Livifem ® Tablets

During and after the menopause, the production of sex hormones by the body decreases. Women may then suffer from complaints such as hot flushes, night sweats, vaginal irritation, depression and loss of sexual desire. In addition, the menopause may cause thinning of the bones (osteoporosis).

LIVIFEM contains tibolone, a substance that can replace the natural sex hormones after the menopause. LIVIFEM can relieve menopausal complaints, also in women who have had their ovaries removed; prevent bone loss and improve bone mineral density in established post-menopausal osteoporosis. Relief of symptoms usually starts within a few weeks, but optimal results are obtained after at least three months of treatment. LIVIFEM is not intended for contraceptive use.

Unlike some other preparations used for hormone replacement therapy, LIVIFEM does not stimulate the lining of the womb. Treatment with LIVIFEM therefore does not lead to monthly vaginal bleeding.

LIVIFEM may not be suitable for you if you suffer from certain medical conditions.

If any of the following applies to you or if you are not sure about any of the points below, talk to your doctor before taking LIVIFEM.

Do not take LIVIFEM

• If you are pregnant or think you may be pregnant.
• If you are breastfeeding.
• 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 anti-thrombin 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 LIVIFEM.

If any of the above conditions appear for the first time while taking LIVIFEM, stop taking it at once and consult your doctor immediately.

Take special care with LIVIFEM

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 LIVIFEM. 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
• 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

Take LIVIFEM as directed by your doctor. You should always read the instructions on the label of your medicine. If you are not sure how to take LIVIFEM, ask your doctor, pharmacist or other healthcare professional.

The usual dosage is one tablet daily, preferably at the same time each day. Swallow the tablet whole without chewing, using some water or other fluid. The LIVIFEM pack contains 28 white tablets. The first tablet should be taken from the upper row of the pack marked with the corresponding day of the week. You should then follow the direction of the arrows and continue taking one tablet each day until the pack is empty.

What to do if you miss a dose

Take the missed dose as soon as you remember unless you are more than 12 hours late. If you are more than 12 hours late, do not take the missed dose and just carry on with the next dose as normal.

What to do in the case of an overdose

If someone has taken several tablets at once, there is no need for great concern. However, you should consult your doctor. Symptoms that may arise are nausea and vomiting and in females vaginal bleeding may occur after a few days.

General instructions

1. This medicine has been prescribed only for your current medical condition. Do not use it for other medical problems.
2. Do not allow other people to use your medicines and do not use medicines meant for other people.
3. Tell any doctor treating you what medicines you are taking. Always carry a medical information card stating which medicines you are using. This can be very important in case you are involved in an accident.
4. Return unused medicines to the pharmacy for disposal.
5. Make sure that other people you live with or who look after you read this information.

The following diseases are reported more often in women using hormone replacement therapy compared to women not using hormone replacement therapy:

• 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 hormone replacement therapy is started over the age of 65

Livifem may have side effects. Most of these side effects are mild.

Common side effects observed in clinical studies (occurring in 1 to 10 % of the women using Livifem) were:

• Vaginal bleeding or spotting
• Abdominal pain
• Weight gain
• Breast pain
• Unnatural hair growth
• Vaginal symptoms such as discharge, itching and irritation

An uncommon side effect (occurring in 0,1 to 1 % of the women using LIVIFEM) was acne.

Other side effects observed with LIVIFEM in market use were:

• Dizziness, headache, migraine, depression
• Rash or itching
• Visual disturbances
• Gastro-intestinal upset
• Fluid retention
• Joint pain, muscle pain

In some women, vaginal bleeding or spotting may occur, mainly during the first months of treatment. Other side effects may occasionally occur, such as headache, swollen feet and lower legs, dizziness, itching, weight gain, nausea, abdominal pain, rash and depression.

Tell your doctor if vaginal bleeding or spotting occurs or if any side effects become troublesome or continue. It is also important to tell your doctor or pharmacist if you experience any other unusual or unexpected symptoms during treatment with LIVIFEM.

You should stop taking LIVIFEM if you experience any signs of thrombosis (headache or pain elsewhere in your body, dizziness, fainting, disturbances in vision, swollen ankles) or jaundice (yellowing of the eyes or skin).

Not all side effects reported for LIVIFEM are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking LIVIFEM, please consult your doctor, pharmacist or other healthcare professional for advice. Tell your doctor if any side effect becomes troublesome or continues.

Store at or below 25 °C, and protect from light and moisture. Keep your LIVIFEM in the original container in a safe place. Store all medicines out of reach of children.

The expiry date (sometimes written as "Exp./Verv:") is printed on the strip of tablets. Do not use LIVIFEM after this date.