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FEMOSTON CONTI 0.5MG/2.5MG FILM-COATED TABLETS

Active substance(s): DYDROGESTERONE / ESTRADIOL

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Active substances: estradiol/dydrogesterone

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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. See section 4.
The full name of your medicine is Femoston-conti
0.5 mg/2.5 mg. In this leaflet the shorter name
Femoston-conti is used.
What is in this leaflet:
1. What Femoston-conti is and what it is used for
2. What you need to know before you take Femostonconti
3. How to take Femoston-conti
4. Possible side effects
5. How to store Femoston-conti
6. Contents of the pack and other information
1. What FEMOSTON-CONTI is and what it is used
for
Femoston-conti is a Hormone Replacement Therapy
(HRT). It contains two types of female hormones,
an oestrogen called estradiol and a progestogen
called dydrogesterone. Femoston-conti is used in
postmenopausal women with at least 12 months since
their last natural period.
Femoston-conti 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-conti alleviates these symptoms
after menopause. You will only be prescribed
Femoston-conti if your symptoms seriously hinder
your daily life.

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2. What you need to know before you take
FEMOSTON-CONTI
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-conti 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-conti.
Go for regular breast screening, as recommended
by your doctor.
DO NOT take Femoston-conti 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-conti.
DO NOT take Femoston-conti
- 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 estradiol,
dydrogesterone or any of the other ingredients of
this medicine (listed in section 6)
If any of the above conditions appear for the first time
while taking Femoston-conti, stop taking it at once
and consult your doctor immediately.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Femoston-conti, if you have ever had any of the
following problems, as these may return or become
worse during treatment with Femoston-conti. 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)
- 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 Femoston-conti 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-conti’ 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)’

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
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 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 Femostonconti 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. 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.
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)
Children
Femoston-conti is not intended for use in children.
Other medicines and Femoston-conti
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
Femoston-conti. 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
nevirapine, efavirenz, ritonavir, nelfinavir)
- 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 Femoston-conti,
because this medicine can affect the results of some
tests.
Femoston-conti with food and drink
Femoston-conti can be taken with or without food.
Pregnancy and breast-feeding
Femoston-conti is for use in postmenopausal women
only.
If you become pregnant
 stop taking Femoston-conti and contact your
doctor.
Femoston-conti is not indicated for use during
breast-feeding.
1101738

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1101738_d2

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Femoston conti 0.5 mg /2.5 mg,
film-coated tablets

Note: Femoston-conti 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-conti 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-conti. However, if the irregular bleeding:
• carries on for more than the first 6 months
• starts after you have been taking Femoston-conti
for more than 6 months
• carries on after you have stopped taking
Femoston-conti
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.

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Driving and using machines
The effect of Femoston-conti on driving or using
machinery has not been studied. An effect is unlikely.
Femoston-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 FEMOSTON-CONTI
Always take this medicine exactly as your
doctor has told you. Check with your doctor or
pharmacist if you are not sure.
When to start taking Femoston-conti
Do not start taking Femoston-conti until at least 12
months after your last natural period.
You can start taking Femoston-conti on any
convenient day if:
• You are currently not taking any HRT product.
• You are switching from a ‘continuous combined’
HRT product. This is when you take a tablet or
use a patch every day that contains both, an
oestrogen and a progestogen.
You start taking Femoston-conti the day after you
finish the 28 day cycle if:
• You are switching from a ‘cyclic’ or ‘sequential’
HRT product. This is when you take a tablet or
use a patch that contains oestrogen 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 prescribe the lowest dose
to treat your symptoms for as short as necessary.
Speak to your doctor if you think this dose is too
strong or not strong enough.
• Take one yellow-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 Femoston-conti. You may need to stop
taking Femoston-conti 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-conti again.
If you take more Femoston-conti than you should
If you (or someone else) take too many Femostonconti tablets, you are unlikely to come to any harm.
You may feel sick (nauseous), or be sick (vomit), may
have tender or painful breasts, dizziness, abdominal
pain, drowsiness/tiredness, or withdrawal bleeding.
No treatment is necessary. But if you are worried,
contact your doctor for advice.
If you forget to take Femoston-conti
Take the missed tablet as soon as you remember. If it
is more than 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 Femoston-conti
Do not stop taking Femoston-conti without first
talking to your doctor.
 If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.
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 may happen with this
medicine:
Very common (may affect more than 1 in 10
patients):
- headache
- abdominal pain
- back pain
- tender or painful breasts
Common (may affect up to 1 in 10 patients):
- vaginal thrush (a vaginal infection due to a fungus
called Candida albicans)
- feeling depressed, nervousness
- migraine. If you have a migraine-like headache for
the first time, stop taking Femoston-conti and see
a doctor immediately
- dizziness
- feeling sick (nausea), vomiting, bloating (swelling
of the abdomen), including wind (flatulence)
- allergic skin reactions (such as rash, severe itching
(pruritus) or hives (urticaria))
- menstrual disorder such as irregular bleeds,
spotting, painful periods (dysmenorrhoea),
heavier or less bleeding
- pelvic pain
- vaginal discharge
- feeling weak, tired or unwell
- swelling of your ankles, feet or fingers (peripheral
oedema)
- weight increase
Uncommon (may affect up to 1 in 100 patients):
- cystitis-like symptoms
- growths in the womb (fibroids) get bigger
- hypersensitivity reactions such as dyspnoea
(allergic asthma)
- change in sex drive
- 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 tortuous (varicose) vein
- indigestion
- 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 Femoston-conti
and see a doctor immediately.
- gallbladder disease
- swelling of your breasts
- pre-menstrual syndrome (PMS)
- weight decrease
Rare (may affect up to 1 in 1,000 patients):
(*Side effects from the market not observed in clinical
trials have been attributed to the frequency “rare”.)
- illness resulting from the destruction of red blood
cells (haemolytic anaemia)*
- meningioma (a brain tumor)*

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- change in the surface of the eye (steepening of
corneal curvature)*, not being able to wear your
contact lenses (contact lense intolerance)*
- heart attack (myocardial infarction)
- stroke*
- swelling of the skin around the face and throat. This
may cause difficulty in breathing (angioedema)
- purplish patches or spots on the skin (vascular
purpura)
- painful reddish skin nodules (erythema nodosum)*,
discoloration of the skin especially of the face or
neck known as “pregnancy patches” (chloasma
or melasma)*
- leg cramps*
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 for more information)
- increased size of tumours that may 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)
- probable dementia
- worsening of fits (epilepsy)
- muscle twitches you cannot control (chorea)
- blood clots in the arteries (arterial thromboembolism)
- inflammation of the pancreas (pancreatitis) in
women with pre-existing high levels of certain
blood fats (hypertriglyceridemia)
- rash with target-shaped reddening or sores
(erythema multiforme)
- urinary incontinence
- painful/lumpy breasts (fibrocystic breast disease)
- erosion of the neck of the womb (uterine cervical
erosion)
- worsening of a rare blood pigment disorder
(porphyria)
- high levels of certain blood fats (hypertriglyceridemia)
- increased total thyroid hormones
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. 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 FEMOSTON-CONTI
Keep this medicine out of the sight and reach of
children.
This medicine does not require any special storage
conditions.
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 to protect the environment.
6. Contents of the pack and other information
What Femoston-conti contains
• The active substances are estradiol as estradiol
hemihydrate and dydrogesterone.
• Each tablet contains 0.5 mg estradiol and
2.5 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), Polyvinyl alcohol, Macrogol 3350, Talc.
What Femoston-conti 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. Each blister strip contains 28 tablets.
• The tablets are yellow coloured.
• The tablets are packed in PVC film with a covering
aluminium 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
BGP Products Ltd.,
Abbott House, Vanwall Business Park, Vanwall Road,
Maidenhead, SL6 4XE, 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:
AT Femoston conti 0,5 mg/2,5 mg - Filmtabletten
BE Femoston Low 0,5 mg/2,5 mg filmcoated
tablets
CZ Femoston mini 0,5 mg/2,5 mg, potahované
tablety
DE Femoston mini 0,5 mg/2,5 mg Filmtabletten
EE Femoston conti 0,5 mg/2,5 mg
FI Femoston conti 0.5/2.5 tabletti,
kalvopäällysteinen
FR Climesta 0.5mg/2.5 mg, comprimé pelliculé
IE Femoston-conti 0.5 mg/ 2.5 mg filmcoated
tablets
IT Femoston 0,5 mg/2,5 mg film-coated tablet
LT Femoston conti 0,5 mg/2,5 mg plévele
dengtos tabletés
LU Femoston Low 0,5 mg/2,5 mg filmcoated
tablet
LV Femoston conti 0,5 mg/2,5 mg filmcoated
tablets
MT Femoston-conti 0.5 mg/2.5 mg filmcoated
tablets
NL Femoston continu 0,5 mg/2,5 mg
filmomhulde tabletten
PL Femoston mini 0,5mg/2,5mg film-coated
tablets
PT Femoston 0,5 mg/2,5 mg – film-coated
tablets
SK Femoston conti 0,5 mg/2,5 mg, filmom
obalené tablety
UK Femoston-conti 0.5 mg/2.5 mg, film-coated
tablets
This leaflet was last revised in April 2015.

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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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