Package leaflet: Information for the user

Elleste Duet™ Conti Tablets 2 mg/1 mg film-coated tablets

(estradiol/norethisterone acetate)

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 of the 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 Elleste Duet Conti Tablets are and what they are used for

2.    What you need to know before you take Elleste Duet Conti Tablets

3.    How to take Elleste Duet Conti Tablets

4.    Possible side effects

5.    How to store Elleste Duet Conti Tablets

6.    Contents of the pack and other information

1. WHAT ELLESTE DUET CONTI TABLETS ARE AND WHAT THEY ARE USED FOR

Elleste Duet Conti Tablets are a Hormone Replacement Therapy (HRT). They contain two types of female hormones, an oestrogen (estradiol hemihy-drate) and a progestogen (norethisterone acetate). Elleste Duet Conti Tablets are used in postmenopausal women with at least one year since their last natural period.

Elleste Duet Conti Tablets are 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"). Elleste Duet Conti Tablets alleviate these symptoms after menopause. You will only be prescribed Elleste Duet Conti Tablets if your symptoms seriously hinder your daily life.

Prevention of osteoporosis

After the menopause some women may develop fragile bones (osteoporosis). You should discuss all available options with your doctor.

If you are at an increased risk of fractures due to osteoporosis and other medicines are not suitable for you, you can use Elleste Duet Conti Tablets to prevent osteoporosis after menopause.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ELLESTE DUET CONTI TABLETS

•    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

Stop taking Elleste Duet Conti Tablets and see a doctor immediately

If you notice any of the following when taking HRT:

•    any of the conditions mentioned in the ‘DO NOT take Elleste Duet Conti Tablets’ section

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

•    a 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 signs of a blood clot, such as:

•    painful swelling and redness of the legs

•    sudden chest pain

•    difficulty in breathing

For more information, see ‘Blood clots in a vein (thrombosis)’

Note: Elleste Duet Conti Tablets are not a contraceptive. If it is less than 12 months since your last menstrual period or you are under 50 years old, you may still need to use additional 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)

Taking oestrogen-only HRT will increase the risk of excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the womb lining (endometrial cancer).

The progestogen in Elleste Duet Conti Tablets protects you from this extra risk.

Irregular bleeding

You may have irregular bleeding or drops of blood (spotting) during the first 3-6 months of taking Elleste Duet Conti Tablets. However, if the irregular bleeding:

•    carries on for more than the first 6 months

•    starts after you have been taking Elleste Duet Conti Tablets for more than 6 months

•    carries on after you have stopped taking Elleste Duet Conti Tablets

see your doctor as 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 a few 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).

•    Regularly check your breasts. See your doctor if you notice any changes such as:

•    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/healthcare 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, in women 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).

Effect of HRT on heart and circulation Blood clots in a vein (thrombosis)

The risk of blood clots in the veins is about 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 travels 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 your doctor if any of these situations 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

For signs of a blood clot, see “Stop taking Elleste Duet Conti Tablets and see a doctor immediately”.

Compare

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

For women in their 50s who have been taking oestrogen-progestogen HRT for over 5 years, there will be 9 to 12 cases in 1000 users (i.e. an extra 5 cases).

Heart disease (heart attack)

There is no evidence that HRT will prevent a heart attack.

Women over the age of 60 years who use oestrogen-progestogen HRT are slightly more likely to develop heart disease than those not taking any HRT.

Stroke

The risk of getting 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.

Compare

Looking at women in their 50s who are not taking HRT, on average, 8 in 1000 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 1000 users, over 5 years (i.e. an extra 3 cases).

Underactive thyroid gland

If you are having medicine for treatment of an underactive thyroid gland, your doctor will carry out tests while you are taking HRT, to ensure that your thyroid hormone levels remain acceptable.

Angioedema

If you have angioedema (a serious allergic reaction often involving swelling of the face, mouth and throat), oestrogens may make this worse.

Other conditions

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

Children

Do not give this medicine to children.

Other medicines and Elleste Duet Conti Tablets

Some medicines may interfere with the effect of Elleste Duet Conti Tablets. This might lead to irregular bleeding. This applies to the following medicines:

•    Medicines for epilepsy (such as phenobarbital, phenytoin and carbamazepin)

•    Medicines for tuberculosis (such as rifampicin, rifabutin)

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

•    Herbal remedies containing St John’s Wort

(Hypericum perforatum)

Please 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.

Laboratory tests

If you need a blood test, tell your doctor or the laboratory staff that you are taking Elleste Duet Conti Tablets, because this medicine can affect the results of some tests.

Pregnancy and breast-feeding

Elleste Duet Conti Tablets are for use in postmenopausal women only. If you become pregnant, stop taking Elleste Duet Conti Tablets and contact your doctor.

Driving and using machines

No effects on driving or using machinery have been observed for Elleste Duet Conti Tablets.

Elleste Duet Conti Tablets contain lactose.

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 TO TAKE ELLESTE DUET CONTI TABLETS

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will aim to prescribe the lowest possible dose to treat your symptoms for as short a time as necessary. Speak to your doctor if you think the dose is too strong or not strong enough.

If you are not taking any HRT

If you are not taking any HRT, you can start taking Elleste Duet Conti Tablets straightaway.

•    Take one tablet each day. You can take the tablets at a time of the day that suits you, but it is best to take them at about the same time each day.

•    Swallow the tablets whole, with some water. All the tablets are the same.

•    The days are marked on the strip to help you to remember to take one each day.

•    Follow the direction of the arrows on the pack and take a tablet every day until the pack is empty.

•    When you finish a foil strip, start a new strip the next day.

Changing from another type of HRT

If you are changing from another type of HRT, and you usually have a monthly bleed, start taking Elleste Duet Conti Tablets on the first day of bleeding.

If you do not have a monthly bleed, start taking Elleste Duet Conti Tablets on any convenient day.

If your doctor gives you instructions on changing from another type of HRT you should follow these instructions. If you have any doubts you should contact your doctor.

If you need to have surgery

If you are going to have surgery, tell the surgeon that you are taking Elleste Duet Conti Tablets. You may need to stop taking Elleste Duet Conti Tablets 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 Elleste Duet Conti Tablets again.

If you forget to take Elleste Duet Conti

Take the tablet as soon as you remember, and take the next one at the normal time.

If you have missed your tablet by more than 12 hours, dispose of this tablet safely and take the next one at the normal time. Do not take a double dose to make up for the forgotten tablet. You may experience some breakthrough bleeding or spotting.

If you take more Elleste Duet Conti than you should

There should be no problems, but you may experience breast tenderness, feel sick or actually be sick, have irregular periods, feel down, feel tired, develop acne or experience an increase in body and facial hair. If you are worried, contact your doctor. Take the usual tablet the following day.

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

Common: feeling down, feeling anxious, mood changes, changes in sex drive, feeling dizzy, difficulty sleeping, feeling sick, bloating, diarrhoea, indigestion, stomach cramps, acne, rashes, itchiness, dry skin, back pain, pain in the extremities, breast enlargement, heavy periods, vaginal discharge, break-through bleeding, spasms (contractions) of the womb, vaginal infection, excessive thickening of the lining of the womb, pain, feeling of weakness, swelling of the ankles, feet and fingers, increase in weight.

Uncommon: migraine, a feeling of dizziness or “spinning”, high blood pressure, varicose veins, being sick, gallstones and gallbladder disease, change in colour of the skin, muscle cramps, breast cancer, increased levels of chemicals in the blood which may indicate disease.

Rare: hypersensitivity, tingling or numbness, blood clot in a vein, inflammation of a vein, muscle weakness, growths in the womb (myoma, cysts, polyps).

Very rare: increase in body and facial hair, yellowing of the skin.

Not known: loss of hair from the scalp.

The following side effects have been reported with other HRTs:

•    various skin disorders

-    discolouration of the 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)

•    dry eyes

•    tear film changes

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

By reporting side effects, you can help provide more information on the safety of this medicine.

5.    HOW TO STORE ELLESTE DUET CONTI TABLETS

Keep this medicine out of the sight and reach of children.

Do not store above 25°C. Store in the original package.

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

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist to throw away medicines you no longer use. These measures will help protect the environment.

6.    CONTENTS OF THE PACK AND OTHER INFORMATION

What Elleste Duet Conti Tablets contains

•    Each tablet contains the active substances:

2 milligrams estradiol (as hemihydrate) and 1 milligram norethisterone acetate.

(The estradiol used to make Elleste Duet Conti Tablets does not come from animals).

•    The tablets also contain: lactose monohydrate, maize starch, povidone, talc, magnesium stearate, macrogol 400, titanium dioxide (E171), black iron oxide (E172), and hypromellose (E464) (see also the warning at the end of section 2).

What Elleste Duet Conti Tablets look like and contents of the pack

Elleste Duet Conti Tablets are grey film-coated tablets with an embossing.

They are supplied in packs containing blister strips of 28 or 84 tablets.

Not all packs sizes may be marketed.

Marketing Authorisation Holder

Meda Pharmaceuticals Ltd, Skyway House,

Parsonage Road, Takeley, Bishop’s Stortford,

CM22 6PU, UK.

Manufacturer

Piramal Healthcare (UK) Ltd.

Whalton Road, Morpeth, Northumberland,

NE61 3YA, UK.

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria    Parapanol kombi

Germany Clionara UK    Elleste Duet Conti Tablets

This leaflet was last revised in 02/2016.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following diseases are reported more often in women using HRT compared to women not using HRT:

•    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 HRT is started over the age of 65

For more information about these side effects, see section 2.

The following side effects have been associated with Elleste Duet Conti Tablets:

Frequencies are defined as follows:

Very common: may affect more than 1 in 10 people Common: may affect up to 1 in 10 people Uncommon: may affect up to 1 in 100 people Rare: may affect up to 1 in 1,000 people Very rare: may affect up to 1 in 10,000 people

Not known: frequency cannot be estimated from the available data

Very common: headache, breast pain, breast tenderness, painful periods, problems with your menstrual cycle.