Consumer medicine information

Tibolone-WGR 2.5 mg Tablets

Tibolone

BRAND INFORMATION

Brand name

Tibolone-WGR

Active ingredient

Tibolone

Schedule

S4

1. Why am I using TIBOLONE-WGR?


TIBOLONE-WGR contains the active ingredient tibolone, which is a synthetic steroid medicine, used for Hormone Replacement Therapy (HRT). TIBOLONE-WGR is used to help relieve symptoms occurring after menopause and for the prevention of osteoporosis.
For more information, see Section 1. Why am I using TIBOLONE-WGR? in the full CMI.

2. What should I know before I use TIBOLONE-WGR?


Do not use if you have ever had an allergic reaction to tibolone or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use TIBOLONE-WGR? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with TIBOLONE-WGR and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use TIBOLONE-WGR?

  • Take TIBOLONE-WGR as directed by your doctor. You should also read the instructions given in this leaflet for your medicine.
  • Take one tablet daily, at about the same time each day. Swallow the tablet with some water or other non-alcoholic drink.

More instructions can be found in Section 4. How do I use TIBOLONE-WGR? in the full CMI.

5. What should I know while using TIBOLONE-WGR?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using TIBOLONE-WGR.
  • See your doctor for regular check-ups (at least once a year) and go for regular breast screening, as recommended by your doctor.
  • If you notice any changes in your own health, or any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist as soon as possible.
Things you should not do
  • TIBOLONE-WGR should not be taken until 12 months after your last natural menstrual bleeding, as the chance of irregular bleeding may be increased
  • Do not take TIBOLONE-WGR if you are pregnant or think you may be pregnant, or breast-feeding.
Driving or using machines
  • As far as is known, TIBOLONE-WGR has no effect on alertness and concentration.
Looking after your medicine
  • Store TIBOLONE-WGR in the original packaging, below 25°C, in a cool, dry place and protect from light and moisture.
  • Keep TIBOLONE-WGR in a safe place out of the reach of children.

For more information, see Section 5. What should I know while using TIBOLONE-WGR? in the full CMI.

6. Are there any side effects?


The most common side effects are vaginal bleeding or spotting, abdominal pain, weight gain, breast pain, unnatural hair growth, vaginal symptoms such as discharge, itching and irritation. Serious side effects include ovarian and breast cancer, increased cell growth or cancer in the lining of the womb, blood clots in the veins or lungs and heart disease.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

BRAND INFORMATION

Brand name

Tibolone-WGR

Active ingredient

Tibolone

Schedule

S4