Femoston-conti 0.5mg/2.5mg film-coated tablets

Ireland - English - HPRA (Health Products Regulatory Authority)

Buy It Now

Active ingredient:
Estradiol; Dydrogesterone
Available from:
Mylan IRE Healthcare Limited
ATC code:
G03FA; G03FA14
INN (International Name):
Estradiol; Dydrogesterone
Dosage:
0.5/2.5 milligram(s)
Pharmaceutical form:
Film-coated tablet
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Progestogens and estrogens, fixed combinations; dydrogesterone and estrogen
Authorization status:
Marketed
Authorization number:
PA2010/012/003
Authorization date:
2010-10-01

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Femoston-conti 0.5 mg /2.5 mg, film-coated tablets

Active substances: estradiol (as hemihydrate)/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 film-coated tablets. In this leaflet the

shorter name Femoston is used.

What is in this leaflet:

What Femoston is and what it is used for

What you need to know before you take Femoston

How to take Femoston

Possible side effects

How to store Femoston

Contents of the pack and other information

1.

What FEMOSTON is and what it is used for

Femoston is a Hormone Replacement Therapy (HRT). It contains two types of female hormones, an

oestrogen called estradiol and a progestogen called dydrogesterone. Femoston is used in postmenopausal

women with at least 12 months since their last natural period.

Femoston is used for

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 alleviates these symptoms after

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

2.

What you need to know before you take FEMOSTON

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 you should see your doctor for regular check-ups (at least once a

year). At these check-ups, discuss with your doctor the benefits and risks of continuing with Femoston.

Go for regular breast screening, as recommended by your doctor.

DO NOT take Femoston

if any of the following applies to you. If you are not sure about any of the

points below,

talk to your doctor

before taking Femoston.

DO NOT take Femoston

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, stop taking it at once and

consult your doctor immediately.

Warnings and precautions

Talk to your doctor or pharmacist before taking Femoston, if you have ever had any of the following

problems, as these may return or become worse during treatment with Femoston. If so, you should see

your doctor more often for check-ups:

fibroids inside your womb

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 and see a doctor immediately

If you notice any of the following when taking HRT:

any of the conditions mentioned in the ‘DO NOT take Femoston’ section

yellowing of your skin or the whites of your eyes (jaundice). These may be signs of a liver

disease

a large rise in your blood pressure (symptoms may be headache, tiredness, dizziness).

migraine-like headaches which happen for the first time

if you become pregnant

if you notice signs of a blood clot, such as:

painful swelling and redness of the legs

sudden chest pain

difficulty in breathing

For more information, see ‘Blood clots in a vein (thrombosis)’

Note:

Femoston is not a contraceptive. If it is less than 12 months since your last menstrual period or you

are under 50 years old, you may still need to use additional contraception to prevent pregnancy. Speak to

your doctor for advice.

HRT and cancer

Excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the lining of

the womb (endometrial cancer)

Taking oestrogen-only HRT will increase the risk of excessive thickening of the lining of the womb

(endometrial hyperplasia) and cancer of the womb lining (endometrial cancer).

The progestogen in Femoston 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. However, if the irregular bleeding:

carries on for more than the first 6 months

starts after you have been taking Femoston for more than 6 months

carries on after you have stopped taking Femoston

see your doctor as soon as possible

Breast cancer

Evidence shows that taking combined oestrogen-progestogen or oestrogen-only hormone replacement

therapy (HRT) increases the risk of breast cancer. The extra risk depends on how long you use HRT. The

additional risk becomes clear within 3 years of use. After stopping HRT the extra risk will decrease with

time, but the risk may persist for 10 years or more if you have used HRT for more than 5 years.

Compare

Women aged 50 to 54 who are not taking HRT, on average, 13 to 17 in 1000 will be diagnosed with

breast cancer over a 5-year period. For women aged 50 who start taking oestrogen-only HRT for 5 years,

there will be 16-17 cases in 1000 users (i.e. an extra 0 to 3 cases). For women aged 50 who start taking

oestrogen-progestogen HRT for 5 years, there will be 21 cases in 1000 users (i.e. an extra 4 to 8 cases).

Women aged 50 to 59 who are not taking HRT, on average, 27 in 1000 will be diagnosed with breast

cancer over a 10-year period. For women aged 50 who start taking oestrogen-only HRT for 10 years,

there will be 34 cases in 1000 users (i.e. an extra 7 cases). For women aged 50 who start taking oestrogen-

progestogen HRT for 10 years, there will be 48 cases in 1000 users (i.e. an extra 21 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 of the breast is increased, mammography may

not detect all lumps.

Ovarian cancer

Ovarian cancer is rare - much rarer than breast cancer. The use of oestrogen-only or combined oestrogen-

progestogen 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/m

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

blood clots

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

you have systemic lupus erythematosus (SLE)

you have cancer

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

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 oestrogen-progestogen 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

oestrogen-progestogen 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 is not intended for use in children.

Other medicines and Femoston

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. 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, because this

medicine can affect the results of some tests.

Femoston with food and drink

Femoston can be taken with or without food.

Pregnancy and breast-feeding

Femoston is for use in postmenopausal women only.

If you become pregnant

stop taking Femoston and contact your doctor.

Femoston is not indicated for use during breast-feeding.

Driving and using machines

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

Femoston tablets contain lactose.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor

before taking this medicinal product.

3.

How to take FEMOSTON

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

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

You can start taking Femoston on any convenient day if:

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.

You start taking Femoston 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. You may need to stop

taking Femoston about 4 to 6 weeks before the operation to reduce the risk of a blood clot (see section 2,

Blood clots in a vein). Ask your doctor when you can start taking Femoston again.

If you take more Femoston than you should

If you (or someone else) take too many Femoston tablets, you are unlikely to come to any harm. You may

feel sick (nauseous), or be sick (vomit), may have tender or painful breasts, dizziness, abdominal pain,

drowsiness/tiredness, or withdrawal bleeding. No treatment is necessary. But if you are worried, contact

your doctor for advice.

If you forget to take Femoston

Take the missed tablet as soon as you remember. If it is more than 12 hours after you should have taken

the tablet, take the next dose at the regular time. Do not take the forgotten tablet. Do not take a double

dose. Bleeding or spotting may occur if you miss a dose.

If you stop taking Femoston

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

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

4.

Possible side effects

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

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

The following side effects may happen with this medicine:

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

headache

abdominal pain

back pain

tender or painful breasts

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 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 and see a doctor immediately.

gallbladder disease

swelling of your breasts

pre-menstrual syndrome (PMS)

weight decrease

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*

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 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

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 national reporting system (details

below). By reporting side effects you can help provide more information on the safety of this medicine.

In Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353

1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie

In Malta: ADR Reporting Website: www.medicinesauthority.gov.mt/adrportal

5.

How to store FEMOSTON

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 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 contains

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, Talc.

What Femoston looks like and contents of the pack

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 (3 x 28) or 280 (10 x 28) film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation Holder is:

Mylan IRE Healthcare Limited,

Unit 35/36, Grange Parade,

Baldoyle Industrial Estate,

Dublin 13.

Manufacturer

Abbott Biologicals B.V.

Veerweg 12

8121 AA Olst

The Netherlands

This medicinal product is authorised in the Member States of the EEA under the following names:

Femoston conti 0,5 mg/2,5 mg - Filmtabletten

Femoston Low 0,5 mg/2,5 mg filmomhulde tabletten

Femoston mini 0,5 mg/2,5 mg

Femoston mini 0,5 mg/2,5 mg Filmtablette

Femoston Conti

Femoston conti 0,5 mg/2,5 mg

Femoston 0,5 mg/2,5 mg comprimidos recubiertos con

película

Femoston conti 0,5/2,5 tabletti, kalvopäällysteinen

Climaston 0.5mg/2.5 mg, comprimé pelliculé

Femoston-conti 0.5 mg/ 2.5 mg film-coated tablets

Femoston 0,5 mg/2,5 mg compresse rivestite con film

Femoston conti 0,5 mg/2,5 mg plévele dengtos tabletés

Read the complete document

Health Products Regulatory Authority

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Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Femoston-conti 0.5mg/2.5mg film-coated tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains estradiol hemihydrate equivalent to 0.5 mg estradiol and 2.5 mg dydrogesterone.

Excipient with known effect: lactose monohydrate 117.4 mg

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Film-coated tablet

Round, biconvex, marked 379 on one side (7mm).

Yellow tablets.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women at least 12 months since

last menses.

The experience in treating women older than 65 years is limited.

4.2 Posology and method of administration

Femoston-conti 0.5 mg/2.5mg is a continuous combined HRT for oral use.

The oestrogen and the progestogen are given every day without interruption.

The dosage is one tablet per day for a 28 day cycle.

Femoston-conti 0.5 mg/2.5mg should be taken continuously without a break between packs.

For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration

(see also section 4.4) should be used.

Continuous combined treatment may be started with Femoston-conti 0.5 mg/2.5mg depending on the time since menopause

and severity of symptoms. Women experiencing a natural menopause should commence treatment with Femoston-conti 0.5

mg/2.5mg not earlier than at least 12 months after their last natural menstrual bleed. For surgically induced menopause,

treatment may start immediately.

Depending on the clinical response, the dosage can subsequently be adjusted.

Patients changing from a continuous sequential or cyclical preparation should complete the 28 day cycle and then change to

Femoston-conti 0.5 mg/2.5mg.

Patients changing from another continuous combined preparation may start therapy at any time

If a dose has been forgotten, it should be taken as soon as possible. If more than 12 hours have elapsed, treatment should be

continued with the next tablet without taking the forgotten tablet. The likelihood of breakthrough bleeding or spotting may be

increased.

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Femoston-conti 0.5 mg/2.5mg can be taken irrespectively of food intake.

Paediatric population:

There is no relevant indication for the use of Femoston-conti 0.5 mg/2.5mg in the paediatric population.

4.3 Contraindications

Known, past or suspected breast cancer

Known or suspected oestrogen-dependent malignant tumours (e.g. endometrial cancer)

Undiagnosed genital bleeding

Untreated endometrial hyperplasia

Previous or current venous thromboembolism (deep venous thrombosis, pulmonary embolism)

Known thrombophilic disorders (e.g. protein C, protein S, or antithrombin deficiency, see section 4.4)

Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction)

Acute liver disease, or a history of liver disease, as long as the liver function tests have failed to return to normal

Porphyria

Known hypersensitivity to the active substances or to any of the excipients listed in section 6.1

4.4 Special warnings and precautions for use

For the treatment of postmenopausal symptoms, HRT should only be initiated for symptoms that adversely affect quality of life.

In all cases, a careful appraisal of the risks and benefits should be undertaken at least annually and HRT should only be

continued as long as the benefit outweighs the risk.

Evidence regarding the risks associated with HRT in the treatment of premature menopause is limited. Due to the low level of

absolute risk in younger women, however, the balance of benefits and risks for these women may be more favourable than in

older women.

Medical examination/follow-up

Before initiating or re-instituting HRT, a complete personal and family medical history should be taken. Physical (including

pelvic and breast) examination should be guided by this and by the contraindications and warnings for use. During treatment,

periodic check-ups are recommended of a frequency and nature adapted to the individual woman. Women should be advised

what changes in their breasts should be reported to their doctor or nurse (see 'Breast cancer' below). Investigations, including

appropriate imaging tools, e.g. mammography, should be carried out in accordance with currently accepted screening

practices, modified to the clinical needs of the individual.

Conditions which need supervision

If any of the following conditions are present, have occurred previously, and/or have been aggravated during pregnancy or

previous hormone treatment, the patient should be closely supervised. It should be taken into account that these conditions

may recur or be aggravated during treatment with Femoston-conti 0.5 mg/2.5mg, in particular:

Leiomyoma (uterine fibroids) or endometriosis

Risk factors for thromboembolic disorders (see below)

Risk factors for oestrogen-dependent tumours, e.g. 1

degree heredity for breast cancer

Hypertension

Liver disorders (e.g. liver adenoma)

Diabetes mellitus with or without vascular involvement

Cholelithiasis

Migraine or (severe) headache

Systemic lupus erythematosus

A history of endometrial hyperplasia (see below)

Epilepsy

Asthma

Otosclerosis

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Meningioma

Reasons for immediate withdrawal of therapy

Therapy should be discontinued in case a contraindication is discovered and in the following situations:

Jaundice or deterioration in liver function

Significant increase in blood pressure

New onset of migraine-type headache

Pregnancy

Endometrial hyperplasia and carcinoma

In women with an intact uterus the risk of endometrial hyperplasia and carcinoma is increased when oestrogens

are administered alone for prolonged periods. The reported increase in endometrial cancer risk among

oestrogen-only users varies from 2- to 12-fold greater compared with non-users, depending on the duration of

treatment and oestrogen dose (see section 4.8). After stopping treatment risk may remain elevated for at least 10

years.

The addition of a progestogen cyclically for at least 12 days per month /28 day cycle or continuous combined

oestrogen-progestogen therapy in non-hysterectomised women can prevent the excess risk associated with

oestrogen-only HRT.

Break-through bleeding and spotting may occur during the first months of treatment. If break-through bleeding or

spotting appears after some time on therapy, or continues after treatment has been discontinued, the reason

should be investigated, which may include endometrial biopsy to exclude endometrial malignancy.

Breast cancer

The overall evidence shows an increased risk of breast cancer in women taking combined oestrogen-progestogen or

oestrogen-only HRT, that is dependent on the duration of taking HRT.

Combined oestrogen-progestogen therapy:

The randomised placebo-controlled trial, the Women's Health Initiative study (WHI), and a meta-analysis of

prospective epidemiological studies are consistent in finding an increased risk of breast cancer in women taking

combined oestrogen-progestogen for HRT that becomes apparent after about 3 (1-4) years (see section 4.8).

Oestrogen-only therapy:

The WHI trial found no increase in the risk of breast cancer in hysterectomised women using oestrogen-only HRT.

Observational studies have mostly reported a small increase in risk of having breast cancer diagnosed that is lower

than that found in users of oestrogen-progestogen combinations (see section 4.8).

Results from a largemeta-analysis showed that after stopping treatment, the excess risk willdecrease with time and the time

needed to return to baseline depends on theduration of prior HRT use. When HRT was taken for more than 5 years, the

riskmay persist for 10 years or more.

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HRT, especially oestrogen-progestogen combined treatment, increases the density of mammographic images which may

adversely affect the radiological detection of breast cancer.

Ovarian cancer

Ovarian cancer is much rarer than breast cancer. Epidemiological evidence from a large meta-analysis suggests a slightly

increased risk in women taking oestrogen-only or combined oestrogen-progestogen HRT, which becomes apparent within 5

years of use and diminishes over time after stopping. Some other studies, including the WHI trial, suggest that the use of

combined HRTs may be associated with a similar, or slightly smaller risk (see section 4.8).

Venous thromboembolism

HRT is associated with a 1.3- 3 fold risk of developing venous thromboembolism (VTE), i.e. deep vein thrombosis

or pulmonary embolism. The occurrence of such an event is more likely in the first year of HRT than later (see

section 4.8).

Patients with known thrombophilic states have an increased risk of VTE and HRT may add to this risk. HRT is

therefore contraindicated in these patients (see section 4.3).

Generally recognised risk factors for VTE include: use of oestrogens, older age, major surgery, prolonged

immobilisation, obesity (BMI > 30 kg/m

), pregnancy/postpartum period, systemic lupus erythematosus (SLE),

and cancer. There is no consensus about the possible role of varicose veins in VTE.

As in all postoperative patients, prophylactic measures need to be considered to prevent VTE following surgery.

If prolonged immobilisation is to follow elective surgery, temporarily stopping HRT 4 to 6 weeks earlier is

recommended. Treatment should not be restarted until the woman is completely mobilised.

In women with no personal history of VTE but with a first degree relative with a history of thrombosis at young age,

screening may be offered after careful counselling regarding its limitations (only a proportion of thrombophilic

defects are identified by screening). If a thrombophilic defect is identified which segregates with thrombosis in

family members or if the defect is 'severe' (e.g. antithrombin, protein S, or protein C deficiencies or a combination

of defects) HRT is contraindicated.

Women already on anticoagulant treatment require careful consideration of the benefit-risk of use of HRT.

If VTE develops after initiating therapy, the drug should be discontinued. Patients should be told to contact their

doctors immediately when they are aware of a potential thromboembolic symptom (e.g. painful swelling of a leg,

sudden pain in the chest, dyspnoea).

Coronary artery disease (CAD)

There is no evidence from randomised controlled trials of protection against myocardial infarction in women with or without

existing CAD who received combined oestrogen-progestogen or oestrogen-only HRT.

Combined oestrogen-progestogen therapy:

The relative risk of CAD during use of combined oestrogen-progestogen HRT is slightly increased. As the baseline absolute risk

of CAD is strongly dependent 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.

Oestrogen-only:

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Randomised controlled data found no increased risk of CAD in hysterectomised women using oestrogen-only therapy.

Ischaemic Stroke

Combined oestrogen-progestogen and oestrogen-only therapy are associated with an up to 1.5-fold increase in risk of

ischaemic stroke. The relative risk does not change with age or time since menopause. However, as the baseline risk of stroke is

strongly age-dependent, the overall risk of stroke in women who use HRT will increase with age (see section 4.8).

Other conditions

Oestrogens may cause fluid retention, and therefore patients with cardiac or renal dysfunction should be carefully

observed.

Women with pre-existing hypertriglyceridaemia should be followed closely during oestrogen replacement or

hormone replacement therapy, since rare cases of large increases of plasma triglycerides leading to pancreatitis

have been reported with oestrogen therapy in this condition.

Oestrogens increase thyroid binding globulin (TBG), leading to increased circulating total thyroid hormone, as

measured by protein-bound iodine (PBI), T4 levels (by column or by radio-immunoassay) or T3 levels (by

radio-immunoassay). T3 resin uptake is decreased, reflecting the elevated TBG. Free T4 and free T3 concentrations

are unaltered. Other binding proteins may be elevated in serum, i.e. corticoid binding globulin (CBG),

sex-hormone-binding globulin (SHBG) leading to increased circulating corticosteroids and sex steroids,

respectively. Free or biological active hormone concentrations are unchanged. Other plasma proteins may be

increased (angiotensinogen/renin substrate, alpha-1-antitrypsin, ceruloplasmin).

HRT use does not improve cognitive function. There is some evidence of increased risk of probable dementia in

women who start using continuous combined or oestrogen-only HRT after the age of 65.

Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose

malabsorption should not take this medicine.

This oestrogen-progestogen combination treatment is not a contraceptive.

4.5 Interaction with other medicinal products and other forms of interactions

No interaction studies have been performed.

The efficacy of oestrogens and progestogens might be impaired:

The metabolism of oestrogens and progestogens may be increased by concomitant use of substances known to

induce drug-metabolising enzymes, specifically P450 enzymes, such as anticonvulsants (e.g. phenobarbital,

carbamazepin, phenytoin) and anti-infectives (e.g. rifampicin, rifabutin, nevirapine, efavirenz).

Ritonavir and nelfinavir, although known as strong inhibitors, by contrast exhibit inducing properties when used

concomitantly with steroid hormones.

Herbal preparations containing St. John’s Wort (Hypericum perforatum) may induce the metabolism of oestrogens

and progestogens.

Clinically, an increased metabolism of oestrogens and progestogens may lead to decreased effect and changes in

the uterine bleeding profile.

4.6 Fertility, pregnancy and lactation

Pregnancy

Femoston-conti 0.5 mg/2.5 mg is not indicated during pregnancy. If pregnancy occurs during medication with Femoston-conti

0.5 mg/2.5 mg treatment should be withdrawn immediately.

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There are no adequate data from the use of estradiol/dydrogesterone in pregnant women. The results of most epidemiological

studies to date relevant to inadvertent fetal exposure to combinations of oestrogens and progestogens indicate no teratogenic

or foetotoxic effect.

Lactation

Femoston-conti 0.5 mg/2.5 mg is not indicated during lactation.

Fertility

Femoston-conti 0.5 mg/2.5 mg is not indicated during fertility.

4.7 Effects on ability to drive and use machines

Femoston-conti 0.5 mg/2.5 mg

has no or negligible influence on the ability to drive and/or to use machines.

4.8 Undesirable effects

The most commonly reported adverse drug reactions of patients treated with estradiol/dydrogesterone in clinical trials are

headache, abdominal pain, breast pain/tenderness and back pain.

The following undesirable effects have been observed with the frequencies indicated below during clinical trials (n=4929).

*Undesirable effects from spontaneous reporting not observed in clinical trials have been attributed to the frequency "rare":

MedDRA system

organ class

Very common

≥1/10

Common

≥1/100 to <1/10

Uncommon

≥1/1,000 to <1/100

Rare

≥1/10,000 to

<1/1,000

Infections and

infestations

Vaginal

candidiasis

Cystitis- like symptoms

Neoplasms

benign,

malignant and

unspecified

Increase in size of leiomyoma

Blood and the

lymphatic

system

disorders

Haemolytic

anaemia*

Immune system

disorders

Hypersensitivity

Psychiatric

disorders

Depression,

nervousness

Influence on libido

Nervous system

disorders

Headache

Migraine,

dizziness

Meningioma*

Eye disorders

Steepening

of corneal

curvature*,

contact

lenses

intolerance*

Cardiac

disorders

Myocardial

infarction

Vascular

disorders

Venous thromboembolism, hypertension,

peripheral vascular disease, varicose vein

Stroke*

Gastrointestinal

disorders

Abdominal pain

Nausea,

vomiting,

abdominal

distension

(including

flatulence)

Dyspepsia

Hepatobiliary

disorders

Abnormal hepatic function occasionally with

jaundice asthenia or malaise, and abdominal

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pain.

gallbladder disorders

Skin and

subcutaneous

tissue disorders

Allergic skin

reactions (e.g.

rash, urticaria,

pruritus)

Angioedema,

vascular

purpura,

erythema

nodosum*,

Chloasma or

melasma,

which may

persist when

drug is

discontinued*

Musculoskeletal

and connective

tissue disorders

Back pain

Leg cramps*

Reproductive

system and

breast disorders

Breast pain/tenderness

Menstrual

disorders

(including

postmenopausal

spotting,

metrorrhagia,

menorrhagia,

oligo-/amenorrh

oea, irregular

menstruation,

dysmenorrhoea),

pelvic pain,

cervical

discharge

Breast enlargement, premenstrual syndrome

General

disorders and

administration

site reactions

Asthenic

conditions

(asthenia,

fatigue, malaise),

peripheral

oedema

Investigations

Increased weight

Decreased weight

Breast cancer risk

An up to 2-fold increased risk of having breast cancer diagnosed is reported in women taking combined

oestrogen-progestogen therapy for more than 5 years.

The increased risk in users of oestrogen-only therapy is lower than that seen in users of oestrogen-progestogen

combinations.

The level of risk is dependent on the duration of use (see section 4.4).

Absolute risk estimations based on results of the largest randomised placebo-controlled trial (WHI-study) and the

largest meta-analysis of prospective epidemiological studies are presented. Largest meta-analysis of prospective

epidemiological studies – Estimated additional risk of breast cancer after 5 years' use in women with BMI

27 (kg/m

2

)

Age at the start of HRT (years)

Incidence

per 1000

never-use

rs of HRT

over a 5

year

period

(50-54

years)*

Risk ratio

Additional

cases per

1000 HRT

users after

5 years

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Oestrogen

only HRT

–13.3

Combined

oestrogen-pr

ogestogen

–13.3

*Taken from baseline incidence rates in England in 2015 in women with BMI 27

(kg/m

Note: Since the background incidence of breast cancer differs by EU country, the

number of additional cases of breast cancer will also change proportionately.

Estimated additional risk of breast cancer after 10 years' use in women with BMI 27 (kg/m

2

)

Age at the start of HRT (years)

Incidence

per 1000

never-use

rs of HRT

over a 10

year

period

(50-59

years)*

Risk ratio

Additional

cases per

1000 HRT

users after

10 years

Oestrogen

only HRT

26.6

Combined

oestrogen-pr

ogestogen

26.6

20.8

*Taken from baseline incidence rates in England in 2015 in women with BMI 27

(kg/m

Note: Since the background incidence of breast cancer differs by EU country, the

number of additional cases of breast cancer will also change proportionately.

US WHI studies - additional risk of breast cancer after 5 years' use

Age range (yrs)

Incidence

per 1000

women in

placebo

arm over

5 years

Risk ratio &

95%CI

Additional

cases per

1000 HRT

users over

5 years

(95%CI)

CEE

oestrogen-on

ly

50 - 79

0.8 (0.7 – 1.0)

-4 (-6 – 0)*

CEE+MPA

oestrogen &

progestogen‡

50 - 79

1.2 (1.0 – 1.5)

+4 (0 – 9)

*WHI study in women with no uterus, which did not show an increase in risk of breast cancer

‡When the analysis was restricted to women who had not used HRT prior to the study there was no increased risk apparent

during the first 5 years of treatment: after 5 years the risk was higher than in non-users.

Endometrial cancer risk

Postmenopausal women with a uterus:

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The endometrial cancer risk is about 5 in every 1000 women with a uterus not using HRT.

In women with a uterus, use of oestrogen-only HRT is not recommended because it increases the risk of endometrial cancer

(see section 4.4).

Depending on the duration of oestrogen-only use and oestrogen dose, the increase in risk of endometrial cancer in

epidemiology studies varied from between 5 and 55 extra cases diagnosed in every 1000 women between the ages of 50 and

Adding a progestogen to oestrogen-only therapy for at least 12 days per cycle can prevent this increased risk. In the Million

Women Study the use of five years of combined (sequential or continuous) HRT did not increase the risk of endometrial cancer

(RR of 1.0 (0.8-1.2)).

Ovarian cancer

Use of oestrogen-only or combined oestrogen-progestogen HRT has been associated with a slightly increased risk of having

ovarian cancer diagnosed (see section 4.4).

A meta-analysis from 52 epidemiological studies reported an increased risk of ovarian cancer in women currently using HRT

compared to women who have never used HRT (RR 1.43, 95% CI 1.31-1.56). For women aged 50 to 54 years taking 5 years of

HRT, this results in about 1 extra case per 2000 users. 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.

Risk of venous thromboembolism

HRT is associated with a 1.3- to 3-fold increased relative risk of developing venous thromboembolism (VTE), i.e. deep vein

thrombosis or pulmonary embolism. The occurrence of such an event is more likely in the first year of using HRT (see section

4.4). Results of the WHI studies are presented:

WHI Studies - Additional risk of VTE over 5 years' use

Age range (years)

Incidence per 1000 women in

placebo arm over 5 years

Risk ratio and 95%CI

Additional cases per 1000

HRT users

Oral oestrogen-only

50 - 59

1.2 (0.6-2.4)

1 (-3 – 10)

Oral combined oestrogen-progestogen

50 - 59

2.3 (1.2 – 4.3)

5 (1 - 13)

Risk of coronary artery disease

The risk of coronary artery disease is slightly increased in users of combined oestrogen-progestogen HRT over the age of 60

(see section 4.4).

Risk of ischaemic stroke

The use of oestrogen-only and oestrogen+progestogen therapy is associated with an up to 1.5-fold increased relative risk of

ischaemic stroke. The risk of haemorrhagic stroke is not increased during use of HRT.

This relative risk is not dependent on age or duration of use, but as the baseline risk is strongly age-dependent, the overall risk

of stroke in women who use HRT will increase with age (see section 4.4).

WHI studies combined - Additional risk of ischaemic stroke[d] over 5 years' use

Age range (years)

Incidence

per 1000 women in

placebo arm over 5 years

Risk ratio and

95%CI

Additional cases per 1000

HRT users over 5 years

50 - 59

1.3 (1.1 - 1.6)

3 (1 - 5)

Other adverse reactions have been reported in association with oestrogen/progestogen treatment:

Neoplasms benign, malignant and unspecified:

Oestrogen- dependent neoplasms both benign and malignant, e.g. endometrial cancer, ovarian cancer. Increase in size of

meningioma.

Immune system disorders:

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Systemic lupus erythematosus

Metabolism and nutrition disorders:

Hypertriglyceridemia

Nervous system disorders:

Probable dementia, chorea, exacerbation of epilepsy

Vascular disorders:

Arterial thromboembolism

Gastrointestinal disorders:

Pancreatitis (in women with pre-existing hypertriglyceridemia)

Skin and subcutaneous tissue disorders:

Erythema multiforme

Renal and urinary disorders:

Urinary incontinence

Reproductive system and breast disorders:

Fibrocystic breast disease, uterine cervical erosion

Congenital, familial and genetic disorders:

Aggravated porphyria

Investigations:

Total thyroid hormones increased

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued

monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected

adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517.

Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

[a] Taken from baseline incidence rates in developed countries

[b] WHI study in women with no uterus, which did not show an increase in risk of breast cancer

[c] Study in women with no uterus

[d] no differentiation was made between ischaemic and haemorrhagic stroke.

4.9 Overdose

Both estradiol and dydrogesterone are substances with low toxicity. Symptoms such as nausea, vomiting, breast tenderness,

dizziness, abdominal pain, drowsiness/fatigue, and withdrawal bleeding could occur in cases of overdosing. It is unlikely that

any specific or symptomatic treatment will be necessary.

Aforementioned information is also applicable for overdosing in children.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Genito urinary system and sex hormones, progestogens and oestrogens, fixed combinations.

ATC code: G03FA14.

Estradiol

The active ingredient, synthetic 17β-estradiol, is chemically and biologically identical to endogenous human estradiol. It

substitutes for the loss of oestrogen production in menopausal women, and alleviates menopausal symptoms.

Dydrogesterone

Dydrogesterone is an orally-active progestogen having an activity comparable to parenterally administered progesterone.

As oestrogens promote the growth of the endometrium, unopposed oestrogens increase the risk of endometrial hyperplasia

and cancer. The addition of a progestogen greatly reduces the oestrogen-induced risk of endometrial hyperplasia in

non-hysterectomised women.

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