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«Package leaflet: Information for the patient DUAVIVE 0.45 mg/20 mg modified-release tablets Conjugated oestrogens/bazedoxifene Read all of this ...»

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Package leaflet: Information for the patient

DUAVIVE 0.45 mg/20 mg modified-release tablets

Conjugated oestrogens/bazedoxifene

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 or pharmacist.

- 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.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

- effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What DUAVIVE is and what it is used for

2. What you need to know before you take DUAVIVE

3. How to take DUAVIVE

4. Possible side effects

5. How to store DUAVIVE

6. Contents of the pack and other information

1. What DUAVIVE is and what it is used for DUAVIVE is a medicine that contains two active substances called conjugated oestrogens and bazedoxifene. Conjugated oestrogens is a medicine that belongs to a group of medicines called hormone replacement therapy (HRT). Bazedoxifene belongs to a group of non-hormonal medicines called selective estrogen receptor modulators (SERMs).

DUAVIVE is used in postmenopausal women who still have their uterus (womb) with at least 12 months since their last natural period.

DUAVIVE is used for:

Relief of symptoms occurring after menopause During the menopause, the amount of the oestrogen produced by a woman’s body drops. This can cause symptoms such as hot face, neck and chest ("hot flushes"). DUAVIVE alleviates these symptoms after menopause. You will only be prescribed this medicine if your symptoms seriously hinder your daily life and your doctor determines that other types of HRT are not appropriate for you.

2. What you need to know before you take DUAVIVE Medical history and regular check-ups The use of DUAVIVE carries risks, which need to be considered when deciding whether to start taking it, or whether to carry on taking it.

There is no experience in treating women with a premature menopause (due to ovarian failure or surgery) with DUAVIVE.

EU DV 014 Page 1 of 10 2016-0015421 Before you start taking this medicine, your doctor will ask you 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 an internal examination, if necessary, or if you have any special concerns. Tell your doctor if you have any medical problems or illnesses.

Once you have started this medicine you should see your doctor for regular check-ups (at least once a year). During these check-ups, discuss with your doctor the benefits and risks of continuing with

DUAVIVE. You are advised to:

• go for regular breast screening and cervical smear tests, as recommended by your doctor.

• regularly check your breasts for any changes such as dimpling of the skin, changes in the nipple, or any lumps you can see or feel.

Do not take DUAVIVE

- If you are allergic to conjugated estrogens, bazedoxifene or any of the other ingredients of this medicine (listed in section 6).

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

- If you have or have had 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 recently had 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), the lungs (pulmonary embolism) or eyes.

- If you have a blood clotting disorder (such as protein C, protein S, or antithrombin 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 liver disease and your liver function tests have not returned to normal.

- If you are pregnant or could still become pregnant or you are breast feeding.

- If you have a rare blood problem called porphyria, which is passed down in families (inherited).

If you are not sure about any of the points above, talk to your doctor before taking this medicine.

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

Warnings and precautions Tell your doctor if you have ever had any of the following problems, as these may return or become

worse during treatment with DUAVIVE. If so, you should see your doctor more often for check-ups:

fibroids inside your womb • growth of womb lining outside your womb (endometriosis) or a history of excessive growth of • the womb lining (endometrial hyperplasia) increased risk of developing blood clots [see “Blood clots in a vein (thrombosis)”] • increased risk of getting a 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 rare disease of the immune system that affects many organs of the body (systemic lupus • erythematosus, SLE) seizures (epilepsy) • asthma •

–  –  –





Children and adolescents This medicine is not for use in children and adolescents below 18 years old.

Stop taking DUAVIVE and see a doctor immediately

If you notice any of the following:

• any of the conditions mentioned under ‘Do not take DUAVIVE’

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

• a large increase in your blood pressure (symptoms may be headache, tiredness, dizziness)

• migraine-like headaches which happen for the first time

• if you become pregnant

• you notice signs of a blood clot, such as painful swelling and redness of the legs, sudden chest pain, or difficulty in breathing. For more information, see ‘Blood clots in a vein (thrombosis)’ DUAVIVE and cancer Excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the lining of the womb (endometrial cancer) Your product contains two medicines, conjugated oestrogens and bazedoxifene and is used to treat women with a uterus (womb).

When you take DUAVIVE do not take additional oestrogens as this may increase the risk of endometrial hyperplasia.

If you have any unexpected vaginal bleeding, you must contact your doctor as soon as possible.

Breast cancer Evidence suggests that taking oestrogen-only HRT possibly increases the risk of breast cancer. The extra risk depends on how long you take HRT. The additional risk becomes clear within a few years.

However, it returns to normal within a few years (at most 5) after stopping treatment. For women who are using oestrogen-only HRT for 5 years, little or no increase in breast cancer risk is shown.

The effect of DUAVIVE on the risk of breast cancer is unknown.

Regularly check your breasts. See your doctor as soon as possible if you notice any changes, such

as:

• dimpling of the skin

• changes in the nipple

• any lumps you can see or feel Ovarian cancer Ovarian cancer is rare - much rarer than breast cancer. The use of oestrogen-only HRT has been associated with a slightly increased risk of ovarian cancer.

The risk of ovarian cancer varies with age. For example, in women aged 50 to 54 who are not taking HRT, about 2 women in 2,000 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 2,000 users (i.e. about 1 extra case). Talk to your doctor if you have any concerns.

The effect of DUAVIVE on the risk of ovarian cancer is unknown.

–  –  –

Blood clots in a vein (thrombosis) DUAVIVE may increase the risk of blood clots.

Oestrogen-only and bazedoxifene monotherapy increase the risk of blood clots in the veins (also called deep vein thrombosis, or DVT), especially during the first year of taking these medicines.

Blood clots can be serious, and if one travels to the lungs, it can cause chest pain, breathlessness, collapse 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 your doctor if any of the following applies to you:

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

• you are seriously overweight (BMI 30 kg/m2)

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

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

• you have systemic lupus erythematosus (SLE).

• you have cancer.

If any of these things apply to you, talk to your doctor to see if you should take this medicine.

Heart disease (heart attack) There is no evidence that HRT will prevent a heart attack. Randomised controlled data found no increased risk of coronary artery disease in hysterectomised women using oestrogen-only therapy.

Stroke The risk of having a stroke is about 1.5 times higher in HRT users than in non-users. The number of extra cases of stroke due to use of HRT will increase with age.

For women in their 50s who are not taking HRT, on average, 8 in 1,000 would be expected to have a stroke over a 5-year period. For women in their 50s who are taking HRT, there will be 11 cases in 1,000 users, over 5 years (i.e., 3 extra cases).

The effect of DUAVIVE on the risk of stroke is unknown.

Other things that can increase the risk of stroke include:

• getting older

• high blood pressure

• smoking

• drinking too much alcohol

• an irregular heartbeat If you are worried about any of these things, talk to your doctor to see if you should take this medicine.

Other conditions

If you have any of the following your doctor may want to monitor you:

- kidney problems

- pre-existing high level of fat in your blood (triglycerides)

- liver problems

- asthma

–  –  –

Oestrogen therapy will not prevent memory loss. There is some evidence of a higher risk of memory loss in women who start using oestrogen therapy after the age of 65. Speak to your doctor for advice.

Other medicines and DUAVIVE Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, herbal medicines or other natural products.

Other medicines may influence the effects of DUAVIVE, or DUAVIVE may affect other medicines.

In particular tell your doctor if you are taking:

• an anticonvulsant (used in the treatment of epilepsy; for example phenobarbital, phenytoin, carbamazepine)

• an anti-infective (for example rifampicin, rifabutin, nevirapine, efavirenz, erythromycin, ketoconazole, ritonavir, nelfinavir, clarithromycin, itraconazole)

• herbal remedies containing St. John’s wort (Hypericum perforatum) DUAVIVE with drink Do not take this medicine with grapefruit or grapefruit juice, as it may increase the chance of side effects.

Pregnancy and breast-feeding This medicine is for use only by postmenopausal women. Do not take this medicine if you are pregnant, or if you think you might be pregnant. Do not take this medicine if you are breast-feeding.

Driving and using machines DUAVIVE has no known effect on the ability to drive or use machines.

If you feel drowsy after taking this medicine, you should avoid driving or operating machines.

The bazedoxifene component of this medicine has been reported to cause problems with eyesight such as blurred vision. If this happens, you should avoid driving or operating machines until your doctor tells you that it is safe to do so.

DUAVIVE contains lactose, sucrose, polydextrose and maltitol liquid This medicine contains lactose (as monohydrate), sucrose, glucose (in polydextrose and maltitol liquid) and sorbitol (in polydextrose) (types of sugars). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using this medicinal product.

–  –  –

Your doctor will aim to prescribe the lowest dose to treat your symptom for as short as necessary.

Speak to your doctor if you think this dose is too strong or not strong enough.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. You should continue taking this medicine for as long as your doctor tells you. In order for this medicine to work, it should be taken daily as prescribed.

–  –  –

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

If you take more DUAVIVE than you should Call your doctor or pharmacist.

If you take too many tablets you may have nausea (feel sick) or vomit. You may experience breast tenderness, dizziness, abdominal pain, drowsiness/fatigue or experience a short period of vaginal bleeding.

If you forget to take DUAVIVE If you forget to take a tablet, take it as soon as you remember. However, if it is almost time to take your next tablet, skip the tablet you missed and only take your next scheduled tablet. Do not take a double dose to make up for a forgotten tablet.



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