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FEMOSTON - CONTI

Active substance: ESTRADIOL

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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 and prolonged menstrual bleeding (menorrhagia)
- feeling depressed, change in your sex drive, nervousness
- dizziness
- 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 tortuos (varicose) vein
- indigestion
- gall bladder 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 periods
(dysmenorrhoea),
- swelling of your ankles, feet or fingers (peripheral oedema)
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)
Very rare (likely to affect less than 1 in 10,000 patients):
- illness resulting from the destruction of red blood cells (haemolytic
anaemia)
- hypersensitivity reactions such as allergic asthma
- muscle twitches you can’t control (chorea)
- heart attack (myocardial infarction)
- a tumour of the brain that may be affected by the levels of progestogens
(meningioma)
- stroke
- vomiting
- 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)
- 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)
- 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)
- loss of mental abilities such as thinking, remembering and reasoning
(dementia)
- worsening of fits (epilepsy)
- blood clots in the arteries (arterial thromboembolism)
- urinary incontinence
- inflammation of the pancreas (pancreatitis) in women with pre-existing 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.
Page 4

5

How to store Femoston-conti

STORING YOUR MEDICINE
- KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF
CHILDREN.
- DO NOT STORE ABOVE 30°C.
- You should keep the blister in the outer carton
- Do not take the tablets after the expiry date shown on the pack and blister
- Do not take your tablets out of the blister strip until it is time to take your
dose.
- If your tablets become discoloured or show any other signs of
deterioration, consult your pharmacist who will tell you what to do.
- Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.
IMPORTANT
Remember this medicine is for you. Only a doctor can prescribe it. Never
give your medicine to other people. It may harm them, even if their
symptoms are the same as yours. This leaflet does not tell you everything
about your medicine. If you have any questions or are not sure about
anything, ask your doctor or pharmacist. He/she will have additional
information about this medicine and will be able to advise you.
EXPIRY DATE
Do not use this medicine after the expiry date shown on the carton or blister
strip. If your doctor tells you to stop taking this medicine, return any unused
medicine to your pharmacist for safe disposal. Only keep this medicine, if
your doctor tells you to. If your medicine becomes discoloured or shows any
other signs of deterioration, consult your pharmacist who will tell you what to
do.

Contents of the pack and other information

PL Number: 15184/1111

®

Femoston-Conti 1mg/5mg Tablets

1 What Femoston-conti is and what it is used for

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

6 Contents of the pack and other information

What Femoston-conti is and what it is used for

What Femoston-conti is
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.
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

Ref: 1111/110313/1/F

(estradiol/dydrogesterone)
Patient Information Leaflet
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. 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 get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet.
Your medicine is called Femoston-Conti 1mg/ 5mg Tablets but will be referred
to as Femoston Conti throughout this leaflet
In this leaflet:
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

1
6

What this medicine contains
Each film-coated tablet contains 1mg of estradiol and 5mg dydrogesterone as
the active ingredients.
Femoston Conti also has the following inactive ingredients: hypromellose,
magnesium stearate, lactose monohydrate, mazie starch, macrogol 400,
colloidal anhydrous silica, titanium dioxide (E171), yellow iron oxides (E172)
and red iron oxides (E172)
What this medicine looks like and contents of the pack
Femoston Conti are a Salmon coloured, round, biconvex, film-coated tablets
imprinted with the Company logo on one side and “379” on the other side.
Femoston Conti comes in packs of 28 and 3 month pack of 84 tablet
calendar pack, which is marked with the days of the week to help you
remember to take your tablets.
Manufacturer and Licence Holder
The tablets are manufactured by Solvay Pharmaceuticals B.V., Veerweg 12,
8121 AA Olst, The Netherlands and are procured from within the EU and
repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

POM

Femoston is a registered trademark of Solvay Pharmaceutical B.V.
Revision date: 12/03/13

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.

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

- 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 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)
- 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)
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
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:
- 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
Page 1

- a disease affecting the eardrum and hearing (otosclerosis)
- a very high level of fat in your blood (triglycerides)
- fluid retention due to cardiac or kidney problems

Ovarian cancer
Ovarian cancer is rare. A slightly increased risk of ovarian cancer has been
reported in women taking HRT for at least 5 to 10 years.

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

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
• you have systemic lupus erythematosus (SLE)
• you have cancer
For signs of a blood clot, see “Stop taking Femostonconti and see a doctor
immediately”.
Compare
Looking at women in their 50s who are not taking HRT, on average, over a 5year 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 oestrogen-progestogen HRT
for over 5 years, there will be 9 to 12 cases in 1000 users (i.e. an extra 5
cases).

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.

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.

Stroke

Breast 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 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.

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

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
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
➢ stop taking Femoston-conti and contact your doctor.
Driving and using machines

How much to take
• 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.
• 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.
If you take more Femoston-conti than you should
If you (or someone else) take too many Femostonconti 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.
If you forget to take Femoston-conti
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
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.
If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicinal product.

4

Possible side effects

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

Heart disease (heart attack)

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. 3 extra 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)

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3

How to take Femoston-conti

Always take Femoston-conti exactly as your doctor has told you. Check
with your doctor or pharmacist if you are not sure.
When to start taking Femoston-conti
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:
• 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.
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 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.
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.

The following diseases are reported more often in women using HRT compared to women not using HRT:
• breast cancer
• abnormal growth or cancer of the lining of the womb
(endometrial hyperplasia or cancer)
ovarian cancer
blood clots in the veins of the legs or lungs (venous thromboembolism)
heart disease
stroke
probable memory loss if HRT is started over the age of 65







For more information about these side effects, see Section 2
The following side effects may happen with this medicine:
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 Femostonconti 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)
-

Ref:1111/120313/1/B

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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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