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ARIMIDEX 1MG FILM COATED TABLETS

Active substance(s): ANASTROZOLE

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Package leaflet: Information for the User
®

P039107

Arimidex 1 mg film‑coated tablets
anastrozole

Read all of this leaflet carefully
before you start taking 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
or nurse.
- 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 side effects, talk
to your doctor, or pharmacist or
nurse. This includes any possible
side effects not listed in this leaflet.
See section 4.
What is in this leaflet
1. What Arimidex is and what it is
used for
2. What you need to know before you
take Arimidex
3. How to take Arimidex
4. Possible side effects
5. How to store Arimidex
6. Contents of the pack and other
information
1. What Arimidex is and what it
is used for
Arimidex contains a substance called
anastrozole. This belongs to a group
of medicines called ‘aromatase
inhibitors’. Arimidex is used to treat
breast cancer in women who have
gone through the menopause.
Arimidex works by cutting down
the amount of the hormone called
estrogen that your body makes.
It does this by blocking a natural
substance (an enzyme) in your body
called ‘aromatase’.
2. What you need to know before
you take Arimidex
Do not take Arimidex
• if you are allergic to anastrozole or
any of the other ingredients of this
medicine (listed in section 6).
• if you are pregnant or breast‑feeding
(see the section called ‘Pregnancy
and breast-feeding’).
Do not take Arimidex if any of the
above apply to you. If you are not
sure, talk to your doctor or pharmacist
before taking Arimidex.
Warnings and precautions
Talk to your doctor, or pharmacist or
nurse before taking Arimidex
• if you still have menstrual periods
and have not yet gone through the
menopause.
• if you are taking a medicine that
contains tamoxifen or medicines
that contain estrogen (see the
section called ‘Other medicines
and Arimidex’).
• if you have ever had a condition
that affects the strength of your
bones (osteoporosis).
• if you have problems with your liver
or kidneys.
If you are not sure if any of the
above applies to you, talk to your
doctor or pharmacist before taking
Arimidex.
If you go into the hospital, let the
medical staff know you are taking
Arimidex.
Other medicines and Arimidex
Tell your doctor or pharmacist if you
are taking or have recently taken
any other medicines. This includes
medicines that you buy without a
prescription and herbal medicines.
This is because Arimidex can affect
the way some medicines work and
some medicines can have an effect
on Arimidex.
Do not take Arimidex if you are
already taking any of the following
medicines:
• Certain medicines used to
treat breast cancer (selective
estrogen receptor modulators),
e.g. medicines that contain
tamoxifen. This is because these
medicines may stop Arimidex from
working properly.
• Medicines that contain estrogen,
such as hormone replacement
therapy (HRT).
If this applies to you, ask your doctor
or pharmacist for advice.

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Tell your doctor or pharmacist if you
are taking the following:
• A medicine known as an ‘LHRH
analogue’. This includes gonadorelin,
buserelin, goserelin, leuprorelin and
triptorelin. These medicines are
used to treat breast cancer, certain
female health (gynaecological)
conditions, and infertility.
Pregnancy and breast-feeding
Do not take Arimidex if you are
pregnant or breast-feeding. Stop
Arimidex if you become pregnant and
talk to your doctor.
Ask your doctor or pharmacist for
advice before taking any medicine.
Driving and using machines
Arimidex is not likely to affect your
ability to drive or use any tools or
machines. However, some people
may occasionally feel weak or sleepy
while taking Arimidex. If this happens
to you, ask your doctor or pharmacist
for advice.
Arimidex contains lactose
Arimidex contains lactose which is
a type of sugar. If you have been
told by your doctor that you have an
intolerance to some sugars, contact
your doctor before taking this medicine.
3. How to take Arimidex
Always take Arimidex exactly as your
doctor or pharmacist has told you.
Check with your doctor or pharmacist
if you are not sure.
• The recommended dose is one
tablet once a day.
• Try to take your tablet at the same
time each day.
• Swallow the tablet whole with a
drink of water.
• It does not matter if you take
Arimidex before, with or after food.
Keep taking Arimidex for as long as
your doctor or pharmacist tells you
to. It is a long-term treatment and you
may need to take it for several years.
Check with your doctor or pharmacist
if you are not sure.
Use in children and adolescents
Arimidex should not be given to
children and adolescents.
If you take more Arimidex than
you should
If you take more Arimidex than you
should, talk to a doctor straight away.
If you forget to take Arimidex
If you forget to take a dose, just take
your next dose as normal.
Do not take a double dose (two doses
at the same time) to make up for a
forgotten dose.
If you stop taking Arimidex
Do not stop taking your tablets unless
your doctor tells you to.
If you have any further questions on
the use of this medicine, ask your
doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine
can cause side effects, although not
everybody gets them.
Very common side effects (affect
more than 1 in 10 people)
• Headache.
• Hot flushes.
• Feeling sick (nausea).
• Skin rash.
• Pain or stiffness in your joints.
• Inflammation of the joints (arthritis).
• Feeling weak.
• Bone loss (osteoporosis).
Common side effects (affect 1 to
10 people in 100)
• Loss of appetite.
• Raised or high levels of fatty
substance known as cholesterol in
your blood. This would be seen in
a blood test.
• Feeling sleepy.
• Carpal tunnel syndrome (tingling,
pain, coldness, weakness in parts
of the hand).
• Tickling, tingling or numbness of
skin, loss/lack of taste.
• Diarrhoea.
• Being sick (vomiting).
• Changes in blood tests that show
how well your liver is working.
• Thinning of your hair (hair loss).
• Allergic (hypersensitivity) reactions
including face, lips, or tongue.
• Bone pain.
• Vaginal dryness.
• Bleeding from the vagina (usually in
the first few weeks of treatment – if
the bleeding continues, talk to your
doctor).
• Muscle pain.

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Uncommon side effects (affect 1 to
10 people in 1,000)
• Changes in special blood tests
that show how your liver is working
(gamma-GT and bilirubin).
• Inflammation of the liver (hepatitis).
• Hives or nettle rash.
• Trigger finger (a condition in which
your finger or thumb catches in a
bent position).
• Increased amounts of calcium
in your blood. If you experience
nausea, vomiting and thirst,
you should tell your doctor, or
pharmacist or nurse as you may
need to have blood tests.
Rare side effects (affect 1 to
10 people in 10,000)
• Rare inflammation of your skin that
may include red patches or blisters.
• Skin rash caused by hypersensitivity
(this can be from allergic or
anaphylactoid reaction).
• Inflammation of the small blood
vessels causing red or purple
colouring of the skin. Very rarely
symptoms of joint, stomach, and
kidney pain may occur; this is
known as ‘Henoch-Schönlein
purpura’.
Very rare side effects (affect less
than 1 person in 10,000 people)
• An extremely severe skin reaction
with ulcers or blisters on the skin.
This is known as ‘Stevens-Johnson
syndrome’.
• Allergic (hypersensitivity) reactions
with swelling of the throat that
may cause difficulty in swallowing
or breathing. This is known as
‘angioedema’.
If any of these happen to you, call an
ambulance or see a doctor straight
away – you may need urgent medical
treatment.
Effects on your bones
Arimidex lowers the amount of the
hormone called estrogen that is
in your body. This may lower the
mineral content of your bones. Your
bones may be less strong and may
be more likely to fracture. Your doctor
will manage these risks according to
treatment guidelines for managing
bone health in women who have
gone through the menopause. You
should talk to your doctor about the
risks and treatment options.
If any of the side effects get serious,
or if you notice any side effects not
listed in this leaflet, please tell your
doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your
doctor, pharmacist or nurse. This
includes any possible side effects
not listed in this leaflet. You can also
report side effects directly (see details
below). By reporting side effects you
can help provide more information on
the safety of this medicine.
UK
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie

6. Contents of the pack and other
information
What Arimidex contains
• The active substance is anastrozole.
Each film-coated tablet contains
1 mg of anastrozole.
• The other ingredients are: lactose
monohydrate, povidone, sodium
starch glycollate, magnesium
stearate, hypromellose,
macrogol 300, titanium dioxide.
What Arimidex looks like and
contents of the pack
White, round, biconvex film-coated
tablets of about 6.1 mm marked ‘A’ on
one side and ‘Adx1’ on the other side.
Arimidex comes in blister packs of
28 tablets.
Marketing Authorisation Holder
The Marketing Authorisation for
Arimidex 1 mg film‑coated tablets
marketed in the UK and Ireland
is held by AstraZeneca UK Ltd,
600 Capability Green, Luton,
LU1 3LU, UK.
The Marketing Authorisation
for Arimidex 1 mg film‑coated
tablets marketed in Malta is
held by AstraZeneca UK Ltd,
2 Kingdom Street, London,
W2 6BD, UK.
Manufacturer
AstraZeneca UK Ltd,
Silk Road Business Park,
Macclesfield, Cheshire, SK10 2NA,
United Kingdom.
This medicinal product is
authorised in the Member States of
the EEA under the following names:
Member State
Name
Austria, Belgium,
Arimidex
Bulgaria, Cyprus,
Czech Republic,
Denmark, Estonia,
Finland, France,
Germany, Greece,
Hungary, Iceland,
Ireland, Italy,
Latvia, Lithuania,
Luxembourg,
Malta, Netherlands,
Norway, Poland,
Portugal, Romania,
Spain, Sweden, UK
Slovenia
Arimidex 1mg
filmsko obložene
tablete

To listen to or request a
copy of this leaflet in Braille,
large print or audio please
call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the
following information:
Product name
Arimidex 1 mg Tablets
Reference number
17901/0002
This is a service provided
by the Royal National
Institute of Blind People.
Leaflet prepared: September 2014
© AstraZeneca 2014
Arimidex is a trade mark of the
AstraZeneca group of companies.
ONC 14 0025

Malta
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D’Argens
GŻR-1368 Gżira
Website:
www.medicinesauthority.gov.mt
e-mail:
postlicensing.medicinesauthority@gov.mt
5. How to store Arimidex
Do not store above 30°C.
Keep this medicine out of the sight
and reach of children. Keep your
tablets in a safe place where children
cannot see or reach them. Your
tablets could harm them.
Do not use this medicine after the
expiry date which is stated on the
carton and blister strip. The expiry date
refers to the last day of that month.
Keep your tablets in the container
they came in.
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 protect the
environment.

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P039107

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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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