ANASTROZOLE 1 MG FILM-COATED TABLETS

Active substance: ANASTROZOLE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Anastrozole 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.
• 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. This includes any possible side effects not listed in this leaflet.

What is in this leaflet:
1. What Anastrozole 1 mg is and what it is used for
2. What you need to know before you take Anastrozole 1 mg
3. How to take Anastrozole 1 mg
4. Possible side effects
5. How to store Anastrozole 1 mg
6. Contents of the pack and other information

1. What Anastrozole 1 mg is and what it is used for
Anastrozole belongs to a group of medicines called aromatase
inhibitors. Anastrozole is used to treat breast cancer in women who
have gone through the menopause.
Anastrozole 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
Anastrozole 1 mg
Do not take Anastrozole 1 mg
• if you are allergic (hypersensitive) to anastrozole or any of
the other ingredients of this medicine (see section 6, What
Anastrozole 1 mg contains).
• if you are pregnant or breast-feeding (see the section called
‘Pregnancy and breast-feeding’).
Do not take Anastrozole 1 mg if any of the above apply to you. If
you are not sure, talk to your doctor or pharmacist before taking
Anastrozole 1 mg.
Warnings and precautions
Talk to your doctor or pharmacist before taking Anastrozole 1 mg.
Before treatment with Anastrozole 1 mg check with your doctor or
pharmacist
• 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 Anastrozole 1 mg’).
• if you 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 Anastrozole 1 mg.
If you go into the hospital, let the medical staff know you are
taking Anastrozole 1 mg.

Other medicines and Anastrozole 1 mg
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription. This includes medicines that you buy
without a prescription and herbal medicines. This is because
anastrozole can affect the way some medicines work and some
medicines can have an effect on anastrozole.
Do not take Anastrozole 1 mg 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
Anastrozole 1 mg 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 Anastrozole 1 mg if you are pregnant or breastfeeding. Stop Anastrozole 1 mg if you become pregnant and talk
to your doctor.
Ask your doctor or pharmacist for advice before taking any
medicine.
Driving and using machines
Anastrozole 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 this medicine. If this happens to you,
ask your doctor or pharmacist for advice.
Anastrozole 1 mg contains lactose
Anastrozole 1 mg 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 Anastrozole 1 mg
Always take this medicine exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.
• The usual 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 Anastrozole 1 mg before, with or
after food.

Keep taking Anastrozole 1 mg for as long as your doctor tells you
to. It is a long-term treatment and you may need to take it for
several years.
Use in children
Anastrozole 1 mg should not be given to children and
adolescents.
If you take more Anastrozole 1 mg than you should
If you take more Anastrozole than you should, talk to a doctor
straight away.
If you forget to take Anastrozole 1 mg
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 Anastrozole 1 mg
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 or pharmacist.

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)
• bone loss (osteoporosis) • feeling weak
Common side effects (affect 1 to 10 people in 100)
Loss of appetite • raised or high levels of a 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) • 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)
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)
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
Anastrozole 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.

5. How to store Anastrozole 1 mg
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.
This medicinal product does not require any special storage
conditions.
Do not use this medicine after the expiry date which is stated on
the packaging after ‘EXP’. The first two digits indicate the month
and the last four digits indicate the year. The expiry date refers to
the last day of that month.
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 Anastrozole 1 mg contains
• The active substance is anastrozole. Each film-coated tablet
contains 1 mg of anastrozole.
• The other ingredients in the tablet core are lactose
monohydrate, sodium starch glycolate (type A), povidone
(E1201), and magnesium stearate (E572).
The ingredients in the tablet coating are macrogol 400,
hypromellose (E464), and titanium dioxide (E171).
What Anastrozole 1 mg looks like and contents of the pack
White film-coated round biconvex tablet, with the inscriptions
“ANA” and “1” on one side.
Anastrozole is available in blisters of 10, 14, 20, 28, 30, 50, 56, 60,
84, 90, 98, 100 or 300 tablets and in hospital blisters of 28, 50, 84,
98, 300 or 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Genthon BV
Microweg 22
6545 CM Nijmegen
The Netherlands
Manufacturers:
Synthon BV
Microweg 22
6545 CM Nijmegen
The Netherlands
Synthon Hispania, S.L.
C/Castelló, 1
Polígono Las Salinas
08830 Sant Boi de Llobregat
Barcelona
Spain
Distributed by:
Consilient Health (UK) Ltd.
500 Chiswick High Road,
London, W4 5RG
United Kingdom
This leaflet was last approved in 07/2012
P0151

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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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