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FEMOSTON 2/10MG TABLETS

Active substance(s): DYDROGESTERONE / ESTRADIOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Femoston® 2/10mg Tablets
(estradiol and dydrogesterone)

This medicine is available using the above name but will be referred to as Femoston
throughout this leaflet. Please note Femoston is also available in other strength (Femoston
1/10mg Tablets).
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.
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.
What is in this leaflet
1. What Femoston is and what it is used for
2. What you need to know before you take Femoston
3. How to take Femoston
4. Possible side effects
5. How to store Femoston
6. Contents of the pack and other information
1. What Femoston is and what it is used for
Femoston is a Hormone Replacement Therapy (HRT). It contains two types of female
hormones, an estrogen and a progestogen. HRT is used in woman who require estrogen
replacement and who have not had their womb removed (hysterectomy). Femoston is used
in postmenopausal women at least 6 months since last menses.

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.
HRT and cancer
Excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer
of the lining of the womb (endometrial cancer)
Taking estrogen-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.

Relief of symptoms occurring after menopause
During the menopause, the amount of estrogen 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.

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

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 to prevent osteoporosis after menopause.

Breast cancer
Evidence suggests that taking combined estrogen-progestogen and possibly also estrogenonly 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.

2. Before you take Femoston

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 estrogen-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

Femoston is used for:

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 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.
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,
Do not take Femoston
■ 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 estrogens, such as cancer of the womb lining
(endometrium), or if you are suspected of having it
■ 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
■ 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 Femoston (listed in section 6 Further information)
If any of the above conditions appear for the first time while taking Femoston, stop taking it
at once and consult your doctor immediately.
When to take special care with Femoston
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 estrogen-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

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.
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).
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.
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 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 estrogen-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 estrogen-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.
Using other medicines
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)
■ Medicines for tuberculosis (such as rifampicin and rifabutin)
■ Medicines for HIV infection (such as nevirapine, efavirenz, ritonavir and nelfinavir)
■ Herbal remedies containing St John’s Wort

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:
– tacrolimus and cyclosporin – used, for example, for organ transplants
– fentanyl – a painkiller
– theophylline – used for asthma and other breathing problems
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.
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.
Pregnancy and breast-feeding
Femoston is for use in postmenopausal women only. If you become pregnant, stop taking
Femoston and contact your doctor.
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.
How to take Femoston
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:
During day 1 to 14 of the cycle, 1 tablet daily containing 1 or 2 mg estradiol.
During day 15 to 28 of the cycle, 1 tablet daily containing 1 or 2 mg estradiol 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 having regular periods you should start taking Femoston within five days of the
start of bleeding.
If you are not having regular 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
estrogen tablet or patch for part of the month, followed by both estrogen 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 you stop taking Femoston
Do not stop taking Femoston without first talking to your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
If you need to have surgery
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.
4. Possible side effects
Like all medicines, Femoston 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 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
■ heart attack
■ tumours that may be affected by the levels of progestagens (e.g. meningioma)
■ heavy, irregular or painful genital bleeding
If any of these side effects occur you should stop treatment immediately and contact your
doctor.





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):
■ symptoms of cystitis
■ fibroids get bigger (growths in the womb increase)
■ change in sex drive
■ high blood pressure
■ peripheral vascular disease
■ 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
■ gall bladder disorder
■ swelling of the breasts
■ pre-menstrual tension (PMT)
■ decrease in weight
Rare (in less than 1 in 1,000, but more than 1 in 10,000 patients treated):
■ heart attack
■ swelling of the skin around the face and neck. This may cause difficulty breathing
■ 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 estrogens, 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)
■ high levels of certain blood fats (hypertriglyceridemia)
■ loss of mental abilities such as thinking, remembering and reasoning (dementia)
■ chorea (muscle twitches)
■ worsening of fits (epilepsy)
■ change in the surface of the eye
■ intolerance to contact lenses
■ blood clots in the arteries (arterial thromboembolism)
■ inflammation of the pancreas (pancreatitis) in women with pre-existing high levels of
certain blood fats (hypertriglyceridemia)
■ 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 target-shaped reddening or sores (erythema multiforme)
■ leg cramps
■ urinary incontinence
■ painful/lumpy breasts (fibrocystic breast changes), uterine cervical erosion
■ 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
national reporting systems listed below.
In the UK: 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 25°C.
Do not use the tablets after the expiry date on the pack. The expiry date refers to the last
day of that month.
If the tablets become discoloured or show signs of any deterioration, you should seek
the advice of your pharmacist who will advise 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.

6. Further information
What Femoston contains
Femoston 2/10mg Tablets: brick red tablets contain 2mg estradiol; yellow tablets contain
2mg estradiol and 10mg dydrogesterone.
Femoston also contains:
Tablet core: lactose monohydrate, hypromellose, maize starch, colloidal anhydrous silica,
magnesium stearate.
Film coating: titanium dioxide (E171), red iron oxide (E172), black iron oxide (E172), yellow
iron oxide (E172), hypromellose, macrogol 400 and talc.
What Femoston looks like and contents of the pack

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

Each pack of Femoston contains two different types of tablets. The arrows marked 1 and 2
show you which order to take the tablets in.
14 brick red tablets marked with ‘S’ with upside down triangle on one side and ‘379’ on the
other.
14 yellow tablets marked with ‘S’ with upside down triangle on one side and ‘379’ on the
other.

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

Femoston is available in three month (84 days) packs.
POM

PL No: 15814/0633

This product is manufactured by Solvay Biologicals B.V., Veerweg 12, 8121 AA Olst
Holland and procured from within the EU and repackaged by the Product Licence Holder:
O.P.D Laboratories Ltd, 6 Colonial Way, Watford, Herts WD24 4PR.
Leaflet issue and revision date (Ref.): 19.05.2015.
Femoston is a registered Trade Mark of Solvay Pharmaceuticals B.V., The Netherlands.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.

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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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