Nuvelle Continuous

Due to regulatory changes, the content of the following Patient Information Leaflet may vary from the one found in your medicine pack. Please compare the 'Leaflet prepared/revised date' towards the end of the leaflet to establish if there have been any changes.

If you have any doubts or queries about your medication, please contact your doctor or pharmacist.

Nuvelle Continuous

Estradiol and norethisterone acetate

Read all of this booklet carefully before you start taking this medicine.

• Keep this booklet. 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as
  yours.


• If any of the side effects get serious, or if you notice any side effects not listed in this booklet, please tell your doctor or
  pharmacist.

In this booklet

1. WHAT NUVELLE CONTINUOUS IS AND WHAT IT IS USED FOR

2. BEFORE YOU TAKE NUVELLE CONTINUOUS
Medical history and regular

check-ups
Do not take Nuvelle Continuous if you

have
When you need to take special care with Nuvelle

Continuous
Effect of Nuvelle Continuous on your heart or circulation
Nuvelle Continuous and blood
clots
Nvelle Continuous and heart disease
Nuvelle Continuous and

stroke
Nuvelle Continuous and

cancer
Nuvelle Continuous and memory

loss
Other

conditions
Nuvelle Continuous and using other

medicines
Pregnancy and

breast-feeding
Driving or using

machines
Important information about some of the ingredients of Nuvelle

Continuous
3. HOW TO TAKE NUVELLE CONTINUOUS
About the pack
When to start
If you take more Nuvelle Continuous than you

should
If you forget to take Nuvelle

Continuous
If you stop taking Nuvelle Continuous
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE NUVELLE CONTINUOUS
6. FURTHER INFORMATION

What Nuvelle Continuous Is And What It Is Used For

What Nuvelle Continuous is

Nuvelle Continuous is a Hormone Replacement Therapy (HRT). It contains two types of female hormone, an oestrogen and a progestogen. Your ovaries no longer make these hormones after the menopause.

What Nuvelle Continuous is used for

Nuvelle Continuous is used for the treatment of symptoms of the menopause such as hot flushes, difficulty in sleeping, nervousness,
dizziness or vaginal dryness.

Nuvelle Continuous is also used for prevention of osteoporosis in postmenopausal women who have a high risk of fractures and who cannot
be given other osteoporosis treatments.

Nuvelle Continuous is not a contraceptive.

Before You Take Nuvelle Continuous

As well as benefits, HRT has some risks which you need to consider when you’re deciding whether to take it, or whether to carry on
taking it.

Medical history and regular check-ups

Before you start taking HRT, your doctor should ask you about your own and your family's medical history. Your doctor may decide to examine your breasts and/or your abdomen, and may do an internal examination - but only if these examinations are necessary for you, or if you have any special concerns.

Once you've started on HRT, you should see your doctor for regular check-ups (at least once a year). At these check-ups, your doctor may discuss with you the benefits and risks of continuing to take HRT.

Be sure to:

- go for regular breast screening and cervical smear tests.

- 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 Nuvelle Continuous if you have:

• 
  breast cancer, or a history of breast cancer


• 
  cancer that depends on oestrogen to grow e.g. endometrial cancer (e.g. cancer of the lining of the womb)


• 
  any unexplained vaginal bleeding
  


• 
  untreated thickening of the lining of the womb (endometrial hyperplasia)


• 
  ever had a blood clot in a vein (thrombosis) such as deep vein thrombosis or a pulmonary embolism, now or in the
  past


• or recently had a heart attack, stroke or angina


• 
  had liver disease, and you have been told by your doctor that your liver function tests have not yet returned to
  normal


• 
  porphyria (a rare, inherited blood pigment disorder)


• 
  an allergy to oestrogens, to progestogens or to any other ingredient in Nuvelle Continuous


• been told to avoid lactose, that you have a rare hereditary condition called Lapp lactase deficiency or
  glucose-galactose malabsorption


• any reason to believe that you either are, or may be, pregnant, or if you are producing milk (lactating) and
  breast-feeding. (See also the 'Pregnancy and breast-feeding' section of this booklet)

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

When you need to take special care with Nuvelle Continuous

If you have ever had (e.g. during pregnancy or previous hormone treatment) any of the following, you may be closely supervised by your
doctor because Nuvelle Continuous may worsen these conditions or cause them to return:

• fibroids of the womb or any tissue of the lining of the womb at inappropriate places (endometriosis)


• a history of, or risk factors for, blood clotting (see "Nuvelle Continuous and blood clots")


• an increased risk for breast cancer (mother, sister or grandmother who has had breast cancer), or other tumours that depend on
  oestrogen to grow


• high blood pressure


• any disorder of the liver


• diabetes


• gallstones


• migraine or severe headaches


• systemic lupus erythematosus (SLE; a chronic inflammatory disease which can affect many parts of the body)


• a history of thickening of the lining of the womb (endometrial hyperplasia)


• epilepsy


• asthma


• deafness due to otosclerosis (excessive growth of the bones in the middle ear)

Effect of Nuvelle Continuous on your heart or circulation

Nuvelle Continuous and blood clots

HRT may increase the risk of blood clots in the veins (also called deep vein thrombosis, or DVT) especially during the first year of taking it.

These blood clots are not always serious but if one travels to the lungs it can cause chest pain, sudden breathlessness,
collapse or even death. This condition is called pulmonary embolism or PE.

DVT and PE are examples of a condition called venous thromboembolism, or VTE.

You are more likely to get a blood clot:

• if you are seriously overweight


• if you have had a blood clot before


• if any of your close family have had blood clots


• if you have had one or more miscarriages


• if you have any blood clotting problem that needs treatment with a medicine such as warfarin


• if you're off your feet for a long time because of major surgery, injury or illness


• if you have a rare condition called SLE

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

Compare

Looking at women in their 50s who are not taking HRT – on average, over a 5-year period, 3 in 1000 would be expected to
get a blood clot.

For women in their 50s who are taking HRT, the figure would be 7 in 1000.

Looking at women in their 60s who are not taking HRT – on average, over a 5-year period, 8 in 1000 would be expected to
get a blood clot.

For women in their 60s who are taking HRT, the figure would be 17 in 1000.

If you get:

• painful swelling in your leg


• sudden chest pain


• difficulty breathing

- See a doctor as soon as possible and do not take any more HRT until your doctor says you can. These may be signs of a blood clot.

If you're going to have surgery, make sure your doctor knows about it. You may need to stop taking HRT about 4 to 6 weeks before
the operation, to reduce the risk of a blood clot. Your doctor will tell you when you can start taking HRT again.

Nuvelle Continuous and heart disease

HRT is not recommended for women who have heart disease, or have had heart disease recently. If you have ever had heart disease,
talk to your doctor to see if you should be taking HRT.

HRT will not help to prevent heart disease.

Studies with one type of HRT (containing conjugated oestrogen plus the progestogen MPA) have shown that women may be slightly more
likely to get heart disease during the first year of taking the medication. For other types of HRT, the risk is likely to be similar,
although this is not yet certain.

If you get:

• a pain in your chest that spreads to your arm or neck

- See a doctor as soon as possible and do not take any more HRT until your doctor says you can. This pain could be a
sign of heart disease.

Nuvelle Continuous and stroke

Recent research suggests that HRT slightly increases the risk of having a stroke. 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, or if you have had a stroke in the past, talk to your doctor to see if you
should take HRT.

Compare

Looking at women in their 50s who are not taking HRT – 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 HRT, the figure would be 4 in 1000.

Looking at women in their 60s who are not taking HRT – 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 HRT, the figure would be 15 in 1000.

If you get:

• unexplained migraine-type headaches, with or without disturbed vision.

- See a doctor as soon as possible and do not take any more HRT until your doctor says you can. These headaches may be an early warning sign of a stroke.

Nuvelle Continuous and cancer

Breast cancer

Women who have breast cancer, or have had breast cancer in the past, should not take HRT.

Taking HRT for 5 years or more slightly increases the risk of breast cancer; so does having a later menopause. The risk for a
post-menopausal woman taking HRT for 5 years is about the same as for a woman of the same age who's still having periods over that time
and not taking HRT.

The extra risk of breast cancer goes up the longer you take HRT, but returns to normal within about 5 years after stopping HRT.

Your risk of breast cancer is also higher:

• if you have a close relative (mother, sister or grandmother) who has had breast cancer


• if you are seriously overweight

If breast cancer is diagnosed in a woman taking HRT, it's more likely to be found before it has spread beyond the breast.

Compare

Looking at women aged 50 who are not taking HRT – on average, 45 in 1000 will be diagnosed with breast cancer by the time
they reach the age of 70.

For women who start taking HRT at age 50 and take it for 5 years, the figure will be 47 in 1000

If they take HRT for 10 years, the figure will be 51 in 1000

If they take HRT for 15 years, the figure will be 57 in 1000

If you notice
any changes in your breast, such as:

• dimpling of the skin


• changes in the nipple


• any lumps you can see or feel

- Make an appointment to see your doctor as soon as possible.

Endometrial cancer (cancer of the lining of the womb)

Taking oestrogen-only HRT for a long time can increase the risk of cancer of the lining of the womb (the endometrium). Taking a
progestogen as well as the oestrogen helps to lower the extra risk.

If you still have your womb, your doctor will prescribe a progestogen as well as oestrogen. These may be prescribed separately,
or as a combined HRT product.

If you have had your womb removed (a hysterectomy), your doctor will discuss with you whether you can safely take oestrogen
without a progestogen.

If you've had your womb removed because of endometriosis, any endometrium left in your body may be at risk. So your doctor may
prescribe HRT that includes a progestogen as well as an oestrogen.

Nuvelle Continuous contains a progestogen.

Compare

Looking at women who still have a womb and who are not taking HRT– on average, 5 in 1000 will be diagnosed with
endometrial cancer between the ages of 50 and 65.

For women who take oestrogen-only HRT the number will be 10 to 60 in 1000, depending on the dose and how long you take
it.

The addition of a progestogen to oestrogen-only HRT greatly lowers the extra risk of endometrial cancer.

If you get breakthrough bleeding or spotting, it's usually nothing to worry about, especially during the first few months
of taking HRT.

But if the bleeding or spotting:

• carries on for more than the first few months


• starts after you've been on HRT for a while


• carries on even after you've stopped taking HRT

- Make an appointment to see your doctor. It could be a sign that your endometrium has become thicker.

Ovarian cancer

Ovarian cancer (cancer of the ovaries) is very rare, but it is serious. It can be difficult to diagnose, because there are often no
obvious signs of the disease.

Some studies have indicated that taking oestrogen-only HRT for more than 5 years may increase the risk of ovarian cancer. It is not yet
known whether other kinds of HRT increase the risk in the same way.

Nuvelle Continuous and memory loss

HRT will not prevent memory loss (dementia).

A study with one type of HRT (containing conjugated oestrogen plus the progestogen MPA) showed that women who started using this HRT
after the age of 65 had a small increase in their risk of developing dementia. It is not known if this applies to other types of HRT, such
as Nuvelle Continuous, or to younger women.

Other conditions

• If you have heart or kidney problems, your doctor should examine you carefully as oestrogens may cause fluid retention resulting in swelling.


• If you have pre-existing elevated triglycerides (a type of blood fat) your doctor should monitor you closely during oestrogen replacement therapy or HRT. Rare cases of large increase of plasma triglycerides (hypertriglyceridemia) leading to inflammation of the pancreas (pancreatitis) have been reported with oestrogen replacement therapy.


• If you have a tendency to develop blotchy brown patches (chloasma) on the face you should avoid exposure to the sun or
  ultraviolet light whilst using Nuvelle Continuous


• Your doctor will monitor you carefully if you have terminal kidney insufficiency as the blood levels of the active substances in Nuvelle Continuous will probably increase

Nuvelle Continuous and using other medicines

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including ones obtained without
prescription.

The following may reduce the effects of Nuvelle Continuous:

• medicines used for the treatment of:
  
  
  • epilepsy (e.g. phenobarbital, phenytoin, carbamazepine)
  • infections (e.g. rifampicin, rifabutin)
  • HIV infection (e.g. nevirapine, efavirenz, nelfinavir, ritonavir)
  • the herbal remedy St. John’s wort (Hypericum perforatum)

- Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy and breast-feeding

Nuvelle Continuous is for use in post-menopausal women. Do not take if you are pregnant or breast-feeding.

If you become pregnant, stop taking Nuvelle Continuous immediately and tell your doctor.

Driving or using machines

There is nothing to suggest that the use of Nuvelle Continuous affects driving or use of machines.

Important information about some of the ingredients of Nuvelle Continuous

Nuvelle Continuous contains lactose (a type of sugar). If you have an intolerance to some sugars, check with your doctor before
taking Nuvelle Continuous.

HOW TO TAKE NUVELLE Continuous

Do not take Nuvelle Continuous until at least 12 months after your last natural period.

Nuvelle Continuous is not for use in children or adolescents.

About the pack

This pack is designed to help you remember to take your medicine. Each tablet is placed in a section marked with the day of the week on
which it should be taken. The arrows between tablets show the order in which they must be taken. Your doctor may tell you when to start
(see "when to start" for further information).

On the day you start, take your first pink tablet from the top row of tablets marked with the correct day. For instance, if you start
on a Tuesday, press out the tablet from the blister marked 'TUE'.

Take one tablet each day, following the directions of the arrows, until you have finished all 28 tablets in the memo strip. It is best
to take your tablet at the same time each day. You can take Nuvelle Continuous with or without food. The tablet should be swallowed whole with a glass of water or milk.

When you have finished each memo strip, start the next memo strip on the following day. Do not leave a break between memo strips.
Tablet taking should be continuous and each memo strip will therefore be started on the same day of the week.

When to start

If you are not currently using an HRT preparation: start taking Nuvelle Continuous on any day.

If you have been taking other HRT preparations: carry on until you have finished your current pack and have taken all the
tablets for that month. Take your first Nuvelle Continuous tablet the next day. Do not leave a break between your old tablets and the
Nuvelle Continuous tablets.

If you take more Nuvelle Continuous than you should

If you have taken too many Nuvelle Continuous tablets by mistake, you may feel sick, vomit or have some menstruation-like bleeding. No
specific treatment is necessary but you should consult your doctor or pharmacist if you are worried.

If you forget to take Nuvelle Continuous

If you forget to take a tablet at your usual time and you are less than 12 hours late, take it as soon as possible. Take the next
tablet at the usual time.

If you are more than 12 hours late, leave the forgotten tablet in the pack. Continue to take the rest of the tablets at the usual time
every day. You may experience irregular bleeding.

If you stop taking Nuvelle Continuous

You may begin to feel the usual symptoms of menopause again, which may include hot flushes, trouble sleeping, nervousness, dizziness or
vaginal dryness. Consult your doctor or pharmacist if you want to stop taking Nuvelle Continuous tablets.

Nuvelle Continuous Side Effects

Like all medicines, Nuvelle Continuous can cause side effects, although not everybody gets them.

If any of the side effects gets serious, or if you notice any side effects not listed in this booklet, please tell your doctor or
pharmacist.

Serious side effects associated with Hormone Replacement Therapy:

• blood clots in the veins


• cancer of the lining of the womb


• breast cancer


• heart disease


• stroke


• dementia

For more information about these side effects see Section 2.

Other side effects that have been linked to the use of Nuvelle Continuous and other oral hormone replacement therapies:

• During the first few months of treatment you may experience some vaginal bleeding at unexpected times (breakthrough bleeding and
  spotting). These symptoms normally lessen with continued treatment. If they don’t, contact your doctor (see section 2 ‘Nuvelle Continuous
  and cancer/Endometrial cancer (cancer of the lining of the womb)’ for more information).


• breast pain, tenderness or enlargement, breast discharge


• painful periods, changes in vaginal secretions, pre-menstrual symptoms, increased size of fibroids in the womb, thrush, changes
  to the neck of the womb


• indigestion, a feeling of being bloated, passing wind, feeling or being sick, abdominal pain, gall bladder disease


• skin rashes or discolouration, itching, eczema, acne, unusual hair loss or hair growth, increased skin pigment especially on the
  face (chloasma – see section 2 ‘other conditions’ for more information), some rare skin problems


• headache, migraine, dizziness, anxiety or depressive symptoms, fatigue


• fast or irregular heartbeat (palpitations), high blood pressure, inflammation of veins usually in the legs


• fluid retention leading to swelling of parts of the body


• changes in body weight and sex drive, increased appetite


• muscle cramps, leg pains


• nose bleeds, visual disturbances (such as blurred vision), discomfort with contact lenses, allergic-type reactions, a worsening
  of glucose tolerance, bladder inflammation, rare disorders (porphyria, chorea).

HOW TO STORE NUVELLE Continuous

Keep out of the reach and sight of children.

Do not use Nuvelle Continuous after the expiry date which is printed on the label after "EXP". The expiry date refers to the last day
of the month stated.

Do not dispose of medicines down the drain or in the household rubbish. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.

Further Information

What Nuvelle Continuous contains

The active substances are estradiol (as hemihydrate) and norethisterone acetate.

The other ingredients are lactose monohydrate, maize starch, pre-gelatinized maize starch, povidone 25 000, talc, magnesium
stearate (E572), methylhydroxypropyl cellulose, macrogol 6000, titanium dioxide (E171) and red ferric oxide pigments (E172).

What Nuvelle Continuous looks like and contents of the pack

Nuvelle Continuous tablets are pink film-coated tablets.

They are supplied in a blister pack (memo strip) containing 28 tablets with the days of the week printed on the blister.

Boxes containing three blister packs are available

Marketing Authorisation Holder

Bayer PLC

Bayer House

Strawberry Hill

Newbury

Berkshire

RG14 1JA

Manufacturer

Bayer Schering Pharma AG

Berlin

Germany

or

Schering GmbH & Co Produktions KG

Weimar

Germany

Date of the last revision of this booklet

April 2010.

Nuvelle is a trademark of Bayer Schering Pharma AG (formerly Schering AG).