FEMOSTON

Main information

  • Trade name:
  • FEMOSTON 1/10 estradiol 1mg and estradiol 1mg with dydrogesterone 10mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FEMOSTON 1/10 estradiol 1mg and estradiol 1mg with dydrogesterone 10mg tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219882
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219882

FEMOSTON 1/10 estradiol 1mg and estradiol 1mg with dydrogesterone 10mg tablet blister pack composite

pack.

ARTG entry for

Medicine Registered

Sponsor

Mylan Health Pty Ltd

Postal Address

Level 1 30 The Bond,30-34 Hickson Road,Millers Point, NSW, 2000

Australia

ARTG Start Date

8/05/2014

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. FEMOSTON 1/10 estradiol 1mg and estradiol 1mg with dydrogesterone 10mg tablet blister pack

Product Type

Composite Pack

Effective date

31/07/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Hormone Replacement therapy (HRT) in oestrogen deficiency associated with natural or artificial menopause in women with an intact uteri. Prevention of

postmenopausal bone mineral density loss in women. For initiation and continuation of treatment of postmenopausal symptoms, the lowest possible

effective dose for the shortest duration should be used with the goal being short term use.,Hormone Replacement therapy (HRT) in oestrogen deficiency

associated with natural or artificial menopause in women with an intact uterus. Prevention of postmenopausal bone mineral density loss in women. For

initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration should be used with the goal

being short term use (See DOSAGE AND ADMINISTRATION and CLINICAL TRIALS). When prescribed solely for the prevention of postmenopausal

bone mineral density loss in women, therapy should only be prescribed for women who are at high risk of future fracture and who are intolerant of, or

contraindicated for non-oestrogen products approved for prevention of osteoporosis. Life style modifications and the risk benefit profile of FEMOSTON

should be taken into careful consideration and discussed with the patient, to allow the patient to make an informed decision prior to prescribing( See

PRECAUTIONS and DOSAGE AND ADMINISTRATION).

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/Al

3 Years

Store below 30

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

84 tablets (3 strips)

(S4) Prescription Only Medicine

56 tablets (2 strips)

(S4) Prescription Only Medicine

28 tablets (1 blister strip)

(S4) Prescription Only Medicine

Components

1. Component 1: OESTRADIOL 1MG TABLET

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Round, biconvex, grey, film-coated tablet, bearing the inscription "379" on

one side.

Active Ingredients

estradiol

1 mg

2. Component 2: OESTRADIOL 1MG WITH DYDROGESTERONE 10MG TABLET

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Round, biconvex, white film-coated tablet, bearing the inscription "379" on

Public Summary

Page 1 of

Produced at 10.11.2017 at 06:13:30 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

one side.

Active Ingredients

Dydrogesterone

10 mg

estradiol

1 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 2 of

Produced at 10.11.2017 at 06:13:30 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet

Femoston

®

1/10

estradiol and dydrogesterone

Consumer Medicine Information (CMI)

What is in this leaflet

This leaflet answers some common

questions about Femoston.

It does not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you taking this medicine

against the benefits they expect it

will have for you.

If you have any concerns about

taking this medicine, ask your

doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

When you must not

use Femoston

Do not use Femoston or other

estrogens, with or without a

progestogen to prevent heart

attacks, stroke or dementia.

A study called the Women's Health

Initiative indicated increased risk of

heart attack, stroke, breast cancer,

and blood clots in the legs or lungs in

women receiving treatment with a

product containing conjugated

estrogens 0.625 mg and the

progestogen medroxyprogesterone

acetate (MPA). The researchers

stopped the study after 5 years when

it was determined the risks were

greater than the benefits in this

group.

The Women's Health Initiative

Memory Study indicated increased

risk of dementia in women aged

65-79 years taking conjugated

estrogens and MPA. There are no

comparable data currently available

for others doses of conjugated

estrogens and MPA or others

combinations of estrogens and

progestogens. Therefore, you should

assume the risks will be similar for

other medicines containing estrogen

and progestogen combinations.

Talk regularly with your doctor

about whether you still need

treatment with Femoston.

Treatment with estrogens, with or

without progestogens should be used

at the lowest effective dose and for

the shortest period of time.

What Femoston is

used for

Femoston is a type of treatment

called hormone replacement therapy

(HRT). It contains the hormones

estradiol and dydrogesterone.

This medicine helps to relieve the

discomfort many women feel during

and after the menopause. It also helps

to prevent thinning of the bones

(osteoporosis), which can cause

fractures. Femoston is used by

women who still have a uterus

(womb).

Menopause may be natural or occur

after surgery or medical treatment.

HRT should not be used for the long-

term maintenance of general health

or to prevent heart disease.

Femoston is not a contraceptive

(birth control) and will not prevent

pregnancy or restore fertility. Since

pregnancy may be possible early in

the menopause while you are still

having menstrual periods, you should

ask your doctor to suggest another

(non-hormonal) method of birth

control.

How it works

Estradiol is a natural female sex

hormone called an estrogen. It is the

same hormone that your ovaries were

producing before the menopause.

Dydrogesterone is a hormone called

a progestogen. It has effects like the

female hormone, progesterone,

which your ovaries also produced

before the menopause.

Menopause generally occurs between

the ages of 45 and 55, because your

body's production of estrogen

decreases. This can cause unpleasant

symptoms such as a feeling of

warmth in the face, neck and chest,

"hot flushes" (sudden intense feelings

of heat and sweating throughout the

body), sleep problems, irritability and

depression. Some women also have

problems with urine control or with

dryness of the vagina causing

discomfort during or after sex.

Estrogens can be given to reduce

these symptoms.

After the age of 40, and especially

after the menopause, some women

develop osteoporosis. This is a

thinning of the bones that makes

them weaker and more likely to

break, especially the bones of the

spine, hip and wrist. The risk of

osteoporosis is increased by lack of

estrogen. Estrogens can be given to

reduce this risk if other treatments

are not suitable.

Women who still have a uterus must

take both estrogen and progestogen

as part of HRT. This is because

estrogen stimulates the growth of the

FEMOSTON

lining of the uterus (called the

endometrium). Before menopause

this lining is removed during your

period through the action of your

natural progestogen. After

menopause, taking estrogen on its

own as HRT may lead to irregular

bleeding and to a disorder called

endometrial hyperplasia.

Progestogens such as dydrogesterone

help to protect the lining of the uterus

from developing this disorder.

Ask your doctor if you have any

questions about why it has been

prescribed for you.

Your doctor may have prescribed it

for another purpose.

This medicine is not addictive.

This medicine is available only with

a doctor's prescription.

Before you take

Femoston

When you must not take it

HRT should only be used if you

have been fully informed of the

risks.

The decision to use HRT should be

based on your symptoms and health,

and made after a careful medical

evaluation.

Do not take Femoston if you have

an allergy to:

any medicine containing

estradiol or dydrogesterone

any of the ingredients listed at

the end of this leaflet

Some symptoms of an allergic

reaction include skin rash, itching,

shortness of breath or swelling of the

face, lips or tongue, which may cause

difficulty in swallowing or breathing.

Do not take Femoston if you have/

have experienced:

A hysterectomy

Cancer of the breast or uterus

(endometrium) or any other

estrogen or progestogen

dependent cancer.

Blood clots. Painful inflammation

or blockages of a blood vessel in

the legs, lungs, brain or heart.

Any condition that increases the

tendency for you to get blood

clots

Untreated endometrial

hyperplasia (the lining of the

uterus becomes too thick)

Abnormal vaginal bleeding that

has not been investigated

Severe liver disease

A condition called porphyria

If you are not sure whether any of the

above conditions apply to you, your

doctor can advise you.

Do not take this medicine if you

are pregnant. Discuss with your

doctor if you are planning on

becoming pregnant.

Do not breastfeed if you are taking

this medicine.

Do not give Femoston to a child

under the age of 18 years.

Safety and effectiveness in children

younger than 18 years have not been

established.

You must stop taking Femoston 4

weeks before certain types of

surgery.

Do not take it after the expiry date

printed on the pack or if the

packaging is damaged or shows

signs of tampering.

If it has expired or is damaged return

it to your pharmacist for disposal.

Before you start to take it

Tell your doctor or pharmacist if

you have any allergies to any other

medicines, foods, preservatives or

dyes.

You must have a thorough medical

check-up before starting HRT for

the first time or recommencing

HRT.

Tell your doctor if you have or

have had any of the following

medical conditions:

a family history of breast cancer

nodules, lumps or cysts in your

breasts or any other benign breast

condition (not cancer)

fibroids or other benign tumours

of the uterus (not cancer)

ovarian cancer

unusual or irregular bleeding or

spotting from the vagina

endometriosis

high blood pressure

liver problems

cholestatic jaundice (obstruction

of bile)

kidney problems

heart problems

diabetes

migraine or severe headache

asthma

epilepsy

systemic lupus erythematosus

gall stones or gall bladder disease

a high level of triglycerides (fats)

in the blood

high or low levels of calcium in

the blood.

Abnormal vision

Hypothyroidism

Otosclerosis - hearing loss due to

a problem with the bones in the

Tell your doctor if you are likely to

have an increased risk of

developing blood clots in your

blood vessels.

The risk increases as you get older

and it may also be increased if:

anyone in your immediate family

has ever had blood clots in the

blood vessels of the legs or lungs

you are overweight

you have varicose veins

you have a disorder called

systemic lupus erythematosus

(SLE).

Your doctor will advise you whether

or not to take Femoston, or if you

need to adjust the dose, or adapt your

treatment.

FEMOSTON

Taking other medicines

Tell your doctor if you are taking

any other medicines, including any

that you buy without a

prescription from your pharmacy,

supermarket or health food store.

Some medicines and Femoston may

interfere with each other. These

include:

herbal medicines containing St

John's wort

some medicines for epilepsy such

as phenytoin, phenobarbitone and

carbamazepine

some antibiotics and anti-

infectives such as rifampicin and

ritonavir

some medicines with a narrow

therapeutic index such as

Tacrolimus, ciclosporin, Fentanyl

and Theophylline

These medicines may be affected by

Femoston, or may affect how well it

works. You may need to use different

amounts of your medicine, or take

different medicines.

Your doctor or pharmacist has more

information on medicines to be

careful with or to avoid while taking

Femoston.

How to take Femoston

Follow all directions given to you

by your doctor carefully.

They may differ from the

information contained in this leaflet.

If you do not understand the

instructions on the box, ask your

doctor or pharmacist for help.

When to start taking it

If you are having regular periods,

you may start taking Femoston on the

first day of your period. If you are

having irregular periods, discuss the

starting day with your doctor. If you

have not had a period for 12 months

or more, you can start Femoston

immediately.

How much to take

The usual dose is one tablet daily.

How to take it

Swallow the tablets whole with a

glass of water.

When to take it

It does not matter if you take this

medicine before or after food.

Take Femoston at about the same

time each day.

Taking it at the same time each day

will have the best effect. It will also

help you remember when to take it.

The tablets are labelled with the days

of the week to help you make sure

you are taking your tablets every day.

You must always start by taking

the tablets in the half of the pack

with an arrow marked "1". When

you come to the end of these

tablets, start taking the tablets in

the other half of the pack marked

"2".

You should start each new pack

the day after you have finished the

old pack. Do not leave a gap

between packs.

How long to take it

Your doctor can advise you how long

you may need to take Femoston.

Your doctor can discuss the risks and

benefits of long-term treatment with

HRT. Some recent studies have

shown that women using HRT have a

small increase in breast cancer risk

after several years of use. The risk

increases with the length of HRT use.

Recent studies have also shown that

HRT is associated with a small

increase in the risk of heart attacks,

strokes, blood clots, including clots

in the lungs. The studies also showed

that the risk of hip fractures and

bowel cancer may be reduced.

Another study has shown that in

women older than 65 years, HRT is

associated with a small increase in

the risk of dementia, including

Alzheimer's disease. It is not known

if this finding applies to younger

women.

Continue taking Femoston for as

long as your doctor recommends.

If you forget to take it

If it is almost time for your next

dose, skip the dose you missed and

take your next dose when you are

meant to.

A slight vaginal bleeding, like an

irregular period, may occur.

Otherwise, take it as soon as you

remember, and then go back to

taking your medicine as you would

normally.

Do not take a double dose to make

up for the dose that you missed.

If you have forgotten to take more

than one tablet, discuss this with

your doctor.

If you are not sure what to do, ask

your doctor or pharmacist.

If you have trouble remembering

when to take your medicine, ask

your pharmacist for advice.

If you take too much

(overdose)

Immediately telephone your

doctor, or the Poisons Information

Centre 13 11 26 or go to Accident

and Emergency at your nearest

hospital, if you think you or

anyone else may have taken too

much Femoston. Do this even if

there are no signs of discomfort or

poisoning.

While you are taking

Femoston

Things you must do

If you are about to be started on

any new medicine, remind your

doctor and pharmacist that you

are taking Femoston.

Tell any other doctors, dentists and

pharmacists who treat you that

you are taking this medicine.

FEMOSTON

Tell your doctor that you are using

Femoston well in advance of any

expected hospitalisation or

surgery. If you go to hospital

unexpectedly, tell the doctor who

admits you that you are using it.

The risk of developing blood clots in

your blood vessels may be

temporarily increased after surgery,

serious injury or having to stay in

bed for a long period of time. If

possible, Femoston should be

stopped at least 4 weeks before

surgery and it should not be restarted

until you are fully mobile.

If you become pregnant while you

are taking this medicine, tell your

doctor or pharmacist immediately.

See your doctor at least once a year

for a check-up. Some women will

need to go more often. Your doctor

will check:

your breasts and order a

mammogram at regular

intervals

your uterus and cervix and do a

pap smear at regular intervals

your blood pressure and

cholesterol level

Check your breasts each month

and report any changes promptly

to your doctor.

Your doctor or nurse can show you

how to check your breasts properly.

If you notice any changes to your

breasts, see your doctor.

Include foods that are good sources

of calcium and Vitamin D in your

daily diet and exercise regularly.

Calcium, Vitamin D and exercise

may help prevent thinning of the

bones. Your doctor can advise you

on which foods and types of

exercise are best for you.

Things you must not do

Do not use this medicine to treat

any other complaints unless your

doctor or pharmacist tells you to.

Do not give this medicine to anyone

else, even if they have the same

condition as you.

Do not stop taking Femoston, or

change the dosage, without

checking with your doctor.

Side effects

Tell your doctor as soon as possible

if you do not feel well while you are

taking Femoston.

It helps most people, but it may have

unwanted side effects in a few

people. All medicines have some

unwanted side effects. Sometimes

they are serious, but most of the time

they are not. You may need medical

attention if you get some of the side-

effects.

Do not be alarmed by this list of

possible side effects. You may not

experience any of them.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor if you notice any

of the following:

irregular vaginal bleeding or

spotting (if bleeding is heavy,

check with your doctor as soon as

possible)

tender, painful or swollen breasts

period-like pain

vaginal itching, inflammation or

fluid discharge

swelling of the lower legs, ankles,

fingers or abdomen due to fluid

retention

nausea (feeling sick), abdominal

cramps, vomiting, heartburn,

wind, diarrhoea

headache, migraine

rise in blood pressure

weakness or dizziness

depression, nervousness, rapid

changes in mood, difficulty

sleeping

worsening of a condition called

epilepsy

back pain

change in sex drive

weight gain or weight loss

acne, itchy or dry skin, skin

discolouration.

The above list includes common and

uncommon side effects of your

medicine. They are usually mild and

short-lived.

If any of the following happen, tell

your doctor immediately or go to

Accident and Emergency at your

nearest hospital:

signs of allergic reaction such as

a rash or hives on the skin,

swelling of the face, lips, tongue

or other parts of the body,

shortness of breath or troubled

breathing

sudden severe headache

sudden loss of coordination

blurred vision or sudden loss of

vision, bulging of eyeball

slurred speech

numbness or tingling in an arm or

painful swelling in the calves or

thighs

chest pain

difficulty breathing

coughing blood

pain or tenderness in the

abdomen, which may be

accompanied by fever, loss of

appetite, nausea and vomiting

a yellow colour to the skin or

eyes, itching, dark coloured urine

or light coloured bowel motions.

The above list includes very serious

side effects. You may need urgent

medical attention. These side effects

are rare.

Tell your doctor or pharmacist if

you notice anything else that is

making you feel unwell.

Other side effects not listed above

may occur in some people.

FEMOSTON

After using Femoston

Storage

Keep your tablets in the pack until

it is time to take them.

If you take the tablets out of the box

or the blister pack they may not keep

well.

Keep the medicine in a cool, dry

place where the temperature stays

below 30°C.

Do not store it or any other

medicine in the bathroom, near a

sink, or on a windowsill. Do not

leave it in the car.

Heat and dampness can destroy some

medicines.

Keep it where children cannot

reach it.

A locked cupboard at least one-and-

a-half metres above the ground is a

good place to store medicines.

Disposal

If your doctor or pharmacist tells

you to stop taking this medicine, or

the medicine has passed its expiry

date, ask your pharmacist what to

do with any that are left over.

Product description

What it looks like

Femoston 1/10 contains two types of

tablets:

14 round, white, estradiol 1 mg

tablets bearing the inscriptions

"379" on one side.

14 round, grey, 1 mg estradiol

combined with 10 mg

dydrogesterone tablets bearing

the inscriptions "379" on one

side.

Femoston 1/10 is available in packs

of 28 tablets.

Ingredients

The white tablets each contain 1 mg

of estradiol (as hemihydrate).

The grey tablets each contain 1mg of

estradiol (as hemihydrate) and 10 mg

of dydrogesterone.

Femoston 1/10 tablets also contain:

Lactose monohydrate

hypromellose

maize starch

colloidal anhydrous silica

magnesium stearate

The colour ingredients used in

Femoston 1/10 is Opadry OY-7000

white (for 1 mg estradiol tablet only)

and Opadry II Grey 85F27664 (for

combination tablet with 1 mg

estradiol and 10 mg dydrogesterone).

Supplier

Femoston is made in the Netherlands

Femoston is supplied in Australia by:

Mylan Health Pty Ltd

Level 1, 30 The Bond

30-34 Hickson Road

Millers Point NSW 2000

Phone: 1800 314 527

® Registered Trademark

This leaflet was prepared on

02 August 2017

Australian Registration Number(s)

AUST R 219882

FEMOSTON

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