ARIMIDEX 1MG TABLETS

Active substance: ANASTROZOLE

View full screen / Print PDF » Download PDF ⇩

Transcript
27mm

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

000-0000D

Arimidex® 1mg/Anastrozole 1mg tablets
(Anastrozole)
Patient Information Leaflet

This product is known as the above names but will be referred to as Arimidex throughout this leaflet.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

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.

WARNING!

Warnings and precautions
Talk to your doctor, or pharmacist or nurse before treatment with 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 ‘Taking other medicines’).
• 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 go into the hospital, let the medical staff know you are taking Arimidex.

DATE:
02/07/13

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

DATE OF PROOF:

DT

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.

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.

6464/0498D
CODE:

Arimidex contains
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.

Arimidae 1mg tabs

ARTWORKER:

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.

PRODUCT:

CUSTOMER: Waymade

PRE-PRESS NO.:

05-0269

Q.A.
APPROVED:

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.

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.

Colour
Swatch

Black

WARNING!

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.

DATE:

CUSTOMER
APPROVED:

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking
Arimidex.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

Notes:

PROOF HISTORY:
v.1 - waymade - 02/08/13

Leaflet Flat Size = 148 x 400
March 2013

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.

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

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

WARNING!

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.

DATE:
02/07/13






5. How to store Arimidex
Arimidex should not be stored at above 30°C and they should be kept in their original blister
packaging.
Do not use after the expiry date printed on the carton label or blister strip. The expiry date refers to
the last day of that month.
KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.
If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe
disposal. Only keep the tablets if your doctor tells you to.
If the tablets become discoloured or show any other signs of deterioration, you should consult your
pharmacist who will advise you what to do.
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.

6. Contents of the pack and other information
Your medicine is called Arimidex. Each tablet contains 1mg of the active ingredient, anastrozole in a white,
round, tablet marked with a logo on one side and marked with 'Adx 1' on the other side.

6464/0498D

DT



DATE OF PROOF:

ARTWORKER:
Arimidae 1mg tabs



Arimidex also contains the following inactive ingredients:
Lactose monohydrate, macrogol, magnesium stearate, methylhydroxypropylcellulose, polyvidone, sodium
starch glycollate and titanium dioxide (E171).
Arimidex are available as calendar blister packs of 28 and 84 tablets.

CODE:

POM
PRODUCT:

CUSTOMER: Waymade

PRE-PRESS NO.:

05-0269

Q.A.
APPROVED:

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.

PL No: 6464/0498

This product is manufactured by AstraZeneca UK Limited, Macclesfield, Cheshire, United Kingdom and is
procured from within the EU and repackaged by the Product Licence holder:
Waymade Plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 2.8.2013
Arimidex® is a registered trademark of ASTRAZENECA UK LIMITED

Colour
Swatch

Black

000-0000D

WARNING!

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.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

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’.

DATE:

CUSTOMER
APPROVED:

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 your 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).
• 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 one of your fingers or your thumb locks 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.

PROOF HISTORY:
v.1 - waymade - 02/08/13

Notes:

Leaflet Flat Size = 148 x 400
March 2013

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).

Expand view ⇕

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.

Hide
(web1)