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

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

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S0097 Leaflet Femoston conti 20170217

S0097 Leaflet Femoston conti 20170217

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.

5.

-

gallbladder disease



-

swelling of your breasts

Do not store above 30°C. Store in the original package in order
to protect from light and moisture.

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.

-

pre-menstrual syndrome (PMS)



-

Keep this leaflet. You may need to read it again.

-

weight decrease

If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.

-

If you have any further questions, ask your doctor or
pharmacist.

If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

-

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.

-

How to store Femoston-conti



KEEP OUT OF THE SIGHT & REACH OF CHILDREN.



Do not use after the expiry date printed on the carton label or
blister strip.


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)

What Femoston-conti looks like and contents of the pack

-

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*

Product Licence holder

-

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 preexisting 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.

FEMOSTON-CONTI 1mg/5mg FILM-COATED TABLETS
(estradiol/dydrogesterone)

-

-

6.

Contents of the pack and other information

What Femoston-conti contains


Each tablet contains 1mg of the active ingredient estradiol and
5mg of the active ingredient dydrogesterone,



Femoston-conti tablets also contain the following inactive
ingredients: lactose monohydrate, hypromellose, maize starch,
colloidal anhydrous silica, magnesium stearate and macrogol
400. The colours used are titanium dioxide (E171), yellow iron
oxide (E172) and red iron oxide (E172).
Femoston-conti is a salmon coloured, round, biconvex, filmcoated tablet marked ‘379’ on one side and plain on the other.

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 FilmCoated Tablets. In this leaflet the shorter name ‘Femoston-conti’ is
used.
1.

What Femoston-conti is and what it is used for

2.

What you need to know before you take Femoston-conti

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.

POM

PL: 19488/0097

Leaflet revision date: 17 February 2017

Blind or partially sighted? Is
this leaflet hard to see or read?
Call 02087997607 to obtain the
leaflet in large print, tape, CD
or Braille.
Femoston is a registered trade mark of Solvay Pharmaceuticals BV,
The Netherlands.
S0097 Leaflet Femoston conti 20170217

-

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

Prevention of osteoporosis

-

a liver disorder such as a benign liver tumour

After the menopause some women may develop fragile bones
(osteoporosis). You should discuss all available options with your
doctor.

-

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

Manufacturer
This product is manufactured by Abbott Biologicals B.V., Weesp,
Netherlands.

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

What is in this leaflet:

Femoston-conti is available as blister packs of 28 or 84 tablets
(3 x 28 tablets).

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.

PACKAGE LEAFLET: INFORMATION FOR THE USER

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.

If you are at an increased risk of fractures due to osteoporosis and
other medicines are not suitable for you, you can use Femostonconti 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

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)’

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 oestrogen-progestogen
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.



you have any blood clotting problem that needs long-term
treatment with a medicine used to prevent blood clots

Pregnancy and breast-feeding

If you forget to take Femoston-conti

Femoston-conti is for use in postmenopausal women only.



if any of your close relatives has ever had a blood clot in the
leg, lung or another organ

If you become pregnant



you have systemic lupus erythematosus (SLE)



Femoston-conti is not indicated for use during breast-feeding.

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.

you have cancer
Driving and using machines

If you stop taking Femoston-conti

Compare

The effect of Femoston-conti on driving or using machinery has not
been studied. An effect is unlikely.

Do not stop taking Femoston-conti without first talking to your
doctor.

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.

Femoston-conti tablets contain lactose.

For women in their 50s who have been taking oestrogenprogestogen HRT for over 5 years, there will be 9 to 12 cases in
1000 users (i.e. an extra 5 cases).

If you have been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this medicinal
product.

Heart disease (heart attack)

3.

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.

Always take Femoston-conti exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not sure.

For signs of a blood clot, see “Stop taking Femoston-conti and see
a doctor immediately”.

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 oestrogen-progestagen 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

Possible side effects

Like all medicines, this medicine can cause side effects, although
not everybody gets them.

How to take Femoston-conti
The following diseases are reported more often in women using
HRT compared to women not using HRT:
breast cancer

Do not start taking Femoston-conti until at least 12 months after
your last natural period.

abnormal growth or cancer of the lining of the womb
(endometrial hyperplasia or cancer)

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.



ovarian cancer

You can start taking Femoston-conti on any convenient day if:





you are currently not taking any HRT product

blood clots in the veins of the legs or lungs (venous
thromboembolism)

Compare



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.



heart disease



stroke



probable memory loss if HRT is started over the age of 65

Stroke

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).

You start taking Femoston-conti the day after you finish the 28 day
cycle if:

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:

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

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

 heart disease



Swallow the tablet with water.

 kidney impairment



You can take your tablet with or without food

 higher than normal levels of certain blood fats
(hypertriglyceridemia)



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.

Common (may affect up to 1 in 10 patients):

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

Children
Femoston-conti is not intended for use in children.



Other medicines and Femoston
 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 ritonavir, nelfinavir,
nevirapine, efavirenz)

-

For more information about these side effects, see Section 2

herbal remedies containing St John’s Wort (Hypericum
perforatum)

How much to take






-

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)

-

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.

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

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.

-

pelvic pain

-

vaginal discharge

-

feeling weak tired or unwell

-

swelling of your ankles, feet or fingers (peripheral oedema)

-

weight increase

Take one salmon-coloured tablet every day for a 28 day cycle.

If you need to have surgery

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:



4.



Blood clots in a vein (thrombosis)



If you have any further questions on the use of this
product, ask your doctor or pharmacist.





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).



When to start taking Femoston-conti

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 stop taking Femoston-conti and contact your doctor.

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)
2

you are seriously overweight (BMI >30 kg/m )

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.

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 Femoston-conti 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.

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

S0097 Leaflet Femoston conti 20170217

Expand Transcript

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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