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ARIMIDEX 1 MG FILM-COATED TABLETS

Active substance(s): ANASTROZOLE

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Arimidex® 1 mg Film-Coated Tablets

2526
07.11.14[6]

(anastrozole)
PATIENT INFORMATION LEAFLET
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.
This medication is available using as the above name but will be referred to
as Arimidex throughout the following leaflet.
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.
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.

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.

MANUFACTURER AND PRODUCT LICENCE HOLDER
Arimidex are manufactured by: AstraZeneca UK Limited., Silk Road
Business Park, Macclesfield, Cheshire, SK10 2NA, UK and Procured from
within the EU by Product Licence holder Star Pharmaceuticals Ltd., 5
Sandridge Close, Harrow, Middlesex HA1 1XD. Repackaged by
Servipharm Ltd.
POM

PLPI 20636 / 2526

Leaflet revision and issue date (Ref) 07.11.14[6]
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 via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects, you can help
provide more information on the safety of this medicine.
5. HOW TO STORE ARIMIDEX
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.
Do not store above 30°C. Store in the original package.
If your tablets become discoloured or shown any other sign of deterioration,
please contact your doctor or pharmacist before taking your medicine.
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.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Arimidex contains
The active substance is anastrozole. Each film-coated tablet contains 1 mg
anastrozole.
The other ingredients are: lactose monohydrate, povidone, sodium starch
glycollate, magnesium stearate, hypromellose, macrogol 300, titanium
dioxide (E171).
What Arimidex looks like and contents of the pack
Arimidex is available as a white, round, biconvex film-coated tablet with an
‘arrow A’ logo on one side and ‘Adx 1’ on the other.
Arimidex comes in calendar blister strips of 28 tablets.

Arimidex is a trademark of the AstraZeneca UK Limited.

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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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