This medication is used by women with a uterus to help reduce symptoms of menopause (such as hot flashes, vaginal dryness). Tibolone is not a hormone, but works by acting like certain hormones (estrogen, progesterone, testosterone) in some parts of the body.

If you are using this medication to treat symptoms only in and around the vagina, consider using products applied directly inside the vagina instead of medications that are taken by mouth, absorbed through the skin, or injected.

Read the Patient Information Leaflet if available from your pharmacist before you start taking tibolone 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 with water or another beverage. Swallow the tablet whole. Do not chew or crush the tablet.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Do not increase your dose or take this medication more often or for longer than prescribed.

Tell your doctor if your condition does not get better or if it gets worse.

See also Warning section.

Stomach upset, nausea/vomiting, bloating, breast tenderness, headache, 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
• lumps in the breast
• mental/mood changes (such as depression, memory loss)
• severe stomach/abdominal pain
• yellowing eyes/skin
• dark urine
• swelling hands/ankles/feet
• increased thirst/urination
• unusual vaginal bleeding (such as spotting, sudden heavy bleeding)

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

This medication may rarely cause serious (sometimes fatal) problems from blood clots (such as heart attack, stroke, blood clots in the lungs or legs). Get medical help right away if you have:

• shortness of breath/rapid breathing
• chest/jaw/left arm pain
• unusual sweating
• confusion
• sudden dizziness/fainting
• pain/swelling/warmth in the groin/calf
• sudden/severe headaches
• trouble speaking
• weakness on one side of the body
• sudden vision changes

A very serious allergic reaction to this product 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.

Before taking this medication, 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:

• vaginal bleeding of unknown cause
• diabetes
• cancer (especially breast cancer, cancer of the uterus/ovaries)
• blood clots
• blood clotting disorders (such as protein C or protein S deficiency)
• family medical history (especially of breast lumps, cancer, blood clots)
• family or personal history of a certain swelling disorder (angioedema)
• gallbladder disease
• heart disease (such as irregular heartbeat, previous heart attack)
• high blood pressure
• high cholesterol/triglyceride levels
• kidney disease
• liver disease
• lupus
• mental/mood disorders (such as dementia, depression)
• migraine headaches
• underactive thyroid (hypothyroidism)
• mineral imbalance (low or high level of calcium in the blood)
• obesity
• a certain hormone problem (hypoparathyroidism)
• uterus problems (such as fibroids, endometriosis)
• asthma
• seizures
• stroke
• a certain blood disorder (porphyria)

Do not smoke or use tobacco. Tibolone combined with smoking further increases your risk of stroke, blood clots, high blood pressure, and heart attack, especially in women older than 35.

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 taking tibolone. You may need to stop this medication for a time or take special precautions.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

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.

If you are nearsighted or wear contact lenses, you may develop vision problems or trouble wearing your contact lenses. Contact your eye doctor if these problems occur.

This medication must not be used during pregnancy. 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. Breastfeeding is not recommended while using this medication. Consult your doctor before breastfeeding.

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.

Some products that may interact with this drug are:

• aromatase inhibitors (such as anastrozole, exemestane, letrozole)
• estrogen agonist/antagonists (such as ospemifene, raloxifene)
• tranexamic acid

This medication may interfere with certain lab tests (such as blood clotting tests, thyroid tests), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

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 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

You should have regular complete physical exams including blood pressure, breast exam, pelvic exam, and screening for cervical cancer (Pap smear). Follow your doctor's instructions for examining your own breasts, and report any lumps right away. Keep all medical and lab appointments. Consult your doctor for more details.

Preventing or controlling high blood pressure, high cholesterol, and diabetes can help to reduce your chances of heart disease and stroke. Lifestyle changes that can help to control or prevent these diseases include reducing stress, eating a low fat/salt diet, losing weight if overweight, exercising regularly, and stopping smoking. Talk to your doctor about lifestyle changes that might benefit you.

Lifestyle changes that may help reduce hot flashes include stopping smoking, dressing lightly or in layers, avoiding/limiting certain foods (spicy foods, caffeine, alcohol), reducing stress, and exercising regularly.

If you miss a dose, take it as soon as you remember. If it is more than 12 hours after the missed dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store in the original package 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.