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FEMUREST 1MG/5MG FILM-COATED TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Femurest 1mg/5mg, film-coated tablets
Active substances: estradiol/dydrogesterone

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.

The full name of your medicine is Femurest 1mg/5mg film-coated tablets. In this leaflet the
shorter name Femurest is used.
What is in this leaflet:
1.
2.
3.
4.
5.
6.

1.

What Femurest is and what it is used for
What you need to know before you take Femurest
How to take Femurest
Possible side effects
How to store Femurest
Contents of the pack and other information

WHAT FEMUREST IS AND WHAT IT IS USED FOR

What Femurest is
Femurest is a Hormone Replacement Therapy ( HRT). It contains two types of female hormones,
an oestrogen called estradiol and a progestogen called dydrogesterone. Femurest is used in
postmenopausal women with at least 12 months since their last natural period.

What Femurest 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"). Femurest alleviates these
symptoms after menopause. You will only be prescribed Femurest 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 Femurest to prevent osteoporosis after menopause.

2.

WHAT YOU NEED TO KNOW BEFORE YOU TAKE FEMUREST

Medical history and regular check-ups
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 a 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 an internal examination, if necessary.
Once you have started on Femurest 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 Femurest.
Go for regular breast screening, as recommended by your doctor.
DO NOT take Femurest 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 Femurest.
Do not take Femurest if you
-

are allergic (hypersensitive) to estradiol, dydrogesterone or any of the other ingredients of
Femurestthis medicine (listed in section 6)

-

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

-

havecancer which is sensitive to oestrogens, such as cancer of the womb lining
(endometrium), or if you are suspected of having it

-

have any unexplained vaginal bleeding

-

have excessive thickening of the womb lining (endometrial hyperplasia ) that is not
being treated

-

have or have ever had a blood clot in a vein (thromboembosis) such as in the legs (deep
venous thrombosis) or in the lungs (pulmonary embolism)

-

have a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency)

-

have or recently have had a disease caused by blood clots in the arteries, such as a heart
attack, stroke or angina

-

have or have ever had a liver disease and your liver function tests have not returned to
normal

-

have a rare blood problem called “porphyria” which is passed down in families
(inherited)

If any of the above conditions appear for the first time while taking Femurest, 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, before you start the
treatment, as these may return or become worse during treatment with Femurest. If so, you
should see your doctor more often for check-ups:
-

-

fibroids inside your womb
growths of womb lining outside your womb (endometriosis) or a history of excessive
growth of the womb lining (endometrial hyperplasia)
a tumour of the brain that may be affected by the levels of progestogens (meningioma)
increased risk of developing blood clots (see “Blood clots in a vein (thrombosis)”)
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

-

-

Stop taking Femurest 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 Femurest’ 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: Femurest is 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 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 Femurest. However, if the irregular bleeding:
 carries on for more than the first 6 months
 starts after you have been taking Femurest for more than 6 months
 carries on after you have stopped taking Femurest
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 of 9 to 14 in 1000 will be diagnosed
with breast cancer over a 5-year period. For women aged 50 to 79 who are taking oestrogenprogestogen HRT over 5 years, there will be 13 to 20 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

Ovarian cancer
Ovarian cancer is rare. A slightly increased risk of ovarian cancer has been reported in women
taking HRT for at least 5 to 10 years.
Compare
Women aged 50 to 69 who are not taking HRT, on average about 2 women in 1000 will be
diagnosed with ovarian cancer over a 5-year period. For women who have been taking HRT for
5 years, there will be between 2 and 3 cases per 1000 users (i.e. up to 1 extra case).

Effects 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 nonusers, 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 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 an other organ




you have systemic lupus erythematosus (SLE)
you have cancer

For signs of a blood clot, see “Stop taking Femurest 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 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..
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. 3 extra cases).

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.
Tell your doctor if you have or have had any of the following medical conditions since he will
have to monitor you more closely:

heart disease

kidney impairment

higher than normal levels of certain blood fats (hypertriglyceridemia)
Femurest is not a contraceptive and is not intended to be used by women who could become
pregnant.


Please ask your doctor for advice

Other medicines and Femurest


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

Some medicines may interfere with the effect of Femurest. This might lead to irregular bleeding.
This applies to the following medicines:
- medicines for epilepsy (such as phenobarbital, carbamazepine, phenytoin),
- medicines for tuberculosis (such as rifampicin, rifabutin),
- medicines for HIV infection [AIDS] (such as ritonavir, nelfinavir, nevirapine, efavirenz)
- herbal remedies containing St John’s Wort (Hypericum perforatum).

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

Taking Femurest with food and drink
can be taken with or without food.

Pregnancy and breast-feeding
Femurest is for use in postmenopausal women only.
If you become pregnant

stop taking Femurest and contact your doctor.

Driving and using machines
The effect of Femurest on driving or using machinery has not been studied. An effect is unlikely.

Femurest 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 FEMUREST

Always take Femurest exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.
When to start taking Femurest
Do not start taking Femurest until at least 12 months after your last natural period.

You can start taking Femurest on any convenient day if:
 you are currently not taking any HRT product
 you are switching from a “continuous combined” HRT product. This is where you take a
tablet or use a patch every day that contains both, an oestrogen and a progestogen.
You start taking Femurest the day after you finish the 28 day cycle if:
 you are switching from a ‘cyclic’ or ‘sequential’ HRT product. This is where you take an
oestrogen tablet or use a patch that contains estrogen for the first part of your cycle.
Afterwards you take a tablet or use a patch containing both an oestrogen and a progestogen
for up to 14 days.
Taking this medicine
 Swallow the tablet with water.
 You can take your tablet with or without food
 Try to take your tablet at the same time each day. This will make sure that there is a
constant amount of the product in your body. This will also help you remember to take
your tablets.
 Take one tablet every day, without a break between packs. The blisters are marked with
the days of the week. This makes it easier for you to remember when to take your tablets

How much to take
 Your doctor will aim to give you the lowest dose for as short as necessary. Speak to your
doctor if you think this dose is too strong or not strong enough.
 If you are taking Femurest to prevent osteoporosis, your doctor will adjust the dose to suit
you. It will depend on your bone mass.
 Take one salmon-coloured tablet every day for a 28 day cycle.

If you need to have surgery
If you are going to have surgery, tell the surgeon that you are taking Femurest. You may need to
stop taking Femurest 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 Femurest again.
If you take more Femurest than you should
If you (or someone else) take too many Femurest tablets, they are unlikely to come to any harm.
You may feel sick (nauseous), sleepy or dizzy or be sick (vomit). No treatment is necessary; but
if you are worried contact your doctor for advice.
If you forget to take Femurest
Take the missed tablet as soon as you remember. If it is more then 12 hours after you should
have taken the tablet, take the next dose at the regular time. Do not take the forgotten tablet. Do
not take a double dose. Bleeding or spotting may occur if you miss a dose.

If you stop taking Femurest
Do not stop taking Femurest without first talking to your doctor.


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

4.

POSSIBLE SIDE EFFECTS

Like all medicines, Femurest 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 may happen with this medicine:

Common (likely to affect between 1 and 10 in every 100 patients):
-

migraine, headache. If you have a migraine-like headache for the first time, stop taking
Femurest and see a doctor immediately
feeling sick (nausea), abdominal pain, wind (flatulence)
leg cramps
tender or painful breasts, irregular bleeds or spotting, pelvic pain
feeling weak (asthenia)
weight changes (up or down)

Uncommon (likely to affect between 1 and 10 in every 1,000 patients):
-

cystitis-like symptom
vaginal thrush (a vaginal infection due to a fungus called Candida albicans)
growths in the womb (fibroids) get bigger
abnormally heavy and prolonged menstrual bleeding (menorrhagia)
feeling depressed, change in your sex drive, nervousness
dizziness
blood clots in the legs or lungs (venous thromboembolism or pulmonary embolism)

-

high blood pressure (hypertension)
problems with your circulation (peripheral vascular disease)
enlarged and tortuos (varicose) vein
indigestion
gall bladder disease
allergic skin reactions (such as rash, severe itching (pruritus) or hives (urticaria))
back pain
erosion of the neck of the womb (uterine cervical erosion), discharge from the neck of
the womb (cervical discharge), painful periods (dysmenorrhoea),
swelling of your ankles, feet or fingers (peripheral oedema)

Rare (likely to affect less than 1 in every 1,000 patients):
-

-

change in the surface of the eye (steepening of corneal curvature), not being able to wear
your contact lenses (contact lenses intolerance)
liver disorders, sometimes with yellowing of the skin (jaundice), feeling weak (asthenia)
or generally feeling unwell (malaise), and abdominal pain. If you notice yellowing of the
skin or the whites of your eyes, stop taking Femurest and see a doctor immediately.
swelling of the breasts, pre-menstrual syndrome (PMS)

Very rare (likely to affect less than 1 in 10,000 patients:
-

-

illness resulting from the destruction of red blood cells (haemolytic anaemia).
hypersensitivity reactions such as allergic asthma.
muscle twitches you can’t control (chorea)
heart attack (myocardial infarction)
a tumour of the brain that may be affected by the levels of progestogens (meningioma)
stroke
vomiting
swelling of the skin around the face and throat this may cause difficulty breathing
(angioedema), rash with target-shaped reddening or sores, painful reddish skin nodules,
(erythema multiforme/nodosum), purplish patches or spots on the skin (vascular
purpura), skin discolouration of the skin especially of the face or neck known as
“pregnancy patches”, which may persist when drug is discontinued (chloasma or
melasma)
worsening of a rare blood pigment disorder (porphyria)

The following side effects have been reported with other HRTs:
-

-

benign or malignant tumours which may be affected by the levels of oestrogens, such as
cancer of the womb lining, ovarian cancer (see section 2 “Do not take Femurest if you” for
more information)
increased size of tumours that my be affected by the levels of progestogens (such as
meningioma)

-

a disease where the immune system abnormally attacks many organs of the body (systemic
lupus erythematosus )
loss of mental abilities such as thinking, remembering and reasoning (dementia).
worsening of fits (epilepsy)
blood clots in the arteries (arterial thromboembolism)
urinary incontinence
inflammation of the pancreas (pancreatitis) in women with pre-existing high levels of
certain blood fats (hypertriglyceridemia)
increased total thyroid hormones
painful/lumpy breasts (fibrocystic breast changes)
high levels of certain blood fats (hypertriglyceridemia)



If you get any side effects talk to your doctor or pharmacist. This includes any side
effects not listed in this leaflet.

5.

HOW TO STORE FEMUREST

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Keep blister in the outer carton in order to protect from light and moisture.
Do not use this medicine after the expiry date, which is stated on the blister and the carton. 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 how
to throw away medicines you no longer use. These measures will help protect the environment.

6.

CONTENTS OF THE PACK AND OTHER INFORMATION

What Femurest contains


The active substances are estradiol as estradiol hemihydrate and dydrogesterone
-

each tablet contains 1 mg estradiol and 5 mg dydrogesterone.



The other ingredients in the tablet core are lactose monohydrate, hypromellose, maize starch,
colloidal anhydrous silica and magnesium stearate.



The other ingredients in the coating are:
-

Titanium dioxide (E171), Iron oxide yellow (E172), Iron oxide red (E172),
Hypromellose, Macrogol 400

What Femurest looks like and contents of the pack


This medicinal product is a film-coated tablet. The tablet is round, biconvex and marked 379
on one side (7mm). Each pack contains 28 tablets.



Salmon-coloured film-coated tablets



The tablets are packed in PVC film with a covering aluminum foil.



The blister packs contain 28, 84 or 280 (10 x 28) film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Abbott Healthcare Products Ltd., Southampton, SO18 3JD, UK
Manufacturer
Abbott Biologicals B.V., Veerweg 12, 8121 AA Olst, The Netherlands

This medicinal product is authorised in the Member States of the EEA under the following
names:
BE
DE
FR
IE
NL
UK

Haruton Conti 1mg/5mg comprimés pelliculés
Femoston conti 1 mg/5 mg Filmtabletten
Climaston 1mg/5mgl comprimé pelliculé
Femurest-conti 1/5 film-coated tablet
Femurest continu 1/5, filmomhulde tabletten
Femurest 1 mg/5 mg film-coated tablets

This leaflet was last revised in November 2012.

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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