Tibolone 2.5 Mg Tablets
PACKAGE LEAFLET/ INFORMATION FOR THE USER
Tibolone 2.5 mg Tablets Tibolone
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If 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.
In this leaflet:
1. What Tibolone is and what is it used for
2. Before you take Tibolone
3. How to take Tibolone
4. Possible side effects
5. How to store Tibolone
6. Further information
1. WHAT TIBOLONE IS AND WHAT IS IT USED FOR
Tibolone belongs to a group of medicinal products that are used in hormone replacement therapy (HRT).
Tibolone is intended to treat symptoms of the menopause in post menopausal women whether occurring naturally or as a result of surgery.
At menopause the body’s production of the female hormone estrogen is considerably reduced. Symptoms of estrogen deficiency include hot flushes (sudden waves of heat and sweating in the whole body), sleeping problems, irritability and dryness of the vagina. Taking Tibolone can relieve these complaints and after a few weeks you should feel an improvement.
There is limited experience in treating women over age of 65 years
2. BEFORE YOU TAKE TIBOLONE
As well as benefits, HRT has some risks that you need to consider when you’re deciding whether to take it, or whether to carry on taking it.
Do not take Tibolone:
- If you are allergic (hypersensitive) to Tibolone or any of the other ingredients of Tibolone
- If you are pregnant or breast feeding
- If you have, or have had breast cancer
- If you have, or have had another type of cancer (particularly one which is ‘hormone dependent’)
- If you have ever had a blood circulation disorder such as blood clots in the veins of the legs or in the lungs
- If you have history of angina pectoris or heart attack such as myocardial infarction
- If you suffer from unusual vaginal bleeding
- If you suffer from porphyria (a hereditary disease)
- If you have a history of, or suffer from, severe liver disease if liver function tests are still abnormal
- If you suffer from endometrial hyperplasia (abnormal growth of the lining of the womb)
- If you have had a history of stroke.
Take special care with Tibolone Medical check-ups
You should not take Tibolone until at least 12 months after your last natural menstrual bleed (period).
Before treatment with Tibolone, your doctor should ask about your own and your family’s medical history.
Your doctor may decide to examine you for breast tenderness or pain, vaginal itching,
discharge or thrush/or your abdomen, and may do an internal examination
Once you have started on HRT, you should see your doctor for regular check-ups (at least
once a year). At these check-ups, your doctor may discuss with you the benefits and risks of
continuing to take HRT. If your doctor discovers, during these check-ups, that you have any of
the conditions or symptoms described below, he will decide whether you should stop
treatment.
Your doctor may regularly check your breasts, especially if you have a history of breast cancer or nodules. Be sure to go for regular breast screening; your doctor may also arrange for mammography if necessary. Check your breasts regularly for any changes such as dimpling of the skin, changes in the nipple, or any lumps you can see your feel. If such changes occur, consult your doctor.
Be sure to also go for regular cervical smear tests.
Compared to non treated women, women who are taking HRT, including tibolone, have an increased risk of developing blood clots (VTE or venous thrombo embolic disease), breast cancer or cancer of the uterus (womb) also known as endometrial cancer, cancer of the ovary, heart disease, stroke or dementia. Women at age of 60 are at greater risk of presenting these risks compared to women of age of 50; the risk increasing with age and the duration of treatment
Tell your doctor if you have history or have any of the following conditions. In these situations, the treatment is not contra-indicated but needs a careful follow-up:
• Uterine (womb) fibroids or endometriosis
• History of endometrial hyperplasia (abnormal growth of the lining of the womb)
• Personal or family history of blood clots or if a specific treatment such as warfarin is needed
• Close relatives (mother, sister, grandmother) who has had breast cancer
• High blood pressure
• Liver disease
• High cholesterol levels and high levels of other lipids
• Diabetes
• If you have heart disease or kidney disease
• Gallstones
• Systemic lupus erythematosus (SLE)
• Epilepsy
• Asthma
• Migraine
• Otosclerosis (a hearing disorder)
• History of one or more miscarriages
You are seriously overweight.
Tell or contact your doctor IMMEDIATELY if you experience any of the following symptoms:
• Sudden pain in the chest that spreads (or not) to your arm or neck, irregular heart rate, sudden breathlessness
• Unexplained migraine-type headaches, with or without disturbed vision, sudden disturbances to your vision, confusion, slurred speech, vertigo, loss of consciousness
• Unusual painful swelling in your legs, weakness of the legs or arms
• Changes in your breast such as dimpling of the skin, changes in the nipple or any lumps you can see or feel
• Allergic reactions such as breathlessness, chest pain, cutaneous eruption such as urticaria, itching
• Jaundice (yellow colour) of the skin and eyes
• A significant increase in blood pressure
• Pregnancy.
Tell your doctor if you are going for major surgery or will be off your feet for a long time because of injury or illness. Your doctor will tell you how to manage the treatment.
Taking estrogen-only HRT for a long time can increase the risk of cancer of the lining of
the womb (the endometrium). Taking a progestogen as well as the estrogen helps to lower the extra risk. Because Tibolone is slightly different from most HRT (see section ‘What Tibolone is and what is it used for’), you don’t need to take a separate progestogen when you are taking Tibolone.
If you get a breakthrough bleeding or spotting, it is usually nothing to worry about, especially during the first few months of taking HRT.
But if the bleeding or spotting:
• carries on for more than the first few months,
• starts after you’ve been on HRT for a while,
• carries on even after you’ve stopped taking HRT,
Tell your doctor immediately. It could be a sign that your endometrium has become thicker. Your doctor will tell you if additional examination is required.
Taking other medicines:
Some medicines can interfere with Tibolone. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is particularly important if the other medicine is:
• Warfarin (anticoagulant or medicines used to treat blood clots). Indeed, tibolone may enhance the effect of anticoagulants. Therefore, the simultaneous use of tibolone and warfarin should be monitored, especially when starting and stopping tibolone, and the warfarin dose should be appropriately adjusted.
• Barbiturates, carbamazepine or phenythoin (medicine used to treat epilepsy).
• Rifampicin (used to treat tuberculosis).
• Herbal preparations containing St. John's wort.
Pregnancy and breastfeeding:
Tibolone is not indicated during pregnancy and lactation. If pregnancy occurs during medication with Tibolone, treatment should be withdrawn immediately.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines:
Tibolone is not known to have any effects on alertness and concentration.
Important information about some of the ingredients of Tibolone:
If you are intolerant to some sugars especially lactose, contact your doctor before taking this medicine.
3. HOW TO TAKE TIBOLONE
Always take Tibolone exactly as your doctor has told you.
The usual dose is one tablet every day.
Tibolone should be swallowed without chewing with some water.
Take your tablet at the same time every day.
If you have never used HRT before, you can start taking Tibolone straight away. If you are changing over from another type of HRT - there are several different types of HRT, such as tablets, patches and gels. Most contain either estrogen or an estrogen and a progestogen. With some you have a period, and with some you don’t (period-free HRT).
If you are changing over from another type of HRT where you have a period, start taking Tibolone as soon as your period ends.
If you are changing over from a period-free HRT you can start taking Tibolone straight away. You can also start straight away if you are being treated for endometriosis.
Use in children:
Tibolone should not be taken by children.
If you take more Tibolone than you should:
Symptoms of overdose may include nausea, vomiting and vaginal bleeding in women and young girls.
Contact your doctor for advice if you have swallowed too many tablets or if you think a child has swallowed any.
Take this leaflet and any of the remaining tablets with you to show the doctor.
The symptoms disappear when the treatment is decreased or stopped.
If you forget to take Tibolone:
If you forget to take a tablet, take it as soon as you remember, unless you are more than 12 hours late. If you’re late by more than 12 hours, just skip the missed tablet.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Tibolone:
Do not stop taking Tibolone because you feel better without first talking to your doctor. It is important to take the medicine for as long as the doctor has told you to. Signs or symptoms of estrogen deficiency can reappear.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Tibolone can cause side effects, although not everybody gets them.
Common side effects (more than 1 in 100 but less than 1 in 10) reported with Tibolone include:
• Weight increase, increased body hair growth, stomach-ache, unusual vaginal bleeding or spotting, vaginal itching, discharge or thrush and breast tenderness or pain.
Uncommon side effects (more than 1 in 1000 but less than 1 in 100) reported with Tibolone include:
Loss of memory.
Other symptoms that have been reported include:
• Dizziness, headaches, migraine, swelling of your ankles, disturbances in vision (including blurred vision), skin problems such as spots, rash or itching, feeling depressed pains in your muscles or joints, liver tests abnormalities, jaundice and biliary disease.
If 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.
5. HOW TO STORE TIBOLONE
Keep out of the reach and sight of children.
Do not use Tibolone after the expiry date which is stated on the blister and carton after Exp. The expiry date refers to the last day of that month.
Store in the original package.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Tibolone contains:
• the active substance is tibolone
• each tablet contains 2.5mg of tibolone.
• the other ingredients are Lactose monohydrate, Maize starch pregelatinized, Ascorbyl palmitate (E304), Sodium citrate, Sodium laurilsulfate, Croscarmellose sodium, Magnesium stearate.
What Tibolone looks like and contents of the pack:
Tibolone 2.5 mg Tablets are round, white to off white tablets, flat bevelled edge tablets, coded ‘TIB’ on one side and ‘2.5’ on the reverse.
Tibolone 2.5 mg Tablets are available in pack sizes of 28, 30, 60, 84 and 100 tablets.
Not all pack sizes are marketed.
Marketing Authorisation Holder and Manufacturer:
IVAX Pharmaceuticals UK, Albert Basin, Royal Docks, London E16 2QJ.
PL Numbers
Tibolone 2.5 mg Tablets 0530/0771
Manufacturer: Norton Waterford T/A Ivax Pharmaceuticals Ireland, Unit 301, Industrial Park, Waterford, Ireland.
This leaflet was last approved in April 2007.