ESTALIS SEQUI 50/250 patches sachet composite pack

Australia - English - Department of Health (Therapeutic Goods Administration)

Buy It Now

Active ingredient:
estradiol,norethisterone acetate
Available from:
Novartis Pharmaceuticals Australia Pty Ltd
Authorization status:
Registered
Authorization number:
338042

Read the complete document

Estalis

®

Sequi

estradiol / norethisterone acetate (NETA)

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about the menopause (the

"change of life"), hormone

replacement therapy and Estalis

Sequi.

It does not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

The information in this leaflet was

last updated on the date listed on the

final page. More recent information

on the medicine may be available.

You should ensure that you speak

to your pharmacist or doctor to

obtain the most up to date

information on the medicine. You

can also download the most up to

date leaflet from

www.novartis.com.au.

Those updates may contain important

information about the medicine and

its use of which you should be aware.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you using this medicine

against the benefits they expect it

will provide.

If you have any concerns about 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 Estalis Sequi

Do not use Estalis Sequi 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 other doses of conjugated

estrogens and MPA or other

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 Estalis Sequi.

Treatment with estrogens, with or

without progestogens should be used

at the lowest effective dose and for

the shortest period of time.

What Estalis Sequi is

used for

Estalis Sequi is a type of treatment

called hormone replacement therapy

(HRT). It is a combination pack

consisting of stick-on patches that

contain hormones. Estalis Sequi

Weeks 1 and 2 patches contain

estradiol. Estalis Sequi Weeks 3 and

4 patches contain estradiol plus

norethisterone acetate (NETA).

Estalis Sequi is used for the short-

term relief of symptoms of the

menopause. This medicine is used

only for women who still have a

uterus (womb).

HRT should not be used for the long-

term maintenance of general health

or to prevent heart disease or

dementia.

Estalis Sequi is not suitable for birth

control and it will not restore

fertility.

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.

NETA is a hormone called a

progestogen. It has effects similar to

the female hormone, progesterone,

which your ovaries also produced

before the menopause.

The menopause occurs naturally in

the course of a woman's life, usually

between the ages of 45 and 55. After

menopause, your body produces

much less estrogen than it did before.

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 dryness of the vagina

causing discomfort during or after

sex. Estrogens can be given to reduce

or eliminate these symptoms.

After the age of 40, and especially

after the menopause, some women

ESTALIS

SEQUI

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. Exercise,

calcium and vitamin D can help

reduce the risk of osteoporosis.

Women who still have a uterus need

to take both estrogen and

progestogen as part of HRT. This is

because estrogen stimulates the

growth of the lining of the uterus

(called the endometrium). Before

menopause this lining is removed

during your period through the action

of a 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 NETA help to

protect the lining of the uterus from

developing this disorder.

Estalis Sequi patches release

estradiol and NETA in a continuous

and controlled way just as your

ovaries were doing before. Because

the medicine does not have to pass

through your stomach and liver, it

allows you to take a much lower dose

than would be needed in a tablet and

helps to avoid some unpleasant side

effects.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you.

Your doctor may have prescribed it

for another purpose.

This medicine is available only with

a doctor's prescription. It is not habit-

forming.

Before you use Estalis

Sequi

When you must not use it

Do not use Estalis Sequi if you

have an allergy to:

estradiol or NETA, the active

ingredients, or to any of the other

ingredients listed at the end of

this leaflet

any other medicine containing

estrogen or progestogen,

including the birth control pill

Some of the symptoms of an allergic

reaction may include shortness of

breath, wheezing or difficulty

breathing; swelling of the face, lips,

tongue or other parts of the body;

rash, itching or hives on the skin.

If you had a severe skin reaction in

the past, you could have a very

serious reaction if you use any type

of estrogen or progestogen (patch,

tablet, cream, etc.) again in the

future.

Do not use Estalis Sequi if you

have:

cancer of the breast or uterus

(womb) or any other estrogen

dependent cancer, or you have

had this condition in the past

blood clots in your blood vessels,

now or in the past. You may have

had painful inflammation of the

veins or blockage of a blood

vessel in the legs, lungs, brain or

heart

a condition that increases the

tendency for you to get blood

clots

endometriosis (a disorder of the

uterus that may cause painful

periods and abnormal bleeding)

abnormal vaginal bleeding that

has not been investigated

severe liver problems

a condition called porphyria

a tumour of the pituitary gland or

hypothalamus

a disease of the connective tissue

hearing loss due to a problem

with the bones in the ear called

otosclerosis

If you are not sure whether any of the

above conditions apply to you, your

doctor can advise you.

Do not use Estalis Sequi if you are

pregnant or breast-feeding.

It may affect your baby.

Do not use this medicine after the

expiry date printed on the pack or

if the packaging is torn or shows

signs of tampering.

In that case, return it to your

pharmacist.

Before you start to use it

Tell your doctor if you have:

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)

had one or more pregnancies

where you lost the baby before

birth

high blood pressure

heart disease

kidney or liver problems

diabetes

epilepsy

migraine or other severe

headaches

gall bladder disease

asthma

a high level of triglycerides in the

blood

a disorder called systemic lupus

erythematosus (SLE)

a condition called hypothyroidism

(your thyroid gland fails to

produce enough thyroid hormone)

a bone disease causing high

calcium levels in the blood

very low calcium levels in the

blood

had a problem in the past with

jaundice (a liver problem) or

itching skin when you took an

estrogen (e.g. the birth control pill

or HRT)

a skin condition that could be

made worse by applying a patch

severe allergic reactions

a condition called hereditary

angioedema or if you have had

episodes of rapid swelling of the

hands, feet, face, lips, eyes,

tongue, throat (airway blockage)

or digestive tract

ESTALIS

SEQUI

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)

Taking other medicines

Tell your doctor if you are taking

birth control pills.

Estalis Sequi is not a contraceptive.

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.

Tell your doctor or pharmacist if

you are taking any other

medicines, including medicines

that you buy without a

prescription from a pharmacy,

supermarket or health food shop.

Some medicines and Estalis Sequi

may interfere with each other. These

include:

herbal medicines containing St.

John's wort

some medicines to help you

sleep, including barbiturates and

meprobamate

some medicines for epilepsy,

including phenytoin and

carbamazepine

phenylbutazone, a medicine for

pain and inflammation

some antibiotics and other anti-

infective medicines, including

rifampicin, ketoconazole,

erythromycin, rifabutin,

nevirapine, efavirenz, ritonavir

and nelfinavir

You may need to take different

amounts of your medicines or to take

different medicines while you are

using Estalis Sequi. Your doctor and

pharmacist have more information.

Tell your doctor that you are on

treatment with Estalis Sequi if you

are going to have laboratory tests.

Some laboratory tests, such as tests

for glucose tolerance or thyroid

function, may be affected by Estalis

Sequi therapy.

If you have not told your doctor

about any of these things, tell him/

her before you start using this

medicine.

How to use Estalis

Sequi

Follow all directions given to you

by your doctor and pharmacist

carefully.

These instructions may differ from

the information contained in this

leaflet.

If you do not understand the

instructions on the label, ask your

doctor or pharmacist for help.

When to start it

If you are not already using HRT,

you can start Estalis Sequi at a

convenient time for you. If you are

already using a different type of

HRT, your doctor can advise you

when to switch to Estalis Sequi.

How much to use

The patches come in two strengths.

You will usually start with the Estalis

Sequi 50/250 patch. Your doctor will

check your progress and may change

to the lower strength Estalis Sequi

50/140 patch.

How to use it

A leaflet in the carton contains

pictures and information on how to

apply the patch properly.

You will have a patch on all the time.

You will apply a new patch twice

weekly (every 3 or 4 days). There are

8 patches in the carton, enough for a

4-week cycle.

The patches for Weeks 1 and 2

contain estradiol and the patches for

Weeks 3 and 4 contain estradiol plus

NETA. It is important to use the

patches in the correct order (i.e.

Weeks 1 & 2 before Weeks 3 & 4).

Most women will have a period at

the end of each 4-week cycle. This is

quite normal. Regardless of whether

or not you have a period, you should

start the next pack of Estalis Sequi as

soon as you have finished the

previous one. If you have irregular or

heavy bleeding, tell your doctor.

How long to use it

If you want to continue using HRT

for longer than a few months,

discuss the possible risks and

benefits with your doctor.

You may have an increased risk of

developing breast cancer, heart

disease, stroke, blood clots on the

lungs and dementia. On the other

hand, the risk of hip fractures and

bowel cancer may be reduced.

Women taking estrogens, alone or in

combination with progestogens, may

have a higher risk of ovarian cancer

that may appear within 5 years of use

and slowly diminishes over time after

discontinuation. Your doctor can

discuss these risks and benefits with

you, taking into account your

particular circumstances.

If you forget to use it

Apply a new patch as soon as you

remember, and then go back to

your usual schedule.

If you have trouble remembering

when to replace your patches, ask

your pharmacist for some hints.

If you use too much

(Overdose)

Immediately telephone your doctor

or Poisons Information Centre

(telephone 13 11 26) or go to

Accident and Emergency at your

nearest hospital, if you think that

an overdose has happened. Keep

ESTALIS

SEQUI

the telephone numbers for these

places handy.

Because of the way this medicine is

used, an intentional overdose is

unlikely. Swallowing a patch may

cause nausea and vomiting.

While you are using

Estalis Sequi

Things you must do

If you become pregnant while

using Estalis Sequi, tell your doctor

immediately.

It should not be used while you are

pregnant or if you want to become

pregnant.

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

check your uterus and cervix and

do a pap smear at regular

intervals

check 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.

Tell your doctor that you are using

Estalis Sequi 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 as a result of

an operation, serious injury or having

to stay in bed for a prolonged period.

If possible, this medicine should be

stopped at least 4 weeks before

surgery and it should not be restarted

until you are fully mobile.

If you are about to be started on

any new medicine, remind your

doctor and pharmacist that you

are using Estalis Sequi.

Tell any other doctor, dentist or

pharmacist who treats you that

you are using Estalis Sequi.

Things you must not do

Do not use this medicine to treat

any other complaints unless your

doctor tells you to.

Do not give it to anyone else, even

if their symptoms seem similar to

yours.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are using Estalis

Sequi.

All medicines can have side effects.

Sometimes they are serious, most of

the time they are not. You may need

medical treatment if you get some of

the side effects.

Do not be alarmed by these lists 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 immediately or go

to Accident and Emergency at

your nearest hospital if you notice

any of the following:

signs of allergy such as rash,

itching or hives on the skin;

swelling of the face, lips, tongue ,

the area around the eyes or other

part of the body; rash, itching,

hives, breathlessness or difficult

breathing, wheezing or coughing,

light-headedness, dizziness,

changes in levels of

consciousness, hypotension, with

or without mild generalized

itching, skin reddening.

signs that blood clots may have

formed, such as sudden severe

headache, sudden loss of

coordination, blurred vision or

sudden loss of vision, slurred

speech, numbness or tingling in

an arm or leg, 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.

Tell your doctor if you notice any

of the following and they worry

you:

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

redness, irritation or itching under

the patch (signs of application site

reaction includes bleeding,

bruising, burning, discomfort,

dryness, skin boils, oedema,

erythema, inflammation,

irritation, pain, tiny solid skin

bumps, rash, skin discolouration,

skin pigmentation, swelling, hives

and blisters)

skin rash

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

back pain

change in sex drive

weight gain

acne, itchy or dry skin, skin

discolouration

tingling or numbness

ESTALIS

SEQUI

gallbladder disorder (tendency to

form gallstones)

fibroids (benign growths in the

uterus)

breast cancer

darkening of the skin particularly

on the face or abdomen

(chloasma)

abnormal tumour growth related

to estrogens, e.g. cancer of the

lining of the womb (endometrial

cancer)

contact lens discomfort

hair loss

inflammatory bowel disease

Tell your doctor if you notice

anything else that is making you

feel unwell.

Some people may have other side

effects not yet known or mentioned

in this leaflet. Some side effects can

only be found when laboratory tests

are done.

After using Estalis

Sequi

Storage

Keep your medicine in the

original container until it is time

to use it.

Store it in a cool dry place.

Do not store Estalis Sequi or any

other medicine in the bathroom or

near a sink.

Do not leave it in the car or on

window sills.

Keep the patches where young

children cannot reach them.

A locked cupboard at least one-and-

a-half metres above the ground is a

good place to store medicines.

Disposal

Fold used patches in half with the

sticky side inwards. Dispose of

them where children cannot reach

them.

Used patches still contain some

estradiol and NETA which could

harm a child.

If your doctor tells you to stop

using this medicine or the expiry

date has passed, ask your

pharmacist what to do with any

patches that are left over.

Product description

What it looks like

Estalis Sequi patches come in two

strengths: 50/140 and 50/250. They

are clear patches sealed in individual

pouches. Each carton contains eight

patches (four patches for Weeks 1

and 2 and four patches for Weeks 3

and 4).

The patch is made up of three layers:

a waterproof backing

a sticky layer containing the

active ingredients

a protective liner (to be removed

before use)

Ingredients

Estalis Sequi Weeks 1 and 2 patches

release approximately 50 micrograms

of estradiol in 24 hours. The

following inactive ingredients are

also used to make the patch:

silicone and acrylic based

synthetic adhesives to make the

patch stick

dipropylene glycol

oleyl alcohol

povidone

Dow BLF 2550 non-removable

backing layer

Scotchpak 1022 removable

release liner

Estalis Sequi Weeks 3 and 4 patches

release approximately 50 micrograms

of estradiol and 140 or 250

micrograms of NETA in 24 hours.

The following inactive ingredients

are also used to make the patch:

silicone and acrylic adhesives to

make the patch stick

povidone

oleic acid

dipropylene glycol

Sponsor

Estalis Sequi is supplied in Australia

NOVARTIS Pharmaceuticals

Australia Pty Limited

ABN 18 004 244 160

54 Waterloo Road

Macquarie Park NSW 2113

Telephone: 1 800 671 203

Web site: www.novartis.com.au

= Registered Trademark

This leaflet was prepared in October

2020.

Australian Registration Number.

Estalis Sequi 50/140 AUST R

338041

Estalis Sequi 50/250 AUST R

338042

(elq091020c.doc) based on PI

(elq091020i.doc)

ESTALIS

SEQUI

Read the complete document

AUSTRALIAN PRODUCT INFORMATION

ESTALIS® SEQUI

Transdermal Matrix Patch combination pack

WARNING

Estrogens and progestogens should not be used for the prevention of cardiovascular disease or

dementia.

The Women’s Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke,

invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to

79 years of age) during 5 years of treatment with conjugated estrogens (0.625 mg) combined with

medroxyprogesterone acetate (2.5 mg) relative to placebo (See Section 5.1 PHARMACODYNAMIC

PROPERTIES Clinical Trials and Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR

USE).

The WHI study reported increased risks of stroke and deep vein thrombosis in postmenopausal

women (50 to 79 years of age) during 6.8 years of treatment with conjugated estrogens (0.625 mg)

relative to placebo (See Section 5.1 PHARMACODYNAMIC PROPERTIES Clinical Trials and

Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE).

The Women’s Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk

of developing probable dementia in postmenopausal women 65 years of age or older during 4 to 5.2

years of treatment with conjugated estrogens, with or without medroxyprogesterone acetate, relative

to placebo. It is unknown whether this finding applies to younger postmenopausal women (See

Section 5.1 PHARMACODYNAMIC PROPERTIES Clinical Trials and Section 4.4 SPECIAL

WARNINGS AND PRECAUTIONS FOR USE).

Other doses of conjugated estrogens and medroxyprogesterone acetate, and other combinations and

dosage forms of estrogens and progestogens were not studied in the WHI clinical trials and, in the

absence of comparable data, these risks should be assumed to be similar. Because of these risks,

estrogens with or without progestogens should be prescribed at the lowest effective doses and for the

shortest duration consistent with treatment goals and risks for the individual woman.

1

NAME OF THE MEDICINE

Estalis Sequi Week 1 and 2 (estradiol)

Estalis Sequi Week 3 and 4 (estradiol and norethisterone acetate)

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

Estalis Sequi is a combination pack consisting of two matrix transdermal drug delivery systems

(patches). Estalis Sequi Week 1 and 2 contains estradiolestradiol and Estalis Sequi Week 3 and 4

contains estradiolestradiol and norethisterone acetate (NETA).

One strength of Estalis Sequi Week 1 and 2 matrix patches and two strengths of Estalis Sequi Week 3

and 4 matrix patches are available, providing the following release rates of estradiol and

norethisterone acetate during 3.5 to 4 days.

Nominal Release rate (µg/day)

Estradiol/NETA**

Estradiol

content

(mg)*

NETA

content (mg)

Surface area

(cm

2

)

Shape

Estalis Sequi Week 1 and 2 50/0

0.78

Rounded

Rectangle

Estalis Sequi Week 3 and 4 50/140

0.62

Round

Estalis Sequi Week 3 and 4 50/250

0.512

Round

* 1 mg estradiol hemihydrate Ph. Eur. is equivalent to 0.968 mg of estradiol.

** NETA = norethisterone acetate

For the full list of excipients, see Section 6.1 List of excipients.

3

PHARMACEUTICAL FORM

Transdermal drug delivery system.

Estalis Sequi (Week 1 and 2): Rectangular patch with round corners, comprising an adhesive layer

with a translucent polymeric backing on one side and a release liner on the other side.

Estalis Sequi 50/140 (Week 3 and 4): Off-white translucent patch with a removable pre-cut liner: 9

round patch.

Estalis 50/250 Sequi (Week 3 and 4): Off-white translucent patch with a removable pre-cut liner: 16

round patch.

4

CLINICAL PARTICULARS

4.1

T

HERAPEUTIC INDICATIONS

For the short-term treatment of symptoms of estrogen deficiency in menopausal women who have an

intact uterus.

Combination HRT should not be used in hysterectomised women because it is not needed in these

women and it may increase the risk of breast cancer.

4.2

D

OSE AND METHOD OF ADMINISTRATION

One treatment cycle of Estalis Sequi consists of 4 matrix patches of Estalis Sequi Week 1 and 2

followed by 4 matrix patches of Estalis Sequi Week 3 and 4. Therapy is started with Estalis Sequi

Week 1 and 2 (50 µg/day) matrix patch. The next treatment cycle should be started immediately after

the removal of the last Estalis Sequi Week 3 and 4 (50/250 or 50/140 µg/day) matrix patch.

Initiation of therapy:

The treatment cycle may be initiated for women who are not currently on any estrogen therapy. For

most menopausal women, therapy may be commenced at any convenient time.

Women currently using estrogen or estrogen/progestogen therapy should complete the current cycle

of therapeutic regimen before initiating Estalis Sequi (Estalis Sequi Week 1 and 2 and Estalis Sequi

Week 3 and 4). At the completion of a cycle of therapy, women often experience withdrawal

bleeding. The first day of this bleeding would be an appropriate time to begin a new treatment cycle

with Estalis Sequi therapy.

Estalis Sequi 50/140 and 50/250 can not be considered to be bioequivalent to other combination

hormone patches.

The mainstays for decreasing the risk of postmenopausal osteoporosis are weight-bearing exercise,

adequate calcium and vitamin D intake, and when indicated, pharmacological therapy.

Postmenopausal women require an adequate daily intake of elemental calcium. Therefore when not

contraindicated, calcium supplementation may be helpful for women with sub-optimal dietary intake.

Vitamin D supplementation may also be required to ensure adequate daily intake in postmenopausal

women.

Therapeutic regimen:

Estalis Sequi Week 1 and 2 matrix patch is applied to the skin (see "Method of application")

every 3

to 4 days

for the first 14 days of a 28-day cycle, followed by the application of Estalis Sequi Week 3

and 4 50/250 µg/day matrix patch to the skin every 3 to 4 days for the remaining 14 days of the 28-

day cycle. The Estalis Sequi Week 3 and 4 dose may be decreased to 50/140 µg/day if progestogen-

related side effects occur.

For all therapeutic indications, the lowest effective dose should be used and consideration should be

given to the shortest duration of use. A careful appraisal of the risks and benefits should be

undertaken over time in women treated with HRT and the need for treatment re-evaluated

periodically. Treatment should only be continued for as long as the benefits outweigh the risks for the

individual (see Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE).

Women should be advised that monthly bleeding will usually occur.

Method of application:

Care should be exercised when applying Estalis Sequi Week 1 and 2 or Estalis Sequi Week 3 and 4.

The matrix patch should be placed on an area of clean, dry skin which is not irritated, abraded or oily

(i.e. should not be used with any moisturising cream, lotion or oil).

Site of application:

The matrix patch should be applied to a smooth (fold-free) hair free area of the skin on the buttocks or

abdomen. The waistline should be avoided, since tight clothing may rub the matrix patch off.

Estalis

Sequi Week 1 and 2 or Estalis Sequi Week 3 and 4 must never be applied to or near the breasts.

The matrix patch should be replaced every 3 to 4 days. The sites of application should be rotated with

an interval of at least one week allowed between applications to a particular site.

Application:

After opening the sachet, remove one half of the protective liner, taking care not to touch the adhesive

part of the sachet with the fingers. Apply the matrix patch to the skin immediately. Remove the

second half of the protective liner and press the matrix patch firmly to the skin with the palm of the

hand for at least 10 seconds, carefully smoothing down the edges. Once in place, the matrix patch

should not be exposed to the sun for prolonged periods of time.

Dislodged patches:

Care should be taken during bathing or other activities so that the matrix patch does not become

dislodged. If the matrix patch falls off (after strenuous physical activity, excessive sweating or friction

from tight clothing), the same matrix patch may be reapplied to another area. If necessary, a new

matrix patch may be applied, in which case the original treatment schedule should be followed.

Removal and disposal:

The removal of the matrix patch should be done carefully and slowly to avoid irritation of the skin.

Should any adhesive remain on the skin after removal of the matrix patch, allow the area to dry for 15

minutes, then gently rubbing the area with an oil-based cream or lotion should remove any adhesive

residue. Once used, Estalis Sequi matrix patches should be folded (adhesive surfaces pressed

together) and discarded.

4.3

C

ONTRAINDICATIONS

Estalis Sequi should not be used by women with any of the following conditions:

Known or suspected pregnancy

Breast-feeding

Known, past or suspected cancer of the breast

Known or suspected estrogen-dependent neoplasia, including cancer of the endometrium

Known or suspected pituitary or hypothalamic tumours

Undiagnosed abnormal vaginal bleeding

Severe hepatic impairment

Endometriosis

Connective tissue disease or otosclerosis

Active venous thromboembolism [VTE] (e.g. deep venous thrombosis, pulmonary embolism),

known thrombophilic or thromboembolic disorders (e.g. thrombophlebitis), arterial

thromboembolic disease (e.g. coronary heart disease, stroke), or a documented history of these

conditions

Porphyria

Hypersensitivity to estrogens and progestogens or to any of the components of this product.

(see Section 6.1 List of excipients)

4.4

S

PECIAL WARNINGS AND PRECAUTIONS FOR USE

The benefits and risks of estrogen / progestogen therapy must always be carefully weighed, including

consideration of the emergence of risks as therapy continues.

When initiating estrogen/progestogen therapy for the prevention of postmenopausal bone mineral

density loss in women, careful consideration should be given to the benefits versus the risks for the

individual. Potential alternative therapies should be considered if the risks outweigh the benefits.

Periodic re-evaluation of continuing treatment is recommended.

Cardiovascular disorders

Estrogen/Progestogen therapy should not be used for the prevention of cardiovascular disease.

Estrogen/progestogen therapy has been associated with an increased risk of cardiovascular events

such as myocardial infarction and stroke, as well as venous thrombosis and pulmonary embolism

(venous thromboembolism or VTE). Should any of these occur or be suspected, estrogen/progestogen

therapy should be discontinued immediately.

Risk factors for arterial vascular disease (e.g. hypertension, diabetes mellitus, tobacco use,

hypercholesterolaemia,and obesity) and/or venous thromboembolism (e.g. personal history or family

history of VTE, obesity and systemic lupus erythematosus) should be managed appropriately.

a.

Coronary heart disease and stroke

In the estrogen plus progestogen substudy of the Women’s Health Initiative (WHI) study, an

increased risk of coronary heart disease (CHD) events (defined as nonfatal myocardial infarction and

CHD death) was observed in women receiving CE + MPA compared to women receiving placebo (37

vs 30 per 10,000 women-years). The increase in risk was observed in year one and persisted. (See

Section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical Trials.)

In the same substudy of WHI, an increased risk of stroke was observed in women receiving

estrogen/progestogen compared to women receiving placebo (29 vs 21 per 10,000 women-years).

The increase in risk was observed after the first year and persisted.

In postmenopausal women with documented heart disease (n = 2,763, average age 66.7 years) a

controlled clinical trial of secondary prevention of cardiovascular disease (Heart and

Estrogen/progestogen Replacement Study; HERS) treatment with CE + MPA demonstrated no

cardiovascular benefit. During an average follow-up of 4.1 years, treatment with CE + MPA did not

reduce the overall rate of CHD events in postmenopausal women with established coronary heart

disease. There were more CHD events in the estrogen/ progestogen-treated group than in the placebo

group in year 1, but not during the subsequent years. Two thousand three hundred and twenty one

women from the original HERS trial agreed to participate in an open label extension of HERS, HERS

II. Average follow-up in HERS II was an additional 2.7 years, for a total of 6.8 years overall. Rates

of CHD events were comparable among women in the estrogen/progestogen-treated group and the

placebo group in HERS, HERS II, and overall.

b.

Venous thromboembolism (VTE)

In the estrogen plus progestogen substudy of WHI, a 2-fold greater rate of VTE, including deep

venous thrombosis and pulmonary embolism, was observed in women receiving CE + MPA

compared to women receiving placebo. The rate of VTE was 34 per 10,000 women-years in the

estrogen/progestogen-treated group compared to 16 per 10,000 women-years in the placebo group.

The increase in VTE risk was observed during the first year and persisted. (See Section 5.1

PHARMACODYNAMIC PROPERTIES, Clinical Trials.)

If feasible, estrogens should be discontinued at least 4 to 6 weeks before surgery of the type

associated with an increased risk of thromboembolism, or during periods of prolonged

immobilisation.

Generally recognised risk factors for VTE include a personal history (see Section 4.3

CONTRAINDICATIONS), a family history of thromboembolic disease (the occurrence of VTE in a

direct relative at a relatively early age may indicate genetic predisposition), severe obesity (Body

Mass Index > 30 kg/m

) and systemic lupus erythematosus (SLE). The risk of VTE also increases

with age. There is no consensus about the possible role of varicose veins in VTE.

A history of recurrent spontaneous abortions should be investigated to exclude thrombophilic

predisposition. In patients in whom this diagnosis is confirmed, the use of Estalis Sequi is

contraindicated.

Patients should be told to contact their doctor immediately if they become aware of a potential

thromboembolic symptom (e.g. painful swelling of a leg, sudden pain in the chest, dyspnoea).

If VTE develops after initiating hormone replacement therapy (HRT), the drug should be

discontinued.

Malignant neoplasms

a.

Breast cancer

The use of estrogens and progestogens by postmenopausal women has been reported to increase the

risk of breast cancer. The most important randomised clinical trial providing information about this

issue is the Women’s Health Initiative (WHI) trial of estrogen plus progestogen (See CLINICAL

TRIALS). The results from observational studies are generally consistent with those of the WHI

clinical trial.

After a mean follow-up of 5.6 years, the WHI trial reported an increased risk of breast cancer in

women who took estrogen plus progestogen. Observational studies have also reported an increased

risk for estrogen/progestogen combination therapy, and a smaller increased risk for estrogen alone

therapy, after several years of use. For both findings, the excess risk increased with duration of use,

and appeared to return to baseline over about five years after stopping treatment (only the

observational studies have substantial data on risk after stopping). In these studies, the risk of breast

cancer was greater, and became apparent earlier, with estrogen/progestogen combination therapy as

compared to estrogen alone therapy.

However, these studies have not found significant variation in the risk of breast cancer among

different estrogens or among different estrogen/progestogen combinations, doses, or routes of

administration.

In the WHI trial of estrogen plus progestogen, 26% of the women reported prior use of estrogen alone

and/or estrogen/progestogen combination hormone therapy. After a mean follow-up of 5.6 years

during the clinical trial, the overall relative risk of invasive breast cancer was 1.24 (95% confidence

interval 1.01-1.54), and the overall absolute risk was 41 vs. 33 cases per 10,000 women-years, for

estrogen plus progestogen compared with placebo. Among women who reported prior use of

hormone therapy, the relative risk of invasive breast cancer was 1.86, and the absolute risk was

46 vs. 25 cases per 10,000 women-years, for estrogen plus progestogen compared with placebo.

Among women who reported no prior use of hormone therapy, the relative risk of invasive breast

cancer was 1.09, and the absolute risk was 40 vs. 36 cases per 10,000 women-years for estrogen plus

progestogen compared with placebo. In the WHI trial, invasive breast cancers were larger and

diagnosed at a more advanced stage in the estrogen plus progestogen group compared with the

placebo group. Metastatic disease was rare with no apparent difference between the two groups.

Other prognostic factors such as histologic subtype, grade and hormone receptor status did not differ

between the groups.

The observational Million Women Study in Europe reported an increased risk of mortality due to

breast cancer among current users of estrogens alone or estrogens plus progestogens compared to

never users, while the estrogen plus progestogen sub-study of WHI showed no effect on breast cancer

mortality with a mean follow-up of 5.6 years.

The use of estrogen plus progestogen has been reported to result in an increase in abnormal

mammograms requiring further evaluation. All women should receive yearly breast examinations by

a healthcare provider and perform monthly breast self-examinations. Women should be advised that

changes in the breasts should be reported to their doctor and in addition, mammography examinations

should be scheduled based on patient age, risk factors, and prior mammogram results.

b.

Endometrial cancer

The reported endometrial cancer risk among unopposed estrogen users is about 2- to 12-fold greater

than in nonusers, and appears dependent on duration of treatment and on estrogen dose. Most studies

show no significant increased risk associated with the use of estrogens for less than one year. The

greatest risk appears associated with prolonged use, with increased risks of 15- to 24-fold for five to

ten years or more, and this risk has been shown to persist for at least 8 to 15 years after estrogen

therapy is discontinued.

Clinical surveillance of all women taking estrogen/progestogen combinations is important. Adequate

diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule

out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding or

spotting and the treatment should be re-evaluated. There is no evidence that the use of natural

estrogens results in a different endometrial risk profile than synthetic estrogens of equivalent estrogen

dose.

Dementia

In the Women’s Health Initiative Memory Study (WHIMS), an ancillary study of WHI, a population

of 4,532 women aged 65 to 79 years was randomised to CE + MPA or placebo.

A population of 2,947 hysterectomised women, aged 65 to 79 years, was randomised to CE

(0.625 mg) alone or placebo. In the planned analysis, pooling the events in women receiving CE

alone or CE + MPA in comparison to those in women on placebo, the overall relative risk (RR) for

probable dementia was 1.76 (95% CI 1.19-2.60). In the estrogen-alone group, after an average follow-

up of 5.2 years a RR of 1.49 (95% CI 0.83-2.66) for probable dementia was observed compared to

placebo. In the estrogen-plus-progestogen group, after an average follow-up of 4 years, a RR of 2.05

(95% CI 1.21-3.48) for probable dementia was observed compared to placebo. Since this study was

conducted in women aged 65 to 79 years, it is unknown whether these findings apply to younger

postmenopausal women. (See

Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR

S, Use in the elderly.)

Gallbladder disease

A 2- to 4-fold increase in the risk of gallbladder disease requiring surgery in postmenopausal women

receiving estrogens has been reported.

Hypercalcaemia

Estrogen administration may lead to severe hypercalcaemia in patients with breast cancer and bone

metastases. If hypercalcaemia occurs, use of the drug should be stopped and appropriate measures

taken to reduce the serum calcium level.

Visual abnormalities

Retinal vascular thrombosis has been reported in patients receiving estrogens. Discontinue medication

pending examination if there is sudden partial or complete loss of vision, or a sudden onset of

proptosis, diplopia, or migraine. If examination reveals papilledema or retinal vascular lesions,

estrogens should be discontinued.

General precautions

Addition of a progestogen when a woman has not had a hysterectomy.

Studies of the addition of a progestogen for 10 or more days of a cycle of estrogen administration, or

daily with estrogen in a continuous regimen, have reported a lowered incidence of endometrial

hyperplasia than would be induced by estrogen treatment alone. Endometrial hyperplasia may be a

precursor to endometrial cancer.

There are, however, possible risks that may be associated with the use of progestogens with estrogens

compared with estrogen-alone regimens. These include a possible increased risk of breast cancer and

impairment of glucose tolerance.

Hysterectomised women who require postmenopausal hormone theraoy should recieve estrogen-only

HRT unless otherwise indicated (e.g. endometriosis).

Elevated blood pressure

In a small number of case reports, substantial increases in blood pressure have been attributed to

idiosyncratic reactions to estrogens. In a large, randomised, placebo-controlled clinical trial, a

generalised effect of estrogen therapy on blood pressure was not seen. Blood pressure should be

monitored at regular intervals with estrogen use.

Hypertriglyceridaemia

In patients with pre-existing hypertriglyceridaemia, estrogen therapy may be associated with

elevations of plasma triglycerides leading to pancreatitis and other complications. These patients

should be monitored closely.

Impaired liver function and past history of cholestatic jaundice

Although transdermally administered estrogen therapy avoids first-pass metabolism, estrogens may be

poorly metabolised in patients with impaired liver function. For patients with a history of cholestatic

jaundice associated with past estrogen use or with pregnancy, caution should be exercised and in the

case of recurrence, medication should be discontinued.

Hypothyroidism

Estrogen administration leads to increased thyroid-binding globulin (TBG) levels. Patients with

normal thyroid function can compensate for the increased TBG by making more thyroid hormone,

thus maintaining free T

and T

serum concentrations in the normal range. Patients dependent on

thyroid hormone replacement therapy who are also receiving estrogens may require increased doses of

their thyroid replacement therapy. These patients should have their thyroid function monitored in

order to maintain their free thyroid hormone levels in an acceptable range.

Fluid retention

Because estrogens/progestogens may cause some degree of fluid retention, patients with conditions

that might be influenced by this factor, such as cardiac or renal dysfunction, warrant careful

observation when estrogens are prescribed.

Hypocalcaemia

Estrogens should be used with caution in individuals with severe hypocalcaemia.

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 estrogen-only or combined estrogen-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 use of combined HRTs may be associated

with a similar or slightly smaller risk (see Section 4.8 ADVERSE EFFECTS (UNDESIRABLE

EFFECTS).”

i. Severe anaphylactic/anaphylactoid reactions

Cases of anaphylactic/anaphylactoid reactions, which developed anytime during the course of

estradiol treatment and required emergency medical management, have been reported in the post

marketing setting. Involvement of skin (utricaria, pruritus, swelling of the faces throat, lips, tongue,

skin and periorbital edema) and either respiratory tract (respiratory compromise) or gastrointestinal

tract (abdominal pain, vomiting) has been noted.

j. Angioderma

Oestogens may induce or exacerbate symptoms of angioedema, in particular in women with

hereditary angioedema.

Exacerbation of endometriosis

Endometriosis may be exacerbated with administration of estrogen therapy.

Exacerbation of other conditions

Estrogen therapy may cause an exacerbation of asthma, diabetes mellitus, epilepsy, migraine or severe

headache, porphyria, systemic lupus erythematosus and hepatic haemangiomas and should be used

with caution in women with these conditions.

The patient should also be closely monitored if any of the following conditions are present or have

occurred previously (including during pregnancy or a previous hormone treatment): leiomyomas

(uterine fibroids) or endometriosis, thromboemolic disorders, hepatic disorders (e.g. liver adenoma),

heart failure, hypertension, renal disorders, diabetes mellitus with or without vascular involvement,

cholelithiasis, migraine or severe headache, systemic lupus erthematosus,

past endometriosis,

endometrial hyperplasia, epilepsy, asthma, otosclerosis, gallbladder disease, estrogen-related jaundice

and pruritus.

It should be taken into account that these conditions may recur or be aggravated during treatment with

estrogens. If worsening of any of the above conditions is diagnosed or suspected during HRT, the

benefits and risks of continuing HRT should be reassessed.

Caution is advised when rist factors or oetrogen-dependant tumours (e.g. first degree blood relatives

who have ever had breast cancer) are present.

Treatment with HRT should be stopped

in the following situations: an increase in epileptic seizures,

jaundice or deterioration in liver function, a significant increase in blood pressure, new onset of

migraine type headache, pregnancy or if a condition described under Section 4.3

CONTRAINDICATIONS develops.

Contact sensitisation

Contact sensitisation is known to occur with all topical applications. Although contact

sensitisation to any component of the patch is extremely rare, patients who develop it should be

warned that a severe hypersensitivity reaction may occur with subsequent exposure to the

causative agent.

Patient monitoring

A complete medical and family history should be taken prior to the initiation or reinstatement of any

estrogen or estrogen/progestogen therapy. The pretreatment and periodic physical examinations

should include special reference to breasts and pelvic organs and should include a Papanicolaou

smear. As a general rule, HRT should not be prescribed for longer than 1 year without another

physical examination being performed.

During treatment, periodic check-ups of a nature and frequency adapted to the individual woman are

recommended. A careful appraisal of the risks and benefits should be undertaken over time in women

treated with HRT, and the need for HRT re-evaluated periodically

Regular examination of the breasts is desirable. Women should be advised that changes in their

breasts should be reported to their doctor or nurse. Investigations, including mammography, should

be carried out in accordance with currently accepted screening practices and adapted to the clinical

needs of the individual woman.

In all cases of undiagnosed persistent or irregular vaginal bleeding or spotting, adequate diagnostic

measures, including endometrial sampling when indicated, should be undertaken to rule out

abnormality and the treatment should be re-evaluated.

Although

observations

to date

suggest

that

estrogens, including

transdermal

estradiol taken

combination with low doses of transdermal progestogen, do not impair carbohydrate metabolism,

diabetic women should be monitored during initiation of therapy until further information is available.

Patients should be advised that Estalis Sequi is not a contraceptive, neither will it restore fertility.

Use in hepatic impairment

No studies were performed in patients with hepatic impairment.

All estrogen preparations are contraindicated in patients with severe hepatic impairment (see

Section

CONTRAINDICATIONS).

Use in renal impairment

No studies were performed in patients with renal impairment.

Use in the elderly

Of the total number of subjects in the estrogen plus progestogen substudy of the Women’s Health

Initiative study, 44% (n = 7320) were 65 years and over, while 6.6% (n = 1,095) were 75 years and

over (See Section 5.1 PHARMACODYNAMIC PROPERTIES Clinical Trials). There was a higher

incidence of stroke and invasive breast cancer in women 75 and over compared to women less than 75

years of age.

In the Women’s Health Initiative Memory Study (WHIMS), an ancillary study of WHI, a population

of 4,532 women aged 65 to 79 years was randomised to conjugated estrogens 0.625 mg/day plus

medroxyprogesterone acetate 2.5 mg/day (CE + MPA) or placebo. A population of

2,947 hysterectomised women, aged 65 to 79 years, was randomised to conjugated estrogens (CE

0.625 mg) or placebo. In the planned analysis, pooling the events in women receiving CE or CE +

MPA in comparison to those in women on placebo, the overall relative risk (RR) for probable

dementia was 1.76 (95% CI 1.19-2.60).

In the estrogen-alone group, after an average follow-up of 5.2 years a RR of 1.49 (95% CI 0.83-2.66)

for probable dementia was observed compared to placebo. In the estrogen-plus-progestogen group,

after an average follow-up of 4 years, a RR of 2.05 (95% CI 1.21-3.48) for probable dementia was

observed compared to placebo. Since this study was conducted in women aged 65 to 79 years, it is

unknown whether these findings apply to younger postmenopausal women. (See

Section 4.4

SPECIAL WARNINGS AND PRECAUTIONS FOR USE

, Dementia.)

With respect to efficacy in the approved indications, there have not been sufficient numbers of

geriatric patients involved in studies utilising estrogens and progestogens to determine whether those

over 65 years of age differ from younger subjects in their response to estrogens and progestogens.

Paediatric use

Estalis Sequi is not to be used in children.

Effects on laboratory tests

Some laboratory tests may be influenced by estrogen therapy, such as tests for glucose tolerance or

thyroid function.

4.5

I

NTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTIONS

Preparations inducing microsomal liver enzymes, e.g. barbiturates, anticonvulsants (including

hydantoins and carbamazepine), meprobamate, phenylbutazone, antibiotics (including rifampicin,

rifabutin, nevirapine, efavirenz), may impair the activity of estrogens and progestogens (irregular

bleeding and recurrence of symptoms may occur). The extent of interference with transdermally

administered estradiol and norethisterone acetate was not evaluated, although it may be limited by this

route which avoids any first pass hepatic metabolism.

Estradiol is predominantly metabolized by CYP3A4; concomitant administration of inhibitors of

CYP3A4 such as ketoconazole, erythromycin or ritonavir may therefore result in an increase of

approximately 50% in estradiol exposure

Caution should be used if the patient is receiving protease inhibitors (e.g. ritonavir and nelfinavir),

which are known as strong inhibitors of cytochrome P450 enzymes, and 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 estrogens and progestogens.

4.6

F

ERTILITY

,

PREGNANCY AND LACTATION

Effects on fertility

None known

Use in pregnancy – Pregnancy Category D

Estalis sequi must not be used during pregnancy. Both estrogens and progestogens may cause foetal

harm when administered to a pregnant woman.

In animal studies, maternal administration of high doses of estrogens has produced urogenital

malformations in the offspring. However, the relevance of this finding for the clinical use of estradiol is

not certain. Animal studies have also shown that high doses of progestogens can cause masculinisation of

the female foetus.

Use in lactation.

Estalis Sequi must not be used while breast-feeding. Estrogens or progestogens are excreted in breast

milk and may reduce the production of breast milk.

4.7

E

FFECTS ON ABILITY TO DRIVE AND USE MACHINES

The effects of this medicine on a person's ability to drive and use machines were not assessed as part

of its registration. However, adverse effects of these medicines include dizziness which could affect

the ability to drive or use machines (see Section 4.8 ADVERSE EFFECT (UNDESIRABLE

EFFECTS)).

Read the complete document

Public Summary

Summary for ARTG Entry:

338042

ESTALIS SEQUI 50/250 patches sachet composite pack

ARTG entry for

Medicine Registered

Sponsor

Novartis Pharmaceuticals Australia Pty Ltd

Postal Address

PO Box 101, NORTH RYDE, NSW, 1670

Australia

ARTG Start Date

17/10/2020

Product Category

Medicine

Status

Active

Approval Area

Drug Safety Evaluation Branch

Conditions

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

Accepted for Registration or Listing as Goods Currently Supplied at the Commencement of the Therapeutic Goods Act 1989"

Except where the sponsor has been contracted by an overseas partry to manufacturer the goods and that party will be responsible for placing the goods on

the market in countries other than Australia, the sponsor must have and shall retain, while the goods remain listed, evidence necessary to substantiate and

support the accuracy of the indications in relation to the listed goods, and upon the request of the Head, Office of Prescription Medicines Authorisation

Branch, Therapeutic Goods Administration, shall produce such evidence to this officer.

The conditions applying to these goods when they are exported from Australia are given below:

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, other than condition No. 8 and condition No. 9.

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, other than condition No.11

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.

The therapeutic goods grouped in this registration/listing as export only goods under the following names are included in the Australian Register of

Therapeutic Goods and may not be supplied in Australia. Export Name(s) to be added:

Products

1 . ESTALIS SEQUI 50/250 patches sachet composite pack

Product Type

Composite Pack

Effective Date

20/01/2021

Permitted Indications

No Permitted Indications included on Record

Indication Requirements

No Indication Requirements included on Record

Standard Indications

No Standard Indications included on Record

Specific Indications

For the short-term treatment of symptoms of oestrogen deficiency in menopausal women who have an intact uterus. Combination HRT should not be used

in hysterectomised women because it is not needed in these women and it may increase the risk of breast cancer.

Warnings

See Product Information and Consumer Medicine Information for this product

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Sachet

Al laminated with

LDPE/paper

2 Years

Store at 2 to 8

degrees Celsius

Not recorded

Do not Freeze

Refrigerate

Public Summary

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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

Pack Size/Poison information

Pack Size

Poison Schedule

4 patches Estalis Sequi 50/250 (Week 3 & 4)

(S4) Prescription Only Medicine

4 patches Estalis oestradiol 50mcg/day (Week 1&2)

(S4) Prescription Only Medicine

Components

1 . Estalis 50/250 Sequi (Week 3 and 4) Combination patches

Dosage Form

Drug delivery system, transdermal

Route of Administration

Transdermal

Visual Identification

An off-white translucent patch with a removable pre-cut liner: 16cm2 round patch.

Active Ingredients

estradiol

.512 mg

Equivalent: estradiol

50 microgram/24 h

Equivalent: estradiol hemihydrate

.529 mg

norethisterone acetate

4.8 mg

Equivalent: estradiol hemihydrate

.806 mg

Equivalent: norethisterone acetate

250 microgram/24 h

Other Ingredients (Excipients)

1,1,1-trimethyl-N-(trimethylsilyl)silanamine

ammonia

dimeticonol

dipropylene glycol

ethanol

ethyl acetate

ethylene/vinyl acetate copolymer

oleic acid

polyethylene terephthalate

polytrimethylhydrosilylsiloxane

polyvinylidene flouride

povidone

toluene

Vinyl acetate/acrylic acid copolymer

xylene

2 . Estalis (Week 1 and 2) oestradiol 50mcg patch

Dosage Form

Drug delivery system, transdermal

Route of Administration

Transdermal

Visual Identification

Rectangular patch with round corners, comprising an adhesive layer with a translucent polymeric backing on one side and a

release liner on the other side.

Active Ingredients

estradiol

.78 mg

Equivalent: estradiol

50 microgram/24 h

Equivalent: estradiol hemihydrate

.806 mg

Other Ingredients (Excipients)

1,1-dichloroethylene, chloroethylene polymer

2,6-di-tert-butyl-4-ethylphenol

acrylates/VA copolymer

butylated hydroxytoluene

calcium stearoyl lactylate

colloidal anhydrous silica

cyclomethicone

Public Summary

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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

diatomaceous earth

dimeticone

dipropylene glycol

epoxidised soy oil

erucamide

ethyl acetate

ethylene/vinyl acetate copolymer

magnesium hydroxide

octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate

oleyl alcohol

oxidised polyethylene

polyethylene terephthalate

polyethylene

polyvinylidene flouride

povidone

quartz

silica

simethicone

stearamide

synthetic paraffin

tetrasodium pyrophosphate

toluene

vinyl acetate

xylene

© 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

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Visit www.tga.gov.au for contact information

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