FEMOSTON CONTI TABLETS

Active substance: ESTRADIOL

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S0097 Leaflet Femoston conti 20130124

S0097 Leaflet Femoston conti 20130124

PACKAGE LEAFLET: INFORMATION FOR THE USER

Do not take Femoston Conti if you

Very rare (likely to affect less than 1 in 10,000 patients):

5. How to store Femoston Conti

-

illness resulting from the destruction of red blood cells
(haemolytic anaemia)



KEEP OUT OF THE SIGHT & REACH OF CHILDREN.

-

hypersensitivity reactions such as allergic asthma



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

-

muscle twitches you can’t control (chorea)



-

heart attack (myocardial infarction)

Do not store above 30°C. Store in original package.

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



-

a tumour of the brain that may be affected by the levels of
progestogens (meningioma)

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.

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.

-

stroke



-

-

vomiting

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

-

swelling of the skin around the face and throat this may cause
difficulty breathing (angioedema), rash with target-shaped
reddening or sores, painful reddish skin nodules, (erythema
multiforme/ nodosum), purplish patches or spots on the skin
(vascular purpura), discolouration of the skin especially of the
face or neck known as “pregnancy patches”, which may persist
when drug is discontinued (chloasma or melasma)

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.

-

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

-

-

worsening of a rare blood pigment disorder (porphyria)

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

benign or malignant tumours which may be affected by the
levels of oestrogens, such as cancer of the womb lining, ovarian
cancer (see section 2 “Do not take Femoston Conti if you” for
more information)

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).
What Femoston Conti looks like and contents of the pack


-

increased size of tumours that may be affected by the levels of
progestogens (such as meningioma)



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

-

a disease where the immune system abnormally attacks many
organs of the body (systemic lupus erythematosus)



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

-

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

Product Licence holder

-

worsening of fits (epilepsy)

-

blood clots in the arteries (arterial thromboembolism)

-

urinary incontinence

-

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

-

increased total thyroid hormones

-

painful/lumpy breasts (fibrocystic breast changes)

-

high levels of certain blood fats (hypertriglyceridemia)

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

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

-

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

-

are allergic (hypersensitive) to estradiol, dydrogesterone or any
of the other ingredients of this medicine (listed in section 6)

-

have or have ever had breast cancer, or if you are suspected
of having it
have cancer which is sensitive to oestrogens, such as
cancer of the womb lining (endometrium), or if you are
suspected of having it
have any unexplained vaginal bleeding

-

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

-

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

-

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

3. How to take Femoston Conti
4. Possible side effects
5. How to store Femoston Conti
6. Contents of the pack and other information

This product is manufactured by Abbott Biologicals B.V., Weesp,
Netherlands.
PL No. 19488/0097

Leaflet revision date: 24 January 2013
S0097 Leaflet Femoston conti 20130124

have excessive thickening of the womb lining (endometrial
hyperplasia ) that is not being treated
have or have ever had a blood clot in a vein (thrombosis) such
as in the legs (deep venous thrombosis) or in the lungs
(pulmonary embolism)
have a blood clotting disorder (such as protein C, protein S,
or antithrombin deficiency)

-

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.

1. What Femoston Conti is and what it is used for

Warnings and precautions

What Femoston Conti is

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

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.

-

fibroids inside your womb

-

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

-

a tumour of the brain that may be affected by the levels of
progestogens (meningioma)

-

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

-

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

-

high blood pressure

-

a liver disorder such as a benign liver tumour

-

diabetes

-

gallstones

-

migraine or severe headaches

-

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

-

epilepsy

-

asthma

-

a disease affecting the eardrum and hearing (otosclerosis)

-

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

-

fluid retention due to cardiac or kidney problems

Femoston Conti is used for

Manufacturer

POM

FEMOSTON CONTI TABLETS
(estradiol/dydrogesterone)

Relief of symptoms occurring after menopause
During the menopause, the amount of the oestrogen produced by a
woman’s body drops. This can cause symptoms such as hot face,
neck and chest ("hot flushes"). Femoston Conti alleviates these
symptoms after menopause. You will only be prescribed Femoston
Conti if your symptoms seriously hinder your daily life.
Prevention of osteoporosis
After the menopause some women may develop fragile bones
(osteoporosis). You should discuss all available options with your
doctor.
If you are at an increased risk of fractures due to osteoporosis and
other medicines are not suitable for you, you can use Femoston
Conti to prevent osteoporosis after menopause.
2. What you need to know before you take Femoston Conti
Medical history and regular check-ups
The use of HRT carries risks which need to be considered when
deciding whether to start taking it, or whether to carry on taking it.
The experience in treating women with a premature menopause
(due to ovarian failure or surgery) is limited. If you have a premature
menopause the risks of using HRT may be different. Please talk to
your doctor.
Before you start (or restart) HRT, your doctor will ask about your
own and your family’s medical history. Your doctor may decide to
perform a physical examination. This may include an examination of
your breasts and/ or an internal examination, if necessary.
Once you have started on Femoston Conti you should see your
doctor for regular check-ups (at least once a year). At these checkups, 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.

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.
Compare
Women aged 50 to 79 who are not taking HRT, on average, 9 to 14
in 1000 will be diagnosed with breast cancer over a 5-year period.
For women aged 50 to 79 who are taking oestrogen-progestogen
HRT over 5 years, there will be 13 to 20 cases in 1000 users (i.e. an
extra 4 to 6 cases).
Regularly check your breasts. See your doctor if you notice
any changes such as:


dimpling of the skin



changes in the nipple

 any lumps you can see or feel
Ovarian cancer
Ovarian cancer is rare. A slightly increased risk of ovarian cancer
has been reported in women taking HRT for at least 5 to 10 years.
Compare
Women aged 50 to 69 who are not taking HRT, on average about 2
women in 1000 will be diagnosed with ovarian cancer over a 5-year
period. For women who have been taking HRT for 5 years, there
will be between 2 and 3 cases per 1000 users (i.e. up to 1 extra
case).
Effects of HRT on heart and circulation
Blood clots in a vein (thrombosis)
The risk of blood clots in the veins is about 1.3 to 3 times higher
in HRT users than in non-users, especially during the first year of
taking it.
Blood clots can be serious, and if one travels to the lungs, it can
cause chest pain, breathlessness, fainting or even death.
You are more likely to get a blood clot in your veins as you get older
and if any of the following applies to you. Inform your doctor if any
of these situations applies to you:


you are unable to walk for a long time because of major
surgery, injury or illness (see also section 3, If you need to have
surgery)



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



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



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



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 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)

3. How to take Femoston Conti

4. Possible side effects

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

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

When to start taking Femoston Conti

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

Do not start taking Femoston Conti until at least 12 months after
your last natural period.
You can start taking Femoston Conti on any convenient day if:



breast cancer



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

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.



you are currently not taking any HRT product



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



ovarian cancer



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

Stroke

You start taking Femoston Conti 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

The risk of getting a stroke is about 1.5 times higher in HRT users
than in non-users. The number of extra cases of stroke due to use
of HRT will increase with age.



Compare

you are switching from a ‘cyclic’ or ‘sequential’ HRT product.
This is where you take an oestrogen tablet or use a patch that
contains estrogen for the first part of your cycle. Afterwards you
take a tablet or use a patch containing both an oestrogen and a
progestogen for up to 14 days.

Looking at women in their 50s who are not taking HRT, on average,
8 in 1000 would be expected to have a stroke over a 5-year period.
For women in their 50s who are taking HRT, there will be 11 cases
in 1000 users, over 5 years (i.e. 3 extra cases).

Taking this medicine


Other conditions

Swallow the tablet with water.



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.

The following side effects may happen with this medicine:

You can take your tablet with or without food.



For more information about these side effects, see Section 2

HRT will not prevent memory loss. There is some evidence of a
higher risk of memory loss in women who start using HRT after the
age of 65. Speak to your doctor for advice.
Tell your doctor if you have or have had any of the following medical
conditions since he will have to monitor you more closely:



 heart disease
 kidney impairment
 higher than normal
(hypertriglyceridemia)

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
levels

of

certain

blood

fats



Femoston Conti is not a contraceptive and is not intended to be
used by women who could become pregnant. Please ask your
doctor for advice

Your doctor will aim to give you the lowest dose for as short as
necessary. Speak to your doctor if you think this dose is too
strong or not strong enough.



If you are taking Femoston Conti to prevent osteoporosis, your
doctor will adjust the dose to suit you. It will depend on your
bone mass.

Other medicines and Femoston Conti
 Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Some medicines may interfere with the effect of Femoston Conti.
This might lead to irregular bleeding.
This applies to the following medicines:
-

medicines for epilepsy (such as phenobarbital, carbamazepine,
phenytoin),
medicines for tuberculosis (such as rifampicin, rifabutin),

-

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

-

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

Laboratory tests
If you need a blood test, tell your doctor or the laboratory staff that
you are taking Femoston Conti, because this medicine can affect
the results of some tests.
Taking Femoston Conti with food and drink
Femoston Conti can be taken with or without food.
Pregnancy and breast-feeding
Femoston Conti is for use in postmenopausal women only.
If you become pregnant

Common (likely to affect between 1 and 10 in every 100
patients):
-

migraine, headache. If you have a migraine-like headache for
the first time, stop taking Femoston Conti and see a doctor
immediately

-

feeling sick (nausea), abdominal pain, wind (flatulence)

-

leg cramps

-

tender or painful breasts, irregular bleeds or spotting, pelvic
pain

-

feeling weak (asthenia)

-

weight changes (up or down)

Uncommon (likely to affect between 1 and 10 in every 1,000
patients):
-

cystitis-like symptoms

-

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

-

growths in the womb (fibroids) get bigger

-

abnormally heavy
(menorrhagia)

-

feeling depressed, change in your sex drive, nervousness

-

dizziness

-

blood clots in the legs or lungs (venous thromboembolism or
pulmonary embolism)

If you take more Femoston Conti than you should

-

high blood pressure (hypertension)

If you (or someone else) take too many Femoston Conti tablets,
they are unlikely to come to any harm. You may feel sick
(nauseous), sleepy or dizzy or be sick (vomit). No treatment is
necessary; but if you are worried contact your doctor for advice.

-

problems with your circulation (peripheral vascular disease)

-

enlarged and tortuos (varicose) vein

-

indigestion

If you forget to take Femoston Conti

-

gall bladder disease

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

-

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

-

back pain

-

erosion of the neck of the womb (uterine cervical erosion),
discharge from the neck of the womb (cervical discharge),
painful periods (dysmenorrhoea),

-

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

 Take one salmon-coloured tablet every day for a 28 day cycle.
If you need to have surgery
If you are going to have surgery, tell the surgeon that you are taking
Femoston Conti. You may need to stop taking Femoston Conti
about 4 to 6 weeks before the operation to reduce the risk of a
blood clot (see section 2, Blood clots in a vein). Ask your doctor
when you can start taking Femoston Conti again.

Do not stop taking Femoston Conti without first talking to your
doctor.
 If you have any further questions on the use of this
product, ask your doctor or pharmacist.

The effect of Femoston Conti on driving or using machinery has not
been studied. An effect is unlikely.
Femoston Conti tablets contain lactose.

prolonged

menstrual

bleeding

Rare (likely to affect less than 1 in every 1,000 patients):
-

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

-

liver disorders, sometimes with yellowing of the skin (jaundice),
feeling weak (asthenia) or generally feeling unwell (malaise),
and abdominal pain. If you notice yellowing of the skin or the
whites of your eyes, stop taking Femoston Conti and see a
doctor immediately

-

swelling of the breasts, pre-menstrual syndrome (PMS)

 stop taking Femoston Conti and contact your doctor.
Driving and using machines

and

you have systemic lupus erythematosus (SLE)



Compare

you have cancer

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

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

S0097 Leaflet Femoston conti 20130124

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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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