Document: Tibolon Orifarm tablet ENG PL change

• Tibolon Orifarm tablet PL
• Tibolon Orifarm tablet ENG PL

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Package leaflet: Information for the user

Tibolon Orifarm 2.5 mg tablets

tibolone

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, pharmacist or nurse.

• 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.

What is in this leaflet

Tibolon Orifarm is a Hormone Replacement Therapy (HRT). Tibolon Orifarm 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 hot face, neck and chest (“hot flushes”). Tibolon Orifarm alleviates these symptoms after menopause. You will only be prescribed Tibolon Orifarm if your symptoms seriously hinder your daily life. Treatment with Tibolon Orifarm normally produces relief of menopausal symptoms during the first few weeks of treatment, but optimum results are only achieved after at least three months of treatment.

Prevention of osteoporosis

After the menopause some women may develop fragile bones (osteoporosis). You should discuss all available options with your doctor. If you have an increased risk of bone fractures due to osteoporosis and other medicines are not suitable for you, you can use Tibolon Orifarm to prevent osteoporosis after menopause.

The use of HRT carries risks which need to be considered when deciding whether to start taking it or whether to carry on taking it.

The experience in treating women with a premature menopause (due to ovarian failure or surgery) is limited. If you have premature menopause the risks of using HRT may be different. Please talk to your doctor.

Before you start (or restart) HRT, 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 internal examination, if necessary.

Once you have started using Tibolon Orifarm 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 Tibolon Orifarm.

Make regular examinations of your breasts and alert your doctor if you notice any changes in your breasts.

Do not take Tibolon Orifarm

if any of the following applies to you. If you are not sure about any of the points below, talk to your doctor before taking Tibolon Orifarm. Do not take Tibolon Orifarm:

• If you have or have ever had breast cancer, or if you are suspected of having it.

• If you have a 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 deficiency, protein S, or antithrombin deficiency).

• If you have or recently have had a disease caused by blood clot 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 to any of the other ingredients of this medicine (listed in section 6).

If any of the above happens to you when you use Tibolon Orifarm for the first time stop taking Tibolon Orifarm and contact your doctor immediately

Warnings and precautions

Tell your doctor if you have ever had any of the following problems, before you start the treatment, as these may return or becomeworse during treatment withTibolon Orifarm. If so, you should see your doctor more often for check-ups:

• growth of womb lining outside your womb (endometriosis) or a history of excessive growth of the womb lining (endometrial hyperplasia)

• fibroids inside your womb

• gallstones

• diabetes

• liver disorder such as benign liver tumour

• asthma

• epilepsy

• migraine or severe headache

• high blood pressure

• increased risk of developing blood clots (thromboembolic disorders, see below)

• a disease affecting the eardrum and hearing (otosclerosis)

• increased risk of getting an oestrogen-sensitive cancer (such as having a mother, sister or grandmother who has had breast cancer)

• a disease of the immune system that affects many organs of the body (systemic lupus erythematosus, SLE)

• a very high level of fat in your blood (triglycerides)

• fluid retention due to cardiac or kidney problems.

You should immediately contact your doctor and suspend treatment if any of the following situations occurs:

• any of the conditions listed under “Do not take Tibolon Orifarm”

• yellowing of your skin or the whites of your eyes (jaundice). These may be signs of a liver disease

• 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 any signs of blood clot as:

• painful swelling and redness of legs

• sudden chest pain

• difficulty in breathing

For more information see “Blood clots in a vein (venous thromboembolism)”

Note: Tibolon Orifarm is not a contraceptive. If it is less than 12 months since your last period, or if you are under 50, you may still need to use 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 risk of uterine cancer in women using Tibolon Orifarm. This risk increases the longer the treatment continues.

You may have irregular bleeding or drops of blood (spotting) during the first 3-6 months of treatment with Tibolon Orifarm. However, if this irregular bleeding:

• carries on for more than the first 6 months

• starts after you have been taking Tibolon Orifarm for more than 6 months

• carries on after you have stopped taking Tibolon Orifarm,

Seeyour doctoras soon as possible.

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 five years. However, it returns to normal within a few years (at most 5) after stopping treatment.

Compare:

Women aged 50 to 79 who are not taking HRT, on average, 9 to 17 in 1000 will be diagnosed with breast cancer over a 5-year period. For women aged 50 to 79 who are taking oestrogen-progestogen HRT over 5 years, there will be 13 to 23 cases in 1000 users (i.e. an extra 4 to 6 cases).

Check your breasts regularly. Contact your doctor if you notice changes:

• Dimpling of the skin

• Changes in the nipple

• Any lumps you can see or feel.

Additionally, you are advised to join mammography screening programs when offered to you. For mammogram screening, it is important that you inform the nurse/health care professional who is actually taking the x-ray that you use HRT, as this medication may increase the density of your breasts which may affect the outcome of the mammogram. Where the density of the breast is increased, mammography may not detect all lumps.

Ovarian cancer

Ovarian cancer is rare - much rarer than breast cancer. The use of oestrogen-only or combined oestrogen-progestagen HRT has been associated with a slightly increased risk of ovarian cancer.

The risk of ovarian cancer varies with age. For example, inwomen aged 50 to 54 who are not taking HRT, about 2 women in 2000 will be diagnosed with ovarian cancer over a 5-year period. For women who have been taking HRT for 5 years, there will be about 3 cases per 2000 users (i.e. about 1 extra case).

With use of Tibolon Orifarmthe increased risk of ovarian cancer is similar to other types of HRT.

Effect of HRT on heart and circulation

Blood clot in veins (venous thromboembolism)

The risk of blood clots in veins is 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 travel 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 you doctor if any of these situations applies to you:

• if you use oestrogens

• if you have had repeated miscarriages

• if you are severely overweight (BMI>30 kg/m²)

• if you have systemic lupus erythematosus (SLE)

• if you have cancer

• if you are unable to walk for a long time because of major surgery, injury or illness (see section 3, If you need to have surgery)

• if you have any blood clotting problem that needs long-term treatment with a medicine used to prevent blood clots.

• if you have experienced a blood clot

• if any of your close relatives has ever had a blood clot in the leg, lung or another organ

Compare:

Looking at women in their 50s who are not taking HRT – on an average over a 5-year period 4-7 in 1000 users, would be expected to experience a blood clot in a vein.

Looking at women in their 50s who are taking HRT with oestrogen plus progestogen - on an average over a 5-year period 9-12 in 1000 users would be expected to experience a blot clot in a vein (i.e. an extra 5 cases).

In using Tibolon Orifarm the increased risk of thrombosis is similar to other types of HRT.

Stroke

Scientific evidence suggests that HRT and tibolone increase the risk of stroke. This increased risk was mainly observed in older postmenopausal women over 60 years. If you have had a stroke in the past, you should discuss with your doctor whether the benefits of treatment outweigh the possible increased risks.

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).

This relative risk is not dependent on age or duration of treatment, but because the baseline risk is strongly dependent on age, the overall risk of stroke among women using HRT or tibolone will increase with age (see section 4.4).

Heart disease (heart attack)

There is no evidence that HRT will prevent a heart attack. Women over the age of 60 who use oestrogen-progestogen HRT are slightly more likely to develop a heart disease than those not taking any HRT. As the risk of heart disease is strongly age-dependent, the number of additional cases of heart disease due to the use of HRT with estrogen-progestogen is very low in healthy women near menopause, but increases with age.

Other conditions

HRT will not prevent memory loss. The risk of memory loss may be higher in women who start using HRT after the age of 65 years. Talk to your doctor.

It is unknown whether these results also apply if treatment is started at a younger age than 65, or if other HRT products are used. Talk to your doctor.

Othermedicines and Tibolon Orifarm

Tellyour doctor or pharmacist if you are taking,have recently taken or might take any other medicines.

Some medicines can affect or be affected by simultaneous use of Tibolon Orifarm. These medicines
include:

• medicines for epilepsy (such as phenobarbital, phenytoin, hydantoin and carbamazepine)

• medicines for diabetes (such as tolbutamide)

• medicines for sedation (such as midazolam)

• anticoagulant medicines (such as wafarin)

• medicines for tuberculosis (such as rifampicin and rifabutin)

• medicines for HIV infection (such as nevirapine, efavirenz, ritonavir and nelfinavir)

• herbal remedies containing St. John´s Wort (Hypericum perforatum)

Laboratory tests

If you need a blood test, tell your doctor or laboratory staff that you are taking Tibolon Orifarm, because this medicinecan affect the results of some test.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, askyour doctor or pharmacist for advice before taking thismedicine.

Pregnancy

Tibolon Orifarm is for use in postmenopausal women only. If you become pregnant, stop taking Tibolon Orifarm and contact your doctor.

Breast-feeding

You should not use Tibolon Orifarm if you are breast-feeding.

Driving and using machines

No effects on ability to drive and use machines have been observed.

Tibolon Orifarm contains lactose

Tibolon Orifarm tablets contain lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How totake Tibolon Orifarm

Always take this medicineexactly as your doctor or pharmacist has told you. Checkwith your doctor or pharmacist if you are not sure.

The recommendeddose is 1 tablet a day. You should take the tablet at about the same time every day. Swallow it without chewing and with a little liquid.

For calendar packs: Take the first tablet on the strip at the mark corresponding to the current day of the week. Then follow the marks for each day, taking one tablet daily. When the strip is empty, you should start a new strip the next day.

For ordinary blister packs: Start with the first tablet on the strip and take one tablet daily. When the strip is empty, you should start a new strip the next day.

Your doctor will aim to prescribe the lowest dose to treat your symptom for as short as necessary. Speak to your doctor if you feel that the effect of the Tibolon Orifarm is too strong or not strong enough.

If you need to have surgery

If you are going to have surgery, tell the surgeon that you are taking Tibolon Orifarm. You may need to stop taking Tibolon Orifarm about 4 to 6 weeks before the operation to reduce the risk of a blood clot (see section 2 “Blood clot in a vein”). Ask your doctor when you can start taking Tibolon Orifarm again.

If you take more Tibolon Orifarm than you should

Contact your doctor, casualty, or the chemist if you have taken more Tibolon Orifarm than stated in this information or more than your doctor has prescribed.

Toxic symptoms are not expected to occur even when several tablets are taken simultaneously. In cases of acute overdose, nausea, vomiting and vaginal bleeding in females may occur.

If you forget to take Tibolon Orifarm

If you forget to take a tablet, you can take it up to 12 hours after the time it was due. Otherwise, skip the missed tablet and take the next tablet at the normal time the next day.

If you take an extra dose by mistake, you must still take the normal dose the next day.

Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

The following diseases are more common in women taking HRT than those who do not:

• Breast cancer

• Abnormal growth or cancer of the lining of the womb (endometrial hyperplasia or cancer)

• ovarian cancer

• blood clot in veins in 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.

Like all medicines, this medicinecan cause side effects, although not everybody gets them. Most of the side effects are mild to moderate, and do not require you to stop taking the tablets.

Irregular vaginal bleeding (break-through bleeding or spotting) may occur during the first months of treatment. Contact your doctor if the irregular bleeding continues for longer than six months, if it starts after the first six months of treatment, or if it continues after the treatment has ended. In such cases, the cause may need to be examined more closely.

Common side effects (may affect up to 1 in 10 people):lower abdominal pain, pelvic pain, weight increase, breast pain, increased hair growth, genital symptoms such as vaginal discharge, itching, bleeding, spotting, inflammation and fungal infection.

Uncommon side effects (may affect up to 1 in 100 people):acne and nipple pain.

Other side effects reported include dizziness, headache, migraine, depression, skin rash or itching, impaired vision, abdominal discomfort, fluid retention, aching joints, aching muscles and changes in liver values.

The following side effects have been reported with other HRTs:

• gall bladder disease

• various skin disorders:

• discoloration of 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)

• red or purple discolorations on the skin (vascular purpura)

Reporting of side effects

If you getany side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effectsnot listed in this leaflet. You can also report side effects directly via (see details below). By reporting side effects, you can help provide more information on the safety of this medicine.

[To be completed nationally]

5. How to store Tibolon Orifarm

Store below 25°C. Store in the original package in order to protect from light.

Keep out of the sightand reachof children.

Do not use this medicine after the expiry date which is stated on carton and blister after EXP. The expiry date refers to the last day of that month.

Donot throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw awaymedicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Tibolon Orifarm contains

• The active substance is tibolone. One tablet contains 2.5 mg tibolone.

• The other ingredients are: potato starch; magnesium stearate; ascorbyl palmitate and lactose monohydrate.

What Tibolon Orifarm looks like and contents of the pack

What Tibolon Orifarm looks like:

Tibolon Orifarm tablets are white to off-white, flat round tablets, with embossing “e” on one side.

Contents of the pack:

The tablets (blister and calendar blisters) are packed in cartons containing blister packs with 28, 30, 3x28 and 3x30 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Orifarm Generics A/S

Energivej 15

5260 Odense S

Denmark

This leaflet was last revisedin 2016-04-15