FEMOSTON - CONTI

Active substance: ESTRADIOL

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PACKAGE LEAFLET: INFORMATION FOR THE
USER
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.
The full name of your medicine is Femoston-conti
1mg/5mg film-coated tablets. In this leaflet the shorter
name Femoston-conti is used.

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.

1. WHAT FEMOSTON-CONTI IS AND WHAT IT IS
USED FOR
What Femoston-conti is
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.

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

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.

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.

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.

for position only

Do not take Femoston-conti if you
- are allergic (hypersensitive) to estradiol,
dydrogesterone or any of the other ingredients of
this medicine (listed in section 6)
- have or have ever had breast cancer, or if you
are suspected of having it
- have cancer which is sensitive to oestrogens,
such as cancer of the womb lining (endometrium),
or if you are suspected of having it
- have any unexplained vaginal bleeding
- have excessive thickening of the womb lining
(endometrial hyperplasia ) that is not being treated
- have or have ever had a blood clot in a vein
(thrombosis) such as in the legs (deep venous
thrombosis) or in the lungs (pulmonary embolism)
- have a blood clotting disorder (such as protein
C, protein S, or antithrombin deficiency)
- have or recently have had a disease caused by
blood clots in the arteries such as a heart attack,
stroke or angina
- have or have ever had a liver disease and your
liver function tests have not returned to normal
- have a rare blood problem called “porphyria” which
is passed down in families (inherited)
If any of the above conditions appear for the first time
while taking Femoston-conti, stop taking it at once and
consult your doctor immediately.
Warnings and precautions
Tell your doctor if you have ever had any of the
following problems, before you start the treatment, as
these may return or become worse during treatment
with 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

BLACK

for position only

Femoston-conti is used for

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.
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 any other 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. 3 extra cases).

for position only

for position only

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

- 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)’

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)
Femoston-conti is not a contraceptive and is not
intended to be used by women who could become
pregnant. Please ask your doctor for advice
Other medicines and 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.
MKP-01830-2012

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This applies to the following medicines:
- medicines for epilepsy (such as phenobarbital,
carbamazepine, phenytoin),
- medicines for tuberculosis (such as rifampicin,
rifabutin),
- medicines for HIV infection [AIDS] (such as
ritonavir, nelfinavir, nevirapine, efavirenz),
- herbal remedies containing St John’s Wort
(Hypericum perforatum).

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

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.
Taking 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.
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 where 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 where you take an oestrogen tablet
or use a patch that contains estrogen for the first
part of your cycle. Afterwards you take a tablet or
use a patch containing both an oestrogen and a
progestogen for up to 14 days.
Taking this medicine
• Swallow the tablet with water.
• You can take your tablet with or without food.
• Try to take your tablet at the same time each day.
This will make sure that there is a constant
amount of the product in your body. This will also
help you remember to take your tablets.
• Take one tablet every day, without a break
between packs. The blisters are marked with the
days of the week. This makes it easier for you to
remember when to take your tablets.
How much to take
• Your doctor will aim to give you the lowest dose for
as short as necessary. Speak to your doctor if you
think this dose is too strong or not strong enough.
• If you are taking 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, they are unlikely to come to any harm.
You may feel sick (nauseous), sleepy or dizzy or be
sick (vomit). No treatment is necessary; but if you are
worried contact your doctor for advice.

Very rare (likely to affect less than 1 in 10,000
patients):
- illness resulting from the destruction of red blood
cells (haemolytic anaemia)
- hypersensitivity reactions such as allergic asthma
- muscle twitches you can’t control (chorea)
- heart attack (myocardial infarction)
- a tumour of the brain that may be affected by the
levels of progestogens (meningioma)
- stroke
- vomiting
- swelling of the skin around the face and throat
this may cause difficulty breathing (angioedema),
rash with target-shaped reddening or sores,
painful reddish skin nodules, (erythema multiforme/
nodosum), purplish patches or spots on the skin
(vascular purpura), discolouration of the skin
especially of the face or neck known as “pregnancy
patches”, which may persist when drug is
discontinued (chloasma or melasma)
- worsening of a rare blood pigment disorder
(porphyria)
The following side effects have been reported with
other HRTs:
- benign or malignant tumours which may be affected
by the levels of oestrogens, such as cancer of the
womb lining, ovarian cancer (see section 2 “Do not
take Femoston-conti if you” 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)
- loss of mental abilities such as thinking,
remembering and reasoning (dementia)
- worsening of fits (epilepsy)
- blood clots in the arteries (arterial
thromboembolism)
- urinary incontinence
- inflammation of the pancreas (pancreatitis) in
women with pre-existing high levels of certain
blood fats (hypertriglyceridemia)
- increased total thyroid hormones
- painful/lumpy breasts (fibrocystic breast changes)
- high levels of certain blood fats (hypertriglyceridemia)
➢ If you get any side effects talk to your doctor or
pharmacist. This includes any side effects not
listed in this leaflet.
5. HOW TO STORE FEMOSTON-CONTI
Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Keep blister in the outer carton in order to protect from
light and moisture.
Do not use this medicine after the expiry date, which is
stated on the blister and the carton. The expiry date
refers to the last day of that month.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help protect the environment.

If you forget to take Femoston-conti
Take the missed tablet as soon as you remember. If it
is more then 12 hours after you should have taken the
tablet, take the next dose at the regular time. Do not
take the forgotten tablet. Do not take a double dose.
Bleeding or spotting may occur if you miss a dose.
If you stop taking 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 product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Femoston-conti can cause side
effects, although not everybody gets them.
The following diseases are reported more often in
women using HRT compared to women not using
HRT:
• breast cancer
• abnormal growth or cancer of the lining of the womb
(endometrial hyperplasia or cancer)
• ovarian cancer
• blood clots in the veins of the legs or lungs (venous
thromboembolism)
• heart disease
• stroke
• probable memory loss if HRT is started over the age
of 65
For more information about these side effects, see
Section 2
The following side effects may happen with this medicine:
Common (likely to affect between 1 and 10 in every
100 patients):
- migraine, headache. If you have a migraine-like
headache for the first time, stop taking Femostonconti and see a doctor immediately
- feeling sick (nausea), abdominal pain, wind
(flatulence)
- leg cramps
- tender or painful breasts, irregular bleeds or
spotting, pelvic pain
- feeling weak (asthenia)
- weight changes (up or down)
Uncommon (likely to affect between 1 and 10 in
every 1,000 patients):
- cystitis-like symptoms
- vaginal thrush (a vaginal infection due to a fungus
called Candida albicans)
- growths in the womb (fibroids) get bigger
- abnormally heavy and prolonged menstrual
bleeding (menorrhagia)
- feeling depressed, change in your sex drive,
nervousness
- dizziness

BLACK

Rare (likely to affect less than 1 in every 1,000
patients):
- change in the surface of the eye (steepening of
corneal curvature), not being able to wear your
contact lenses (contact lenses intolerance)
- liver disorders, sometimes with yellowing of the
skin (jaundice), feeling weak (asthenia) or generally
feeling unwell (malaise), and abdominal pain. If
you notice yellowing of the skin or the whites of
your eyes, stop taking Femoston-conti and see a
doctor immediately
- swelling of the breasts, pre-menstrual syndrome
(PMS)

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.
Salmon-coloured film-coated tablets.
• The tablets are packed in PVC film with a covering
aluminum foil.
• The blister packs contain 28, 84 or 280 (10 x 28)
film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Abbott Healthcare Products Ltd., Southampton,
SO18 3JD, UK
Manufacturer
Abbott Biologicals B.V., Veerweg 12, 8121 AA Olst, The
Netherlands
This medicinal product is authorised in the
Member States of the EEA under the following
names:
AT
BE
DE
FI
IE
IT
LU
NL
PT
UK

Femoston conti 1mg/5mg - Filmtabletten
Femoston Conti 1mg/5mg comprimés
pelliculés
Femoston conti 1mg/5 mg Filmtabletten
Femoston conti 1/5 tabletti,
kalvopäällysteinen
Femoston-conti 1mg/5mg film-coated tablet
Femoston 1/5 conti
Femoston Conti 1mg/5mg comprimés
pelliculés
Femoston continu 1/5, filmomhulde
tabletten
Femoston 1/5
Femoston-conti 1 mg/5 mg film-coated
tablets

This leaflet was last revised in November 2012.
MKP-01830-2012

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MKP-01830-2012_d2

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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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