Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. When you must not use ZUMENON?
Do not use ZUMENON or other estrogens, with or without progestogen to prevent heart
attacks, stroke or dementia. Talk regularly with your doctor about whether you still
need treatment with ZUMENON.
2. Why am I using ZUMENON?
ZUMENON contains the active ingredient estradiol hemihydrate. ZUMENON is a type of
treatment called hormone replacement therapy (HRT) that helps to relieve the symptoms
many women feel during and after menopause.
For more information, see Section
2. Why am I using ZUMENON? in the full CMI.
3. What should I know before I use ZUMENON?
Do not use if you have ever had an allergic reaction to any medicine containing estradiol
or any of the ingredients listed at the end of this leaflet. HRT should only be used
if you have been fully informed of the risks. Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
4. What if I am taking other medicines?
5. How do I use ZUMENON?
The usual dose is one tablet daily.
Swallow the tablet whole with a glass of water. Take ZUMENON at about the same time
each day.
6. What should I know while using ZUMENON?
|
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are using ZUMENON.
Tell your doctor that you are using ZUMENON 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.
Tell your doctor immediately if you have any sore veins or suspected blood clots,
disturbances in vision, sudden onset of migraine, significant increase in blood pressure,
or yellowing of the skin or eyes (jaundice) while taking ZUMENON tablets.
If you become pregnant while using ZUMENON, tell your doctor immediately.
Check your breasts each month and report any changes promptly to your doctor.
See your doctor at least once a year for a check-up.
|
|
Things you should not do
|
Do not use this medicine to treat any other complaints unless your doctor or pharmacist
tells you to.
Do not stop taking ZUMENON, or change the dosage, without checking with your doctor.
|
|
Looking after your medicine
|
Keep the medicine in a cool, dry place where the temperature stays below 30°C.
|
7. Are there any side effects?
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking ZUMENON.
For more information, including what to do if you have any side effects, see Section
7. Are there any side effects? in the full CMI.
Active ingredient(s):
estradiol hemihydrate
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using ZUMENON. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using ZUMENON.
Where to find information in this leaflet:
1. When you must not use ZUMENON
Do not use ZUMENON or other estrogens, with or without progestogen to prevent heart
attacks, stroke or dementia.
A study called the Women's Health Initiative indicated increased risk of 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.
This Women's Health Initiative also indicated increased risk of stroke, and blood
clots in the legs or lungs in women receiving treatment with a product containing
conjugated estrogens 0.625 mg alone. The researchers stopped the study after 7 years
when it was determined the risks were greater than benefit in this group.
The Women's Health Initiative Memory Study indicated increased risk of dementia in
women aged 65 years or older taking conjugated estrogens and MPA. Increased risk of
dementia was also reported in women taking conjugated estrogens alone. 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 ZUMENON.
Treatment with estrogens, with or without progestogens should be used at the lowest
effective dose and for the shortest period of time.
2. Why am I using ZUMENON?
ZUMENON is a type of treatment called hormone replacement therapy (HRT). ZUMENON tablets contain a hormone called estradiol.
This medicine helps to relieve the symptoms many women feel during and after menopause. ZUMENON may be used by women who still have a uterus (womb). Menopause may be natural
or occur after surgery or medical treatment.
Women with an intact womb should generally be prescribed ZUMENON and another medicine,
a progestogen, to protect the lining of the uterus from over stimulation.
HRT should not be used for the long-term maintenance of general health or to prevent
heart disease or dementia.
ZUMENON 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.
Menopause generally occurs between the ages of 45 and 55, because your body's production
of estrogen decreases. It may happen sooner if the ovaries are removed by surgery
(e.g. total hysterectomy). This can cause unpleasant symptoms such as a feeling of
warmth in the face, neck and chest, "hot flushes" (sudden intense feelings of heat
and sweating throughout the body), sleep problems, irritability and depression. Some
women also have problems with urine control or with dryness of the vagina causing
discomfort during or after sex. Estrogens can be given to reduce or eliminate these
symptoms.
Ask your doctor if you have any questions about why it has been prescribed for you.
Your doctor may have prescribed it for another purpose.
This medicine is not addictive.
3. What should I know before I use ZUMENON?
Warnings
HRT should only be used if you have been fully informed of the risks.
The decision to use HRT should be based on your symptoms and health, and made after
a careful medical evaluation.
Do not use ZUMENON if:
you are allergic to any medicine containing estradiol or any of the ingredients listed
at the end of this leaflet
Some symptoms of an allergic reaction include skin rash, itching, shortness of breath
or swelling of the face, lips or tongue, which may cause difficulty in swallowing
or breathing.
If you have or have had:
Cancer of the breast or uterus (endometrium) or any other estrogen dependent cancer
Blood clots. Painful inflammation of the veins or blockage of a blood vessel in the
legs, lungs, brain or heart
Any condition that increases the tendency for you to get blood clots
Abnormal vaginal bleeding
Severe liver disease
A condition called porphyria
Hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose
malabsorption
If you are not sure whether any of the above conditions apply to you, your doctor
can advise you.
You must stop taking ZUMENON 4 weeks before certain types of surgery.
Do not take it after the expiry date printed on the pack or if the packaging is damaged
or shows signs of tampering.
If it has expired or is damaged return it to your pharmacist for disposal.
Before you start to take it
Tell your doctor or pharmacist if you have any allergies to any other medicines, foods,
preservatives or dyes.
You must have a through medical check-up before starting HRT for the first time or
recommencing HRT.
Tell your doctor if you have or have had any of the following medical conditions:
a family history of breast cancer
nodules, lumps or cysts in your breasts or any other benign breast condition (not
cancerous)
fibroids or other benign tumours of the uterus (not cancerous)
ovarian cancer
unusual or irregular bleeding or spotting from the vagina
endometriosis
liver problems, including yellowing of the skin and whites of the eyes and a condition
called porphyria
cholestatic jaundice (obstruction of the bile duct)
kidney problems
high blood pressure
heart problems
diabetes
migraine or severe headaches
asthma
epilepsy
gall bladder disease
a high level of triglycerides (fats) in the blood
high or low levels of calcium in the blood
abnormal vision
hypothyroidism
hearing loss due to a problem with the bones in the ear called otosclerosis
hereditary angioedema or acquired angioedema
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
If you have not told your doctor about any of the above, tell them before you take
ZUMENON.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
7. Are there any side effects?
Pregnancy and breastfeeding
Do not take this medicine if you are pregnant. Discuss with your doctor if you are
planning on becoming pregnant.
Do not breastfeed if you are taking this medicine.
Special Warning
Treatment with estrogens alone over a prolonged period may expose women with an intact
womb to an increased risk of cancer of the lining of the womb.
4. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines and ZUMENON may interfere with each other. These include:
herbal medicines containing St John's Wort
some medicines used to treat epilepsy, e.g. lamotrigine
some antibiotic and anti-infective medicines
some medicines which require precise dosing e.g. tacrolimus, ciclosporin, fentanyl
and theophylline
the hepatitis C treatment combination regimen of ombitasvir/paritaprevir/ritonavir
with and without dasabuvir
These medicines may be affected by ZUMENON, or may affect how well it works. You may
need to use different amounts of your medicine, or take different medicines.
Your doctor or pharmacist has more information on medicines to be careful with or
to avoid while taking ZUMENON.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect ZUMENON.
5. How do I use ZUMENON?
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the box, ask your doctor or pharmacist
for help.
How much to take
The usual dose is one tablet daily.
If you have not had a period for twelve months or more or if you have had a hysterectomy,
you can start ZUMENON immediately.
If you are having irregular periods, start taking ZUMENON on day 5 of the menstrual
cycle.
If your uterus is still intact your doctor will generally prescribe another medicine
(progesterone) to take with ZUMENON during part of your menstrual cycle.
How much to take
Swallow the tablet whole with a glass of water.
When to take ZUMENON
Take ZUMENON at about the same time each day.
Taking it at the same time each day will have the best effect. It will also help you
remember when to take it.
The pack is labelled with the days of the week to help you with taking your tablets
every day.
You should start each new pack the day after you have finished the current pack. Do
not leave a gap between packs.
How long to take it
Your doctor can advise you how long you may need to take ZUMENON.
Your doctor can discuss the risks and benefits of long-term treatment with HRT. Some
recent studies have shown that women using HRT have a small increase in breast cancer
risk after several years of use. The risk increases with the length of HRT use.
Recent studies have also shown that HRT is associated with a small increase in the
risk of heart attacks, strokes, blood clots, including clots in the lungs. However,
the risk of hip fractures and bowel cancer may be reduced.
Another study has shown that in women older than 65 years, HRT is associated with
a small increase is the risk of dementia, including Alzheimer's disease. It is not
known if this finding applies to younger women.
Continue taking ZUMENON for as long as your doctor recommends.
If you forget to take ZUMENON
If it is less than 12 hours before your next dose, skip the dose you missed and take
your next dose when you are meant to.
Otherwise, take it as soon as you remember, and then go back to taking your medicine
as you would normally.
Do not take a double dose to make up for the dose that you missed.
This may increase the chance of getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering when to take your medicine, ask your pharmacist for
advice.
If you take too much ZUMENON
If you think that you have used too much ZUMENON, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26) for advice, or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
6. What should I know while using ZUMENON?
Things you should do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking ZUMENON.
Tell any other doctors, dentists and pharmacists who treat you that you are taking
this medicine.
Tell your doctor that you are using ZUMENON well in advance of any expected hospitalisation
or surgery. If you go to hospital unexpectedly, tell the doctor who admits you that
you are using it.
The risk of developing blood clots in your blood vessels may be temporarily increased
after surgery, serious injury or having to stay in bed for a long period of time.
If possible, ZUMENON should be stopped at least 4 weeks before surgery and it should
not be restarted until you are fully mobile.
Tell your doctor immediately if you have any sore veins or suspected blood clots,
disturbances in vision, sudden onset of migraine, significant increase in blood pressure,
or yellowing of the skin or eyes (jaundice) while taking ZUMENON tablets.
If you are still having periods of any kind, you should continue to use non-hormonal
contraceptive methods (such as a condom) to prevent pregnancy.
If you become pregnant while using ZUMENON, tell your doctor immediately.
ZUMENON should not be used while you are pregnant.
Check your breasts each month and report any changes promptly to your doctor. Particularly
if you have breast lumps or a family history of breast cancer.
See your doctor at least once a year for a check-up. Some women will need to go more
often. Your doctor may:
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.
Things you should not do
Do not use this medicine to treat any other complaints unless your doctor or pharmacist
tells you to.
Do not give this medicine to anyone else, even if they have the same condition as
you.
Do not stop taking ZUMENON, or change the dosage, without checking with your doctor.
Looking after your medicine
Keep the medicine in a cool, dry place where the temperature stays below 30°C.
Keep your tablets in the pack until it is time to take them.
If you take the tablets out of the box or the blister pack they may not keep well.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
Getting rid of any unwanted medicine
If your doctor or pharmacist tells you to stop taking this medicine, or the medicine
has passed its expiry date, ask your pharmacist what to do with any that are left
over.
Do not use this medicine after the expiry date.
7. Are there any side effects?
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking ZUMENON.
All medicines have some unwanted side effects. Sometimes they are serious but most
of the time they are not. You may need medical attention if you get some of the side-effects.
Do not be alarmed by this list of possible side effects. You may not experience any
of them.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
|
Less serious side effects
|
What to do
|
|
irregular vaginal bleeding or spotting (if bleeding is heavy, check with your doctor
as soon as possible)
tender, painful or swollen breasts
period-like pain
vaginal itching, inflammation or discharge
swelling of the lower legs, ankles, fingers or abdomen due to fluid retention
nausea (feeling sick), abdominal pain or tenderness, vomiting, heartburn, bloating,
diarrhoea
headache, migraine
rise in blood pressure, palpitations
fatigue or dizziness
depression, anxiety
back pain, muscle cramps
change in sex drive
weight change
acne, itchy or dry skin, skin discolouration
unusually excessive hair growth
vision changes
contact lens intolerance
|
Tell your doctor or pharmacist if you notice any of these common side effects. They
are usually mild however tell your doctor or pharmacist if you notice anything that
is making you feel unwell.
|
Serious side effects
|
Serious side effects
|
What to do
|
|
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, loss of coordination,
blurred or loss of vision, slurred speech, numbness or tingling, painful swelling
in the calves or thighs, chest pain, coughing blood
pain or tenderness in the abdomen, which may be accompanied by fever, loss of appetite,
nausea and vomiting
chest pain
difficulty breathing
new onset migraine-like headache
a yellow colour to the skin or eyes, itching, dark coloured urine or light-coloured
bowel motions.
sudden loss of vision
|
Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these very serious side effects. These side effects are rare.
|
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
8. Product details
This medicine is only available with a doctor's prescription.
What ZUMENON contains
|
Active ingredient
(main ingredient)
|
2 mg of estradiol (as hemihydrate)
|
|
Other ingredients
(inactive ingredients)
|
lactose monohydrate
hypromellose
maize starch
colloidal anhydrous silica
magnesium stearate
Opadry complete film coating system OY-6957 Pink (ARTG PI No: 4158)
|
|
Potential allergens
|
ZUMENON tablets contain sugars as lactose.
|
Do not take this medicine if you are allergic to any of these ingredients.
What ZUMENON looks like
ZUMENON tablets are round, biconvex, brick-red, film-coated tablets of 7 mm diameter
each containing 2 mg estradiol bearing the inscription "379" on one side. (AUST R
75888).
ZUMENON is available in boxes of 56 tablets.
ZUMENON is made in the Netherlands.
Who distributes ZUMENON
Viatris Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
ZUMENON® is a Viatris company trade mark
This leaflet was prepared in November 2023.
ZUMENON_cmi\Nov23/00