches; it may cause ovarian cysts; it may cause nausea or, rarely, vomiting; it may cause weight gain, mostly with prolonged use; it may cause your breasts to feel swollen and tender; it may cause irregular vaginal bleeding. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

Each white-to-off-white, round, flat-faced, bevelled-edged tablet embossed "B" on one side contains 2 mg Visanne (Dienogest). Nonmedicinal ingredients: crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, potato starch, povidone K 25 and talc.

Do not take Visanne (Dienogest) if you:

• are allergic to Visanne (Dienogest) or any ingredients of the medication
• are allergic to other progestins
• are or may be pregnant
• are breast-feeding
• have abnormal liver test results caused by liver disease or liver problems
• have a history of known or suspected estrogen-dependent tumours such as breast or Uterine Cancer
• have a history of migraine Headaches with aura (classical migraine)
• have any eye lesions, vision loss, or other vision problems due to ophthalmic vascular disease (disease involving blood vessels of the eye)
• have circulation problems due to Diabetes
• have or have had benign or malignant liver tumours
• have or have had a history of Blood Clots (e.g., in the legs or lungs), Heart Attack, Stroke, or heart disease
• have undiagnosed abnormal vaginal bleeding

There may be an interaction between Visanne (Dienogest) and any of the following:

• Apixaban
• Aprepitant
• argatroban
• azole antifungals (e.g., ketoconazole, itraconazole, Voriconazole)
• benzodiazepines (e.g., Alprazolam, Diazepam, Lorazepam)
• barbiturates (e.g., butalbital, Phenobarbital)
• Bosentan
• calcium channel blockers (e.g., Diltiazem, Nifedipine, Verapamil)
• Carbamazepine
• Cholestyramine
• Clobazam
• Colestipol
• Cobicistat
• Colesevelam
• conivaptan
• Cyclosporine
• dabigatran
• Dabrafenib
• Danazol
• Deferasirox
• Dexamethasone
• diabetes medications (e.g., Glyburide, insulin, Linagliptin, Metformin, Rosiglitazone)
• grapefruit juice
• Heparin
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delavirdine, efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• hormonal birth control (e.g., birth control pills, patches, rings)
• Lamotrigine
• low molecular weight heparins (e.g., Dalteparin, Enoxaparin, Tinzaparin)
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• mifepristone
• mycophenolate
• Mitotane
• Modafinil
• nefazodone
• Oxcarbazepine
• Perampanel
• Phenytoin
• primidone
• Prucalopride
• Ranitidine
• retinoic acid derivatives (e.g., acitretin, Alitretinoin, bexarotene, Isotretinoin, tretinoin)
• rifabutin
• rifampin
• Rivaroxaban
• St. John's wort
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• Selegiline
• thalidomide
• Tocilizumab
• Topiramate
• Tranexamic acid
• Ulipristal
• Warfarin

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 Visanne (Dienogest). 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 using 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 use Visanne (Dienogest).

Birth control: Visanne (Dienogest) is not a birth control pill. While taking Visanne (Dienogest) a non-hormonal method of birth control should be used, such as condoms or a diaphragm. Hormonal methods of birth control (e.g., birth control pills, patches, rings) should not be used in combination with Visanne (Dienogest).

Blood clots: Visanne (Dienogest) may increase the risk of developing blood clots in the lungs and legs. This risk also increases with age, a personal or family history of blood clots, smoking, and Obesity. The risk of blood clots is also increased if you are immobilized for prolonged periods and with major surgery. If possible, Visanne (Dienogest) should be stopped 4 weeks before major surgery. Talk about the risk of blood clots with your doctor.

Breast Cancer: Some studies have shown that the risk of developing breast cancer does not appear to be increased by using progestin-only medication such as Visanne (Dienogest). However, more studies are needed to confirm that there is no increased risk. The most significant risk factors for breast cancer are increasing age and a strong history of breast cancer in the family (sister or mother).

Let your doctor know if you notice any breast lumps. Talk to your doctor about regular breast exams.

Cigarette smoking: Cigarette smoking increases the risk of serious side effects on the heart and blood vessels. This risk increases with age and becomes significant after age 35. Do not smoke if you use Visanne (Dienogest), especially if you are over 35. Consider stopping smoking before taking Visanne (Dienogest). If you smoke, discuss with your doctor how Visanne (Dienogest) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Visanne (Dienogest), and whether any special monitoring is needed.

Depression: Hormones, such as estrogen and progestins, 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 Visanne (Dienogest) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Visanne (Dienogest), 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 Visanne (Dienogest) contact your doctor as soon as possible.

Diabetes: As with other progestins, Visanne (Dienogest) may cause changes in blood glucose control. Women with diabetes should monitor their blood glucose closely to detect any changes in blood glucose control that sometimes occur with use of hormones. If you have diabetes or are at risk for developing diabetes, discuss with your doctor how Visanne (Dienogest) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Visanne (Dienogest), and whether any special monitoring is needed. If you experience symptoms of high blood glucose such as increased need to urinate at night, a fruity odour to your breath or wounds that require longer than normal to heal, contact your doctor.

Irregular menstruation: Irregular menstrual patterns are common among women taking progestin like Visanne (Dienogest). If you notice changes in your usual menstrual patterns, check with your doctor. If you go a prolonged time without bleeding, you should have a pregnancy test.

Liver disease: Visanne (Dienogest) may affect liver function. Visanne (Dienogest) is not recommended for people with liver problems. If you have a history of liver problems, discuss with your doctor how Visanne (Dienogest) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Visanne (Dienogest), and whether any special monitoring is needed.

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.

Osteoporosis: Visanne (Dienogest) may decrease estrogen levels in the body and increase the risk of osteoporosis (a condition where parts of the bone become weak and prone to fracture). When Visanne (Dienogest) is taken by adolescents, it may cause a decrease in the development of bones and increase the risk of developing osteoporosis. If you are at an increased risk of osteoporosis, your doctor will monitor you while you are taking Visanne (Dienogest).

Pregnancy: Visanne (Dienogest) should not be used during pregnancy. If you become pregnant while taking Visanne (Dienogest), contact your doctor immediately. Women who become pregnant while taking Visanne (Dienogest) are at a slightly increased risk of having an Ectopic Pregnancy (a pregnancy where the embryo develops outside the uterus).

Breast-feeding: It is not known if Visanne (Dienogest) passes into breast milk. Visanne (Dienogest) should not be taken while breast-feeding.

Children: The safety and effectiveness of using Visanne (Dienogest) have not been established for females who have not begun to menstruate.

This medication is typically used only once a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. This medication may be taken with or without food.