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Anastrozole 1mg Film Coated Tablets

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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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 your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

ASANDOZ

IWhat Anastrozole is and what it is used for

Anastrozole contains a substance 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 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

Do not take Anastrozole

• 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 ‘Pregnancy and breast-feeding’).

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

Warnings and precautions

Before treatment with Anastrozole 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 ‘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 or pharmacist before taking Anastrozole.

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

Other medicines and Anastrozole

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 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 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 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 this 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 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.

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 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 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 and adolescents.

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 (two doses at the same time) 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 or pharmacist.

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4 Possible side effects	effects you can help provide more information on the safety of this medicine.
Like all medicines, this medicine can cause side effects, although not everybody gets them.	5 How to store Anastrozole
Very common side effects (may affect more than 1 in 10 people)	Keep this medicine out of the sight and reach of
• Headache	children. Keep your tablets in a safe place where
• Hot flushes	children cannot see or reach them. Your tablets could
• Feeling sick (nausea) • Skin rash	harm them.
• Pain or stiffness in your joints	Do not use this medicine after the expiry date which is
• Inflammation of the joints (arthritis)	stated on the carton]. The expiry date refers to the last
• Feeling weak • Bone loss (osteoporosis).	day of that month.
	[PVC/aluminium blister]
Common side effects (may affect up to 1 in 10	This medicinal product does not require any special
people) • Loss of appetite	storage conditions.
• Raised or high levels of a fatty substance known as	[HDPE container]
cholesterol in your blood. This would be seen in a blood test	Do not store above 30°C.
• Feeling sleepy • Carpal tunnel syndrome (tingling, pain, coldness,	Keep your tablets in the container they came in.
weakness in parts of the hand)	Do not throw away medicines via wastewater or
• Diarrhoea	household waste. Ask your pharmacist how to throw
• Being sick (vomiting)	away medicines you no longer use. These measures
• Changes in blood tests that show how well your liver	will help to protect the environment.
is working • Thinning of your hair (hair loss) • Allergic (hypersensitivity) reactions including face, lips, or tongue • Bone pain • Vaginal dryness	Contents of the pack and other information
• Bleeding from the vagina (usually in the first few	What Anastrozole contains
weeks of treatment - if the bleeding continues, talk to your doctor)	The active substance is anastrozole.
• Muscle pain.	One film-coated tablet contains 1 mg anastrozole.
Uncommon side effects (may affect up to 1 in 100	The other ingredients are:
people)	• Tablet core: lactose monohydrate, cellulose
• Changes in special blood tests that show how your	microcrystalline, sodium starch glycollate type A,
liver is working (gamma-GT and bilirubin)	magnesium stearate, silica colloidal anhydrous,
• Inflammation of the liver (hepatitis) • Hives or nettle rash	hydroxypropylcellulose
• Trigger finger (a condition in which your finger or	• Tablet coating: Opadry II white: lactose
thumb catches in a bent position)	monohydrate, hypromellose, macrogol 4000,
• Increased amounts of calcium in your blood. If you	titanium dioxide E171.
experience nausea, vomiting and thirst, you should tell your doctor, or pharmacist or nurse as you may	What Anastrozole looks like and contents of the
need to have blood tests.	pack Anastrozole is a white, round and biconvex film-coated
Rare side effects (may affect up to 1 in 1,000	tablet with embossment “A1” on one side and
people)	available in PVC/aluminium blister packs or HDPE
• Rare inflammation of your skin that may include red	containers containing 7, 10, 14, 20, 28, 30, 50, 56, 60,
patches or blisters	84, 90, 98 or 100 film-coated tablets.
• Skin rash caused by hypersensitivity (this can be from allergic or anaphylactoid reaction) • Inflammation of the small blood vessels causing red	Not all pack sizes may be marketed.
or purple colouring of the skin. Very rarely	Marketing Authorisation Holder and Manufacturer
symptoms of joint, stomach, and kidney pain may	Marketing Authorisation Holder
occur; this is known as ‘Henoch-Schonlein purpura’.	Sandoz Ltd, Frimley Business Park, Frimley,
Very rare side effects (may affect up to 1 in 10,000	Camberley, Surrey, GU16 7SR, UK.
people) • An extremely severe skin reaction with ulcers or	Manufacturer
blisters on the skin. This is known as	Salutas Pharma GmbH
‘Stevens-Johnson syndrome’	Otto-von-Guericke-Alle 1, 39179 Barleben,
• Allergic (hypersensitivity) reactions with swelling of	Germany
the throat that may cause difficulty in swallowing or breathing. This is known as ‘angioedema’.	or
If any of these happen to you, call an ambulance or	Lek Pharmaceuticals d.d.
see a doctor straight away - you may need urgent	Verovskova 57, 1526 Ljubljana,
medical treatment.	Slovenia.
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.	This leaflet was last revised in 10/2013.
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 (www.mhra.gov.uk/yellowcard). By reporting side	000000
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