ESTROFEM estradiol (as hemihydrate) 2mg tablet dial dispenser pack

Main information

  • Trade name:
  • ESTROFEM estradiol (as hemihydrate) 2mg tablet dial dispenser pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ESTROFEM estradiol (as hemihydrate) 2mg tablet dial dispenser pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 188521
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

188521

ESTROFEM estradiol (as hemihydrate) 2mg tablet dial dispenser pack

ARTG entry for

Medicine Registered

Sponsor

Novo Nordisk Pharmaceuticals Pty Ltd

Postal Address

PO Box 7586,BAULKHAM HILLS, NSW, 2153

Australia

ARTG Start Date

17/11/2011

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. ESTROFEM estradiol (as hemihydrate) 2mg tablet dial dispenser pack

Product Type

Single Medicine Product

Effective date

27/09/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Short term symptomatic treatment of oestrogen deficiency due to natural or surgical menopause in hysterectomised postmenopausal women. In women

with intact uteri, use of opposed therapy must be considered.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Dial Dispenser Pack

Not recorded

4 Years

Store below 25

degrees Celsius

Not recorded

Do not Refrigerate

Store in a Dry Place

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

28 tablets

(S4) Prescription Only Medicine

Components

1. Medicine Component

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

blue tablets, 6 millimetres in diameter, stamped with 'Novo 280'

Active Ingredients

estradiol hemihydrate

2.07 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 1 of

Produced at 29.11.2017 at 01:13:33 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: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Estrofem

tablets

Page 1 of 6

Estcmi8.docx

Estrofem

®

1 mg tablets

Estrofem

®

2 mg tablets

Estradiol

Consumer Medicine Information

What is in this leaflet

What Estrofem

®

is used for ........ 1

Before you take Estrofem

®

......... 1

How to take Estrofem

®

................ 4

While you are taking Estrofem

®

4

Side effects .................................... 4

Storage .......................................... 5

Product Description .................... 5

User instructions .......................... 6

This leaflet answers some common

questions about Estrofem

. It does

contain

available

information.

does

take

place of talking to your doctor or

pharmacist.

medicines

have

risks

benefits. Your doctor has weighed

the risks of you using Estrofem

against the benefits they expect it

will have for you.

Ask your doctor or pharmacist if

you

have

any

concerns

about

using this medicine.

Keep

this

leaflet

with

the

medicine.

You may need to read it again.

Estrofem

available

only

prescription at pharmacies.

What Estrofem

®

is

used for

Estrofem

hormone

replacement therapy (HRT) that is

used for the short-term symptomatic

treatment of women who have had

their

womb

surgically

removed

(which is called hysterectomy) and

who have signs and symptoms of

estrogen deficiency.

A woman’s last menstrual period is

called the menopause and usually

occurs between the ages of 45 and

55 years. Around the time of the

menopause, the body slowly stops

producing

hormones

called

estrogen

progesterone.

Periods become irregular until they

finally stop.

If a woman has surgical or natural

menopause the production of these

hormones is diminished or stopped.

Estrofem

replaces

hormone

called

estrogen

which

your

body

stops

making

after

surgical

natural menopause.

falling

reduced

hormone

levels may cause you to experience

uncomfortable

symptoms

such

flushes,

night

sweats,

sleeplessness,

vagina,

urinary

problems, headaches, mood swings,

lack

concentration

loss

energy.

The estrogen in Estrofem

relieves

the symptoms caused by a lack of

estrogen.

If you have not had a hysterectomy

your doctor may prescribe another

medicine

progesterone

type

medicine called a ‘progestagen’) to

be taken with Estrofem

for 10-14

days of your 28 day cycle. It is very

important to take both medications

exactly

your

doctor

prescribed.

If you have any questions about

the

combination

of

the

two

medicines

please

talk

to

your

doctor.

Your doctor may have prescribed

Estrofem

®

for

another

reason.

Ask your doctor if you have any

questions

about

why

Estrofem

®

has been prescribed for you.

Before you take

Estrofem

®

When you must not take it

Do not take Estrofem

®

if:

you are pregnant or suspect you

may be pregnant, or you are

breast-feeding

you know or suspect you have,

have

had,

tumour

which

depends

hormones

(e.g. cancer of the breast or the

lining of the womb)

you know or suspect you have,

or you have had, breast cancer

have

recently

developed

liver

disease;

have

history of liver disease where

your blood test results have not

returned to normal

have

porphyria

rare

disease of blood pigments)

have

unexplained

vaginal bleeding

you have excessive thickening

womb

lining

(endometrial

hyperplasia)

that

is not being treated

you know that you are allergic

ingredients

Estrofem

you have or ever had any kind

of blood clots

have

blood

clotting

disorder

(such

protein

protein

antithrombin

deficiency)

you have pain in your calf and

your leg is swelling

after

expiry

date

(‘Expiry’) printed on the pack

the packaging is torn or shows

signs of tampering

Estrofem

tablets

Page 2 of 6

Estcmi8.docx

Before you start to take it

Medical check-ups

Before you start taking HRT, your

doctor should ask about your own

and your family’s medical history.

Your doctor may decide to examine

your breasts and/or your abdomen,

and may do an internal examination

— but only if these examinations

are necessary for you, or if you have

any special concerns.

Once you’ve started on HRT, you

should see your doctor for regular

check-ups (at least once a year). At

these check-ups, your doctor may

discuss with you the benefits and

risks of continuing to take HRT.

Be sure to:

go for regular breast screening

and pap smear tests

regularly check your breasts for

any changes such as dimpling

skin,

changes

nipple, or any lumps you can

see or feel

There is only limited experience of

treating women older than 65 years

with Estrofem

Tell your doctor if:

have

hysterectomy, because another

medicine may be more suitable

for you

have

previously

taken

estrogen

itself

menopausal

symptoms

have not had a hysterectomy.

The long-term use of estrogen

without

progesterone

increase the risk of cancer of

the lining of the womb

you have a family history of

blood clots

you are to be hospitalised or

undergoing

surgery,

particularly where you are or

will be off your feet for a long

time.

need

stop

taking Estrofem

4 to 6 weeks

before

your

operation,

reduce the risk of a blood clot

have

intolerance

some

specific

sugars

e.g.

lactose (found in milk and milk

products).

Estrofem

tablets

contain lactose

Tell your doctor if you have or

have had any medical conditions,

especially the following:

fibroids

womb

endometriosis and you have not

hysterectomy.

Fibroids

increase

size

while

taking

Estrofem

symptoms

endometriosis

may worsen

a history of excessive growth of

the cells which line the womb

family

history

hormone-

dependent cancer e.g. cancer of

the breast or of the lining of

the womb

increased

risk

developing

blood clots (see

Blood clots in

a vein (thrombosis)

high blood pressure

inflammation

pancreas

due to high levels of blood fats

(triglycerides)

systemic

lupus

erythematosus

(SLE)

epilepsy,

migraine,

severe

headache

diabetes

asthma

gallstones

liver

disorder,

such

benign liver tumour

heart disease

kidney disease

fluid retention (oedema)

otosclerosis

(hearing

loss

sometimes linked to pregnancy)

This is because you will need to be

seen regularly by your doctor while

you are taking Estrofem

HRT and cancer

Excessive thickening of the lining of

the womb (endometrial hyperplasia)

and

cancer

of

the

lining

of

the

womb (endometrial cancer)

Taking

estrogen-only

will

increase

risk

excessive

thickening

lining

womb

(endometrial

hyperplasia)

cancer

womb

lining

(endometrial cancer).

Taking a progestagen in addition to

the estrogen for at least 10 days of

each 28 day cycle protects you from

this extra risk. So your doctor will

prescribe a progestagen separately if

you still have your womb. If you

have had your womb removed (a

hysterectomy),

discuss

with

your

doctor whether you can safely take

this product without a progestagen.

Compare

In women who still have a womb

and who are not taking HRT, on

average,

1,000

will

diagnosed with endometrial cancer

between the ages of 50 and 65.

For women aged 50 to 65 who still

have

womb

take

estrogen-only HRT, between 10 and

women

1,000

will

diagnosed with endometrial cancer

(i.e. between 5 and 55 extra cases),

depending on the dose and for how

long it is taken.

Unexpected bleeding

You will have a bleed once a month

(so-called withdrawal bleed) while

taking Estrofem

See

your

doctor

as

soon

as

possible

if

you

have

not

had

a

hysterectomy

and

you

have

unexpected bleeding or drops of

blood

(spotting)

besides

your

monthly bleeding, which:

carries on for more than the

first 6 months, or

starts

after

have

been

taking Estrofem

more than 6

months, or

carries

after

have

stopped taking Estrofem

Breast cancer

Evidence

suggests

that

taking

combined estrogen-progestagen and

possibly

also

estrogen-only

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,

returns

normal

within a few years (at most 5) after

stopping treatment.

women

have

their

womb removed and who are using

estrogen-only

years,

little or no increase in breast cancer

risk is shown.

Compare

Women aged 50 to 79 who are not

taking HRT, on average, 9 to 17 in

1,000 will be diagnosed with breast

cancer

over

5-year

period.

women

aged

taking

estrogen-progestagen

over 5 years, there will be 13 to 23

Estrofem

tablets

Page 3 of 6

Estcmi8.docx

cases in 1,000 users (i.e. 4 to 6 extra

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,

advised

join

mammography

screening

programs when offered to you. For

mammogram

screening,

important

that

inform

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

breast

increased,

mammography may not detect all

lumps.

Ovarian cancer

Ovarian cancer is rare - much rarer

than

breast

cancer.

estrogen-only

combined

estrogen-progestagen 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 2,000 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 2,000 users (i.e. about 1 extra

case).

Effect

heart

circulation

Blood clots in a vein (thrombosis)

The risk of

blood clots in the veins

is about 1.3- to 3-times higher in

users

than

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

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

medicine

used

prevent

blood clots

if any of your close relatives

has ever had a blood clot in

leg,

lung

another

organ

have

systemic

lupus

erythematosus (SLE)

you have cancer.

For signs of a blood clot, see ‘

When

you must not take it

’.

Compare

Looking at women in their 50s who

taking

HRT,

average,

over a 5-year period, 4 to 7 in 1,000

would be expected to get a blood

clot in a vein.

For women in their 50s who have

been

taking

estrogen-progestagen

HRT for over 5 years, there will be

9 to 12 cases in 1,000 users (i.e. 5

extra cases).

For women in their 50s who have

had their womb removed and have

been taking estrogen-only HRT for

over 5 years, there will be 5 to 8

cases in 1,000 users (i.e. 1 extra

case).

Heart disease (heart attack)

There is no evidence that HRT will

prevent a heart attack.

Women over the age of 60 years

who use estrogen-progestagen HRT

are slightly more likely to develop

heart disease than those not taking

any HRT.

women

have

their

womb

removed

taking

estrogen-only

therapy

there

increased risk of developing a heart

disease.

Stroke

The risk of getting 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 1,000 would be expected to have

a stroke over a 5-year period. For

women in their 50s who are taking

HRT,

there

will

cases

1,000

users,

over

years

(i.e.

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.

Talk to your doctor for advice.

Tell your doctor immediately if

any

of

the

following

conditions

occur (because you may be told to

stop taking Estrofem

®

):

yellowing of your skin or eyes,

worsening

your

liver

function

significant

increase

your

blood pressure

migraine-like

headache,

have

previously

migraines

sudden development of visual

problems

pregnancy

or if you experience any of the

conditions

listed

above

under

‘When you must not take it’

If you have not told your doctor

about any of the above, tell them

before you take Estrofem

®

.

Estrofem

should only be used to

treat symptoms of the menopause

that adversely affect your quality of

life.

Review the risks and benefits of

continued

treatment

with

Estrofem

®

at

least

once

a

year

with your doctor.

Taking other medicines

Tell your doctor if you are taking

or plan to take other medicines,

including:

some

medicines

help

sleep, including barbiturates

some

medicines

epilepsy

e.g.

phenytoin

carbamazepine

Estrofem

tablets

Page 4 of 6

Estcmi8.docx

some antibiotics and other anti-

infective

medicines

e.g.

rifampicin,

rifabutin,

nevirapine, efavirenz

some

anti-infectives

such

ritonavir and nelfinavir, when

used at the same time as steroid

hormones

St. John’s Wort – used to treat

depression

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 shop.

effect

Estrofem

reduced

other

medicines,

affect

your

vaginal

bleeding

pattern.

How to take

Estrofem

®

How to take it

Read

carefully

the

instructions

included in this leaflet, in order to

correctly use the calendar pack.

Take one tablet a day, preferably

at the same time each day, until

all

28

tablets

have

been

taken.

Swallow each tablet with a glass

of water. When you have finished

each

pack,

start

the

next

pack

immediately.

If you are not on any other hormone

replacement therapy and you have

had a hysterectomy you can start

taking Estrofem

on any day that is

convenient.

still

experiencing

bleeds,

should

start using Estrofem

on day 5.

Estrofem

should not be taken by

children, men, during pregnancy or

while breast-feeding.

Duration of therapy:

HRT should be prescribed at the

lowest effective dose and for the

shortest

duration

necessary

(see

‘Before you start to take it’). The

continuation of the treatment should

re-evaluated

annually.

Women

who have undergone a premature

menopause (e.g. hysterectomy) may

require longer term treatment.

If you forget to take it

If you forget to take your tablet at

the usual time, take it within the

next 12 hours. If more than 12

hours

have

gone

by,

skip

the

missed

dose

and

start

again

as

normal the next day. Do not take

a double dose to make up for a

forgotten tablet. Forgetting a dose

may

increase

the

likelihood

of

breakthrough

bleeding

and

spotting

if

you

still

have

your

womb.

If you take too much

(overdose)

If you take more tablets than you

have

been

prescribed,

contact

your doctor for advice.

Overdose

cause

nausea

vomiting.

If you need to have surgery

If you are going to have surgery,

tell

the

surgeon

that

you

are

taking Estrofem

®

.

need

stop

taking

Estrofem

about

weeks

before the operation to reduce the

risk of a blood clot (see ‘

Blood clots

in a vein

’).

Ask your doctor when you can

start taking Estrofem

®

again.

While you are taking

Estrofem

®

You can expect your symptoms to

improve

within

months

starting Estrofem

If you get breakthrough bleeding or

spotting,

usually

nothing

worry about, especially during the

first few months of taking HRT (see

also ‘

Before you start to take it

Unexpected

bleeding

more

information).

Estrofem

can be stopped at any

time. You should discuss this with

your doctor.

Estrofem

contraceptive

will

prevent

pregnancy.

Estrofem

is only recommended for

women

have

signs

symptoms

estrogen

deficiency

surgical

natural

menopause

have

hysterectomy

performed.

After

hysterectomy

cannot

pregnant.

your

routine

check-up,

your

doctor may reassess your continued

need

Estrofem

Alternative

treatment

given

troublesome symptoms remain.

If you have any concerns about

taking

Estrofem

®

,

ask

your

doctor

or

pharmacist.

If

your

doctor

tells

you

to

stop

taking

Estrofem

®

,

return

any

unused

medicine to your pharmacist.

Things you must not do

This medicine is for you only. Do

not give it to someone else even if

they

seem

to

have

the

same

symptoms as you.

Do not take Estrofem

®

to treat

any other complaints unless your

doctor tells you to.

Do not change the way you take

Estrofem

®

, or lower the dosage,

without

checking

with

your

doctor.

Side effects

All medicines can have side effects.

Sometimes they are serious, most of

the time they are not.

Tell your doctor or pharmacist if

you

experience

any

side

effects

while you are taking Estrofem

®

(whether

or

not

they

are

mentioned below).

You may need medical treatment if

experience

some

side

effects.

When

start

taking

Estrofem

your

body

adjust

hormone

levels.

experience

following

side

effects:

abdominal

(stomach)

pain,

feeling sick (nausea), vomiting,

diarrhoea, bloating, flatulence,

indigestion

skin

rash

itching,

skin

reactions,

changes

hair

growth

headache,

migraine,

epilepsy,

dizziness

changes

libido,

problems

getting to sleep

breast tenderness, enlargement

or pain

Estrofem

tablets

Page 5 of 6

Estcmi8.docx

asthma, or worsening of asthma

gall bladder problems

leg cramps

weight increase

fluid retention (oedema)

fungal infection of the vagina

(thrush)

These

side

effects

usually

temporary and disappear.

Tell your doctor if:

you think you may be suffering

from depression

you are not feeling well or find

side

effect

uncomfortable or unacceptable

any side effect becomes worse

have

hysterectomy

vaginal

bleeding or spotting suddenly

becomes heavier

Tell your doctor immediately if

any

of

the

following

conditions

occur (because you may be told to

stop taking Estrofem

®

):

pain in your calf and your leg is

swelling

any kind of blood clots

yellow

colouring

skin

and eyes (jaundice)

migraine

sudden

severe

headache,

have

previously had migraines

problems

with

your

eyesight

which develop suddenly

marked rise in blood pressure

have

hysterectomy

vaginal

bleeding or spotting occurring

after you have been period-free

for some time

you can see or feel a lump in

your

breast,

notice

dimpling of the skin or changes

in the nipple

you know or suspect you are

pregnant

Tell your doctor immediately or

go to Accident and Emergency at

your nearest hospital if you notice

any of the following

skin rashes over a large part of

the body

shortness of breath, wheezing

swelling

face,

lips

tongue

fast pulse

sweating

This list includes very serious side

effects.

need

urgent

medical attention or hospitalisation.

These side effects are very rare.

addition

possible

side

effects listed above, ovarian cancer,

heart disease, stroke and dementia

have been reported with HRT.

Do not be alarmed by these lists

of possible side effects.

experience

them.

Storage

Keep all medicines out of reach of

children.

Do not use Estrofem

®

after the

expiry date stated on the carton

and label.

The expiry date refers to the last

day of that month.

Keep

Estrofem

®

in

a

cool

dry

dark place where the temperature

stays

below

25

o

C.

Do

not

put

Estrofem

®

in the refrigerator.

Do not dispose of medicines down

the

sink

or

in

your

household

rubbish. Ask you pharmacist how

to

dispose

of

medicines

you

no

longer require.

These

measures

will

help

preserve the environment.

Product Description

What Estrofem

®

looks like

Estrofem

comes in a calendar dial

pack.

Each

pack

holds

round

tablets.

Estrofem

tablets

red,

film-coated,

round,

biconvex,

marked ‘NOVO 282’ on one side.

Estrofem

2 mg tablets are blue,

film-coated,

round,

biconvex,

marked ‘NOVO 280’ on one side.

Ingredients

Each

Estrofem

tablet

contains

estradiol

hemihydrate)

active

ingredient

iron

oxide

CI77491

(E172)

colouring

agent.

Each

Estrofem

tablet

contains

estradiol

hemihydrate)

active

ingredient

indigo

carmine

CI73015

(E132)

colouring

agent.

Estradiol

identical

natural

human estrogen.

tablets

also

contain

lactose,

hyprolose,

maize

starch,

talc,

propylene glycol (red 1 mg tablets),

Macrogol 400 (blue 2 mg tablets),

magnesium

stearate,

hypromellose

and titanium dioxide (E171).

Estrofem

is gluten-free.

Manufacturer

Estrofem

is made in Denmark and

supplied in Australia by:

Novo Nordisk Pharmaceuticals Pty

Level 3

21 Solent Circuit

Baulkham Hills NSW 2153

This

leaflet

prepared

October 2016.

Australian Registration Numbers:

Estrofem

1 mg AUST R 188520

Estrofem

2 mg AUST R 188521

Estrofem

is a registered trademark

of Novo Nordisk Healthcare AG.

NovoCare

registered

trademark of Novo Nordisk A/S.

© 2016

Novo Nordisk A/S

further

information

call

NovoCare

Customer Care Centre

on 1800 668 626.

www.novonordisk.com.au

Estrofem

tablets

Page 6 of 6

Estcmi8.docx

Estrofem

®

Estradiol

User instructions

How to use the calendar pack

1. Set the day reminder

Turn the inner disc to set the day of the

week opposite the little plastic tab.

2. Take the first day’s tablet

Break the plastic tab and tip out the first

tablet.

.

3. Move the dial every day

On the next day, simply move the

transparent dial clockwise 1 space as

indicated by the arrow. Tip out the

next tablet. Remember to take only 1

tablet once a day.

You can only turn the transparent

dial after the tablet in the opening

has been removed.