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Estraderm oestradiol Consumer Medicine Information What is in…
Tags: combinations, comparable data, consumer medicine, dementia, estraderm, female sex, health, hysterectomy, initiative, leaflet, medicine, medicine information, medicines, memory study, menopause, oestrogen, oestrogens, pharmacist, risk,Pages: 5
Language: english
Created: Fri Sep 8 11:55:01 2006
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Estraderm
oestradiol
Consumer Medicine Information
What is in this leaflet group. The Women's Health How it works
Initiative Memory Study indicated
increased risk of dementia in women Oestradiol is a natural female sex
This leaflet answers some common hormone called an oestrogen. It is
questions about the menopause aged 65-79 years taking conjugated
the same hormone that your ovaries
("change of life"), hormone oestrogens and MPA. There are no
comparable data currently available were producing before the
replacement therapy and Estraderm. menopause.
for other doses of conjugated
It does not contain all the available oestrogens and MPA or other The menopause occurs naturally in
information. It does not take the combinations of oestrogens and the course of a woman's life, usually
place of talking to your doctor or progestogens. Therefore, you should between the ages of 45 and 55. It may
pharmacist. assume the risks will be similar for happen sooner if the ovaries are
All medicines have risks and other medicines containing oestrogen removed by surgery (e.g. total
benefits. Your doctor has weighed and progestogen combinations. hysterectomy). After menopause,
the risks of you using this medicine Talk regularly with your doctor your body produces much less
against the benefits they expect it about whether you still need oestrogen than it did before. This
will provide. treatment with Estraderm. can cause unpleasant symptoms such
as a feeling of warmth in the face,
If you have any concerns about this Treatment with oestrogens, with or
neck and chest, "hot flushes"
medicine, ask your doctor or without progestogens should be used
(sudden, intense feelings of heat and
pharmacist. at the lowest effective dose and for
sweating throughout the body), sleep
the shortest period of time.
Keep this leaflet with the medicine. problems, irritability and depression.
You may need to read it again. Some women also have problems
with dryness of the vagina causing
discomfort during or after sex.
What Estraderm is Oestrogens can be given to reduce or
used for eliminate these symptoms.
When you must not use
After the age of 40, and especially
Estraderm Estraderm is a type of treatment
after the menopause, some women
called hormone replacement therapy
develop osteoporosis. This is a
Do not use Estraderm or other (HRT). It is a stick-on patch that
thinning of the bones that makes
oestrogens, with or without a contains a hormone called oestradiol.
them weaker and more likely to
progestogen to prevent heart Estraderm is used for the short-term
attacks, stroke or dementia. break, especially the bones of the
relief of symptoms of the menopause. spine, hip and wrist. Exercise,
A study called the Women's Health It can also be used to prevent calcium and vitamin D can help
Initiative indicated increased risk of thinning of the bones in women with reduce the risk of osteoporosis.
heart attack, stroke, breast cancer, a high risk of fractures due to
and blood clots in the legs or lungs in osteoporosis who cannot use other Estraderm releases oestradiol in a
women receiving treatment with a continuous and controlled way just
treatments.
product containing conjugated as your ovaries were doing before.
HRT should not be used for the Because the medicine does not have
oestrogens 0.625 mg and the long-term maintenance of general
progestogen medroxyprogesterone to pass through your stomach and
health or to prevent heart disease or liver, it allows you to take a much
acetate (MPA). The researchers dementia.
stopped the study after 5 years when lower dose of oestrogen than would
Estraderm is not suitable for birth be needed in a tablet and helps to
it was determined the risks were
control and it will not restore avoid some unpleasant side effects.
greater than the benefits in this
fertility.
ESTRADERM 1
Ask your doctor if you have any * abnormal vaginal bleeding that * epilepsy
questions about why this medicine has not been investigated * migraine or other severe
has been prescribed for you. * severe liver disease headaches
Your doctor may have prescribed it * a condition called porphyria * gall bladder disease
for another purpose. If you are not sure whether any of the * asthma
This medicine is available only with above conditions apply to you, your * a high level of triglycerides in the
a doctor's prescription. It is not doctor can advise you. blood
habit-forming. * a disorder called systemic lupus
Do not use Estraderm if you are
pregnant or breast-feeding. erythematosus (SLE)
* low levels of thyroid hormone
It may affect your baby.
* a bone disease causing high
If you still have a uterus (womb), calcium levels in the blood
Before you use do not use Estraderm unless you * very low calcium levels in the
Estraderm are also taking another medicine blood
called a progestogen. * had a problem in the past with
When you must not use it Women who still have a uterus must jaundice (a liver problem) or
take both oestrogen and progestogen itching skin when you took an
Do not use Estraderm if you have as part of HRT. This is because oestrogen (e.g. the birth control
an allergy to: oestrogen stimulates the growth of pill or HRT)
* oestradiol, the active ingredient, the lining of the uterus (called the * a skin condition that could be
or to any of the other ingredients endometrium). Before menopause made worse by applying the
listed at the end of this leaflet this lining is removed during your patch
period through the action of a natural Your doctor may want to take special
* any other medicine containing
progestogen. After menopause, precautions if you have any of the
oestrogen, including the birth
taking oestrogen on its own as HRT above conditions.
control pill
may lead to irregular bleeding and to
Some of the symptoms of an allergic a disorder called endometrial Tell your doctor if you are likely to
reaction may include shortness of hyperplasia. Your doctor will have an increased risk of
breath, wheezing or difficulty developing blood clots in your
prescribe a progestogen to protect the
breathing; swelling of the face, lips, blood vessels. The risk increases as
lining of the uterus from the effects
tongue or other parts of the body; you get older and it may also be
of oestrogen. increased if:
rash, itching or hives on the skin.
Do not use this medicine after the * anyone in your immediate family
If you had a severe skin reaction in expiry date printed on the pack or has ever had blood clots in the
the past, you could have a very if the packaging is torn or shows blood vessels of the legs or lungs
serious reaction if you use any type signs of tampering.
of oestrogen (patch, tablet, cream, * you are overweight
In that case, return it to your * you have varicose veins
etc.) again in the future.
pharmacist. * you have a disorder called
Do not use Estraderm if you have: systemic lupus erythematosus
* cancer of the breast or uterus Before you start to use it (SLE)
(womb) or any other oestrogen
Tell your doctor if you have: Taking other medicines
dependent cancer, or you have
had this condition in the past * a family history of breast cancer
Tell your doctor if you are taking
* nodules, lumps or cysts in your
* blood clots in your blood vessels, birth control pills.
breasts or any other benign breast
now or in the past. You may
condition (not cancer) Estraderm is not a contraceptive.
have had painful inflammation of
* fibroids or other benign tumours Since pregnancy may be possible
the veins or blockage of a blood
of the uterus (not cancer) early in the menopause while you are
vessel in the legs, lungs, brain or
still having menstrual periods, you
heart * had one or more pregnancies
should ask your doctor to suggest
* a condition that increases the where you lost the baby before
another (non-hormonal) method of
tendency for you to get blood birth
birth control.
clots * high blood pressure
* heart disease Tell your doctor or pharmacist if
* endometriosis (a disorder of the
you are taking any other
uterus that may cause painful * kidney or liver problems
medicines, including medicines
periods and abnormal bleeding) * diabetes
ESTRADERM 2
that you buy without a How much to use If you forget to use it
prescription from a pharmacy,
supermarket or health food shop. The patches come in three strengths. Apply a new patch as soon as you
To reduce symptoms of the remember, and then go back to
Some medicines and Estraderm may
menopause, you will usually start your usual schedule.
interfere with each other. These
with the Estraderm 50 patch. Your
include: If you have trouble remembering
doctor will check your progress and when to use or replace your
* herbal medicines containing St. may change you to a lower or higher patches, ask your pharmacist for
John's wort strength, depending on your response some hints.
* some medicines to help you to treatment. To prevent thinning of
sleep, including barbiturates and the bones, Estraderm 50 or 100 may
If you use too much
meprobamate be suitable.
(Overdose)
* some medicines for epilepsy,
including phenytoin and How to use it Immediately telephone your doctor
carbamazepine or Poisons Information Centre
A leaflet in the carton contains
(telephone 13 11 26) or go to
* phenylbutazone, a medicine for pictures and information on how to
Accident and Emergency at your
pain and inflammation apply the patch properly. nearest hospital, if you think that
* some antibiotics and other You will usually have a patch on all an overdose has happened. Keep
anti-infective medicines, the time. You will apply a new patch the telephone numbers for these
including rifampicin, rifabutin, twice weekly (every 3 or 4 days). places handy.
nevirapine, efavirenz, ritonavir There are 8 patches in the carton, Because of the way this medicine is
and nelfinavir enough for a 4-week cycle. used, an intentional overdose is
You may need to take different Estraderm can also be used in cycles unlikely. Swallowing a patch may
amounts of your medicines or to take of 3 weeks of patches and then 1 cause nausea and vomiting.
different medicines while you are week with no treatment. Your doctor
using Estraderm. Your doctor and will advise you on the method that is
pharmacist have more information. best for you.
If you have not had a hysterectomy
If you have not told your doctor While you are using
(operation to remove the uterus), you
about any of these things, tell
must take another type of hormone
Estraderm
him/her before you start using this
medicine. called a progestogen as well as using
the patches. A progestogen helps to
Things you must do
protect the lining of the uterus. If
you have not been asked to take a If you become pregnant while
progestogen, talk to your doctor. using Estraderm, tell your doctor
How to use Estraderm immediately.
How long to use it It should not be used while you are
Follow all directions given to you
If you want to continue using HRT pregnant.
by your doctor and pharmacist
carefully. for longer than a few months,
See your doctor at least once a year
discuss the possible risks and for a check-up. Some women will
These instructions may differ from benefits with your doctor. need to go more often. Your
the information contained in this
You may have an increased risk of doctor will:
leaflet.
developing breast cancer, heart
* check your breasts and order a
If you do not understand the disease, stroke, blood clots on the
mammogram at regular intervals
instructions on the label, ask your lungs and dementia. On the other
doctor or pharmacist for help. hand, the risk of hip fractures and * check your uterus and cervix and
do a pap smear at regular
bowel cancer may be reduced. If you
have had a hysterectomy but still intervals
When to start it
have your ovaries, there may also be * check your blood pressure and
If you are not already using HRT, a small increase in the risk of cholesterol level.
you can start Estraderm at a developing cancer of the ovaries. Check your breasts each month
convenient time for you. If you are Your doctor can discuss these risks and report any changes promptly
already using a different type of and benefits with you, taking into to your doctor.
HRT, your doctor can advise you account your particular
when to switch to Estraderm. circumstances.
ESTRADERM 3
Your doctor or nurse can show you Tell your doctor immediately or go * muscle or nerve pain, leg pain
how to check your breasts properly. to Accident and Emergency at * worsening of varicose veins
your nearest hospital if you notice
Tell your doctor that you are using any of the following: * ringing in the ears
Estraderm well in advance of any * changes in weight
expected hospitalisation or * signs of allergy such as rash,
surgery. If you go to hospital itching or hives on the skin; * reversible skin discolouration
unexpectedly, tell the doctor who swelling of the face, lips, tongue * blurred vision
admits you that you are using it. or other part of the body;
Tell your doctor if you notice
shortness of breath, wheezing or
The risk of developing blood clots in anything else that is making you
troubled breathing feel unwell.
your blood vessels may be
temporarily increased as a result of * signs that blood clots may have
Some people may have other side
an operation, serious injury or having formed, such as sudden severe
effects not yet known or mentioned
to stay in bed for a prolonged period. headache, sudden loss of
in this leaflet. Some side effects can
If possible, this medicine should be coordination, blurred vision or
only be found when laboratory tests
stopped at least 4 weeks before sudden loss of vision, slurred
are done.
surgery and it should not be restarted speech, numbness or tingling in
until you are fully mobile. an arm or leg, painful swelling in
the calves or thighs, chest pain,
If you are about to be started on difficulty breathing, coughing
any new medicine, remind your blood After using Estraderm
doctor and pharmacist that you
* pain or tenderness in the
are using Estraderm.
abdomen, which may be
Tell any other doctor, dentist or accompanied by fever, loss of Storage
pharmacist who treats you that appetite, nausea and vomiting * Keep your medicine in the
you are using Estraderm.
* a yellow colour to the skin or original container until it is time
eyes, itching, dark coloured urine to use it.
Things you must not do or light coloured bowel motions. * Store it in a cool dry place.
Do not use this medicine to treat Tell your doctor if you notice any * Do not store Estraderm or any
any other complaints unless your of the following and they worry other medicine in the bathroom
doctor tells you to. you:
or near a sink.
Do not give it to anyone else, even * irregular vaginal bleeding or
* Do not leave it in the car or on
if their symptoms seem similar to spotting (if bleeding is heavy,
window sills.
yours. check with your doctor as soon as
possible) Keep the patches where young
children cannot reach them.
* tender, painful or swollen breasts
* period-like pain A locked cupboard at least
one-and-a-half metres above the
Side effects * redness, irritation or itching
ground is a good place to store
under the patch
medicines.
Tell your doctor or pharmacist as * itching or inflammation of the
soon as possible if you do not feel vagina
well while you are using Disposal
* pain during sex or when
Estraderm. urinating (passing water) Fold used patches in half with the
All medicines can have side effects. * palpitations (feeling of fast or sticky side inwards. Dispose of
Sometimes they are serious, most of irregular heartbeat) them where children cannot reach
the time they are not. You may need * swelling of the lower legs, them.
medical treatment if you get some of ankles, fingers or abdomen due to Used patches still contain some
the side effects. fluid retention oestradiol which could harm a child.
Do not be alarmed by these lists of * nausea (feeling sick), abdominal If your doctor tells you to stop
possible side effects. You may not cramps, bloating using this medicine or the expiry
experience any of them. Ask your * headache, migraine date has passed, ask your
doctor or pharmacist to answer pharmacist what to do with any
* rise in blood pressure
any questions you may have. patches that are left over.
* dizziness
* tiredness, nervousness,
irritability, depression
ESTRADERM 4
Product description Sponsor
Estraderm is supplied in Australia
by:
What it looks like
Estraderm patches come in three NOVARTIS Pharmaceuticals
strengths: 25, 50 and 100. They are Australia Pty Limited
round or oblong transparent patches ABN 18 004 244 160
sealed in individual pouches. Each 54 Waterloo Road
carton contains 8 patches (enough for North Ryde NSW 2113
4 weeks of treatment). Telephone: 1 800 671 203
* Estraderm 25 patches are marked
Web site: www.novartis.com.au
CG DWD
* Estraderm 50 patches are marked This leaflet was prepared in August
CG EFE 2006.
* Estraderm 100 patches are
marked CG FBF. (est020806c.doc) based on PI
Estraderm patches are made up of (est050805i.doc)
five layers:
Australian Registration Numbers:
* a waterproof transparent backing
Estraderm 25 AUST R 9972
film
Estraderm 50 AUST R 9971
* a drug reservoir containing the Estraderm 100 AUST R 9970
active ingredient, oestradiol
* a membrane which controls the
release of oestradiol into the skin
* an adhesive (sticky) layer
* a protective liner (to be removed
before use)
Ingredients
Estraderm patches release
approximately 25, 50 or 100
micrograms oestradiol in 24 hours.
The following inactive ingredients
are also used to make the patch:
* ethanol
* hydroxypropylcellulose
* polyethylene terephthalate
* ethylene/vinylacetate copolymer
* liquid paraffin
* polyisobutylene
* silicone coating on the release
liner
ESTRADERM 5