Tibolone 2.5 Mg Tablets
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Tibolone 2.5 mg tablets
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 of the side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
What is in this leaflet
1. What Tibolone Tablets is and what it is used for
2. What you need to know before you take Tibolone Tablets
3. How to take Tibolone Tablets
4. Possible side effects
5. How to store Tibolone Tablets
6. Contents of the pack and other information
1. What Tibolone Tablets is and what it is used for
Tibolone Tablets is a Hormone Replacement Therapy (HRT). Tibolone Tablets is used in postmenopausal women with at least 12 months since their last natural period.
Relief of symptoms occurring after menopause
During the menopause, the amount of oestrogen produced by a woman’s body drops. This can cause symptoms such as a hot face, neck and chest (“hot flushes”). Tibolone Tablets alleviates these symptoms after menopause. You will only be prescribed this medicine if your symptoms seriously hinder your daily life. Prevention of osteoporosis
After the menopause some women may develop fragile bones (osteoporosis). You should discuss all available options with your doctor.
If you are at an increased risk of fractures due to osteoporosis and other medicines are not suitable for you, you can use Tibolone Tablets to prevent osteoporosis after menopause.
2. What you need to know before you take Tibolone Tablets
Medical History and regular check-ups
The use of HRT or Tibolone Tablets carries risks that need to be considered when deciding whether to start taking it, or whether to carry on taking it.
Experience in treating women with a premature menopause (due to ovarian failure or surgery) is limited. If you have a premature menopause the risks of using HRT or Tibolone Tablets may be different. Please talk to your doctor.
Before you start taking (or restart) HRT or Tibolone Tablets
Your doctor will ask about your own and your family’s medical history. Your doctor may decide to perform a physical examination. This may include an examination of your breasts and /or an internal examination, if necessary.
Tell your doctor if you have any medical problems or illnesses. Regular check-ups
Once you have started on Tibolone Tablets, you should see your doctor for regular check-ups (at least once a year). At these check-ups, discuss with your doctor the benefits and risks of continuing with Tibolone Tablets.
Go for regular breast screening, as recommended by your doctor.
Do not take Tibolone Tablets
If any of the following applies to you do not take this medicine. If you are not sure about any of the points below, talk to your doctor before taking this medicine
• If you have or have ever had breast cancer, or if you are suspected of having it
• If you have cancer which is sensitive to oestrogens, such as cancer of the womb lining (endometrium), or if you are suspected of having it
• If you have any unexplained vaginal bleeding
• If you have excessive thickening of the womb lining (endometrial hyperplasia) that is not being treated.
• If you have or have ever had a blood clot in a vein (thrombosis), such as in the legs (deep venous thrombosis) or the lungs (pulmonary embolism)
• If you have a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency)
• If you have or recently have had a disease caused by blood clots in the arteries, such as a heart attack, stroke or angina
• If you have or have ever had a liver disease and your liver function tests have not returned to normal
• If you have a rare blood problem called “porphyria” which is passed down in families (inherited)
• If you are allergic (hypersensitive) to tibolone or any of the other ingredients of Tibolone Tablets (listed in section 6)
• If you are pregnant or think you might be pregnant.
• If you are breastfeeding.
If any of the above conditions appear for the first time while taking Tibolone Tablets, stop taking it at once and consult your doctor immediately.
If you have started the menopause you should not take Tibolone Tablets until 12 months after your last natural period. If you take it sooner than this you may have irregular bleeding.
Warnings and precautions
When to take special care with Tibolone Tablets
Tell your doctor if you have ever had any of the following problems,
before you start the treatment, as these may return or become worse
during treatment with Tibolone Tablets. If so, you should see your
doctor more often for check-ups:
• fibroids inside your womb
• growth of the womb lining outside your womb (endometriosis) or a history of excessive growth of the womb lining (endometrial hyperplasia)
• increased risk of developing blood clots (see “Blood clots in a vein (thrombosis)”)
• increased risk of getting an oestrogen-sensitive cancer (such as having a mother, sister or grandmother who has had breast cancer)
• high blood pressure
• a liver disorder, such as a benign liver tumour
• diabetes
• gallstones
• migraine or severe headaches
• a disease of the immune system that affects many organs of the body (systemic lupus erythematosus, SLE)
• epilepsy
• asthma
• a disease affecting the eardrum and hearing (otosclerosis)
• a very high level of fat in your blood (triglycerides)
• fluid retention due to cardiac or kidney problems
Stop taking Tibolone Tablets and see a doctor immediately If you notice any of the following when taking HRT or Tibolone Tablets:
• any of the conditions mentioned in the “Do not take Tibolone Tablets “ section
• yellowing of your skin or the whites of your eyes (jaundice). These may be signs of a liver disease
• a large rise in your blood pressure (symptoms may be headache, tiredness, dizziness)
• migraine-like headaches which happen for the first time
• if you become pregnant
if you notice signs of a blood clot, such as:
- painful swelling and redness of the legs
- sudden chest pain
- difficulty in breathing
For more information, see “Blood clots in a vein (thrombosis)”.
Note: Tibolone Tablets is not a contraceptive. If it is less than 12 months since your last menstrual period or you are under 50 years old, you may still need to use additional contraception to prevent pregnancy. Speak to your doctor for advice.
HRT and Cancer
Excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the lining of the womb (endometrial cancer)
There have been reports of increased cell growth or cancer of the lining of the womb in women using Tibolone Tablets. The risk of cancer of the lining of the womb increases the longer you take the medicine.
Irregular bleeding
You may have irregular bleeding or drops of blood (spotting) during the first 3-6 months of taking Tibolone Tablets. See your doctor as soon as possible if the bleeding or spotting:
• Carries on for more than the first 6 months
• Starts after you have been taking Tibolone Tablets for more than 6 months
• Carries on even after you’ve stopped taking Tibolone Tablets Breast Cancer
Evidence suggests that taking combined oestrogen-progestogen and possibly also oestrogen-only HRT increases the risk of breast cancer. The extra risk depends on how long you take HRT. The additional risk becomes clear within a few years. However, it returns to normal within a few years (at most 5) after stopping treatment.
Compare
Women taking Tibolone Tablets have a lower risk than women using combined HRT and a comparable risk with oestrogen-only HRT.
Regularly check your breasts. See your doctor as soon as possible if you notice any changes such as:
• Dimpling or sinking of the skin
• Changes in the nipple
• Any lumps you can see or feel
Ovarian Cancer
Ovarian cancer is rare. A slightly increased risk of ovarian cancer has been reported in women taking HRT for at least 5 to 10 years.
Compare
For women aged 50 to 69 who are not taking HRT, on average about 2 women in 1000 will be diagnosed with ovarian cancer over a 5-year period. For women who have been taking HRT for 5 years, there will be between 2 and 3 cases per 1000 users (i.e. up to 1 extra case).
With use of Tibolone Tablets, the increased risk of ovarian cancer is similar to other types of HRT.
Effect of HRT on heart and circulation Blood clots in a vein (thrombosis)
The risk of blood clots in the veins is about 1.3 to 3-times higher in HRT users than in non-users, especially during the first year of taking it.
Blood clots can be serious, and if one travels to the lungs, it can cause chest pain, breathlessness, fainting or even death.
You are more likely to get a blood clot in your veins as you get older and if any of the following applies to you. Inform your doctor if any of these situations apply to you:
• you are pregnant or recently had a baby
• you use oestrogens
• you are unable to walk for a long time because of major surgery, injury or illness (see also section 3, If you need to have surgery)
• you are seriously overweight (BMI >30 kg/m2)
• you have any blood clotting problem that needs long-term treatment with a medicine used to prevent blood clots
• if any of your close relatives has ever had a blood clot in the leg, lung or another organ
• you have systemic lupus erythematosus (SLE)
• you have cancer.
For signs of a blood clot, see “Stop taking Tibolone Tablets and see a doctor immediately”.
Compare
Looking at women in their 50s who are not taking HRT, on average, over a 5-year period, 4 to 7 in 1000 would be expected to get a blood clot in a vein.
For women in their 50s who have been taking oestrogen-progestogen HRT for over 5 years, there will be 9 to 12 cases in 1000 users (i.e. an extra 5 cases).
With the use of Tibolone Tablets, the increased risk of getting a blood clot in a vein is lower than with other types of HRT.
Heart disease (heart attack)
There is no evidence that HRT or Tibolone Tablets will prevent a heart attack.
Women over the age of 60 who use oestrogen-progestogen HRT are slightly more likely to develop heart disease than those not taking any HRT.
Stroke
The risk of getting stroke is about 1.5 times higher in HRT users than in non-users. The number of extra cases of stroke due to use of HRT will increase with age.
Compare
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).
Other conditions
HRT will not prevent memory loss. There is some evidence of a higher risk of memory loss in women who start using HRT after the age of 65. Speak to your doctor for advice.
Other medicines and Tibolone Tablets
Some medicines may interfere with the effect of Tibolone Tablets. This might lead to irregular bleeding. This applies to the following medicines:
• Medicines against blood clotting (such as warfarin)
• Medicines for epilepsy (such as phenobarbital, phenytoin and carbamazepin)
• Medicines for HIV infection (such as nevirapine, efavirenz, ritonavir and nelfinavir)
• Medicines for tuberculosis (such as rifampicin)
• Herbal remedies containing St John’s Wort (Hypericum perforatum).
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without a prescription, herbal medicines or other natural products.
Laboratory tests
If you need a blood test, tell your doctor or the laboratory staff that you are taking Tibolone Tablets, because this medicine can affect the results of some tests.
Tibolone Tablets with Food and Drink
You can eat or drink normally while you are taking Tibolone Tablets.
Pregnancy and Breast-Feeding
Tibolone Tablets are for use in postmenopausal women only. If you become pregnant, stop taking Tibolone Tablets and contact your doctor.
Driving and Using Machines
Tibolone Tablets have no known effect on the ability to drive or use machines.
Tibolone Tablets contain Lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using this medicinal product.
If you are worried about anything in this section, talk to your doctor about the risks and benefits of HRT.
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 Yellow Card Scheme (Website: www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Tibolone Tablets
3. How to take Tibolone Tablets
Always use Tibolone Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. How much Tibolone Tablets should you take and how often
Unless otherwise prescribed by the doctor, the usual dose is:
One tablet daily after a meal, preferably at the same time each day.
Your doctor will aim to prescribe the lowest dose to treat your symptoms for as short as necessary. Speak to your doctor if you think this dose is too strong or not strong enough.
Do not take a progestogen preparation in addition to Tibolone Tablets.
How to take Tibolone Tablets
You should take the tablets with a little water or other beverage, preferably at the same time every day.
What to take into account when you start treatment with Tibolone Tablets
If the menopause occurred naturally in your case, you should start taking Tibolone Tablets at the earliest 1 year after your last natural monthly bleeding. If your ovaries have been removed by surgery, you can start taking Tibolone Tablets immediately.
If you wish to start taking Tibolone Tablets and have had irregular or unexpected vaginal bleeding, please ensure that you contact the doctor who is treating you before starting Tibolone treatment, so that any malignant disease can be excluded.
If you wish to switch over to Tibolone Tablets from a medicinal product that contains an oestrogen and a progestogen, please ask your doctor what you should take into account.
If you need to have surgery
If you are going to have surgery, tell the surgeon that you are taking Tibolone Tablets. You may need to stop taking Tibolone Tablets about 4 to 6 weeks before the operation to reduce the risk of a blood clot (see section 2, ‘Blood clots in a vein’). Ask your doctor when you can start taking Tibolone Tablets again.
If you have the impression that the effect of the Tibolone Tablets is too strong or too weak, please consult your doctor or pharmacist.
If you take more Tibolone Tablets than you should
Toxic symptoms are unlikely even if several tablets are taken at the same time. In case of acute overdose, nausea, vomiting and withdrawal bleeding may occur. If necessary, please contact your doctor so that these symptoms can be treated.
If you forget to take Tibolone Tablets
If you forget to take a tablet at the usual time, you should take it as soon as possible unless more than 12 hours have passed since the time at which it was due. In this case, skip the missed tablet and take the next tablet at the usual time.
If you have any further questions on the use ofTibolone Tablets, please ask your doctor or pharmacist.
Keep this medicine out of the sight and reach of children.
Do not use Tibolone Tablets after the expiry date which is stated on the carton/blister pack after EXP: The expiry date refers to the last day of that month.
Do not use this medicine if you notice the blister pack is damaged or even missing, despite the package being intact.
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 protect the environment.
This medicinal product does not require any special storage conditions.
6. Contents of the pack and other information
What Tibolone Tablets contains
The active substance is Tibolone.
One tablet contains 2.5 mg Tibolone.
The other ingredients are:
Potato starch, lactose monohydrate, magnesium stearate, palmitoyl ascorbic acid.
What Tibolone Tablets look like and contents of the pack Tibolone Tablets are white to whitish, round tablets of approximately 6 mm diameter.
Tibolone Tablets are available in packs of 1 x 28 tablets and 3 x 28 tablets.
Marketing Authorisation Holder
Glenmark Pharmaceuticals Europe Limited,
Laxmi House, 2B Draycott Avenue,
Kenton, Middlesex, HA3 OBU.
United Kingdom
Manufacturer
Glenmark Pharmaceuticals Europe Limited,
Building 2, Croxley Green Business Park,
Croxley Green, Hertfordshire, WD18 8YA,
United Kingdom
This Package Leaflet was last revised in February 2014.
4. Possible side effects
Like all medicines, Tibolone Tablets can cause side effects, although not everybody gets them. Most side effects are mild.
The following diseases are reported more often in women using HRT compared to women not using HRT: breast cancer
abnormal growth or cancer of the lining of the womb (endometrial hyperplasia or cancer) ovarian cancer
blood clots in the veins of the legs or lungs (venous thromboembolism) heart disease stroke
probable memory loss if HRT is started over the age of 65 For more information about these side effects, see section 2.
Tell your doctor or pharmacist if you are worried about any side effects which you think may be due to Tibolone Tablets see also section 2 ‘Stop taking Tibolone Tablets and see a doctor immediately’
Serious side effects - see a doctor straight away
If you think you may have signs of a serious side effect, see a doctor straight away.
You may need to stop taking Tibolone Tablets:
If your blood pressure rises
If your skin or the whites of your eyes go yellow (jaundice)
If you suddenly have migraine-type headaches (see section 2 above)
If you have signs of a blood clot (see section 2 above)
If you get any of the problems listed in section 2 (Do not take Tibolone Tablets)
Other side effects
Common (affect up to 1 in 10 women): breast pain
stomach or pelvic pain unusual hair growth vaginal bleeding or spotting.
This is usually nothing to worry about in the first few months of taking HRT. If bleeding continues, or starts after you have been on HRT for a while see Section 2.
vaginal problems such as more secretions, itching, irritation and thrush
thickening of the lining of the womb or the lining of the cervix weight gain.
Uncommon (affects up to 1 in 100 women): acne
painful nipples or breasts feeling uncomfortable vaginal infections Some women taking Tibolone Tablets have also reported: depression, dizziness, headache joint pain or muscle pain skin problems such as rash or itching swollen hands, ankles or feet - a sign of fluid retention tummy upset
loss of vision or blurred vision changes in liver tests
There have been reports of breast cancer and of an increased cell growth or cancer of the lining of the womb in women using Tibolone Tablets.
Tell your doctor if any of the above mentioned side effects
continues or becomes troublesome.
The following side effects have been reported with other HRTs: gall bladder disease various skin disorders:
discolouration of the skin especially of the face or neck known as “pregnancy patches” (chloasma) painful reddish skin nodules (erythema nodosum) rash with target-shaped reddening or sores (erythema multiforme)
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