Livial 2.5 mg Tablet 28pcs

Product Description:

• Livial is a preparation used for hormone replacement therapy (Hormone Replacement Therapy), which is abbreviated as HRT.
• Livial contains tibolone, a substance that has effects on various tissues in the body, such as the brain, vagina and bones. 
• Livial is used for postmenopausal women (women after menopause) who have had their last natural period at least 12 months ago.

Livial is used for:

Alleviation of symptoms that occur after menopause:

• During menopause , the amount of estrogen produced decreases. 
• This can cause hot flushes such as heat in the face, neck and chest. 
• Livial relieves these symptoms after menopause. 
• You will only be prescribed Livial if the symptoms seriously hamper your daily life.

Prevention of osteoporosis:

• After the menopause , some women may develop bone fragility ( osteoporosis ).
• You should discuss all available treatment options with your doctor.
• If you have an increased risk of fractures due to osteoporosis and other medicines are not suitable for you, you can use Livial to prevent osteoporosis after menopause .
• In section 6 you will find more information about Livial and what it is used for.

How to use:

• Always use this medicine exactly as your doctor has told you. 
• Contact a doctor or pharmacist if you are unsure.

Livial is for oral use.

 The recommended dose is:

• 1 tablet daily. Swallow the tablet with a little water or other drink. 
• Take the tablet at the same time every day.
• The trays with Livial are marked with days of the week. 
• Start by taking the tablet marked with the relevant day of the week.
• If it e.g. is Monday, you take a tablet marked Monday from the top row of the board. 
• Follow the days of the week until the board is empty. Start on the next board the following day.
• Do not take a break between trays or boxes.
• Livial should not be taken until twelve months have passed since your last natural period. 
• If Livial is taken earlier than this, the risk of irregular abdominal bleeding may increase.
• Your doctor's intention will be to prescribe the lowest dose necessary to treat your symptoms for as short a period as necessary.
• Talk to your doctor if you think the dose is too strong or not strong enough.

If you take too much Livial:

• Contact a doctor or hospital if you have ingested too much medication or if a child has ingested medication by accident. 
• For other questions about the medicine, contact your doctor or pharmacist.
• Signs of overdose can be nausea , vomiting or bleeding from the vagina.

If you have forgotten to take Livial:

• You should not take a double dose to make up for a missed dose.
• If you forget to take a tablet, take it as soon as you remember if you are not more than 12 hours late. 
• If you are more than 12 hours late, just skip that tablet.

If you are going to have surgery:

• If you are going to have surgery, tell the surgeon that you are taking Livial.
• You may need to stop taking Livial about 4 to 6 weeks before surgery to reduce the risk of a blood clot.
• Talk to your doctor about when you can start taking Livial again.

Warnings and precautions:

Do not use Livial:

• If any of the following applies to you. If you are unsure about any of the points below , you must talk to your doctor before taking Livial.

Do not use Livial if you:

• have or have ever had breast cancer , or are suspected of having it,
• have , or are suspected of having, cancer that is sensitive to oestrogens , such as cancer of the lining of the womb (endometrium),
• have unexplained abdominal bleeding,
• have significant thickening of the lining of the uterus (endometrial hyperplasia) which is not being treated,
• have or have ever had a blood clot in a vein ( thrombosis ), such as in the legs ( deep vein thrombosis ) or in the lungs ( pulmonary embolism ),
• have a blood coagulation disorder (such as a lack of protein C, protein S or antithrombin),
• have or have recently had a disease caused by blood clots in the arteries, such as a heart attack , stroke or angina ( heart spasm ),
• have or have ever had a liver disease and the liver function tests are not normalised,
• have a rare blood problem called " porphyria " which is passed down in families (hereditary),
• are allergic to tibolone or any of the other ingredients of this medicine
• are pregnant or think you may be pregnant, breastfeed.
• If any of the conditions above occur for the first time while you are taking Livial, you must stop taking it immediately and talk to your doctor immediately.
• Tell your doctor before starting treatment if you have had any of the following problems, because they may return or worsen during treatment with Livial. 

If this happens, you should visit your doctor more often:

• uterine fibroids (benign tumors),growth of the endometrium outside the uterus ( endometriosis ) or significant growth of the endometrium in the medical history (endometrial hyperplasia),increased risk of developing a blood clot (see "Blood clot in a vein ( thrombosis )"),increased risk of getting an estrogen -sensitive cancer (for example, when first-degree relatives such as mother, sister or grandmother have had breast cancer ),high blood pressure ,a liver disease, such as benign liver tumor,diabetes,gallstone,migraine or severe headache,a disease of the immune system that affects many of the body's organs (systemic lupus erythematosus, SLE),epilepsy ,asthma ,a disease affecting the eardrum and hearing (otosclerosis),a very high level of fat in the blood (triglycerides),fluid accumulation in the body due to heart or kidney disease.

Stop taking Livial and contact a doctor immediately

If you notice any of the following while taking Livial or other HRT:

• Any of the conditions mentioned in the section "Do not use Livial",
• Yellowing of the skin or the whites of the eyes ( jaundice ). This may be a sign of a liver disease).
• A sharp increase in blood pressure (symptoms may be headache, fatigue, dizziness),
• Migraine-like headache that occurs 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.
• Breathing difficulties.

NB : Livial is not a contraceptive.

• If it has been less than 12 months since your last period or you are younger than 50, you may still need to use additional contraception to avoid pregnancy. 
• Talk to your doctor.
• HRT and cancerSignificant thickening of the lining of the uterus (endometrial hyperplasia) and cancer of the lining of the uterus (endometrial cancer)
• There have been reports and studies of increased cell growth or cancer in the lining of the uterus in women who use Livial. 
• The risk of endometrial cancer increases with the duration of treatment.

Irregular bleeding:

You may have irregular bleeding or spotting in the first 3-6 months you take Livial.

But if the irregular bleeding:

• continues beyond the first 6 months.
• starts after you have used Livial for more than 6 months.
• continues after you stop taking Livial.

See your doctor as soon as possible .

Breast cancer:

Research shows that the use of tibolone increases the risk of breast cancer .

• The increased risk depends on how long you use tibolone. 
• After stopping HRT treatment in studies, the increased risk decreased over time, but the risk may persist for 10 years or more in women who have used HRT for more than 5 years. 
• No data regarding the duration of the risk after the end of treatment are available for tibolone, but a similar course cannot be excluded.
• Women taking Livial have a lower risk of developing breast cancer than women using oestrogen/progestogen HRT combinations, and a risk comparable to the use of oestrogen-only HRT.

Ovarian cancer:

• you are very overweight ( BMI > 30 kg/m²),
• you have a problem with blood clotting that requires long-term treatment with a medicine used to prevent blood clots,
• if one of your close relatives has ever had a blood clot in the leg, lung or other organ,
• you have systemic lupus erythematosus (SLE),
• you have cancer .

Intake of Livial together with food and drink:

• You can eat and drink as usual while taking Livial.

Pregnancy, breastfeeding and fertility:

• Livial should only be used by women after menopause (postmenopausal women). 
• If you become pregnant, you must stop taking Livial and contact your doctor.

Driving and using machines:

• As far as is known, Livial has no effect on alertness and concentration.

Ingredients:

• The active substance is tibolone.