Skip to Content

FEMOSTON CONTI 0.5MG/2.5MG FILM-COATED TABLETS

Active substance(s): DYDROGESTERONE / ESTRADIOL

View full screen / Print PDF » Download PDF ⇩
Transcript
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 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.
- 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. See section 4.
The full name of your medicine is Femoston-conti
0.5 mg/2.5 mg. In this leaflet the shorter name Femostonconti is used.
What is in this leaflet:
1. What Femoston-conti is and what it is used for
2. What you need to know before you take Femoston-conti
3. How to take Femoston-conti
4. Possible side effects
5. How to store Femoston-conti
6. Contents of the pack and other information
1. What FEMOSTON-CONTI is and what it is used for
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.
Femoston-conti is used for
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.
2. What you need to know before you take FEMOSTONCONTI
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 check-ups, 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.
DO NOT take Femoston-conti
- 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
- 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 any of the above conditions appear for the first time
while taking Femoston-conti, stop taking it at once
and consult your doctor immediately.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Femoston-conti, if you have ever had any of the
following problems, as these may return or become
worse during treatment with Femoston-conti. 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)
- 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
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.

PROCESS BLACK

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 Femostonconti. 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 Femostonconti
see your doctor as soon as possible.
Breast cancer
Evidence suggests that taking combined oestrogenprogestogen and possibly also oestrogen-only HRT
increases the risk of breast cancer. The extra risk depends
on how long you take HRT. The additional risk becomes
clear within a few years. However, it returns to normal
within a few years (at most 5) after stopping treatment.
Compare
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:
• dimpling of the skin
• changes in the nipple
• any lumps you can see or feel
Additionally, you are advised to join mammography
screening programs when offered to you. For
mammogram screening, it is important that you
inform the nurse/healthcare professional who is
actually taking the x-ray that you use HRT, as this
medication may increase the density of your breasts
which may affect the outcome of the mammogram.
Where the density is increased, mammography may
not detect all lumps.
Ovarian cancer
Ovarian cancer is much rarer than breast cancer.
The use of oestrogen-only or combined oestrogenprogestogen HRT has been associated with a slightly
increased risk of ovarian cancer. The risk of ovarian
cancer varies with age. For example in women aged
50 to 54 who are not taking HRT, about 2 women
in 2000 will be diagnosed with ovarian cancer over
a 5-year period. For women who have been taking
HRT for 5 years, there will be about 3 cases per 2000
users (i.e. about 1 extra case).
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 another organ
• you have systemic lupus erythematosus (SLE)
• you have cancer
For signs of a blood clot, see “Stop taking Femoston-conti
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 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)
There is no evidence that HRT will prevent a heart attack.
Women over the age of 60 years who use oestrogenprogestogen HRT are slightly more likely to develop heart
disease than those not taking any HRT.
Stroke
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
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.
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 levels of certain blood fats
(hypertriglyceridemia)
Children
Femoston-conti is not intended for use in children.
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 Femostonconti. 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 nevirapine,
efavirenz, ritonavir, nelfinavir)
- 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.
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
 stop taking Femoston-conti and contact your
doctor.
Femoston-conti is not indicated for use during breastfeeding.

FRONT

MKP-00263-2016

MKP-00263-2016_d3

Driving and using machines
The effect of Femoston-conti on driving or using machinery
has not been studied. An effect is unlikely.
Femoston-conti tablets contain lactose.
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
taking this medicinal product.

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

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)*
- change in the surface of the eye (steepening of corneal
curvature)*, not being able to wear your contact lenses
(contact lense intolerance)*
- 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)
- painful reddish skin nodules (erythema nodosum)*,
discoloration of the skin especially of the face or neck
known as “pregnancy patches” (chloasma or melasma)*
- leg cramps*

You can start taking Femoston-conti on any convenient
day if:

The following side effects have been reported with other
HRTs:

• 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.

- 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)
- 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 pre-existing high levels of certain blood fats
(hypertriglyceridemia)
- rash with target-shaped reddening or sores (erythema
multiforme)
- urinary incontinence
- painful/lumpy breasts (fibrocystic breast disease)
- erosion of the neck of the womb (uterine cervical
erosion)
- worsening of a rare blood pigment disorder (porphyria)
- high levels of certain blood fats (hypertriglyceridemia)
- increased total thyroid hormones

3. How to take FEMOSTON-CONTI
Always take this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if you
are not sure.
When to start taking Femoston-conti

You start taking Femoston-conti the day after you finish
the 28 day cycle if:
• 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.
Taking this medicine
• Swallow the tablet with water.
• You can take your tablet 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.
• 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
• 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.
• Take one yellow-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.
If you take more Femoston-conti than you should
If you (or someone else) take too many Femoston-conti
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-conti
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.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the
Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects
you can help provide more information on the safety of
this medicine.
5. How to store FEMOSTON-CONTI
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage
conditions.
Do not use this medicine after the expiry date, which is
stated on the blister and the carton. The expiry date refers
to the last day of that month.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help to
protect the environment.
6. Contents of the pack and other information
What Femoston-conti contains

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

• The active substances are estradiol as estradiol
hemihydrate and dydrogesterone.
• Each tablet contains 0.5 mg estradiol and 2.5 mg
dydrogesterone.
• The other ingredients in the tablet core are lactose
monohydrate, hypromellose, maize starch, colloidal
anhydrous silica and magnesium stearate.
• The other ingredients in the coating are:
• Titanium Dioxide (E171), Iron oxide yellow (E172),
Polyvinyl alcohol, Macrogol 3350, Talc.

4. Possible side effects

What Femoston-conti looks like and contents of the
pack

If you stop taking Femoston-conti
Do not stop taking Femoston-conti without first talking to
your doctor.

Like all medicines, this medicine 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

• This medicinal product is a film-coated tablet. The
tablet is round, biconvex and marked 379 on one side.
Each blister strip contains 28 tablets.
• The tablets are yellow coloured.
• The tablets are packed in PVC film with a covering
aluminium foil.
• The blister packs contain 28, 84 or 280 (10 x 28) filmcoated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder

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

BGP Products Ltd.,
Abbott House, Vanwall Business Park, Vanwall Road,
Maidenhead, SL6 4XE, UK.

The following side effects may happen with this medicine:

Manufacturer

Very common (may affect more than 1 in 10 patients):
- headache
- abdominal pain
- back pain
- tender or painful breasts

Abbott Biologicals B.V.
Veerweg 12
8121 AA Olst
The Netherlands

Common (may affect up to 1 in 10 patients):
- 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-conti 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
- pelvic pain
- vaginal discharge
- feeling weak, tired or unwell
- swelling of your ankles, feet or fingers (peripheral
oedema)
- weight increase
Uncommon (may affect up to 1 in 100 patients):
- cystitis-like symptoms
- 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
- 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.
- gallbladder disease
- swelling of your breasts
- pre-menstrual syndrome (PMS)
- weight decrease

This medicinal product is authorised in the Member
States of the EEA under the following names:
AT Femoston conti 0,5 mg/2,5 mg - Filmtabletten
BE Femoston Low 0,5 mg/2,5 mg filmcoated
tablets
CZ Femoston mini 0,5 mg/2,5 mg, potahované
tablety
DE Femoston mini 0,5 mg/2,5 mg Filmtabletten
EE Femoston conti 0,5 mg/2,5 mg
FI Femoston conti 0.5/2.5 tabletti,
kalvopäällysteinen
FR Climesta 0.5mg/2.5 mg, comprimé pelliculé
IE Femoston-conti 0.5 mg/ 2.5 mg filmcoated
tablets
IT Femoston 0,5 mg/2,5 mg film-coated tablet
LT Femoston conti 0,5 mg/2,5 mg plévele
dengtos tabletés
LU Femoston Low 0,5 mg/2,5 mg filmcoated
tablet
LV Femoston conti 0,5 mg/2,5 mg filmcoated
tablets
MT Femoston-conti 0.5 mg/2.5 mg filmcoated
tablets
NL Femoston continu 0,5 mg/2,5 mg
filmomhulde tabletten
PL Femoston mini 0,5mg/2,5mg film-coated
tablets
PT Femoston 0,5 mg/2,5 mg – film-coated
tablets
SK Femoston conti 0,5 mg/2,5 mg, filmom
obalené tablety
UK Femoston-conti 0.5 mg/2.5 mg, film-coated
tablets
This leaflet was last revised in February 2016.

MKP-00263-2016

PROCESS BLACK

BACK

MKP-00263-2016_d3

Expand view ⇕

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.

Hide