Uses

This medication is used to treat endometriosis. It works by lowering the amount of certain hormones in the body and decreasing the growth of abnormal tissues that cause endometriosis. This helps reduce pain and other symptoms. Dienogest is a type of hormone (progestin).

How To Use

Read the Patient Information Leaflet if available from your pharmacist before you start taking this drug and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Tell your doctor if your condition does not improve or if it worsens.

Side Effects

Headache, breast swelling/tenderness, nausea, or weight changes may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• nausea/vomiting that doesn't stop
• yellowing eyes/skin
• dark urine
• severe stomach/abdominal pain
• unusual vaginal bleeding (such as spotting, breakthrough bleeding, prolonged/recurrent bleeding)
• mental/mood changes (such as depression)
• swelling hands/ankles/feet

This medication may rarely cause serious problems from blood clots (such as heart attacks, strokes, deep vein thrombosis, pulmonary embolism). Get medical help right away if you have any serious side effects, including:

• chest/jaw/left arm pain
• unusual sweating
• sudden/severe headache
• weakness on one side of the body
• confusion
• trouble speaking
• sudden vision changes (such as partial/complete blindness)
• pain/redness/swelling of legs
• trouble breathing
• coughing up blood
• severe dizziness/fainting

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking dienogest, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• blood clots
• heart disease (heart attack, coronary artery disease, heart failure)
• stroke
• diabetes
• liver disease
• certain cancers (such as breast cancer, cancer of the uterus/ovaries)
• vaginal bleeding of unknown cause
• migraine headaches
• family medical history (especially breast lumps, cancer, blood clots)
• obesity
• lupus
• high blood pressure
• depression
• seizures
• asthma
• kidney disease
• high blood cholesterol/triglyceride levels

Do not smoke or use tobacco. Smoking combined with this medication further increases your risk for stroke, blood clots, high blood pressure, and heart attack.

Tell your doctor if you just had or will be having surgery, or if you will be confined to a chair or bed for a long time (such as a long plane flight). These conditions increase your risk of getting blood clots, especially if you are using this product. You may need to stop this medication for a time or take special precautions.

This medication may cause blotchy, dark areas on your face and skin (melasma). Sunlight may worsen this effect. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors.

This medication should not be used during pregnancy. Consult your doctor for more details and to discuss the use of reliable forms of non-hormonal birth control (such as condoms, diaphragm with spermicide) while taking this medication. If you become pregnant or think you may be pregnant, tell your doctor right away.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Other medications can affect the removal of dienogest from your body, which may affect how dienogest works. Examples include azole antifungals (such as itraconazole, ketoconazole), rifamycins (such as rifampin), among others.

This medication may interfere with certain laboratory tests, possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Regular complete physical exams which include lab and/or medical tests (such as blood pressure, breast exam/mammogram, pelvic exam, Pap smear) should be done while you are taking this medication. Follow your doctor's instructions for examining your breasts, and report any lumps right away. Keep all medical and lab appointments. Consult your doctor for more details.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.