Tibolone 2.5 Mg Tablets
teva uk Ref; 231-30-45008-A LEA TIBOLONE 2.5mg TABS TUK <CHEMO Version; 4 13 June 2014
TIBOLONE 2.5 mg TABLETS
package leaflet: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
what IS in this leaflet:
1. What Tibolone is and what it is used for
2. What you need to know before you take Tibolone
3. How to take Tibolone
4. Possible side effects
5. How to store Tibolone
6. Contents of the pack and other information
What Tibolone is and what it is used for
Tibolone belongs to a group of medicinal products that are used in hormone replacement therapy (HRT).
Tibolone can relieve symptoms of the menopause (the change of life) whether occurring naturally or as a result of surgery in postmenopausal women. There is limited experience in treating women over the age of 65 years. It can also be used to prevent osteoporosis (thinning of the bones) if you are at high risk of future fractures and you are unable to take other medicines for this purpose.
At menopause (or after removal of the ovaries) the body's production of the female hormone oestrogen is considerably reduced. Symptoms of oestrogen 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.
A shortage of oestrogen may cause osteoporosis (thinning of the bones). The bones become brittle as you get older and break more easily. Tibolone may be used to prevent osteoporosis if you are unable to take other medicines for this purpose.
You and your doctor should discuss the benefits and risks of Tibolone and the other alternative therapies.
What you need to know before you take Tibolone
Do not take Tibolone if you:
• are allergic to Tibolone or any of the other ingredients of this medicine (listed in section 6)
• are pregnant, or may become pregnant
• have, or have had breast cancer
• have, or have had another type of cancer (particularly one which is 'hormone dependent')
• have ever had a blood circulation disorder such as blood clots in the veins of the legs or in the lungs
• have ever had a heart condition such as angina or a heart attack
• suffer from unusual vaginal bleeding
• suffer from an hereditary condition called porphyria
• suffer from severe liver disease or a history of liver disease as long as liver function tests have failed to return to normal
• have abnormal growth of the lining of the womb (endometrial hyperplasia)
• have had a history of stroke.
Warnings and precautions
Talk to your doctor or pharmacist before taking Tibolone.
Tibolone will not protect you from pregnancy.
As well as benefits, HRT has some risks which you need to consider when you are deciding whether to take it, or whether to carry on taking it.
Medical check-ups
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/pain, vaginal itching/discharge/thrush or examine 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 at any time during these check-ups discovers you have any of the symptoms described in the section "Do not take Tibolone" experience a problem with your liver, increased blood pressure or onset of migraine-type headaches, they may decide to stop you taking Tibolone.
Be sure to:
• go for regular breast screening and cervical smear tests
• regularly check your breasts for any changes such as dimpling of the skin, changes in the nipple, or for any lumps you can see or feel.
Your doctor may need to keep a close watch on you if you have, or have ever had, any of the following conditions:
• uterine (womb) fibroids or endometriosis
• blood clots or risk factors for it
• relatives who have had blood clots
• close relatives (mother, sister, grandmother) who have had breast cancer
• high blood pressure
• liver disease
• high cholesterol levels
• diabetes
• gallstones
• a rare disease called systemic lupus erythematosus
• epilepsy
• asthma
• migraine
• otosclerosis (a hearing disorder).
If any of the above apply to you, talk to the doctor as soon as you can before taking Tibolone. They may want to do some tests, or give you more advice about taking Tibolone.
Effects on your heart or circulation Heart disease
HRT is not recommended for women who have heart disease, or have had heart disease recently. If you have ever had heart disease, talk to your doctor to see if you should be taking HRT. There is no evidence that HRT will prevent a heart attack.
If you get:
A pain in your chest that spreads to your arm or neck, see a doctor as soon as possible and do not take any more HRT until your doctor says you can. This pain could be a sign of heart disease. Stroke
Some studies have shown that the use of HRT slightly increases the risk of stroke. The absolute risk increase is 2.3 strokes per 1000 women treated per year. If you have already had a stroke, talk with your doctor about whether the benefits of the treatment outweigh the possibly enhanced risk.
Compare
Looking at women in their 50s who are not taking HRT - on average, over a 5-year period, 3 in 1000 would be expected to have a stroke.
For women in their 50s who are taking HRT, the figure would be 4 in 1000.
Looking at women in their 60s who are not taking HRT - on average, over a 5-year period, 11 in 1000 would be expected to have a stroke.
For women in their 60s who are taking HRT, the figure would be 15 in 1000.
Looking at women in their 50s who are not taking Tibolone - on
average, over a 5-year period, 3 in 1000 would be expected to have a stroke. For women in their 50s who are taking Tibolone, the figure would be 7 in 1000 (i.e. an extra 4 cases).
Looking at women in their 60s who are not taking Tibolone - on average, over a 5-year period, 11 in 1000 would be expected to have a stroke. For women in their 60s who are taking Tibolone, the figure would be 24 in 1000 (i.e. an extra 13 cases).
If you get:
Unexplained migraine-type headaches, with or without disturbed vision, see a doctor as soon as possible and do not take any more HRT until your doctor says you can. These headaches may be an early warning sign of a stroke.
Blood clots
HRT may increase the risk of blood clots in the veins (also called deep vein thrombosis, or DVT), especially during the first year of taking it.
These blood clots are not always serious, but if one travels to the lungs, it can cause chest pain, breathlessness, collapse or even death. This condition is called pulmonary embolism or PE. DVT and PE are examples of a condition called venous thromboembolism, or VTE.
You are more likely to get a blood clot:
• if you are seriously overweight
• if you have had a blood clot before
• if any of your close family have had blood clots
• if you have had one or more miscarriages
• if you have any blood clotting problem that needs treatment with a medicine such as warfarin
• if you're off your feet for a long time because of major surgery, injuries or illness
• if you have a rare condition called systemic lupus erythematosus (SLE).
If any of these things apply to you, talk to your doctor to see if you should take HRT.
Compare
Looking at women in their 50s who are not taking HRT - on average, over a 5-year period, 3 in 1000 would be expected to get a blood clot.
For women in their 50s who are taking HRT, the figure would be 7 in 1000.
Looking at women in their 60s who are not taking HRT - on average, over a 5-year period, 8 in 1000 would be expected to get a blood clot.
For women in their 60s who are taking HRT, the figure would be 17 in 1000.
With use of Tibolone, the increased risk of getting a blood clot in a vein is lower than with other types of HRT
If you get:
• painful swelling in your leg
• sudden chest pain
• difficulty breathing.
See a doctor as soon as possible and do not take any more HRT
until your doctor says you can. These may be signs of a blood clot.
If you're going to have surgery, make sure your doctor knows about it. You may need to stop taking HRT about 4 to 6 weeks before the operation, to reduce the risk of a blood clot. Your doctor will tell you when you can start taking HRT again.
Effects on your risk of developing cancer Breast cancer
Women who have breast cancer, or have had breast cancer in the past, should not take HRT or Tibolone.
Taking HRT slightly increases the risk of breast cancer; so does having a later menopause. The risk for a post-menopausal woman taking oestrogen-only HRT for 5 years is about the same as for a woman of the same age who is still having periods over that time and not taking HRT The risk for a woman who is taking oestrogen plus progestogen HRT is higher than for oestrogen-only HRT and for tibolone (but oestrogen plus progestogen HRT is beneficial for the endometrium, see 'Endometrial cancer' below).
For all kinds of HRT, the extra risk of breast cancer goes up the longer you take it, but returns to normal within 5 years after stopping HRT
Your risk of breast cancer is also higher:
• if you have a close relative (mother, sister or grandmother) who has had breast cancer
• if you are seriously overweight.
Compare
Looking at women aged 50 who are not taking HRT - on average, 32 in 1000 will be diagnosed with breast cancer by the time they reach the age of 65.
For women who start taking oestrogen-only HRT at age 50 and take it for 5 years, the figure will be between 33 and 34 in 1000 (i.e. an extra 1-2 cases).
If they take oestrogen-only HRT for 10 years, the figure will be 37 in 1000 (i.e. an extra 5 cases).
For women who start taking oestrogen plus progestogen HRT at age 50 and take it for 5 years, the figure will be 38 in 1000 (i.e. an extra 6 cases).
If they take oestrogen plus progestogen HRT for 10 years, the figure will be 51 in 1000 (i.e. an extra 19 cases).
Women taking Tibolone have a lower risk than women using combined HRT and a comparable risk with oestrogen-only HRT.
If you notice any changes in your breast, such as:
• dimpling of the skin
• changes in the nipple
• any lumps you can see or feel.
Make an appointment to see your doctor as soon as possible.
Endometrial cancer (cancer of the lining of the womb)
Taking oestrogen-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 oestrogen helps to lower the extra risk. If you still have your womb, your doctor may prescribe a progestogen as well as oestrogen. If so, these may be prescribed separately, or as a combined HRT product or tibolone.
If you have had your womb removed (a hysterectomy), your doctor will discuss with you whether you can safely take oestrogen without progestogen.
If you have had your womb removed because of endometriosis,
any endometrium left in your body may be at risk. So your doctor may prescribe HRT that includes a progestogen as well as an oestrogen. Because Tibolone is slightly different from most HRT (see section 1. 'What Tibolone is and what it is used for'), you do not need to take a separate progestogen when you are taking Tibolone.
There have been reports of an increased cell growth or cancer of the lining of the womb in women using Tibolone. The risk of cancer of the lining of the womb increases the longer you take the medicine.
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 have been on HRT for a while
• carries on even after you have stopped taking HRT
Make an appointment to see your doctor. It could be a sign that your endometrium has become thicker.
Ovarian cancer
Ovarian cancer (cancer of the ovaries) is very rare, but it is serious. It can be difficult to diagnose, because there are often no obvious signs of the disease.
Some studies have indicated that taking oestrogen-only HRT for more than 5 years may increase the risk of ovarian cancer. It is not yet known whether other kinds of HRT increase the risk in the same way. With use of Tibolone, the increased risk of ovarian cancer is similar to other types of HRT.
Dementia
HRT will not prevent memory loss. In one study of women who started using combined HRT after the age of 65, a small increase in the risk of dementia was observed.
Other medicines and Tibolone
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is particularly important if the other medicine is:
• medicine used to treat epilepsy (fits) such as barbiturates, carbamazepine or phenytoin
• rifampicin (used to treat tuberculosis)
• medicines used to treat blood clots (thrombosis) e.g. warfarin/anticoagulant/blood thinning tablets
• herbal preparations containing St.John's wort.
Pregnancy, breast-feeding and fertility
Do not use Tibolone during pregnancy and lactation. If pregnancy occurs during medication with Tibolone, stop taking this medicine immediately.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Tibolone is not known to have any effects on alertness and concentration.
Tibolone contains lactose
The tablet contains a small amount of lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
How to take Tibolone
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is one tablet every day.
Tibolone should be swallowed without chewing with some water. Take your tablet at the same time every day.
You should not take Tibolone until at least 12 months after your last natural menstrual bleed (period).
If you have had your womb and ovaries removed or are being treated with drugs known as gonadotrophin releasing hormone (GnRH) analogues, for conditions such as endometriosis, you can start taking Tibolone immediately.
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 oestrogen or an oestrogen and a progestogen. With some you have a period, and with some you do not (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 and adolescents
Tibolone should not be taken by children.
If you take more Tibolone than you should
It is important not to take too many tablets. Contact your nearest hospital Accident and Emergency department or a doctor for
advice if you have swallowed too many tablets or if you think a child has swallowed any. Symptoms of overdose may include nausea, vomiting and vaginal bleeding in women and young girls. Take this leaflet and any of the remaining tablets with you to show the doctor.
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 are 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. Otherwise the problem might come back.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
^ Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking this medicine and tell your doctor immediately if you get yellow skin (jaundice) or develop symptoms of a blood clot which are the following:
• coughing up blood
• sudden,severe headache
• weakness or numbness in an arm or leg
• sudden discolouration of your skin
• slurred speech
• unusual pains or swelling of your arms or legs
• pains or feelings of heaviness in your chest
• sudden shortness of breath
• dizziness or fainting
• if your liver test becomes abnormal or if you develop jaundice, your doctor may stop your treatment
• sudden disturbances to your vision.
Stop taking this medicine and tell your doctor immediately if you experience any of the following side effects:
Common: may affect up to 1 in 10 people
• unusual vaginal bleeding or spotting, vaginal itching, discharge or thrush.
Not known: frequency cannot be estimated from the available data
• migraine
• swelling of your ankles.
If you experience any of the following other side effects tell your doctor:
Common: may affect up to 1 in 10 people
• weight increase
• stomach-ache
• increased body hair growth
• breast tenderness or pain.
Uncommon: may affect up to 1 in 100 people
• loss of memory.
Not known: frequency cannot be estimated from the available data
• headaches
• disturbances in vision (including blurred vision)
• skin problems such as spots, rash or itching
• feeling sick
• feeling depressed
• pains in your muscles or joints.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
How to store Tibolone
Keep this medicine out of the sight and reach of children.
Do not use this medicine 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.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
^ Contents of the pack and other information
What Tibolone contains
• The active substance is tibolone.
• Each tablet contains 2.5 mg of tibolone.
• The other ingredients are Lactose monohydrate, Maize starch pregelatinized, Ascorbyl palmitate (E304), Sodium citrate, Sodium laurilsulfate, Croscarmellose sodium, Magnesium stearate. See section 2, 'Tibolone contains lactose'.
What Tibolone looks like and contents of the pack
Tibolone 2.5 mg Tablets are round, white to off white, 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
TEVA UK Limited, Eastbourne BN22 9AG, UK
Manufacturer
Norton (Waterford) Limited T/A IVAX Pharmaceuticals Ireland T/A Teva Pharmaceuticals Ireland, Unit 27/35 IDA Industrial Park, Cork Road, Waterford, Ireland.
This leaflet was last revised in 06/2014.
PL 00289/1401
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TEVA UK LIMITED 510 X 222