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FEMOSTON CONTI TABLETS

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S0097 Leaflet Femoston conti 20150702

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)*

-

S0097 Leaflet Femoston conti 20150702

PACKAGE LEAFLET: INFORMATION FOR THE USER

5. How to store Femoston


KEEP OUT OF THE SIGHT & REACH OF CHILDREN.



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



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

change in the surface of the eye (steepening of corneal
curvature)*, not being able to wear your contact lenses (contact
lense intolerance*



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.

-

heart attack (myocardial infarction)



-

stroke*

-

swelling of the skin around the face and throat.
This may cause difficulty in breathing (angioedema)

-

purplish patches or spots on the skin (vascular purpura)

6. Contents of the pack and other information

-

painful reddish skin nodules (erythema nodosum)*,
discoloration of the skin especially of the face or neck known as
“pregnancy patches” (chloasma or melasma)*

What Femoston contains

-

leg cramps*

The following side effects have been reported with other HRTs:
-

-

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

-

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



Femoston 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).

erosion of the neck of the womb (uterine cervical erosion)

-

What Femoston looks like and contents of the pack


Famoston is a salmon coloured, round, biconvex, film-coated
tablet marked ‘379’ on one side and plain on the other.



Femoston is available as blister packs of 28 or 84 tablets (3 x
28 tablets).
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.
Manufacturer

worsening of a rare blood pigment disorder (porphyria)

-

high levels of certain blood fats (hypertriglyceridemia)

-

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

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.

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

-

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

-

if you have cancer which is sensitive to oestrogens, such as
cancer of the womb lining (endometrium), or if you are
suspected of having it

-

if you have any unexplained vaginal bleeding

-

if you have excessive thickening of the womb lining
(endometrial hyperplasia) that is not being treated

-

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 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 you get any side effects, talk to your doctor or pharmacist.
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 oestrogen called
estradiol and a progestogen called dydrogesterone. Femoston is
used in postmenopausal women with at least 12 months since their
last natural period.
Femoston is used for

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

-

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 alleviates these
symptoms after menopause. You will only be prescribed Femoston
if your symptoms seriously hinder your daily life.

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)”)

Prevention of osteoporosis

PL. 19488/0097

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

-

Leaflet revision date: 02 July 2015

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

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.

-

high blood pressure

Femoston is a registered trade mark of Solvay Pharmaceuticals BV,
The Netherlands.

-

a liver disorder such as a benign liver tumour

-

diabetes

2. What you need to know before you take Femoston

-

gallstones

Medical history and regular check-ups

-

migraine or severe headaches

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.

-

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

The experience in treating women with a premature menopause
(due to ovarian failure or surgery) is limited.

-

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

increased total thyroid hormones

Reporting of side effects

The name of your medicine is Femoston Conti Tablets but will be
referred to as Femoston throughout the following leaflet.

Do not take Femoston

Relief of symptoms occurring after menopause

painful/lumpy breasts (fibrocystic breast disease)

-

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.



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)

FEMOSTON CONTI TABLETS
(estradiol/dydrogesterone)

S0097 Leaflet Femoston conti 20150702

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.

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 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).

Compare

3. How to take Femoston

4. Possible side effects

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.

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

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

When to start taking Femoston

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

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).
Heart disease (heart attack)

The progestogen in Femoston protects you from this extra risk.

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.

Irregular bleeding

Stroke

You may have irregular bleeding or drops of blood (spotting) during
the first 3-6 months of taking Femoston. However, if the irregular
bleeding:

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.



carries on for more than the first 6 months
starts after you have been taking Femoston for more than 6
months

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).

 carries on after you have stopped taking Femoston
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.
Women aged 50 to 79 who are not taking HRT, on average, 9 to 17
in 1000 will be diagnosed with breast cancer over a 5-year period.
For women aged 50 to 79 who are taking oestrogen-progestogen
HRT over 5 years, there will be 13 to 23 cases in 1000 users (i.e. an
extra 4 to 6 cases).
Regularly check your breasts. See your doctor if you notice
any changes such as:


changes in the nipple

you are currently not taking any HRT product



you are switching from a “continuous combined” HRT product.
This is when you take a tablet or use a patch every day that
contains both, an oestrogen and a progestogen.



ovarian cancer



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

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



heart disease



stroke



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



abdominal pain

You can take your tablet with or without food

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.



-

back pain

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.

-

tender or painful breasts

Tell your doctor if you have or have had any of the following medical
conditions since he will have to monitor you more closely:

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 and see a doctor immediately

-

dizziness

-

feeling sick (nausea), vomiting, bloating (swelling of the
abdomen), including wind (flatulence)

-

allergic skin reactions (such as rash, severe itching (pruritus) or
hives (urticaria))

-

menstrual disorder such as irregular bleeds, spotting, painful
periods (dysmenorrhoea), heavier or less bleeding

 Take one salmon-coloured tablet every day for a 28 day cycle.
If you need to have surgery

-

pelvic pain

-

vaginal discharge

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.

-

feeling weak, tired or unwell

-

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

-

weight increase

If you take more Femoston than you should

-

cystitis-like symptoms

If you (or someone else) take too many Femoston tablets, you are
unlikely to come to any harm. You may feel sick (nauseous), or be
sick (vomit), may have tender or painful breasts, dizziness,
abdominal pain, drowsiness/tiredness, or withdrawal bleeding. No
treatment is necessary. But if you are worried, contact your doctor
for advice.
If you forget to take Femoston

-

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

-

Femoston is for use in postmenopausal women only.

Take the missed tablet as soon as you remember. If it is more than
12 hours after you should have taken the tablet, take the next dose
at the regular time. Do not take the forgotten tablet. Do not take a
double dose.
Bleeding or spotting may occur if you miss a dose.
If you stop taking Femoston

-

If you become pregnant

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

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 and see a doctor
immediately.

-

gallbladder disease

-

swelling of your breasts

-

pre-menstrual syndrome (PMS)

-

weight decrease

 heart disease
 kidney impairment
 higher than normal levels of certain blood fats
(hypertriglyceridemia)
Children

 Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.

-

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

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



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



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



you have systemic lupus erythematosus (SLE)



you have cancer

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

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


Using other medicines

medicines for HIV infection [AIDS] (such as ritonavir, nelfinavir,
nevirapine, efavirenz)





Femoston is not intended for use in children.

-

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)

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

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).

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:

Very common (may affect more than 1 in 10 patients):



medicines for tuberculosis (such as rifampicin, rifabutin),

Blood clots can be serious, and if one travels to the lungs, it can
cause chest pain, breathlessness, fainting or even death.

The following side effects may happen with this medicine:

Other conditions

-

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.

Taking this medicine

For more information about these side effects, see Section 2

headache

Compare

Blood clots in a vein (thrombosis)

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.

-

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.

Effects of HRT on heart and circulation

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



-

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, carbamazepine,
phenytoin),

 any lumps you can see or feel
Ovarian cancer

breast cancer



Swallow the tablet with water.

dimpling of the skin







Compare



You can start taking Femoston on any convenient day if:

Compare



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

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.
Femoston with food and drink
Femoston can be taken with or without food.
Pregnancy and breast-feeding

 stop taking Femoston and contact your doctor.
Femoston is not indicated for use during breast-feeding.
Driving and using machines
The effect of Femoston on driving or using machinery has not been
studied. An effect is unlikely.
Femoston tablets contain lactose.



Your doctor will aim to prescribe the lowest dose to treat your
symptoms for as short as necessary.
Speak to your doctor if you think this dose is too strong or not
strong enough.
If you are taking Femoston to prevent osteoporosis, your doctor
will adjust the dose to suit you. It will depend on your bone
mass.

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

Uncommon (may affect up to 1 in 100 patients):

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

S0097 Leaflet Femoston conti 20150702

+ 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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