Consumer medicine information

Xyvion 2.5 mg Tablets

Tibolone

BRAND INFORMATION

Brand name

Xyvion

Active ingredient

Tibolone

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Xyvion 2.5 mg Tablets.

1. Why am I using XYVION?


XYVION contains the active ingredient tibolone, which is a synthetic steroid medicine, used for Hormone Replacement Therapy (HRT). XYVION 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 XYVION? in the full CMI.

2. What should I know before I use XYVION?


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 XYVION? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with XYVION 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 XYVION?

  • Take XYVION 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 XYVION? in the full CMI.

5. What should I know while using XYVION?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using XYVION.
  • 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
  • XYVION 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 XYVION if you are pregnant or think you may be pregnant, or breast-feeding.
Driving or using machines
  • As far as is known, XYVION has no effect on alertness and concentration
Looking after your medicine
  • Store XYVION in the original packaging, below 25°C, in a cool, dry place and protect from light.
  • Keep XYVION in a safe place out of the reach of children

For more information, see Section 5. What should I know while using XYVION? 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

Xyvion

Active ingredient

Tibolone

Schedule

S4

 

1 Name of Medicine

Tibolone.

2 Qualitative and Quantitative Composition

Each tablet containing 2.5 mg of the steroid tibolone.
List of excipients with known effect. Lactose.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Tablets.
Xyvion (tibolone) tablets 2.5 mg are 6 mm in diameter, white, round and flat with bevelled edges, coded "MK" above "2" on one side and "Organon" and a star on the reverse side.

4 Clinical Particulars

4.9 Overdose

The acute toxicity of tibolone in animals is very low. Therefore, toxic symptoms are not expected to occur if several tablets are taken simultaneously. In cases of acute overdose, nausea, vomiting, and withdrawal bleeding in females may develop. No specific antidote is known. Symptomatic treatment can be given if necessary.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Tibolone did not show any evidence of genotoxicity in assays for gene mutations, chromosomal damage and DNA damage.
Carcinogenicity. Tibolone treatment, similar to treatment with other sex hormones, in rodent studies demonstrated an association with the development of a range of tumours in long-term oral carcinogenicity studies. These included pituitary adenomas, mammary carcinomas and fibroadenomas, hepatic adenomas, uterine carcinoma, stromal polyps and stromal sarcoma, and carcinomas of the urinary bladder and testes.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Tibolone exists as white to almost white crystals or crystalline powder. Tibolone is related to and derived from naturally occurring steroids. It is optically pure and has the D-configuration. It is practically insoluble in water, aqueous acid or alkali at 20°C.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSTIBOLO.gif Molecular formula C21H28O2.
Molecular mass 312.45.
Chemical name. (7α, 17α) - 17 - hydroxy-7-methyl-19-norpregn-5 (10)-en-20-yn-3-one.
Other name. 17α-ethynyl-17-hydroxy-7α-methyl-5(10)-estren-3-one.
CAS number. 5630-53-5.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine (Schedule 4).

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/XYVIONST.gif