March 21, 2017

Tibolone tablets

What are tibolone tablets?

TIBOLONE (Xyvion®) is a synthetic hormone. This drug is only used in women and has actions essential for maintaining normal female functions. Tibolone can help relieve symptoms of the menopause (hot flashes, night sweats, mood changes, and vaginal dryness and irritation). It can also help to prevent osteoporosis (a loss of bone mass, so that bones become brittle and easily broken). Generic tibolone tablets are not yet available.

NOTE: This drug is discontinued in the United States.

What should my health care professional know before I take tibolone?

They need to know if you have any of these conditions:

  • blood vessel disease, blood clotting disorder, or suffered a stroke

  • breast, cervical, endometrial or uterine cancer

  • diabetes

  • fluid retention

  • heart disease

  • high blood lipids or cholesterol

  • high blood pressure

  • hysterectomy

  • kidney disease

  • liver disease

  • mental depression

  • migraine

  • porphyria

  • seizure disorder

  • tobacco smoker

  • vaginal bleeding

  • an unusual or allergic reaction to tibolone, other hormones, medicines, foods, dyes, or preservatives

  • pregnant or trying to get pregnant

  • breast-feeding

How should I take this medicine?

Take tibolone tablets by mouth. Follow the directions on the prescription label. Swallow the tablet with a full glass of water. If this medicine upsets your stomach you can take the tablets with food. Take your doses at regular intervals; tibolone works best when taken at the same time each day. Do not take your medicine more often than directed.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What drug(s) may interact with tibolone?

  • warfarin

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking tibolone?

Visit your prescriber or health care professional for regular checks on your progress. You should have a complete check-up every 6 months. You will need a regular breast and pelvic exam and "Pap" smear while on tibolone therapy. You should also discuss the need for regular mammograms with your health care professional, and follow his or her guidelines for these tests.

Tibolone can make your body retain fluid, making your fingers, hands, or ankles swell. Your blood pressure can go up. Contact your prescriber or health care professional if you feel you are retaining fluid.

If you have any reason to think you are pregnant; stop taking tibolone at once and contact your prescriber or health care professional.

Tobacco smoking increases the risk of getting a blood clot or having a stroke while you are taking tibolone, especially if you are more than 35 years old. You are strongly advised not to smoke.

What side effects may I notice from taking tibolone?

Side effects that you should report to your prescriber or health care professional as soon as possible:

  • breakthrough bleeding and spotting

  • chest pain

  • leg, arm or groin pain

  • nausea, vomiting

  • severe headaches

  • stomach pain (severe)

  • sudden shortness of breath

  • swelling of the hands, feet or ankles, or rapid weight gain

  • vision or speech problems

  • yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):

  • breast tenderness

  • increased or decreased appetite

  • mild stomach upset

  • mood changes, anxiety, depression, frustration, anger, or emotional outbursts

  • skin rash

  • vaginal discharge

  • weight gain

Where can I keep my medicine?

Keep out of the reach of children in a container that small children cannot open.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.


March 21, 2017


U.S. FDA-approved Package Insert