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ESTRADERM MX 100

Active substance(s): ESTRADIOL / ESTRADIOL HEMIHYDRATE

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Estraderm MX is used for:
Relief of symptoms occuring after menopause
During the menopause, the amount of the oestrogen produced by a
woman’s body drops. This can cause symptoms such as hot face, neck
and chest (hot flushes). Estraderm MX alleviates these symptoms after
menopause. You will only be prescribed Estraderm MX if your symptoms
seriously hinder your daily life.

Package leaflet: Information for the user

Estraderm® MX 25, 50, 75 and 100
(oestradiol (as hemihydrate))

Prevention of osteoporosis (for Estraderm MX 50 and 75 only)
After the menopause some women may develop fragile bones
(osteoporosis). You should discuss all available options with your doctor.

Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on
to others. It may harm them, even if their signs of illness are the
same as yours.
• If you get any of the side effects talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.
What is in this leaflet:
1. What Estraderm MX is and what it is used for
2. What you need to know before you use Estraderm MX
3. How to use Estraderm MX
4. Possible side effects
5. How to store Estraderm MX
6. Contents of the pack and other information

If you are at an increased risk of fractures due to osteoporosis and other
medicines are not suitable for you, you can use Estraderm MX to prevent
osteoporosis after menopause.
2. What you need to know before you use Estraderm MX
Medical history and regular check-ups
The use of HRT carries risks which need to be considered when
deciding whether to start taking it, or whether to carry on taking it.
The experience in treating women with a premature menopause
(due to ovarian failure or surgery) is limited. If you have a premature
menopause the risks of using HRT may be different. Please talk to
your doctor.
Before you start (or restart) HRT, your doctor will ask about your own
and your family’s medical history. Your doctor may decide to perform a
physical examination. This may include an examination of your breasts
and/or an internal examination, if necessary.

1. What Estraderm MX is and what it is used for
Estraderm MX is a Hormone Replacement Therapy (HRT).
It contains the female hormone oestrogen. Estraderm MX is used
in postmenopausal women with at least 12 months since their last
natural period.
Estraderm MX is a patch that is applied to the skin. The patch
contains a supply of oestradiol which is released from the patch
and absorbed through the skin into your blood stream. This is called
a transdermal patch.

Once you have started on Estraderm MX you should see your doctor
for regular check-ups (at least once a year). At these check-ups,
discuss with your doctor the benefits and risks of continuing with
Estraderm MX.
Go for regular breast screening, as recommended by your doctor.
Do not take Estraderm MX
if any of the following applies to you. If you are not sure about any of
the points below, talk to your doctor before taking Estraderm MX,

Do not take Estraderm MX
• If you have or have ever had breast cancer, or if you are
suspected of having it
• If you have cancer which is sensitive to oestrogens, such as
cancer of the womb lining (endometrium), or if you are suspected
of having it
• If you have any unexplained vaginal bleeding
• If you have excessive thickening of the womb lining (endometrial
hyperplasia) that is not being treated
• If you have or have ever had a blood clot in a vein (thrombosis),
such as in the legs (deep venous thrombosis) or the lungs
(pulmonary embolism)
• If you have a blood clotting disorder (such as protein C, protein S,
or antithrombin deficiency)
• If you have or recently have had a disease caused by blood clots in
the arteries, such as a heart attack, stroke or angina
• If you have or have ever had a liver disease and your liver function
tests have not returned to normal
• If you have a rare blood problem called ‘porphyria’ which is passed
down in families (inherited)
• If you are allergic (hypersensitive) to oestradiol or any of the other
ingredients of this medicine (listed in section 6)
• You are pregnant or breastfeeding.
If any of the above conditions appear for the first time while taking
Estraderm MX, stop taking it at once and consult your doctor
immediately.

• fibroids inside your womb
• growth of womb lining outside your womb (endometriosis) or a
history of excessive growth of the womb lining (endometrial
hyperplasia)
• increased risk of developing blood clots (see Blood clots in a vein
(thrombosis))
• increased risk of getting a oestrogen-sensitive cancer (such as
having a mother, sister or grandmother who has had breast cancer)
• high blood pressure
• a liver disorder, such as a benign liver tumour
• diabetes
• gallstones
• migraine or severe headaches
• a disease of the immune system that affects many organs of the
body (systemic lupus erythematosus, SLE)
• epilepsy
• asthma
• a disease affecting the eardrum and hearing (otosclerosis)
• a very high level of fat in your blood (triglycerides)
• fluid retention due to cardiac or kidney problems
• Do you have hypothyroidism (a condition in which your thyroid
gland fails to produce enough thyroid hormone and for which you
are treated with thyroid hormone replacement therapy)?
• Do you have 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?

When to take special care with Estraderm MX
Take special care with Estraderm MX
If you experience:
• difficulty breathing or swallowing, tightness of the chest, hives,
general rash, swelling, itching, dizziness, vomiting, abdominal pain
(possible signs of a severe allergic reaction) or
• swelling of the face, lips, tongue, throat, and/or extremities
(possible signs of angioedema)
Stop using Estraderm MX and tell your doctor immediately.
Tell your doctor if you have ever had any of the following problems,
before you start the treatment, as these may return or become worse
during treatment with Estraderm MX. If so, you should see your doctor
more often for check-ups:

Stop taking Estraderm MX and see a doctor immediately
If you notice any of the following when taking HRT:
–– any of the conditions mentioned in the ‘DO NOT take Estraderm MX’
section
–– yellowing of your skin or the whites of your eyes (jaundice). These
may be signs of a liver disease
–– a large rise in your blood pressure (symptoms may be headache,
tiredness, dizziness).
–– migraine-like headaches which happen for the first time.
–– if you become pregnant
–– if you notice signs of a blood clot, such as:
–– painful swelling and redness of the legs
–– sudden chest pain
–– difficulty in breathing

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Note: Estraderm MX is not a contraceptive. If it is less than 12 months
since your last menstrual period or you are under 50 years old, you
may still need to use additional contraception to prevent pregnancy.
Speak to your doctor for advice.
HRT and cancer
Excessive thickening of the lining of the womb (endometrial
hyperplasia) and cancer of the lining of the womb (endometrial
cancer)
Taking oestrogen-only HRT will increase the risk of excessive
thickening of the lining of the womb (endometrial hyperplasia)
and cancer of the womb lining (endometrial cancer).
Taking a progestogen in addition to the oestrogen for at least 12 days of
each 28 day cycle protects you from this extra risk. So your doctor will
prescribe a progestogen separately if you still have your womb. If you
have had your womb removed (a hysterectomy), discuss with your
doctor whether you can safely take this product without a progestogen.
In women who still have a womb and who are not taking HRT,
on average, 5 in 1000 will be diagnosed with endometrial cancer
between the ages of 50 and 65.
For women aged 50 to 65 who still have a womb and who take
oestrogen-only HRT, between 10 and 60 women in 1000 will be
diagnosed with endometrial cancer (i.e. between 5 and 55 extra
cases), depending on the dose and for how long it is taken.
Estraderm MX 75 and Estraderm MX 100 contains a higher dose of
oestrogens than other oestrogen-only HRT products. The risk of
endometrium cancer when using Estraderm MX together with a
progestogen is not known.
Breast cancer
Evidence suggests that taking combined oestrogen-progestogen and
possibly also oestrogen-only HRT increases the risk of breast cancer.
The extra risk depends on how long you take HRT. The additional risk
becomes clear within a few years. However, it returns to normal within
a few years (at most 5) after stopping treatment.

For women who have had their womb removed and who are using
oestrogen-only HRT for 5 years, little or no increase in breast cancer
risk is shown.
Compare
Women aged 50 to 79 who are not taking HRT, on average,
9 to 17 in 1000 will be diagnosed with breast cancer over a
5-year period. For women aged 50 to 79 who are taking
oestrogen-progestogen HRT over 5 years, there will be
13 to 23 cases in 1000 users (i.e. an extra 4 to 6 cases).
• Regularly check your breasts. See your doctor if you notice any
changes such as:
• dimpling of the skin
• changes in the nipple
• any lumps you can see or feel
Ovarian cancer
Ovarian cancer is rare. A slightly increased risk of ovarian cancer has
been reported in women taking HRT for at least 5 to 10 years.
Women aged 50 to 69 who are not taking HRT, on average about
2 women in 1000 will be diagnosed with ovarian cancer over a 5-year
period. For women who have been taking HRT for 5 years, there will be
between 2 and 3 cases per 1000 users (i.e. up to 1 extra case).
Effect of HRT on heart and circulation
Blood clots in a vein (thrombosis)
The risk of blood clots in the veins is about 1.3 to 3- times higher in
HRT users than in non-users, especially during the first year of taking it.
Blood clots can be serious, and if one travels to the lungs, it can cause
chest pain, breathlessness, fainting or even death.
You are more likely to get a blood clot in your veins as you get older
and if any of the following applies to you. Inform your doctor if any of
these situations applies to you:
• you are unable to walk for a long time because of major surgery,
injury or illness (see also section 3, If you need to have surgery)
• you are seriously overweight (BMI >30 kg/m2)
• you have any blood clotting problem that needs long-term
treatment with a medicine used to prevent blood clots
• if any of your close relatives has ever had a blood clot in the leg,
lung or another organ

• you have systemic lupus erythematosus (SLE)
• you have cancer.
For signs of a blood clot, see ‘Stop taking Estraderm MX and see a
doctor immediately’.
Compare
Looking at women in their 50s who are not taking HRT, on average, over
a 5-year period, 4 to 7 in 1000 would be expected to get a blood clot in
a vein.
For women in their 50s who have been taking oestrogen-progestogen
HRT for over 5 years, there will be 9 to 12 cases in 1000 users
(i.e. an extra 5 cases).
For women in their 50s who have had their womb removed and have
been taking oestrogen-only HRT for over 5 years, there will be
5 to 8 cases in 1000 users (i.e. 1 extra case).
Heart disease (heart attack)
There is no evidence that HRT will prevent a heart attack.
Women over the age of 60 years who use oestrogen-progestogen HRT
are slightly more likely to develop heart disease than those not taking
any HRT.
For women who have had their womb removed and are taking
oestrogen-only therapy there is no increased risk of developing a heart
disease.
Stroke
The risk of getting stroke is about 1.5 times higher in HRT users than in
non-users. The number of extra cases of stroke due to use of HRT will
increase with age.
Compare
Looking at women in their 50s who are not taking HRT, on average,
8 in 1000 would be expected to have a stroke over a 5-year period. For
women in their 50s who are taking HRT, there will be 11 cases in
1000 users, over 5 years (i.e. an extra 3 cases).
Other conditions
• HRT will not prevent memory loss. There is some evidence of a
higher risk of memory loss in women who start using HRT after the
age of 65. Speak to your doctor for advice.

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For more information, see ‘Blood clots in a vein (thrombosis)’

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Other medicines and Estraderm MX
Some medicines may interfere with the effect of Estraderm MX. This
might lead to irregular bleeding. This applies to the following
medicines:
• Medicines for epilepsy (such as phenobarbital, phenytoin and
carbamazepine)
• Medicines for tuberculosis (such as rifampicin, rifabutin)
• Medicines for HIV infection (such as nevirapine, efavirenz,
ritonavir and nelfinavir)
• Herbal remedies containing St John’s Wort (Hypericum perforatum)
• Other anti-infective medicines (such as ketoconazole,
erythromycin).
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines including medicines obtained without
a prescription, herbal medicines or other natural products.
Laboratory tests
If you need a blood test, tell your doctor or the laboratory staff that
you are taking Estraderm MX, because this medicine can affect the
results of some tests. Some laboratory tests, such as tests for
glucose tolerance or thyroid function, may be affected by
Estraderm MX therapy.
Pregnancy and breast-feeding
Estraderm MX is for use in postmenopausal women only. If you
become pregnant, stop taking Estraderm MX and contact your doctor.
Driving and using machines
Estraderm MX has no known effect on the ability to drive and use
machines.
3. How to use Estraderm MX
Always use this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
Your doctor will aim to prescribe the lowest dose to treat your
symptom for as short as necessary. Speak to your doctor if you think
this dose is too strong or not strong enough.
If you have not had a hysterectomy, your doctor will give you tablets
containing another hormone called progestogen to offset the effects of
oestrogens on the lining of the womb. (See the section above on
ovarian cancer.) Your doctor will explain to you how to take these
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tablets. Withdrawal bleeding may occur at the end of the progestogen
treatment period. Tell your doctor if you get irregular and/or heavy
bleeding (see ovarian cancer).
When to start treatment
• If you are not currently using any form of HRT (patch or tablets), if
you have had a hysterectomy or if you have been using a continuous
combined HRT product (where oestrogen and the progestogen are
given every day without interruption), you can start to use Estraderm
MX on any convenient day.
• If you are changing from a cyclic or sequential HRT treatment (where
the progestogen is added for 12-14 days of the cycle), start to use
Estraderm MX the day after you complete the cycle.
• If you are still having periods you should start to use Estraderm MX
within 5 days of starting your period, irrespective of how long you
bleed.
How long to use Estraderm MX
It is important that you use the lowest possible effective dose and
only as long as needed. You should apply a new patch twice a week
i.e. every 3 or 4 days.
From time to time, you should discuss with your doctor whether you
still need the treatment
Where to apply Estraderm MX
• Estraderm MX patches are applied to the skin. You wear them all
the time.
Stick the patch on to a hairless area of skin below the waist. Most
patients find that the buttock is the best place. Choose an area of the
buttock where the skin is not inflamed, broken, or irritated. You could
also try the lower back, hip or abdomen.
Never put a patch on or near the breasts.
Choose a clean, dry area of skin. To help the patch stick, the skin
should be clean, dry, and free of creams, lotions, oil, or powder. You
should use a different area of skin each time. Wait a week before
using the same area again. Avoid skin which is red or irritated.
Do not expose the patch to direct sunlight.
How to apply Estraderm MX
Each Estraderm MX patch is sealed in an airtight sachet. Tear open
one of the sachets at the notch (do not use scissors) and take out the

patch. Don’t take the patch out of the sachet until immediately before
you intend to use it.

Removing the lining
A stiff, transparent protective lining covers the sticky side of the
patch, i.e. the side that will be placed against your skin. First remove
the smaller piece of the transparent liner. Then peel off the larger
piece. Try to avoid touching the adhesive and remember not to allow
the patch to become folded so that the sticky surfaces come in
contact with each other. Now apply the patch.

Applying the patch
With the palm of your hand press the sticky side of the patch firmly onto
the spot you have chosen. Hold it there for about 10-20 seconds. Make
sure that it sticks well, especially around the edges, but once the patch
is in place do not pull at it to test that it is sticking properly.

When and how to remove the patch
The patches should be changed twice a week on the same two days of
the week, e.g. Mondays and Thursdays. Choose two days which you are
likely to remember.

You will find a table at the end of this leaflet for you to fill in to jog your
memory. Tick the day of the week on which you are starting the treatment
and keep this leaflet somewhere safe so that you can refer back to it if you
need to.
When the time comes to change the patch, peel it off and fold it in half
with the sticky side inside. Dispose of the patch carefully (see Section 5),
making sure that it is kept out of the reach of children because it will
still contain some medication. Stick a new patch onto a different area of
skin.
What to do if a patch comes off
If a patch falls off it will not stick to your skin again. Use another patch on
a different area of your skin (see Where to apply the patch). Make sure
you choose a clean, dry, lotion-free area of the skin. No matter what day
this happens, go back to changing the patch on the same days as usual.
Further useful information
• Bathing, swimming, showering or exercising should not affect the
patch if it has been correctly applied. You may wear the patch
under your swimming costume.
• Never apply a patch on a sweaty area or after a hot bath or shower.
Wait until the skin is completely cool and dry.
• Do not remove the patch and try to put it somewhere else, it will
not stick to your skin again. Instead apply a new patch in the usual
way. Remember to apply your next patch at the normal time. If you
have run out of patches, please contact your doctor straight away.
(See also advice on ‘What to do if a patch comes off’.)
• Sunbathing: always make sure your patch is covered by clothing.
• Using a sunbed: cover up the patch
• The drug in your patch is contained in the adhesive and not in a
special reservoir.
• The drug in your patch is a gel which is colourless. This does not
mean that the patch does not contain any medication.
If you use more Estraderm MX than you should
Remove the patch if you have used too much Estraderm MX.
Symptoms of overdose are usually tenderness of the breasts and/or
vaginal bleeding. Acute overdose is unlikely due to the way Estraderm
is used (patch). If symptoms persist contact your doctor.
If you forget to use Estraderm MX
If you forget to apply a patch, apply a new patch as soon as you
remember. No matter what day that happens, go back to changing this

patch on the same day as you usually do. There is an increased chance
of breakthrough bleeding or spotting if there is a break in treatment.
Do not use a double dose to make up for the forgotten patch.
If you stop using Estraderm MX
Stopping use of Estraderm MX may increase the risk of breakthrough
bleeding or spotting. Talk to your doctor if this occurs. After a long break
in treatment, consult your doctor before starting to use the patch again.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.
If you need to have surgery
If you are going to have surgery, tell the surgeon that you are taking
Estraderm MX. You may need to stop taking Estraderm MX about
4 to 6 weeks before the operation to reduce the risk of a blood clot
(see section 2, Blood clots in a vein). Ask your doctor when you can
start taking Estraderm MX again.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
The following diseases are reported more often in women using HRT
compared to women not using HRT:
• breast cancer
• abnormal growth or cancer of the lining of the womb (endometrial
hyperplasia or cancer)
• ovarian cancer
• blood clots in the veins of the legs or lungs (venous thromboembolism)
• heart disease
• stroke
• probable memory loss if HRT is started over the age of 65
For more information about these side effects, see Section 2.
Stop using Estraderm MX immediately and tell your doctor if you
develop any of the following:
• Signs of a severe allergic reaction may include rash, itching, hives,
breathlessness or difficulty in breathing, wheezing or coughing,
light-headedness, dizziness, changes in levels of consciousness,
hypotension, with or without mild generalised itching, skin reddening,
swelling of the face, throat, lips, tongue, skin and periorbital edema
• Migraine or unusually severe headaches, or signs of stroke
• You become pregnant
• Signs of jaundice (yellowing of your skin or eyes).

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Very common, may affect more than 1 in 10 people:
• Redness, pain and itching where the patch has been applied (signs
of application site reaction includes bleeding, bruising, burning,
discomfort, dryness, skin boils, edema, erythema, inflammation,
irritation, pain, tiny solid skin bumps, rash, skin discolouration,
skin pigmentation, swelling, hives, and blisters)
• Tender, painful or swollen breasts
• Breakthrough bleeding
Common, may affect up to 1 in 10 people:
• Headache
• Feeling sick or bloated, stomach ache
Uncommon, may affect up to 1 in 100 people:
• Breast cancer.
Rare, may affect up to 1 in 1,000 people:
• Unusual weight changes, fluid retention (swelling or accumulation
of fluid in the lower legs or ankles), leg pain.
• Dizziness
Very rare, may affect up to 1 in 10,000 people:
• Blood clots, bruising, worsening varicose veins, raised blood pressure
• Abnormal liver function test results, jaundice
• Rash and itching over large areas of the skin. This sensitivity
reaction may become severe if you carry on using the patches
without talking to your doctor.
• Changes in the pigmentation in your skin (lightening or darkening of
your skin colour)
Other side effects include:
• Dry eyes.
• Contact lens discomfort.
Not known: frequency cannot be estimated from the available data
• Rapid changes in mood (e.g. depression, nervousness, etc.)
• Changes in sex drive
• Migraine
• Diarrhoea
• Vomiting
• Gallbladder disorder (tendency to form gallstones)
• Hair loss
• Darkening of the skin particularly on the face or abdomen (chloasma)

• Irregular heavy vaginal bleeding or constant spotting (possible
signs of endometrial hyperplasia)
• Fibroids (benign growths in the uterus)
• Hives
• Menstrual cramps
• Breast discharge
• Lumps in the breast (non cancerous)
If any of these apply to you and are severe, tell your doctor.
The following side effects have been reported with other HRTs:
• gall bladder disease
• various skin disorders:
–– discoloration of the skin especially of the face or neck known as
‘pregnancy patches’ (chloasma)
–– painful reddish skin nodules (erythema nodosum)
–– rash with target-shaped reddening or sores (erythema multiforme)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly via the internet at www.mhra.gov.uk/yellowcard.
Alternatively you can call Freephone 0808 100 3352 (available from
10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from
your local pharmacy. By reporting side effects, you can help provide more
information on the safety of this medicine.
5. How to store Estraderm MX
• Keep this medicine out of the sight and reach of children.
• Store below 25°C.
• Store Estraderm MX in the original package, in order to protect from
light. Once opened or once the protective pouch has been removed,
the patch should be applied to the skin immediately.
• Do not use this medicine after the expiry date which is stated on
the carton and patch after ‘EXP’. The expiry date refers to the last
day of that month.
• Do not use this medicine if you notice that the pack is damaged or
shows signs of tampering.
• Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help to protect the environment.

6. Contents of the pack and other information
What Estraderm MX contains
Estraderm MX 25 contains 0.75 mg oestradiol releasing about
25 micrograms of oestradiol a day.
Estraderm MX 50 contains 1.5 mg oestradiol releasing about
50 micrograms of oestradiol a day.
Estraderm MX 75 contains 2.25 mg oestradiol releasing about
75 micrograms of oestradiol a day.
Estraderm MX 100 contains 3.0 mg oestradiol releasing about
100 micrograms of oestradiol a day.
• The active substance is oestradiol (as hemihydrate).
• The other ingredients are isopropyl palmitate, acrylic adhesive
(in solution in ethylacetate/hexane) and ethyl acetate.
• The backing film consists of ethylene vinyl acetate/polyester film
laminate.
• The protective liner, which is removed before the patch is used, is a
siliconized polyester film.
What Estraderm MX looks like and contents of the pack
Estraderm MX is a square-shaped, self-adhesive, transparent,
transdermal patch for application to the skin surface. Each patch
comprises an impermeable polyester backing film, an adhesive matrix
containing oestradiol and an oversized protective liner which is
removed prior to application of the patch to the skin.
Estraderm MX is available in four different strengths: 25, 50,
75 and 100 micrograms/ day.

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Business Park, Frimley, Camberley, Surrey, GU16 7SR, England, United
Kingdom.
This leaflet was revised in October 2014.
Fill this in to remind you when to change your patch. Please tick the
box for the days of the week when you should change your patch.
Monday

+

Thursday

Tuesday

+

Friday

Wednesday

+

Saturday

Thursday

+

Sunday

Friday

+

Monday

Saturday

+

Tuesday

Sunday

+

Wednesday

If you would like any more information, or would like the leaflet in a
different format, please contact Medical Information at Novartis
Pharmaceuticals UK Ltd, telephone number 01276 698370.
ESTRADERM MX is a registered trade mark
Copyright Novartis Pharmaceuticals UK Limited

Not all strengths may be marketed.
Estraderm MX is available in cartons of 8 patches (1 month pack) and
24 patches (3 month pack). Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, England.
Manufacturer:
Novartis Pharmaceuticals UK Ltd, Wimblehurst Road, Horsham,
West Sussex, RH12 5AB, England, United Kingdom and Frimley

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6510027_GB_p1_LFT.indd 2

Proof Number: 1
Braille:

The side effects listed below have also been reported:

6510027 GB

19/02/2015 16:30

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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