Livial 2.5 mg. 28 tablets

The active substance is: tibolone (tibolone).
• Excipients include: potato starch, lactose, ascorbyl palmitate, and magnesium stearate.

• Livial 2,5 mg tablets are white and marked "MK2" on one side and "Organon" the other side. The tablets are packaged in cartons containing one or three packs of 28 tablets.


1. WHAT IS Livial AND WHAT IT IS USED
Livial belongs to a group of medicines called hormone - replacement therapy (HRT). During menopause (or after surgery to remove the ovaries), the production of the female hormone estrogen stops. This can cause symptoms such as hot flushes, night sweats, vaginal inflammation, depression and loss of sexual desire. Livi can be used to treat the symptoms of menopause. Especially if you are older than 60 years, your doctor should discuss the benefits and risks of implementing Livia. Relief of symptoms usually starts within a few weeks, but optimal results are obtained after at least three months of lechenie.Ponizhavaneto of sex hormones can lead to thinning of the bones (osteoporosis). If you are at increased risk of fractures due to osteoporosis, but can not take other treatments or if other therapies have proven ineffective, you can also use Livial.V point 6 will find more information about how Livio and what it is used.

2. BEFORE YOU TAKE LIVIAL

Do not take Livial if:
• Are pregnant or think you may be pregnant
• Breast milk
• Have or have had, or is likely to have breast cancer
• You have or may have estrogen-dependent tumor such as cancer of the uterine lining
• You have abnormal vaginal bleeding, which was not tested by your doctor
• Do aberrant growth of the uterine lining (endometrial hyperplasia)
• You have or have had a blood circulation disorder such as blood clots (in the veins of the legs or the lungs)
• You had heart problems such as angina or heart attack
• You have had a stroke or flick without residual effects
• You have or have had liver disease and liver functions are not normalized
• Are allergic to tibolone or any of the other ingredients of Livia
• You have porphyria (an inherited disease)

Be especially careful with Livial
Besides the positive results of its use, HRT carries risks which need to be aware of before you decide whether to use or continue to use and.

Medical examinations
Before starting HRT, tell your doctor about your current and past health, and health problems in your family. Your doctor may examine your chest and / or abdomen, and explore your internal organs. Along with this, you will be scheduled periodic medical examinations and especially reviews gardite.Sled starting HRT periodically (at least once a year) You should be conducted medical examination during which your doctor will discuss with you the benefits and risks of continuing HRT.
Certain health problems may be exacerbated / degraded due to HRT. If you have suffered or are suffering from any of these diseases, talk to your doctor, who will closely monitor your condition: fibroid growth, endometriosis, blood clots in the blood vessels if you or a member of your family has had estrogen-dependent cancer, e. a close relative who has had breast cancer or cancer of the uterine lining, high blood pressure, liver disease, diabetes, gallstones, migraine or (severe) headache Systemic lupus erythematosus (rare condition) over endometrial hyperplasia, epilepsy, asthma, otosclerosis (inherited deafness). Tell your doctor if you notice changes in your condition during the use of Livia. HRT can sometimes cause fluid retention.
Livi not contraceptive and can not be used to prevent pregnancy


Immediately stop using Livial at:
• Jaundice (yellowing of the skin)
• Sudden increase in blood pressure
• Migraine or severe headache, which have not suffered so far


Influence on the risk of cancer induction
Endometrial cancer (cancer of the uterine lining)
There are reports and studies for growth of uterine cells or cancer of the uterine lining in women using Leavitt. The risk of endometrial cancer increases with duration of administration of the product. If you get breakthrough bleeding or spotting, it is usually not a cause for concern, especially during the first few months of taking HRT.
But if the bleeding or spotting:
• lasts more than 6 months
• occur after you are eligible for six months
• continue even after stopping HRT
Ask your doctor. They may be a sign that the endometrium has grown.


Breast cancer
Women with breast cancer, or those who have had breast cancer, should not take HZT.Priemaneto estrogen or estrogen-progestogen combined HRT or Livi a period of several years slightly increases the risk of breast cancer. The risk increases with increasing duration of HRT and normalize to about five years after its termination. Women eligible, have a lower risk of breast cancer than women who used combined HRT, and with approximately the same risk as women using estrogen only HRT. In women between the ages of 50 and 64 years of age who are not using HRT, 32 per 1000 will be diagnosed with breast cancer. In 1000 women who are eligible for a period of five years, can register two additional cases of breast cancer and in women eligible for 10 years - 5 additional cases. Periodically inspect your breasts for changes, such as dents in the skin, changes in nipple or lumps that you can see or feel.

Ovarian Cancer
Ovarian cancer occurs very rare but very serious. It can be found difficult because there is often no obvious symptoms of the disease.
Some studies have shown that taking only estrogen HRT for a longer period of 5 years increases the risk of ovarian cancer. It is not yet known whether other types of HRT increase the risk accordingly.

Effects on heart and circulation
Heart disease
HRT is not recommended for women who are now or have recently had heart disease. If this is the case, discuss with your doctor whether to take HRT. HRT does not help prevent heart disease.
Studies of type HRT (containing progestagen and estrogen related MPA) show that women are probably marginally more prone to heart disease in the first year of taking medication. For other types of HRT risk may be similar, although this is not proven yet.

If you feel:
• Pain in the chest, covering the upper arms or neck Visit as soon as your doctor and stop taking HRT until it your resolve. The pain may be a symptom of heart disease.

Stroke
A recent study shows that HRT and Livia increase the risk of stroke. This increased risk is mainly observed in older postmenopausal women aged 60 and over.
In women aged 50-59 years who do not use HRT, it is expected every 5 years, an average of 3 per 1,000 suffer from stroke. In women aged 50-59 years who use HRT, 7 of 1000 is likely to get a stroke.
In women aged 60-69 years who do not use HRT, every five years, is expected an average of 11 in 1000 to get hit. In women between the ages of 60-69 years who were undergoing HRT medium 24 1000 is likely to have a stroke.
If you are experiencing:
• Unclear headaches (migraine) with or without impaired vision
Visit as soon as your doctor and stop taking HRT until he advises you to restart treatment. The pain can be a warning sign of a possible stroke.

Blood clots
Estrogen HRT and estrogen-progestogen combined HRT may increase the risk of venous blood clots (ie. Deep vein thrombosis - DVT), especially during the first year of treatment. It is not known whether Livia increases the risk accordingly. These blood clots are not always serious, but if one of them reaches the lungs, it can cause chest pain, shortness of breath, fainting, and even death. This condition is known as pulmonary embolism (WAS). DVT and PE are examples of a condition called venous thromboembolism (VTE). The risk of blood clot formation is higher if:
• you are severely overweight
• You have ever had similar conditions
• A member of your family has ever had such conditions
• If you have had one or more miscarriages
• If you had any health problems related to blood clots that were treated with drugs such as warfarin
• If you have been a long time in bed because of major surgery, injury or illness
• If you suffer from a rare disease systemic lupus erythematosus

If any of these apply to you, talk to your doctor to determine if HRT is not contraindicated for you.
In women aged 50-59 years who do not use HRT, it is expected every 5 years, on average 3 in 1000 to have problems with the formation of blood clots. In women aged between 50-59 years, that HRT, is expected every 5 years, on average 7 of 1000 to have problems associated with the formation of blood clots. In women aged 60-69 years who do not use HRT, every five years, is expected to average 8 1000 to have problems with the formation of blood clots. In women aged between 60-69 years, that HRT, is expected every 5 years, on average 17 1,000 have problems associated with the formation of blood clots.

If you feel:
• Painful swelling in the legs
• Sudden chest pain
• Difficulty in breathing
Visit as soon as your doctor and stop HRT until it your resolve. Some of these conditions may be a sign formed kravosasirek.Ako will undergo surgery, tell your doctor. You may need to stop HRT 4 to 6 weeks before surgery to reduce the risk of a blood clot. Your doctor will tell you when you can resume taking HRT.
Adoption of Livia with food and drinks.
You can eat normally and to drink fluids while taking Livia.


Pregnancy and lactation

Ask your doctor or pharmacist before taking any lekarstvo.Ne Livia take if you are pregnant or breast-feeding or think you may be pregnant.


Ability to drive and use machines
Insofar as is known, Livia has no effect on alertness and concentration.


Important information about some of the ingredients of Livia
Livia tablets contain lactose. Tell your doctor or pharmacist if you react badly to lactose or milk.


Using other medicines
Other drugs can affect the action of Livy Livy or can influence the effect of other drugs. Tell your doctor or pharmacist if you are taking (or plan to start taking) any other medicines, especially:
• Medicines for thrombotic problems such as warfarin, as your doctor may change the dose of these medicines do not forget to inform and medicines without prescription.



3. HOW TO TAKE LIVIAL
Livial taken orally. Take one tablet daily, her swallow a little water or other liquid. Take the tablet at the same time each day. Blisters with Livia are marked with the days of the week. Start with the tablet corresponding to each day of the week. For example, if you start on Monday, take a tablet from the top row marked with Monday. Follow the days of the week while spending blister. Start a new blister on the next day. Do not pause between the intake of blister or packaging.
Livial should not be taken earlier than 12 months after the last menstrual bleeding. If you take Livia rather increases the likelihood of irregular vaginal kravotecheniya.Informirayte your doctor immediately if you think that the effect of Livia is too strong or too weak.

If you take more than necessary Livial:
Tell your doctor or pharmacist immediately if you take more than Livia neobhodimoto.Nyama need to worry if adopted several tablets at once, but you should immediately consult your doctor. Symptoms of overdose may include feeling sick, unwell or vaginal bleeding.

If you forget to take Livial:
If you forget to take a dose, take it as soon as you remember, but only if you have not forgotten for more than 12 hours. If you miss more than 12 hours, skip the tablet and take the next. Do not take a double dose if you forget to take a tablet.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Livial can cause side effects. Most of these side effects are not highly izrazeni.Chesti adverse reactions observed in clinical trials (registered in 1-10% of women eligible) were:
• Vaginal bleeding or spotting
• Pain in the abdomen
• weight gain
• Chest pain
• Unnatural hair
• vaginal symptoms, such as secretion, itching and inflammation

An uncommon side effect (recorded at 0.1-1% of women eligible) or acne.
Other side effects reported with the use of Livia, were:
• Dizziness, headache, migraine, depression
• rash or itching
• Visual disturbances
• Gastrointestinal disorders
• Fluid retention
• Pain in muscles and joints
• Changes in liver function
Have been reported cases of breast cancer and increased cell growth or endometrial cancer in women using Livi.
Tell your doctor if you experience vaginal bleeding or spotting, or if any of the side effects listed above become bothersome or izchezva.Drugi side effects that can occur when taking estrogen-progestogen combined HRT are :
• Benign and malignant hormone-dependent tumors
• Blood clots in the veins
• Heart attack or stroke
• Diseases of bile
• Skin problems such as rashes, discoloration or red spots on the skin
• dementia (deterioration of mental activity, characterized by loss of memory)
If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.


5. HOW TO STORE Livial
Keep Livio of the reach of children.
Keep your tablets in the original Leavitt secondary packaging at under 25 ° S.Check package for special storage requirements.
Do not use Livial after the expiry date stated on the packaging.