General Information
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.
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 oestrogens, 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 oestrogens 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 oestrogens and MPA. There are no
comparable data currently available for other
doses of conjugated oestrogens and MPA or other
combinations of oestrogens and progestogens.
Therefore, you should assume the risks will be
similar for other medicines containing oestrogen
and progestogen combinations.
Talk
regularly with your doctor about whether you still
need treatment with Estalis Sequi. Treatment with
oestrogens, 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 oestradiol.
Estalis Sequi Weeks 3 and 4 patches contain
oestradiol plus norethisterone acetate (NETA).
Estalis Sequi is used for the
short-
term relief of symptoms of the menopause. It can
also be used to prevent thinning of the bones in
women with a high risk of fractures due to
osteoporosis who cannot use other treatments. 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
Oestradiol
is a natural female sex hormone called an
oestrogen. 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 oestrogen 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. Oestrogens can be given to reduce or
eliminate 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. Exercise, calcium and vitamin D can help
reduce the risk of osteoporosis.
Women who
still have a uterus need to take both oestrogen
and progestogen as part of HRT. This is because
oestrogen 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
oestrogen 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 oestradiol 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:
oestradiol or NETA,
the active ingredients, or to any of the other
ingredients listed at the end of this leaflet
any other medicine containing oestrogen 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 oestrogen
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 oestrogen 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 disease
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)
low levels of 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
oestrogen (e.g. the birth control pill or HRT)
a skin condition that could be made worse by
applying a patch
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,
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.
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
oestradiol and the patches for Weeks 3 and 4
contain oestradiol 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. 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 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.
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 or other
part of the body; shortness of breath, wheezing or
troubled breathing
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
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
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 oestradiol 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 round
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 oestradiol in 24
hours. The following inactive ingredients are also
used to make the patch:
silicone and rubber
based synthetic adhesives to make the patch stick
polyisobutylene
oleic acid
bentonite
(558)
ethylene vinyl acetate copolymer
1,3
butylene glycol
liquid paraffin
dipropylene glycol
lecithin/polypropylene
glycol mixture
Estalis Sequi Weeks 3 and 4
patches release approximately 50 micrograms of
oestradiol 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 by:
NOVARTIS
Pharmaceuticals Australia Pty Limited
ABN 18
004 244 160
54 Waterloo Road
North Ryde NSW
2113
Telephone: 1 800 671 203
Web site:
www.novartis.com.au
®= Registered
Trademark
This leaflet was prepared in
August 2006.
(elq020806c.doc) based on PI
(elq050805i.doc)
Australian Registration
Numbers: Estalis Sequi 50/140 AUST R
70818
Estalis Sequi 50/250 AUST R 70826