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FEMOSTON 1/10 MG FILM-COATED TABLETS

Active substance(s): DYDROGESTERONE MICRONISED / ESTRADIOL HEMIHYDRATE MICRONISED

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FPO

pharma code

MKP-00260-2016

Black

FRONT

MKP-00260-2016_d1

pharma code

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. HRT is used in
woman who require oestrogen replacement and who
have not had their womb removed (hysterectomy).
Femoston is used in postmenopausal women at least
6 months since last menses.
Femoston is used for:
Relief of symptoms occurring after menopause
During the menopause, the amount of 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 a tumor which is sensitive to progestogen,
such as a tumor of the brain (meningioma)
• 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 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 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
withdrawal 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 oestrogenonly 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 much rarer than breast cancer. The use
of oestrogen-only or combined oestrogen-progestogen
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 3times 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 any 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 oestrogenprogestogen HRT are slightly more likely to develop heart
disease than those not taking any HRT.
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.
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 carbamazepine)
• Medicines for tuberculosis (such as rifampicin and
rifabutin)
• Medicines for HIV infection (such as nevirapine,
efavirenz, ritonavir and nelfinavir)
• Herbal remedies containing St John’s Wort
Problems due to high levels of the following medicines
may occur when you take Femoston so careful
drug monitoring and dose decrease may become
necessary:
- tacrolimus and cyclosporin – used, for example, for
organ transplants
- fentanyl – a painkiller
- theophylline – used for asthma and other breathing
problems
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines including

FPO

-

PACKAGE LEAFLET:
INFORMATION FOR THE USER

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, 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, breast tenderness, dizziness, abdominal
pain, drowsiness/fatigue, and withdrawal bleeding 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 than 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:
• allergic reactions that may cause 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:
Very common (in more than 1 in 10 patients
treated):
• headache
• abdominal pain
• back pain
• breast pain or tenderness
Common (in less than 1 in 10, but more than 1 in
100 patients treated):
• vaginal thrush (a vaginal infection due to a fungus
called Candida albicans)
• depression
• nervousness
• migraine
• dizziness
• feeling sick
• vomiting
• wind (flatulence)
• allergic skin reactions (including rash or itching)
• unscheduled bleeding or spotting, heavy, irregular
or painful periods
• pelvic pain
• vaginal discharge
• generally feeling unwell, weak or tired
• swelling of the ankles, feet or fingers (peripheral
oedema)
• increase in weight
Uncommon (in less than 1 in 100, but more than 1
in 1,000 patients treated):
• symptoms of cystitis
• fibroids get bigger (growths in the womb increase)
• change in sex drive
• high blood pressure
• peripheral vascular disease
• varicose veins
• blood clots in the veins of the legs or lungs (venous
thromboembolism)
• indigestion

• liver disorders, which may include jaundice
(yellowing of the skin), asthenia (feeling weak) and
general malaise and abdominal pain
• gall bladder disorder
• swelling of the breasts
• pre-menstrual tension (PMT)
• decrease in weight
Rare (in less than 1 in 1,000, but more than 1 in
10,000 patients treated):
• heart attack
• swelling of the skin around the face and neck. This
may cause difficulty breathing
• red or brown patches on the skin
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
HRTs (including Femoston):
• benign or malignant tumours which may be affected
by the levels of oestrogens, such as cancer of the
womb lining, ovarian cancer
• increased size of tumours that may be affected by the
levels of progestogens (such as meningioma)
• reduction in red blood cells which can make the
skin pale and cause weakness or breathlessness
(anaemia)
• a disease where the immune system abnormally
attacks many organs of the body (systemic lupus
erythematosus)
• high levels of certain blood fats (hypertriglyceridemia)
• loss of mental abilities such as thinking,
remembering and reasoning (dementia)
• chorea (muscle twitches)
• worsening of fits (epilepsy)
• change in the surface of the eye
• intolerance to contact lenses
• blood clots in the arteries (arterial thromboembolism)
• inflammation of the pancreas (pancreatitis) in
women with pre-existing high levels of certain blood
fats (hypertriglyceridemia)
• 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)
• Leg cramps
• urinary incontinence
• painful/lumpy breasts (fibrocystic breast changes),
uterine cervical erosion
• worsening of porphyria (a rare blood pigment
disorder)
• increased total thyroid hormones
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.
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 national reporting systems listed below.
In the UK:
The Yellow Card Scheme at: www.mhra.gov.uk/
yellowcard
In Malta:
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D’Argens
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt
By reporting side effects you can help provide more
information on the safety of this medicine.
5. HOW TO STORE FEMOSTON
Keep
medicinal
Keepout
outof
ofthe
thereach
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andsight
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children. This
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product
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notnot
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above 30°C.
take any
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Do
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date, which
date,
is stated on
thethe
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the last
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thatbefore”
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day
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not
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not of
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disposed
via wastewater
household
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wastewater
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Ask your
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Ask your pharmacist
how
to dispose
of pharmacist
medicines no
tolonger
dispose
of medicines
no longer required.
required.
These measures
will help toThese
protect the
measures
will help to protect the environment.
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
BGP Products Ltd., Abbott House,
Vanwall Business Park, Vanwall Road, Maidenhead,
SL6 4XE, UK.
Manufacturer
Abbott Biologicals B.V.
8121 AA, Olst
The Netherlands
This leaflet was last revised in January
2016.
March 2016.

MKP-00260-2016

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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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