FEMOSTON CONTI 0.5MG/2.5MG FILM-COATED TABLETS

Active substance: ESTRADIOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Femoston-conti 0.5 mg /2.5 mg, film-coated tablets
Active substances: estradiol/dydrogesterone
Read all of this leaflet carefully before you start taking this medicine.
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. Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
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.
In this leaflet:
1.
2.
3.
4.
5.
6.

1.

What Femoston-conti 0.5mg/2.5mg is and what it is used for
Before you take Femoston-conti 0.5mg/2.5mg
How to take Femoston-conti 0.5mg/2.5mg
Possible side effects
How to store Femoston-conti 0.5mg/2.5mg
Further information

WHAT FEMOSTON-CONTI 0.5MG/2.5MG IS AND WHAT IT IS USED FOR

Femoston-conti 0.5mg/2.5mg is a continuous combined Hormone Replacement Therapy or HRT
which is taken each day without interruption. Femoston-conti 0.5mg/2.5mg is suitable for
postmenopausal women who have not had their periods since more than a year.
Femoston-conti 0.5mg/2.5mg contains estradiol and dydrogesterone. Your body’s natural
oestrogen is also called estradiol. Estradiol replaces your body’s natural oestrogen, thereby
controlling your menopausal symptoms. Women who still have a womb should normally take
some form of progesterone (a progestogen), because oestrogen alone can cause problems due to
a build up of the womb lining and cancer of the womb lining. Taking dydrogesterone helps to
prevent a build up of the womb lining and cancer of the womb lining.
Femoston-conti 0.5mg/2.5mg is used to
− treat symptoms of oestrogen deficiency like hot flushes, night sweats and vaginal dryness in
postmenopausal women. Femoston-conti 0.5 mg/2.5 mg should be used only in
postmenopausal women more than 12 months after menopause. The experience in treating
women older than 65 years is limited.

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2.

BEFORE YOU TAKE FEMOSTON-CONTI 0.5MG/2.5MG

DO NOT take Femoston-conti 0.5mg/2.5mg if you:
are allergic (hypersensitive) to estradiol, dydrogesterone or to any of the other
ingredients of Femoston-conti 0.5mg/2.5mg.
have, have had or your doctor thinks you might have breast cancer
have, or your doctor thinks you might have a malignant tumour that is related to the
levels of oestrogens in the blood (such as cancer of the lining of the womb
(endometrial cancer).
have, or your doctor thinks you might have progestogen dependent tumours
(neoplasms)
have undiagnosed vaginal bleeding.
have untreated overgrowth of the lining of the womb (endometrial hyperplasia).
have or have had blood clots in the veins or lungs (venous thromboembolism )
have a clotting disorder (thrombophilic disorder, such as protein C, protein S, or
antithrombin deficiency)
have or have recently had a disease caused by blood clots in the arteries, such as
angina pectoris or a heart attack.
have or have had liver disease that has not recovered completely.
have a rare blood pigment disorder (porphyria).
Stop taking Femoston-conti 0.5mg/2.5mg and see a doctor as soon as possible if you notice
any of the following conditions or symptoms:
If you develop any of the conditions mentioned in the ‘Do not take’ section
if you develop yellowing of the skin (jaundice).
if you develop liver problems.
if your blood pressure increases considerably.
if you develop migraine-like headaches.
if you become pregnant.
When to take special care with Femoston-conti 0.5mg/2.5mg
HRT should only be initiated for symptoms that adversely affect your quality of life. As well as
benefits, HRT has some risks which need to be considered when deciding whether to take it, or
whether to carry on taking it. A careful appraisal of the risks and benefits should be undertaken
at least annually and HRT should only be continued as long as the benefits outweigh the risks.
Before starting or restarting HRT, your doctor will ask about your own and your family’s
medical history. A physical examination will also be performed which may include examination
of your breasts and pelvis.

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Screening tests including appropriate imaging tools, e.g. mammography (an X-ray of the
breasts), should be performed according to current medical recommendations. Your doctor will
inform you how often these tests should be performed
Periodic check-ups are recommended at least once a year while you are on HRT. Your doctor
will tell you how often these check-ups should take place. More frequent check-ups may be
required if you suffer or have suffered from any of the conditions listed below or if any of these
conditions have been aggravated during pregnancy or previous HRT, since these may return or
be aggravated under HRT:
growths in the womb (fibroids)
lining of the womb growing outside the womb (endometriosis)
risk factors for blood clots in the veins or lungs (thromboembolic disorders)
an increased risk of developing tumours related to the levels of oestrogens in the blood
(such as having a close relative with breast cancer)
high blood pressure
liver problems
diabetes
gallstones (cholelithiasis)
migraine or severe headache
systemic lupus erythematosus (a disease of the immune system that affects many organs
of the body)
a history of an overgrowth of the lining of the womb (endometrial hyperplasia )
epilepsy
asthma
disease affecting the eardrum and hearing (otosclerosis)
Please also 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
a high level of fat in the blood (hypertriglyceridemia)

Effects on your risk of developing cancer
Overgrowth of the lining of the womb (endometrial hyperplasia) and cancer of the womb
lining (endometrial cancer)
In women with an intact womb taking oestrogen-only HRT for a longer time the risk of
overgrowth of the lining of the womb (endometrial hyperplasia) and cancer of the womb lining
(endometrial cancer) is increased.
Taking a progestogen as well as the oestrogen, such as Femoston-Conti, helps to lower the extra
risk.

3

Breakthrough bleeding or spotting may occur during the first few months of HRT. But if it
continues for more than a few months, appears after you have been on HRT for a while or carries
on after you have stopped HRT,
• make an appointment to see your doctor.
Your doctor will investigate the cause which may include a biopsy of the womb lining in order
to find out whether you have cancer of the womb lining.
Compare
Looking at women who still have a womb and who are not taking HRT on average 5 in 1000 will
be diagnosed with endometrial cancer.
For women who take oestrogen-only HRT the number of extra cases will be between 5 and 55 in
1000 users between the ages of 50 and 65 depending on the dose and for how long it is taken.
The addition of a progestogen to oestrogen-only HRT substantially reduces the risk of
endometrial cancer.

Breast cancer
Evidence suggests that taking combined oestrogen-progestogen and possibly also oestrogen-only
HRT increases the risk of breast cancer. This depends on how long you take HRT, and the extra
risk is visible after about 3 years. However, it returns to normal within a few (at most five) years
after stopping.
Therefore, you should regularly check your breasts (self-examination) and tell your doctor
about any changes. Your doctor will tell you what signs to look out for.
Compare
Looking at women aged 50 to 65 who are not taking HRT on average, 9 – 12 in 1000 will be
diagnosed with breast cancer over a 5 year period.
For women aged 50 – 65 who are taking oestrogen plus progestogen HRT over 5 years the
number of extra cases will be 6 in 1000 users. Looking at women aged 50 to 79 who are not
taking HRT on average, 14 in 1000 will be diagnosed with breast cancer over a 5 year period.
For women aged 50 – 79 who are taking oestrogen plus progestogen HRT over 5 years the
number of extra cases will be 4 in 1000 users.

Ovarian cancer
Ovarian cancer is much rarer than breast cancer. Long-term (at least 5-10 years) use of
oestrogen-only HRT products is thought to carry a slightly increased risk of ovarian cancer.
Some studies suggest that the long-term use of combined HRTs may carry a similar, or slightly
smaller, risk. For women who are taking HRT over 5 years there will be one extra case per 2500
users.

Effects on your heart and circulation

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Blood clots in the veins or lungs (venous thromboembolism or VTE)
HRT increases the risk of VTE 1.3-3 fold, especially during the first year of taking it.
You are generally more likely to get a blood clot if one or more of the following applies to you:
• use of oestrogens
• older age
• major surgery (if surgery is planned, tell your doctor well in advance that you are on
HRT, since treatment might have to be stopped as a precaution. Your doctor will tell you
when to start again)
• being bed-ridden for a longer period through surgery, injury or illness
• being very overweight
• pregnancy/period after birth
• an autoimmune collagen disease, which may affect many organ systems (systemic lupus
erythematosus (SLE))
• cancer
• any of your close family have had blood clots at young age
Compare
Looking at women in their 50s who are not taking HRT on average, over a 5-year period, 4 in
1000 would be expected to get a blood clot.
For women in their 50s who are taking HRT over 5 years, the number of extra cases will be 5 in
1000 users.
If you get painful swelling in your leg, sudden chest pain or have difficulty breathing:
• see a doctor as soon as possible
• do not take any more HRT until your doctor says you can.
These may be signs of a blood clot
If you have any blood clotting problem that needs treatment with a medicine to prevent clots (an
anticoagulant) your doctor needs to pay special attention to the benefit-risk of using HRT.
Heart disease (Coronary artery disease (CAD))
There is no evidence that HRT will help to prevent heart disease.
Women taking oestrogen-progestogen HRT are slightly more likely to get heart disease than
those not taking any HRT. As the risk of CAD strongly depends on age, the number of extra
cases of CAD due to oestrogen+progestogen use is very low in healthy women close to
menopause, but will rise with more advanced age.
If you get a pain in your chest that spreads to your arm or neck:
• see a doctor as soon as possible
• do not take any more HRT until your doctor says you can.
This pain could be a sign of heart disease.
Stroke
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Combined oestrogen-progestogen and oestrogen-only HRT increase the risk of stroke up to 1.5fold. The risk of users compared to non-users does not change with age or time since menopause.
However, as the risk of stroke is strongly age-dependent, the overall risk of stroke in women who
use HRT will increase with age.
Compare
Looking at women in their 50s who are not taking HRT on average, over a 5-year period, 8 in
1000 would be expected to have a stroke.
For women in their 50s who are taking HRT over 5 years, the number of extra cases will be 3 in
1000 users.

If you get a severe unexplained headache or migraine (which can include disturbed vision):

see a doctor as soon as possible

do not take any more HRT until your doctor says you can.
This may be an early warning sign of a stroke.
HRT will not improve thought processes. There are hints of an increased risk of probable
dementia in women who start using HRT after the age of 65.
Femoston-conti 0.5mg/2.5mg is not intended to be used by women who still have child bearing
potential. In case of doubt, use a non hormonal contraceptive. Consult your doctor.
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.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines. This includes medicines, herbal remedies, health foods or supplements that you have
obtained without a prescription.
You must tell your doctor and take special care if you are taking any of the following medicines:
anticonvulsants (such as phenobarbital, carbamazepine, phenytoin),
anti-infectives (such as rifampicin, rifabutin, nevirapine, efavirenz),
ritonavir, nelfinavir (treatments for HIV infection [AIDS])
herbal preparations containing St John’s wort (the extract of the plant called St. John’s
wort is included in certain herbal preparations used particularly for menopausal
symptoms).
These medicines can stop Femoston-conti 0.5mg/2.5mg working properly, which can give rise to
bleeding or spotting.
Taking Femoston-conti 0.5mg/2.5mg with food and drink
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Femoston-conti 0.5mg/2.5mg can be taken with or without food.
Children
Femoston-conti 0.5mg/2.5mg is intended for postmenopausal women only.
Pregnancy and breast-feeding
Femoston-conti 0.5mg/2.5mg is intended for postmenopausal women only.
Do not take Femoston-conti 0.5mg/2.5mg if you are pregnant. If you are not sure if you are
pregnant you should carry out a pregnancy test. If you are pregnant or think you are pregnant,
you should stop taking Femoston-conti 0.5mg/2.5mg and tell your doctor.
Do not take Femoston-conti 0.5mg/2.5mg if you are breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
The effect of Femoston-conti 0.5mg/2.5mg on driving or using machinery has not been studied.
An effect is unlikely.
Important information about some of the ingredients of Femoston-conti 0.5mg/2.5mg
tablets
Femoston-conti 0.5mg/2.5mg tablets contain lactose (milk sugar). If you have been informed that
you have intolerance to certain sugars, tell your doctor before taking this medicine. This includes
some rare hereditary disorders that affect how the body uses lactose.
3.

HOW TO TAKE FEMOSTON-CONTI 0.5MG/2.5MG

Always take Femoston-conti 0.5mg/2.5mg exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.
How to take Femoston-conti 0.5mg/2.5mg
Do not start taking Femoston until at least 12 months after your last natural period.
If you are currently not taking any HRT product or your ovaries have been removed or are
switching from a continuous combined preparation you can start taking Femoston on any
convenient day.
If you are switching from a ‘cyclic’ or ‘sequential’ HRT product (this is where you take an
oestrogen tablet or use a patch for the first part of your cycle, followed by both an oestrogen and
a progestogen for up to 14 days) start taking Femoston the day after you finish the pack that is at
the end of the progestogen phase.
Take one tablet every day, without a break between packs. The blisters are marked with the days
of the week to make it easier for you to remember when to take your tablets.
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Swallow the tablet with water. Femoston-conti 0.5mg/2.5mg can be taken with or without food.
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.
Your doctor will aim to give you the lowest dose for the shortest time to treat your symptoms but
he may increase the dose, if necessary.
Femoston-conti 0.5mg/2.5mg:
Take one yellow coloured tablet daily for a 28 day cycle
If you take more Femoston-conti 0.5mg/2.5mg than you should
If you or somebody else takes too many Femoston-conti 0.5mg/2.5mg tablets, they are unlikely
to come to any harm. Nausea (feeling sick), vomiting, sleepiness and dizziness may occur. No
treatment is necessary, but if you are worried contact your doctor for advice.
If you forget to take Femoston-conti 0.5mg/2.5mg
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 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-conti 0.5mg/2.5mg
Do not stop taking Femoston-conti 0.5mg/2.5mg without first talking to your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4.

POSSIBLE SIDE EFFECTS

Like all medicines, Femoston-conti 0.5mg/2.5mg can cause side effects, although not
everybody gets them. Evaluation of the side effects is based on the following frequencies:
Very common:
Common:
Uncommon:
Rare:
Very rare:

In more than 1 in 10 patients treated
In less than 1 in 10, but more than 1 in 100 patients treated
In less than 1 in 100, but more than 1 in 1,000 patients treated
In less than 1 in 1,000, but more than 1 in 10,000 patients treated
In less than 1 in 10,000 patients treated, not known (cannot be
estimated from the available data)

Common:
- migraine; headache
- feeling sick (nausea); abdominal pain; wind (flatulence)
- leg cramps
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-

breast pain or tenderness; irregular periods (metrorrhagia) and postmenopausal spotting;
pelvic pain
feeling weak (asthenia)
weight changes

Uncommon:
- bladder inflammation (cystitis)-like syndrome; vaginal thrush (a vaginal infection due to a
fungus called Candida albicans)
- increased size of growths in the womb (increased fibroids)
- depression; change in sex drive; nervousness
- dizziness
- narrowing of blood vessels in the legs or arms restricting blood flow (peripheral vascular
disease); varicose veins; blood clots in the legs or lungs (venous thromboembolism)
- dyspepsia
- gallbladder disease
- 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 menstruation (dysmenorrhoea); heavy periods
(menorrhagia)
- fluid collection under the skin usually observed as swelling of the ankles (peripheral oedema)
Rare:
- change in the surface of the eye (steepening of corneal curvature); intolerance to contact
lenses
- liver disorders, which may include yellowing of the skin (jaundice), feeling weak (asthenia),
general malaise, and abdominal pain
- swelling of the breasts; pre-menstrual syndrome (PMS)
Very rare:
- not enough red blood cells (haemolytic anaemia)
- hypersensitivity reactions
- involuntary muscle twitches (chorea)
- heart attack (myocardial infarction)
- stroke (see “Effects on your heart or circulation” for more information)
- vomiting
- swelling of the skin around the face and throat. This may cause difficulty breathing
(angioedema); red or brown patches on the skin (erythema multiforme/nodosum); purplish
patches or spots on the skin (vascular purpura); skin discolouration, which may persist when
drug is discontinued (chloasma or melasma).
- worsening of porphyria (a rare blood pigment disease).
There is a slightly increased risk of developing the following diseases in women on HRT:
9

-

breast cancer (see “Effects on your risk of developing cancer” for more information).
overgrowth or cancer of the lining of the womb (endometrial hyperplasia or cancer) (see
“Effects on your risk of developing cancer” for more information).
blood clots in the legs or lungs (venous thromboembolism) (see “Effects on your heart or
circulation” for more information)
coronary artery disease (see “Effects on your heart or circulation” for more information)

Other side effects reported with the use of HRT:
-

tumours that may be affected by the levels of oestrogens, such as endometrial cancer,
ovarian cancer (see “Effects on your risk of developing cancer” for more information).
increased size of tumours that may be affected by the levels of progestogens (such as
meningioma)
systemic lupus erythematosus (a disease where the immune system malfunctions and affects
the body’s own organs and tissues)
probable dementia
worsening of epilepsy
arterial thromboembolism

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.
5.

HOW TO STORE FEMOSTON-CONTI 0.5MG/2.5MG

This medicinal product does not require any special storage conditions.
Keep out of the reach and sight of children.
Do not use Femoston-conti 0.5 mg/2.5 mg after the expiry date which is stated on the blister and
the carton after {exp date}. The expiry date refers to the last day of that month
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-conti 0.5mg/2.5mg contains
The active substances are estradiol as estradiol hemihydrate and dydrogesterone.

10

One film-coated tablet contains 0.5 mg estradiol as estradiol hemihydrate and 2.5 mg
dydrogesterone

-

-

The other ingredients are:
Core:
lactose monohydrate,
hypromellose,
maize starch,
colloidal anhydrous silica,
magnesium stearate
Film-coating:
macrogol 3350
polyvinyl alcohol
talc
titanium dioxide (E171)
yellow iron oxide (E172)

What Femoston-conti 0.5mg/2.5mg looks like and the contents of the pack
This medicinal product is a film-coated tablet. The tablet is round, biconvex, yellow with the
inscription 379 on one side and S on the other side
PVC/Aluminium blister strips in a printed carton.
Packs of 28, 84, 280 and 14 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder for Femoston-conti 0.5mg/2.5mg is:
Abbott Healthcare Products Ltd
Mansbridge Road
West End
Southampton SO18 3JD
UK
Femoston-conti 0.5mg/2.5mg is made by:
Abbott Biologicals B.V.
Veerweg 12
8121 AA Olst
The Netherlands

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This medicinal product is authorised in the Member States of the EEA under the following
names:
Austria:
Femoston conti 0,5 mg/2,5 mg - Filmtabletten
Belgium:
Femoston Low 0,5 mg / 2,5 mg film-coated tablets
Czech Republic: Femoston mini 0,5 mg/2,5 mg potahované tablety
Estonia:
Femoston Conti 0,5 mg/2,5 mg film-coated tablet
Finland:
Femoston conti 0.5/2.5 tabletti, kalvopäällysteinen
France:
CLIMASTON 0.5 mg/2.5 mg, comprimé pelliculé
Germany:
Femoston mini 0,5 mg/2,5 mg, Filmtabletten
Greece:
FEMASTON CONT fc tabs (0.5+2.5) mg/tab
Hungary:
Femoston mini 0,5 mg /2,5 mg film-coated tablet
Ireland:
Femoston-conti 0.5 mg/2.5 mg film-coated tablets
Italy:
Femoston 0,5 mg/2,5 mg film-coated tablet
Latvia:
Femoston Conti 0,5 mg/2,5 mg film-coated tablets
Lithuania:
Femoston Conti 0,5 mg/2,5 mg plėvele dengtos tabletės
Luxembourg:
Femoston Low 0,5 mg/2,5 mg film-coated tablet
Malta:
Femoston-Conti 0.5 mg/2.5 mg, film-coated tablets
Netherlands:
Femoston continu 0,5 mg/2,5 mg filmhulde tabletten
Poland:
Femoston mini
Portugal:
Femoston 0,5 mg/2,5 mg - film-coated tablets
Romania:
Femoston mini 0,5 mg/2,5 mg comprimate filmate
Slovakia:
Femoston conti 0,5 mg/2,5 mg film-coated tablet
United Kingdom: Femoston-Conti 0.5 mg/2.5 mg,film-coated tablets
This leaflet was last approved in

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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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