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Package Leaflet: Information for the User

Anastrozole 1 mg Film-Coated Tablets

Anastrozole

What is in this leaflet:

1.    What Anastrozole is and what it is used for

2.    What you need to know before you take Anastrozole

3.    How to take Anastrozole

4.    Possible side effects

5.    How to store Anastrozole

6.    Contents of the pack and other information

1.    What Anastrozole is and what it is used for

Anastrozole contains a medicine called anastrozole. This 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 oestrogen 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

Do not take Anastrozole:

■    if you are allergic (hypersensitive) to anastrozole or any of the other ingredients of Anastrozole (see Section 6: Contents of the pack and other information).

■    if you are pregnant or breast-feeding (see the section called "Pregnancy, breastfeeding and fertility" overleaf.)

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

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Anastrozole

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

If you go into the hospital, let the medical staff know you are taking Anastrozole.

Other medicines and Anastrozole

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 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 if you are already taking any of the following medicines:

■    Certain medicines used to treat breast

cancer (selective estrogen receptor moduladors), e.g., medicines that contain tamoxifen. This is because these medicines may stop Anastrozole 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, breast-feeding and fertility

Do not take Anastrozole if you are pregnant or breast-feeding. Stop Anastrozole 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 Anastrozole. If this happens to you, ask your doctor or pharmacist for advice.

Anastrozole contains lactose

Anastrozole 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

Always take this medicine exactly as your doctor has told you. 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 before, with or after food.

Keep taking Anastrozole 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 should not be given to children.

If you take more Anastrozole than you should

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

If you forget to take Anastrozole

If you forget to take a dose, just take your next dose as normal.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Anastrozole

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, Anastrozole can cause side effects, although not everybody gets them.

Very common side effects (may 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 (may affect up to 1 in 10 people)

■    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).

■    Muscle pain

Uncommon side effects (may affect up to 1 in 100 people)

■    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, pharmacist or nurse as you may need to have blood tests.

Rare side effects (may affect up to 1 in 1,000 people)

■    Changes 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-Schonlein purpura".

Very rare side effects (may affect up to 1 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.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme website:

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 Anastrozole

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 use this medicine after the expiry date which is stated on the carton. 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 dispose of medicines you no longer use. These measures will help to protect the environment

6.    Contents of the pack and other information

What Anastrozole contains

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

■    The other ingredients are: lactose monohydrate, sodium starch glycolate, povidone, magnesium stearate, hypromellose, titanium dioxide (E171), macrogol 400 (see Section 2: What you need to know before you take Anastrozole)

What Anastrozole looks like and contents of the pack

Anastrozole 1 mg film coated tablets.

White coloured, round shaped biconvex, film-coated tablets debossed with '1' on one side and 'H' on the other side.

Anastrozole is supplied in the following pack sizes:

PVC/Aluminium foil blisters in cartons of 10,

20, 28, 30, 84, 98, 100 and 300 tablets.

Not all pack sizes may be marketed. Marketing Authorisation Holder

Hetero Europe, S.L.

Viladecans Business Park - Edificio Brasil Catalunya 83-85 - 08840 Viladecans Barcelona - Spain

Manufacturer:

Pharmadox Healthcare, Ltd.

KW20A Kordin Industrial Park, Paola, PLA 3000 Malta

This medicinal product is authorised in the Member States of the EEA under the following names:

Norway: Anastrozol Hetero 1 mg tablett, filmdrasjert

Germany: Anastrozol Hetero 1 mg Filmtabletten

Denmark: Anastrozol Hetero

The Netherlands: Anastrozol Hetero 1 mg,

filmomhulde tablet

Sweden: Anastrozol Hetero 1 mg,

filmdragerad tablett

United Kingdom: Anastrozole 1 mg film-coated tablet

This leaflet was last revised in 11 /2014

Detailed information on this medicine is available on the web site of MHRA.