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ANASTROZOLE 1MG FILM COATED TABLETS

Active substance(s): ANASTROZOLE

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S1658 LEAFLET Arimidex 20160407

PACKAGE LEAFLET: INFORMATION FOR THE USER
®

ARIMIDEX 1mg FILM-COATED TABLETS
(anastrozole)
The name of your medicine is Arimidex 1mg Film-coated Tablets
but will be referred to as Arimidex throughout the following leaflet.
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.

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).



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 this applies to you, ask your doctor or pharmacist for advice.



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.

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
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

Do not take Arimidex if you are pregnant or breast-feeding. Stop
Arimidex if you become pregnant and talk to your doctor.

3. How to take Arimidex

Ask your doctor or pharmacist for advice before taking any
medicine.

4. Possible side effects

Driving and using machines

5. How to store Arimidex
6. Contents of the pack and other information

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.

1. WHAT ARIMIDEX IS AND WHAT IT IS USED FOR

Arimidex contains lactose

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 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.

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’.

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.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
ARIMIDEX



Try to take your tablet at the same time each day.

Do not take Arimidex



Swallow the tablet whole with a drink of water.





It does not matter if you take Arimidex before, with or after food.



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.

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.

Warnings and precautions

If you take more Arimidex than you should

Talk to your doctor, or pharmacist or nurse before taking Arimidex

If you take more Arimidex than you should, talk to a doctor straight
away.



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 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 have ever had a condition that affects the strength of your
bones (osteoporosis).

If you stop taking Arimidex



if you have problems with your liver or kidneys.

If you have any further questions on the use of this medicine, ask
your doctor, pharmacist or nurse.

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.

Do not stop taking your tablets unless your doctor tells you to.

4. POSSIBLE SIDE EFFECTS

Effects on your bones

Like all medicines, this medicine can cause side effects, although
not everybody gets them.

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.

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).



Reporting of side effects

Feeling weak.



Bone loss (osteoporosis).

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 via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.

Common side effects (affect 1 to 10 people in 100)

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.

By reporting side effects, you can help provide more information on
the safety of this medicine.



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).

6. CONTENTS OF THE PACK AND OTHER INFORMATION



Muscle pain.

What Arimidex contains

Uncommon side effects (affect 1 to 10 people in 1,000)

5. HOW TO STORE ARIMIDEX


KEEP 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 store your tablets above 30°C.



Keep your tablets in the container they came in.



Do not use Arimidex after the expiry date which is stated on the
carton and blister strip. The expiry date refers to the last day of
that month.



Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.



The active substance is anastrozole. Each film-coated tablet
contains 1 mg of anastrozole.



The other ingredients are: lactose monohydrate, povidone,
sodium starch glycolate, magnesium stearate, hypromellose,
macrogol 300, titanium dioxide.



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.



What Arimidex looks like and contents of the pack

Trigger finger (a condition in which your finger or thumb catches
in a bent position).



Arimidex tablets are white, round, biconvex tablets with an ‘arrowed
A’ on one side and ‘Adx 1’ on the other side.

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.

Arimidex comes in blister packs of 28 tablets.
Product Licence holder

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’.

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by:


AstraZeneca UK Ltd, Silk Road Business Park, Macclesfield,
Cheshire SK10 2NA, United Kingdom.



AstraZeneca, Parc Industriel Pompelle, Chemin de Vrilly, Box
1050, 51689 Reims Cedex, France.

Very rare side effects (affect less than 1 person in 10,000
people)



AstraZeneca GmbH, Tinsdaler Weg 183, D-22880 Wedel,
Germany.



An extremely severe skin reaction with ulcers or blisters on the
skin. This is known as ‘Stevens-Johnson syndrome’.



AndersonBrecon (UK) Ltd., Forest Road, Hay-On-Wye,
Herefordshire, HR3 5EH, United Kingdom.



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.

POM

PL 19488/1658

Leaflet revision date: 7 April 2016
Arimidex® is a registered trademark of AstraZeneca UK Limited,
UK.
S1658 LEAFLET Arimidex 20160407

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