LIVIAL 2.5 mg. 84 tablets

WHAT IS LIVIAL AND WHAT IT IS USED FOR
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 may result in symptoms such as hot flushes, night sweats, vaginal inflammation, depression and loss of sexual desire. Livial can be used to treat menopausal symptoms. Especially if you are older than 60 years, your doctor should discuss with you the benefits and risks of using Livial. Symptoms relief usually begins within a few weeks, but optimal results are observed after at least three months of treatment. Sex hormones can also lead to thinning of the bone (osteoporosis). If you are at increased risk of osteoporosis fractures, but you can not take any other treatment or if other therapies have proven to be ineffective, you can also use Livial. In section 6, you will find more information on how Livial works and what it is used for Uses.

2. BEFORE YOU TAKE LIVIAL

Do not take Livial if:
• You are pregnant or think you may be pregnant
• Breastfeeding
• You have or have had or might have breast cancer
• You have or may have an estrogen-dependent tumor such as uterine mucosal cancer
• You have abnormal vaginal bleeding that has not been studied by your doctor
• You have atypical enlargement of the uterine lining (endometrial hyperplasia)
• You have or have had blood circulation disorders such as blood clots (in the veins of the legs or lungs)
• You have had heart problems such as a frog or a heart attack
• You have had a stroke or a light stroke without residual consequences
• You have or have had liver disease and liver function has not been normalized
• You are allergic to tibolone or any of the other ingredients of Livial
• Have porphyria (hereditary illness)

Be especially careful with Livial
Besides the positive results of its use, HRT hides risks that you need to know before deciding whether to use it or to continue using it.

Medical examinations
Before you start HRT, tell your doctor about your current and past health status as well as about the health problems in your family. Your doctor may examine your chest and / or the abdomen, as well as examine your internal organs. In addition, you will be scheduled to have periodic medical check-ups and especially breast examinations. After you start HRT, you should have periodic checkups (at least once a year) for medical check-ups during which your doctor will discuss with you the benefits and The risks of continuing HRT.
Certain health problems can be exacerbated / degraded as a result of HRT. If you suffer or suffer from any of these conditions, talk to your doctor who will closely monitor your condition: fibroid growth of the uterus, endometriosis, blood clotting if you or a member of your family had an estrogen-dependent Cancer, e.g. A close relative who has had breast cancer or cervical mucosal cancer, high blood pressure, liver disease, diabetes, gallstones, migraine or (severe) headache, systemic lupus erythematosus (rare), endometrial hyperplasia, Asthma, otosclerosis (inherited deafness). Tell your doctor if you notice a change in your condition during the use of Livial. HRT can sometimes lead to fluid retention.
Livial is not a contraceptive and can not be used to prevent pregnancy

Immediately stop using Livial when:
• Jaundice (yellowing of the skin)
• Increased blood pressure
• Migraine or severe headache from which you have not suffered to date

Impact on the risk of cancer
Endometrial cancer (cervical mucosal cancer)
There are reports and studies of the growth of uterine cells or uterine cancer in women using Livial. The risk of uterine mucosal cancer increases with the duration of administration of the medicinal product. If you experience sudden bleeding or spotting, this is usually not a cause for concern, especially during the first few months of HRT intake.
But if hemorrhages or spotting:
• Continue more than 6 months
• Appear after taking Livial for 6 months
• They continue even after discontinuation of HRT
Ask your doctor for advice. 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 HRT. Taking estrogen or estrogen-progestagen combined HRT or Livil over a period of several years only slightly increases the risk of breast cancer. The risk increases with prolonged HRT and normalizes to about 5 years after discontinuation. Women taking Livial have a lower risk of breast cancer than women using combination HRT and at approximately the same risk as women , Using only estrogenic HRT. In women between 50 and 64 years of age who do not use HRT, an average of 32 per 1000 will be diagnosed with breast cancer. In 1000 women who have taken Livial over a 5-year period, two additional cases of breast cancer may be recorded, and for women taking Livial over a period of 10 years - 5 additional cases. Periodically look at your chest for changes like dents on the skin, changes in the nipples or lumps you see or feel.

Ovarian cancer
Ovarian cancer appears very rarely, but it is very serious. It can be found difficult because there are often no obvious symptoms of the disease.
Some studies have shown that taking estrogen only HRT over 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 analogously.

Influence on the heart and blood circulation
Heart diseases
HRT is not recommended for women who have had or have recently had heart disease. If this is the case, discuss with your doctor whether you should take HRT. HRT does not help to prevent heart disease.
Types of HRT (containing related estrogen and progestagen MPA) show that women are probably slightly less prone to heart disease in the first year of taking the drug. For other types of HRT, the risk may be similar, although this is not yet proven.

If you feel:
• Chest pain, covering the upper arms or neck Do not stop taking your HRT as soon as he or she does not allow you to see your doctor. Pain may be a symptom of heart disease.

Stroke
A recent study shows that HRT and Livial increase the risk of stroke. This increased risk was mainly seen in older postmenopausal women over 60 years of age.
In women aged 50-59 years who do not take HRT, it is expected that every 5 years, an average of 3 per 1000 will suffer a stroke. In women between 50 and 59 years of age who take HRT, 7 per 1000 are likely to have a stroke.
In women aged 60-69 years who do not take HRT every 5 years, an average of 11 per 1000 is expected to get a stroke. In women aged 60-69 years who are undergoing HRT, an average of 24 per 1000 is likely to experience a stroke.
If they occur:
• Unexplained headaches (migraine) with or without visual disturbance
Visit your doctor as soon as possible and stop taking HRT until he advises you to start treatment again. Pain may be a warning sign of a possible stroke.

Blood coagulants
Estrogen HRT and estrogen-progestagen combined HRT may increase the risk of venous blood clots (DVT), especially during the first year of treatment. It's not known whether Livial raises the risk alike. These blood clots are not always serious, but if one of them reaches the lungs, it can cause chest pain, shortness of breath, seizure, and even death. This condition is known as pulmonary embolism (BE). DVT and BE are examples of a condition called venous thromboembolism (VTE). The risk of blood clot formation is higher if:
• You are significantly overweight
• You have ever had such conditions
• Your family member has ever had similar conditions
• If you have had one or more spontaneous abortions
• If you have any health problems associated with blood clots that have been treated with medicines like warfarin
• If you have been in bed for a long time due to serious surgery, injury or illness
• If you suffer from the rare disease systemic lupus erythematosus

If any of the listed conditions apply to you, contact your doctor to find out whether HRT is contraindicated for you.
In women between 50-59 years of age who do not take HRT, it is expected that every 5 years, an average of 3 out of 1000 will have problems associated with blood clotting. In women aged 50-59 years who receive HRT, it is expected that every 5 years, an average of 7 out of 1000 will have problems with blood clotting. In women aged 60-69 years who do not take HRT every five years, an average of 8 per 1000 is expected to have problems with blood clotting. Women of 60-69 years of age who take HRT are expected to be expected everybody
Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine. Do not take Livil if you are pregnant or breast-feeding, or think you may be pregnant.

Ability to drive and use machines
As far as is known, Livial has no effect on active attention and concentration.

Important information about some of the ingredients of Livil
Livial tablets contain lactose. Tell your doctor or pharmacist if you have a bad reaction to lactose or milk.

Using other medicines
Other medicines may affect the effects of Livial or Livial may affect the effect of other medicines. Tell your doctor or pharmacist if you are taking (or plan to start) any other medicines, especially:
• Drugs for thrombotic problems such as warfarin, as your doctor may change the dose of these medicines Do not forget to inform yourself about the medicines you are taking without a prescription.

3. HOW TO TAKE LIVIAL
Livial is taken orally. Take one tablet a day, swallow it with some water or another liquid. Take the tablet at the same time each day. Liwali blisters are tagged with the days of the week. Start with a tablet corresponding to the day of the week. For example, if you start on Monday, take the tablet from the top row marked Monday. Follow the days of the week while you spend the blister. Start a new blister the next day. Do not pause between blister packs or packs.
Livial should not be taken earlier than 12 months after the last menstrual bleeding. If you take Livial sooner, the likelihood of irregular vaginal bleeding increases. Immediately tell your doctor if you think the effect of Livial is too strong or too weak.

If you take more Livil than you need:
Tell your doctor or pharmacist immediately if you take more Livil than you need. No need to worry if several tablets are taken at once, but you should consult your doctor immediately. Symptoms of overdose may include feeling unwell, malaise or vaginal bleeding.

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

4. POSSIBLE SIDE EFFECTS
Like all medicines, Livial can cause side effects. Most of these side effects are not very pronounced. The side effects seen in clinical trials (seen in 1-10% of women taking Livial) were:
• Vaginal bleeding or spotting
• Abdominal pain
• Increase in weight
• Chest pain
• Unnatural hair
• Vaginal symptoms such as secretion, itching and inflammation

An uncommon side effect (reported in 0.1-1% of women taking Livil) was acne.
Other side effects seen with Livial were:
• Dizziness, headache, migraine, depression
• Rash or itching
• Visual disturbances
• Gastrointestinal disturbances
• Retention of liquids
• Pain in the muscles and joints
• Changes in liver function
Cases of breast cancer and increased cell growth or endometrial cancer have been reported in women using Livial.
Tell your doctor if you get a vaginal bleeding or spotting or if any of the side effects listed above become worrying or do not disappear. Other side effects that may occur with estrogen-progestagen combined HRT are :
• Benign and malignant hormone-dependent tumors
• Blood clots in the veins
• Infarction or stroke
• Diseases of the bile
• Skin problems such as rashes, discoloration or red spots on the skin
• Dementia (worsening of mental activity, characterized by memory loss)
If you notice any other side effects not mentioned in this leaflet, tell your doctor or pharmacist.

5. STORAGE OF LIVIAL
Keep Livial in a place that is out of reach of children.
Store your Livial tablets in the original secondary packaging at temperatures below 25 ° C. Check the packaging for special storage requirements.
Do not use Livil after the expiry date which is stated on the package.

6. MORE ABOUT LIVIAL
The most important natural female sex hormones are estrogen and progesterone. They are necessary for the normal sexual development of the woman and for the regulation of the menstrual cycle. Estrogens have an important role in the formation of bone. The bones are built in the youth years and the largest bone mass is reached at the age of 20-30 years, after which it decreases, at first slowly. Later in the life cycle - accelerated, especially after menopause
The active substance is tibolone (tibolone).
• The other ingredients are: potato starch, lactose, ascorbyl palmitate and magnesium stearate.

• Livial 2.5 mg tablets are white and marked "MK2" on one side and "Organon" on the other side. The tablets are packed in cartons containing one or three packs of 28 tablets.

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