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.