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FEMOSTON-CONTI 1MG/5MG FILM-COATED TABLETS

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

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Femoston-conti 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. See section 4.
The full name of your medicine is Femoston-conti
1mg/ 5mg. In this leaflet the shorter name Femostonconti 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 Femostonconti 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-conti to prevent
osteoporosis after menopause.
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 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-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).
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- 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-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 Femostonconti 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.
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
Additionally, you are advised to join mammography
screening programs when offered to you. For
mammogram screening, it is important that you inform
the nurse/healthcare professional who is actually
taking the x-ray that you use HRT, as this medication
may increase the density of your breasts which may
affect the outcome of the mammogram. Where the
density of the breast is increased, mammography may
not detect all lumps.
Ovarian cancer
Ovarian cancer is much rarer than breast cancer.
The use of oestrogen-only or combined oestrogenprogestagen 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).
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:
Ø heart disease
Ø kidney impairment
Ø higher than normal levels of certain blood fats
(hypertriglyceridemia)
Children
Femoston-conti is not intended for use in children.
Other medicines and Femoston
Ø 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),

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PACKAGE LEAFLET: INFORMATION FOR THE USER

- 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 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
Ø stop taking Femoston-conti and contact your
doctor.
Femoston-conti is not indicated for use during breastfeeding.
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 Femoston-conti 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.
• If you are taking Femoston-conti 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 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.
Ø If you have any further questions on the use of
this product, 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)*
- 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.
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 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 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 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 (7mm). Each pack contains 28 tablets. Salmoncoloured film-coated tablet.
• 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 1mg/5mg - Filmtabletten
BE Femoston Conti 1mg/5mg comprimés pelliculés
DE Femoston conti 1mg/5 mg Filmtabletten
FI Femoston conti 1/5 tabletti, kalvopäällysteinen
IE Femoston-conti 1mg/5mg film-coated tablet
IT Femoston 1/5 conti
LU Femoston Conti 1mg/5mg comprimés pelliculés
NL Femoston continu 1/5, filmomhulde tabletten
1mg, 5mg
PT Femoston 1/5
UK Femoston-conti 1 mg/5 mg film-coated tablets
This leaflet was last revised in February 2016.

MKP-00262-2016

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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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