FEMOSTON 1/10 MG FILM-COATED TABLETS

Active substance: ESTRADIOL HEMIHYDRATE MICRONISED

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Active substances: oestradiol hemihydrate and
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 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.
- If you get any side effects, talk to your doctor, or
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet.
What is in this leaflet
1. What Femoston is and what it is used for
2. What you need to know before you take Femoston
3. How to take Femoston
4. Possible side effects
5. How to store Femoston
6. Contents of the pack and other information
1. WHAT FEMOSTON IS AND WHAT IT IS USED
FOR
Femoston is a Hormone Replacement Therapy (HRT).
It contains two types of female hormones, an oestrogen
and a progestogen.
Femoston 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"). Femoston alleviates these symptoms after
menopause. You will only be prescribed Femoston 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 Femoston to prevent osteoporosis
after menopause.
2. BEFORE YOU TAKE FEMOSTON
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 Femoston 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 Femoston.
Go for regular breast screening, as recommended by
your doctor.
Do not take Femoston
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 Femoston,
Do not take Femoston
• If you have or have ever had breast cancer, or if
you are suspected of having it
• If you have 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, 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 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 oestradiol/
dydrogesterone or any of the other ingredients of
Femoston (listed in section 6 Further information)
If any of the above conditions appear for the first time
while taking Femoston, stop taking it at once and consult your doctor immediately.
When to take special care with Femoston
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 Femoston. 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 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 Femoston 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
Femoston’ 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: Femoston 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 Femoston 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
Femoston. However, if the irregular bleeding:
• carries on for more than the first 6 months
• starts after you have been taking Femoston for
more than 6 months
• carries on after you have stopped taking Femoston
see your doctor as soon as possible.
Unexpected bleeding
You will have a bleed once a month (so-called
with-drawal bleed) while taking Femoston. But, if you
have unexpected bleeding or drops of blood (spotting)
besides your monthly bleeding, which:
• carries on for more than the first 6 months
• starts after you have been taking Femoston more
than 6 months
• carries on after you have stopped taking Femoston
see your doctor as soon as possible
Breast cancer
Evidence suggests that taking combined oestrogenprogestogen 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 14 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 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.
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).
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 an other organ
• you have systemic lupus erythematosus (SLE)
• you have cancer.
For signs of a blood clot, see “Stop taking Femoston
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).
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.
Using other medicines
Some medicines may interfere with the effect of
Femoston. 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 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 xxxxxxx

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 Femoston, because this medicine
can affect the results of some tests.
Pregnancy and breast-feeding
Femoston is for use in postmenopausal women only. If
you become pregnant, stop taking Femoston and
contact your doctor.
3. HOW TO TAKE FEMOSTON
Always take Femoston exactly as your doctor has
told you. You should check with your doctor or
pharmacist if you are not sure.
How to take Femoston
Take one tablet every day, without a break between
packs. Swallow the tablet with water and with or
without food.
Your doctor will aim to give you the lowest dose
for the shortest time to treat your symptoms.
Speak to your doctor if you think this dose is too
strong or not strong enough
The usual starting dose is:
During day 1 to 14 of the cycle, 1 tablet daily containing
1 or 2 mg oestradiol.
During day 15 to 28 of the cycle, 1 tablet daily containing
1 or 2 mg oestradiol and 10 mg dydrogesterone.
Immediately after the 28-day cycle you should begin
the next treatment.
The days of the week are printed on the back of the
blister strips. The tablets from the part marked with
arrow 1 should be taken first, then the tablets from the
part marked with arrow 2 should be taken.
If you are having regular periods you should start
taking Femoston within five days of the start of bleeding.
If you are not having regular periods and are not taking
any other Hormone Replacement Therapy (HRT)
preparations, or you are switching from a combined
continuous HRT product, you can start taking
Femoston on any convenient day.
If you are currently using a ‘cyclic’ or ‘sequential’ HRT
preparation (which involves taking an oestrogen tablet
or patch for part of the month, followed by both oestrogen
and progestagen tablet or patch for up to 14 days) start
taking Femoston the day after you finish the pack i.e.
at the end of the progestagen phase.
The doctor may increase the dose later, if necessary.
The different tablet strengths are colour-coded for your
convenience.
If you are taking Femoston to treat symptoms of the
menopause (change of life), your treatment should
begin with the dosage Femoston 1/10.
Your doctor will then increase this dose according to
your symptoms.
If you are taking Femoston to prevent osteoporosis,
your doctor will adjust the dose individually according
to your bone mass.
If you take more Femoston than you should
If you or somebody else takes too many Femoston
tablets, they are unlikely to come to any harm. Nausea
(feeling sick), vomiting, sleepiness and dizziness may
occur. No treatment is necessary, but if you are worried
contact your doctor for advice.
If you forget to take Femoston
Take the missed tablet as soon as you remember.
If it is more then 12 hours since you took the last one,
take the next dose without taking the forgotten tablet.
Do not take a double dose. Bleeding or spotting may
occur if you miss a dose.
If you stop taking Femoston
Do not stop taking Femoston without first talking to
your doctor.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
If you need to have surgery
If you are going to have surgery, tell the surgeon that
you are taking Femoston. You may need to stop taking
Femoston 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 Femoston again.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Femoston 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 serious side effects may occur
during treatment with Femoston:
• swelling of the skin around the face and neck. This
may cause difficulty breathing
• heart attack
• tumours that may be affected by the levels of
progestagens (e.g. meningioma)
• heavy, irregular or painful genital bleeding
If any of these side effects occur you should stop
treatment immediately and contact your doctor.
The following side effects may occur during treatment:
Common (in less than 1 in 10, but more than 1 in
100 patients treated):
• migraine
• headache
• feeling sick
• leg cramps
• breast pain or tenderness
• abdominal pain
• pelvic pain
• unscheduled bleeding or spotting
• wind (flatulence)
• feeling weak (asthenia)
• weight changes
Uncommon (in less than 1 in 100, but more than 1
in 1,000 patients treated):
• allergic skin reactions (including rash or itching)
• feeling down (depression)
• vaginal thrush (a vaginal infection due to a fungus
called Candida albicans)
• symptoms of cystitis
• high blood pressure
• swelling of the ankles, feet or fingers (peripheral
oedema)
• peripheral vascular disease
• varicose veins
• gallbladder disease
• change in sex drive

• back pain
• indigestion
• nervousness
• dizziness
• vaginal discharge
• fibroids get bigger (growths in the womb increase)
• changes in the cervix (the lower end of the womb)
Rare (in less than 1 in 1,000, but more than 1 in
10,000 patients treated):
• liver disorders, which may include jaundice (yellowing
of the skin), asthenia (feeling weak) and general
malaise
• change in the surface of the eye
• intolerance to contact lenses
• pre-menstrual tension (PMT)
• swelling of the breasts
Very rare (in less than 1 in 10,000 patients treated,
not known (cannot be estimated from the available
data)):
• reduction in red blood cells which can make the
skin pale and cause weakness or breathlessness
(anaemia)
• chorea (muscle twitches)
• vomiting
• skin discolouration
• red or brown patches on the skin
• worsening of porphyria (a metabolic disease).
There is a slightly increased risk of developing the following
diseases in women taking Hormone Replacement
Therapy (HRT):
• dementia (there is no conclusive evidence that this
can develop)
If unscheduled bleeding occurs after some time on
HRT, you should contact your doctor. If unscheduled
bleeding continues after stopping HRT, it may be
necessary to perform tests to exclude disease of the
endometrium (the lining of the uterus).
Changes can occur in the levels of certain proteins and
hormones in the blood. The action of the hormones in the
body is not affected. You should tell your doctor that
you are taking HRT if you are to have a blood test.
The following side effects have been reported with
other HRTs:
• various skin disorders:
- discoloration 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)
If any of the side effects gets serious , or if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
5. HOW TO STORE FEMOSTON
Keep out of the reach and sight of children.
Do not store above 30°C.
Do not take Femoston after the “use before” date,
which is stated on the pack. The “use before” date
refers to the last day of that month.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose
of medicines no longer required. These measures will
help to protect the environment.
6. FURTHER INFORMATION
What Femoston contains
• The active substances are:
- oestradiol
-dydrogesterone
Femoston 1/10
Contains 14 white tablets with 1 mg oestradiol per
tablet for the first 14 days of the cycle and 14 grey
tablets with 1 mg oestradiol and 10 mg dydrogesterone
for the second 14 days of the cycle.
Femoston 2/10
Contains 14 brick red tablets with 2 mg oestradiol per
tablet for the first 14 days of the cycle and 14 yellow
tablets with 2 mg oestradiol and 10 mg dydrogesterone
for the second 14 days of the cycle.
• The other ingredients in the tablet core are: lactose,
hypromellose, maize starch, colloidal anhydrous silica,
magnesium stearate
• The other ingredients in the film coating for

Femoston 1/10 oestradiol only are:
hypromellose, macrogol 400, titanium dioxide (E171)

• The other ingredients in the film coating for
Femoston 1/10 oestradiol/dydrogesterone are:
hypromellose, macrogol 400, titanium dioxide (E171),
black iron oxide (E172).

• The other ingredients in the film coating for
Femoston 2/10 oestradiol only are: hypromellose,
talc, macrogol 400, titanium dioxide (E171), black,
red, and yellow iron oxides (E172).

• The other ingredients in the film coating for
Femoston 2/10 oestradiol/dydrogesterone are:
hypromellose, talc, macrogol 400, titanium dioxide
(E171), yellow iron oxide (E172).
What Femoston looks like and contents of the pack
Film-coated tablets.
Femoston 1/10
Round white film-coated tablets and round grey
film-coated tablets
The inscription on the tablets is ‘379’ on one side.
The tablets are packed in a PVC film with a covering
aluminium foil.
The blister packs contain 84 film-coated tablets.
Femoston 2/10
Round brick red film-coated tablets and round yellow
film-coated tablets
The inscription on the tablets is ‘379’ on one side.
The tablets are packed in a PVC/PVdC or PVC film
with a covering aluminium foil.
The blister packs contain 28 or 84 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Abbott Healthcare Products Limited
Mansbridge Road
West End
Southampton
SO18 3JD
Manufacturer
Abbott Pharmaceuticals B.V.
8121 AA, Olst
The Netherlands
This leaflet was last approved in 01/2012
For information in large print, tape, CD or Braille,
phone 02380 467000 (UK) or +44 2380 467000
(Ireland)

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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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