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FEMOSTON 2/10MG TABLETS

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

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Rare (in less than 1 in 1,000, but more than 1 in 10,000 patients
treated):

6. Contents of the pack and other information



heart attack





swelling of the skin around the face and neck. This may cause
difficulty breathing

Each pack of Femoston 2/10mg Tablets contains two different
type of tablets. The arrows marked 1 and 2 show you which
order to take the tablets in.



red or brown patches on the skin



If unscheduled bleeding occurs after some time on HRT, you should
contact your doctor. If unscheduled bleeding continues after
stopping HRT, it may be necessary to perform tests to exclude
disease of the endometrium (the lining of the uterus). Changes can
occur in the levels of certain proteins and hormones in the blood.
The action of the hormones in the body is not affected. You should
tell your doctor that you are taking HRT if you are to have a blood
test.
The following side effects have been reported with HRTs (including
Femoston):






benign or malignant tumours which may be affected by the
levels of oestrogens, such as cancer of the womb lining,
ovarian cancer
increased size of tumours that may be affected by the levels of
progestogens (such as meningioma)
reduction in red blood cells which can make the skin pale and
cause weakness or breathlessness (anaemia)
a disease where the immune system abnormally attacks many
organs of the body (systemic lupus erythematosus)



FEMOSTON® 2/10mg TABLETS
(oestradiol hemihydrate and dydrogesterone)

If you have or have ever had breast cancer, or if you are
suspected of having it



Each round brick-red tablet contains 2mg of the active
ingredient estradiol (as the hemihydrate).

Your medicine is known as Femoston 2/10mg Tablets but will be
referred to as Femoston throughout the following patient information
leaflet.

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





Each yellow tablet contains two ingredients: 2mg of estradiol (as
the hemihydrate) and 10mg of dyhydrogesterone.

Information for other strengths of Femoston also may be present in
this leaflet.

If you have a tumor which is sensitive to progestogen, such as
a tumor of the brain (meningioma)



If you have any unexplained vaginal bleeding



The estradiols in the tablets are made from plant materials.





Both the tablets also contain lactose, hypromellose, maize
starch, colloidal anhydrous silica and magnesium stearate,
macrogol 400, talc, titanium dioxide (E171) and yellow iron
oxide (E172).

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)



The brick-red tablets also contain red iron oxide (E172) and
black iron oxide (E172).



If you have a blood clotting disorder (such as protein C,
protein S, or antithrombin deficiency)



If you have or recently have had a disease caused by blood
clots in the arteries, such as a heart attack, stroke or angina



If you have or have ever had a liver disease and your liver
function tests have not returned to normal



If you have a rare blood problem called “porphyria” which is
passed down in families (inherited)



If you are allergic (hypersensitive) to oestradiol/
dydrogesterone or any of the other ingredients of Femoston
(listed in section 6 Further information)

What Femoston contains

What Femoston looks like and contents of the pack
Each blister pack contains 14 round, biconvex, brick-red coated
tablets marked ‘379’ on one side and plain on the other and 14
round, biconvex, yellow coated tablets marked ‘379’ on one side
and plain on the other.
Femoston 2/10mg Tablets are available in packs containing 84
tablets.



worsening of fits (epilepsy)

Manufacturer



change in the surface of the eye



intolerance to contact lenses

This product is manufactured by Abbott Biologicals BV, Veerweg
12, NL-8121 AA Olst, The Netherlands.



blood clots in the arteries (arterial thromboembolism)



inflammation of the pancreas (pancreatitis) in women with preexisting high levels of certain blood fats (hypertriglyceridemia)

POM



various skin disorders: discoloration of the skin especially of the
face or neck known as “pregnancy patches” (chloasma), painful
reddish skin nodules (erythema nodosum), rash with targetshaped reddening or sores (erythema multiforme)

Leaflet revision date: 19 January 2017



worsening of porphyria (a rare blood pigment disorder)



increased total thyroid hormones

If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the 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


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 30°C.



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



If your doctor tells you to stop taking the capsules, please take
them back to the pharmacist for safe disposal. Only keep the
capsules if your doctor tells you to.



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



Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

1. What Femoston is and what it is used for
2. What you need to know before you take Femoston

5. How to store Femoston

chorea (muscle twitches)

painful/lumpy breasts (fibrocystic breast changes), uterine
cervical erosion

What is in this leaflet

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



urinary incontinence

If you get any side effects, talk to your doctor, or pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet.

4. Possible side effects

loss of mental abilities such as thinking, remembering and
reasoning (dementia)



-

3. How to take Femoston





Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, or
pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their signs of illness are
the same as yours.

Product Licence holder

high levels of certain blood fats (hypertriglyceridemia)

Leg cramps

Do not take Femoston

PACKAGE LEAFLET: INFORMATION FOR THE USER





S065 LEAFLET Femoston 20170119

6. Contents of the pack and other information
When to take special care with Femoston
1. What Femoston is and what it is used for

PL 19488/0065

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 BGP Products Operations
GmbH, Switzerland.
S065 LEAFLET Femoston 20170119

If any of the above conditions appear for the first time while taking
Femoston, stop taking it at once and consult your doctor
immediately.

Femoston is a Hormone Replacement Therapy (HRT). It contains
two types of female hormones, an oestrogen and a progestogen.
HRT is used in woman who require oestrogen replacement and
who have not had their womb removed (hysterectomy). Femoston
is used in postmenopausal women at least 6 months since last
menses.

Tell your doctor if you have ever had any of the following problems,
before you start the treatment, as these may return or become
worse during treatment with Femoston. If so, you should see your
doctor more often for check-ups:


fibroids inside your womb



growth of womb lining outside your womb (endometriosis) or a
history of excessive growth of the womb lining (endometrial
hyperplasia)



increased risk of developing blood clots (see “Blood clots in a
vein (thrombosis)”)



increased risk of getting an oestrogen-sensitive cancer (such as
having a mother, sister or grandmother who has had breast
cancer)



high blood pressure



a liver disorder, such as a benign liver tumour

Prevention of osteoporosis



diabetes

After the menopause some women may develop fragile bones
(osteoporosis). You should discuss all available options with your
doctor. If you are at an increased risk of fractures due to
osteoporosis and other medicines are not suitable for you, you can
use Femoston to prevent osteoporosis after menopause.



gallstones



migraine or severe headaches



a disease of the immune system that affects many organs of
the body (systemic lupus erythematosus, SLE)

Femoston is used for:
Relief of symptoms occurring after menopause
During the menopause, the amount of oestrogen produced by a
woman’s body drops. This can cause symptoms such as hot face,
neck and chest ("hot flushes"). Femoston alleviates these
symptoms after menopause. You will only be prescribed Femoston
if your symptoms seriously hinder your daily life.



epilepsy

2. What you need to know before you take Femoston



asthma

Medical history and regular check-ups



a disease affecting the eardrum and hearing (otosclerosis)

The use of HRT carries risks which need to be considered when
deciding whether to start taking it, or whether to carry on taking it.
The experience in treating women with a premature menopause
(due to ovarian failure or surgery) is limited. If you have a premature
menopause the risks of using HRT may be different. Please talk to
your doctor. Before you start (or restart) HRT, your doctor will ask
about your own and your family’s medical history. Your doctor may
decide to perform a physical examination. This may include an
examination of your breasts and/or an internal examination, if
necessary. Once you have started on Femoston you should see
your doctor for regular check-ups (at least once a year). At these
check-ups, discuss with your doctor the benefits and risks of
continuing with Femoston. Go for regular breast screening, as
recommended by your doctor.



a very high level of fat in your blood (triglycerides)



fluid retention due to cardiac or kidney problems

Do not take Femoston
If any of the following applies to you. If you are not sure about any
of the points below, talk to your doctor before taking Femoston,

Stop taking Femoston and see a doctor immediately
If you notice any of the following when taking HRT:


any of the conditions mentioned in the ‘Do not take Femoston’
section



yellowing of your skin or the whites of your eyes (jaundice).
These may be signs of a liver disease



a large rise in your blood pressure (symptoms may be
headache, tiredness, dizziness)



migraine-like headaches which happen for the first time



if you become pregnant



if you notice signs of a blood clot, such as:


painful swelling and redness of the legs



sudden chest pain



difficulty in breathing

For more information, see ‘Blood clots in a vein (thrombosis)’
Note: Femoston is not a contraceptive. If it is less than 12 months
since your last menstrual period or you are under 50 years old, you
may still need to use additional contraception to prevent pregnancy.
Speak to your doctor for advice.

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)

HRT and cancer



you are seriously overweight (BMI >30 kg/m2)

Excessive thickening of the lining of the womb (endometrial
hyperplasia) and cancer of the lining of the womb (endometrial
cancer)



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

Taking oestrogen-only HRT will increase the risk of excessive
thickening of the lining of the womb (endometrial hyperplasia) and
cancer of the womb lining (endometrial cancer).
The progestogen in Femoston protects you from this extra risk.
Irregular bleeding
You may have irregular bleeding or drops of blood (spotting) during
the first 3-6 months of taking Femoston. However, if the irregular
bleeding:


carries on for more than the first 6 months



starts after you have been taking Femoston for more than 6
months



carries on after you have stopped taking Femoston

see your doctor as soon as possible.
Unexpected bleeding
You will have a bleed once a month (so-called withdrawal bleed)
while taking Femoston. But, if you have unexpected bleeding or
drops of blood (spotting) besides your monthly bleeding, which:


carries on for more than the first 6 months



starts after you have been taking Femoston more than 6
months



carries on after you have stopped taking Femoston

see your doctor as soon as possible
Breast cancer
Evidence suggests that taking combined oestrogenprogestogen
and possibly also 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.



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



you have systemic lupus erythematosus (SLE)



you have cancer.

For signs of a blood clot, see “Stop taking Femoston and see a
doctor immediately”.
Compare
Looking at women in their 50s who are not taking HRT, on average,
over a 5-year period, 4 to 7 in 1000 would be expected to get a
blood clot in a vein. For women in their 50s who have been taking
oestrogen-progestogen HRT for over 5 years, there will be 9 to 12
cases in 1000 users (i.e. an extra 5 cases).
Heart disease (heart attack)
There is no evidence that HRT will prevent a heart attack.
Women over the age of 60 years who use oestrogen-progestogen
HRT are slightly more likely to develop heart disease than those not
taking any HRT.
Stroke
The risk of having a stroke is about 1.5 times higher in HRT users
than in non-users. The number of extra cases of stroke due to use
of HRT will increase with age.
Compare
Looking at women in their 50s who are not taking HRT, on average,
8 in 1000 would be expected to have a stroke over a 5-year period.
For women in their 50s who are taking HRT, there will be 11 cases
in 1000 users, over 5 years (i.e. an extra 3 cases).
Other conditions


HRT will not prevent memory loss. There is some evidence of a
higher risk of memory loss in women who start using HRT after
the age of 65. Speak to your doctor for advice.

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).

Using other medicines





Regularly check your breasts. See your doctor if you notice any
changes such as:

Some medicines may interfere with the effect of Femoston. This
might lead to irregular bleeding. This applies to the following
medicines:
Medicines for epilepsy (such as phenobarbital, phenytoin and
carbamazepine)



dimpling of the skin



Medicines for tuberculosis (such as rifampicin and rifabutin)



changes in the nipple





any lumps you can see or feel

Medicines for HIV infection (such as nevirapine, efavirenz,
ritonavir and nelfinavir)



Herbal remedies containing St John’s Wort

Ovarian cancer
Ovarian cancer is much rarer than breast cancer. The use of
oestrogen-only or combined oestrogen-progestogen HRT has been
associated with a slightly increased risk of ovarian cancer. The risk
of ovarian cancer varies with age. For example, in women aged 50
to 54 who are not taking HRT, about 2 women in 2000 will be
diagnosed with ovarian cancer over a 5-year period. For women
who have been taking HRT for 5 years, there will be about 3 cases
per 2000 users (i.e. about 1 extra case).
Effect of HRT on heart and circulation Blood clots in a vein
(thrombosis)
The risk of blood clots in the veins is about 1.3 to 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.

Problems due to high levels of the following medicines may occur
when you take Femoston so careful drug monitoring and dose
decrease may become necessary:

3. How to take Femoston
Always take Femoston exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not
sure.

The following serious side effects may occur during treatment
with Femoston:


allergic reactions that may cause swelling of the skin around the
face and neck. This may cause difficulty breathing

How to take Femoston



heart attack

Take one tablet every day, without a break between packs.
Swallow the tablet with water, with or without food. Your
doctor will aim to give you the lowest dose for the shortest
time to treat your symptoms. Speak to your doctor if you think
this dose is too strong or not strong enough. The usual
starting dose is:



tumours that may be affected by the levels of progestagens
(e.g. meningioma)



heavy, irregular or painful genital bleeding

During day 1 to 14 of the cycle, 1 tablet daily containing 1 or 2 mg
oestradiol.
During day 15 to 28 of the cycle, 1 tablet daily containing 1 or 2 mg
oestradiol and 10 mg dydrogesterone. Immediately after the 28-day
cycle you should begin the next treatment.
The days of the week are printed on the back of the blister strips.
The tablets from the part marked with arrow 1 should be taken first,
then the tablets from the part marked with arrow 2 should be taken.
If you are not having periods and are not taking any other Hormone
Replacement Therapy (HRT) preparations, or you are switching
from a combined continuous HRT product, you can start taking
Femoston on any convenient day.
If you are currently using a ‘cyclic’ or ‘sequential’ HRT preparation
(which involves taking an oestrogen tablet or patch for part of the
month, followed by both oestrogen and progestagen tablet or patch
for up to 14 days) start taking Femoston the day after you finish the
pack i.e. at the end of the progestagen phase. The doctor may
increase the dose later, if necessary. The different tablet strengths
are colour-coded for your convenience. If you are taking Femoston
to treat symptoms of the menopause (change of life), your
treatment should begin with the dosage Femoston 1/10. Your
doctor will then increase this dose according to your symptoms. If
you are taking Femoston to prevent osteoporosis, your doctor will
adjust the dose individually according to your bone mass.
If you take more Femoston than you should
If you or somebody else takes too many Femoston tablets, they are
unlikely to come to any harm. Nausea (feeling sick), vomiting,
breast tenderness, dizziness, abdominal pain, drowsiness/fatigue,
and withdrawal bleeding may occur. No treatment is necessary, but
if you are worried contact your doctor for advice.
If you forget to take Femoston
Take the missed tablet as soon as you remember. If it is more than
12 hours since you took the last one, take the next dose without
taking the forgotten tablet. Do not take a double dose. Bleeding or
spotting may occur if you miss a dose.

If any of these side effects occur you should stop treatment
immediately and contact your doctor. The following side effects may
occur during treatment:
Very common (in more than 1 in 10 patients treated):


headache



abdominal pain



back pain



breast pain or tenderness

Common (in less than 1 in 10, but more than 1 in 100 patients
treated):


vaginal thrush (a vaginal infection due to a fungus called
Candida albicans)



depression



nervousness



migraine



dizziness



feeling sick



vomiting



wind (flatulence)



allergic skin reactions (including rash or itching)



unscheduled bleeding or spotting, heavy, irregular or painful
periods



pelvic pain



vaginal discharge



generally feeling unwell, weak or tired



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



increase in weight

Uncommon (in less than 1 in 100, but more than 1 in 1,000
patients treated):

If you stop taking Femoston



symptoms of cystitis

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



fibroids get bigger (growths in the womb increase)

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



change in sex drive



high blood pressure

If you need to have surgery



peripheral vascular disease

If you are going to have surgery, tell the surgeon that you are taking
Femoston. You may need to stop taking Femoston about 4 to 6
weeks before the operation to reduce the risk of a blood clot (see
section 2, Blood clots in a vein). Ask your doctor when you can start
taking Femoston again.



varicose veins



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



indigestion



liver disorders, which may include jaundice (yellowing of the
skin), asthenia (feeling weak) and general malaise and
abdominal pain

4 Possible side effects

tacrolimus and cyclosporin – used, for example, for organ
transplants

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



gall bladder disorder

-

fentanyl – a painkiller



swelling of the breasts

-

theophylline – used for asthma and other breathing problems

The following diseases are reported more often in women using
HRT compared to women not using HRT:



pre-menstrual tension (PMT)



breast cancer



decrease in weight



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



ovarian cancer

Laboratory tests



If you need a blood test, tell your doctor or the laboratory staff that
you are taking Femoston, because this medicine can affect the
results of some tests.

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

-

Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines including medicines obtained
without a prescription, herbal medicines or other natural products.

Pregnancy and breast-feeding
Femoston is for use in postmenopausal women only. If you become
pregnant, stop taking Femoston and contact your doctor.

For more information about these side effects, see Section 2.

S065 LEAFLET Femoston 20160818

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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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