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Anastrozole 1 mg Film-coated Tablets

Active substance: anastrozole

Read all of this leaflet carefully before you start

taking this medicine.

•    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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed In this leaflet, please tell your doctor or pharmacist.

In this leaflet:

T| What Anastrozole Actavis 1 mg is and what it is used for

3 Before you take Anastrozole Actavis 1 mg 3 How to take Anastrozole Actavis 1 mg 3 Possible side effects _5| How to store Anastrozole Actavis 1 mg 3 Further information

3 WHAT ANASTROZOLE ACTAVIS 1 MG IS AND WHAT IT IS USED FOR

The growth of some breast cancers is stimulated or maintained by oestrogens (female sex hormone). Anastrozole belongs to a group of medicines called aromatase inhibitors. This means that it interferes with some of the actions of aromatase, an enzyme within the body which lowers the level of certain female sex hormones such as oestrogens.

Anastrozole is used to treat breast cancer in postmenopausal women.

3 BEFORE YOU TAKE ANASTROZOLE ACTAVIS 1 MG

Do not takeAnastrozole Actavis 1 mg

•    if you are allergic (hypersensitive) to anastrozole or

any of the other ingredients of Anastrozole Actavis 1 mg (see section 2, Important information about some of the ingredients of Anastrozole Actavis 1 mg and section 6, What Anastrozole Actavis 1 mg contains).

•    if you are pre-menopausal.

•    if you are pregnant.

•    if you are breast feeding.

•    if you suffer from a serious disorder or disease which affects your liver or kidneys

•    if you use tamoxifen (see section 2, Taking other medicines).

•    if you use oestrogen-containing medicines, for example hormone replacement therapy (see section 2, Taking other medicines).

Take special care with Anastrozole Actavis 1 mg

Anastrozole is not intended for pre-menopausal women or children.

Check if one of the warnings listed below applies to you or applied to you in the past. Consult your doctor immediately:

•    If you are unsure whether or not you have gone through menopause yet. Your doctor should check your hormone levels.

•    If you have a history of or are suffering from any condition which affects the strength of your bones. Anastrozole lowers the levels of female hormones and this may lead to a loss of the mineral content of bones, which might decrease their strength. You may have to have bone density tests during treatment. Your doctor can give you medicine to prevent or treat the bone loss.

•    If you use LHRH analogues (medicines to treat breast cancer, certain gynaecological conditions and infertility, such as goserelin). No studies have been done on the combination of LHRH analogues and anastrozole. Therefore, anastrozole and LHRH analogues should not be used in combination.

Taking other medicines

Other medicines may be affected by anastrozole. They, in turn, may affect how well anastrozole works. Anastrozole can interact with:

•    tamoxifen (a particular medicine used in breast cancer).

•    oestrogen-containing medicines, for example hormone replacement therapy.

These medicines can reduce the effect of anastrozole. These medicines should not be taken in combination with anastrozole (see section 2, Do not take Anastrozole Actavis 1 mg).

Please tell your doctor or pharmacist if you are taking or have recently taken any of the medicines listed above or any other medicines, including medicines obtained without a prescription.

Taking Anastrozole Actavis 1 mg with food and drink

Food and drink do not affect anastrozole.

Pregnancy and breast-feeding Anastrozole must not be used during pregnancy and breast-feeding. Contact your doctor immediately if you think you are pregnant.

Anastrozole is only used to treat breast cancer in postmenopausal women (see section 1, What Anastrozole Actavis 1 mg is and what it is used for, and section 2, Do not take Anastrozole Actavis 1 mg).

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

Driving and using machines

Anastrozole is unlikely to adversely affect your ability to drive a car or to operate machinery. However, you might occasionally feel weak or sleepy, in which case you should not drive or use any tools or machines.

Important information about some of the ingredients of Anastrozole Actavis 1 mg

Anastrozole tablets contain the milk sugar lactose. If you have been told by your doctor that you have an intolerance to some sugars, such as lactose, contact your doctor before taking this medicinal product.

J HOW TO TAKE ANASTROZOLE ACTAVIS 1 MG

Always take anastrozole exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

The usual dose is one tablet (1 mg anastrozole)taken once daily.

No dosage adjustment is required for elderly patients or for patients with mild liver or mild to moderate kidney problems. Patients suffering from a serious disorder or disease which affects the liver or kidneys should not take anastrozole.

Anastrozole is not intended for children.

If you take more Anastrozole Actavis 1 mg than you should

If you have taken more anastrozole than you should, contact your doctor or pharmacist immediately.

If you forget to take Anastrozole Actavis 1 mg

Do not take a double dose to make up for a forgotten tablet. Skip the missed dose and take the next tablet at the usual time.

If you stop taking Anastrozole Actavis 1 mg

Do not stop taking your tablets even if you are feeling well, unless your doctor tells you. Your doctor will advise you on how long you should continue to take your tablets. You may need to take it for 5 years.,

If you have any further questions on the use of this product, ask your doctor or pharmacist.

AAAB7816

J POSSIBLE SIDE EFFECTS

Like all medicines, anastrozole can cause side effects, although not everybody gets them.

Side effects can be:

•    Very common: affects more than 1 user in 10

•    Common: affects 1 to 10 users in 100

•    Uncommon: affects 1 to 10 users in 1,000

•    Rare: affects 1 to 10 users in 10,000

•    Very rare: affects less than 1 user in 10,000

•    Not known: frequency cannot be estimated from the available data

Serious allergic reactions

If any of the following happen to you, immediatley call an ambulance or see a doctor - you may need urgent medical treatment:

•    difficulty in breathing or dizziness (anaphylactoid reaction, a rare side effect),

•    swelling of the face or throat and problems with breathing (angioedema, the frequency of this side effect is not known),

•    an extremely severe skin reaction with ulcers or blisters on the skin, mouth, eyes and genitals, and even (high) fever and pain in the joints (Stevens-Johnson syndrome, the frequency of this side effect is not known).

Liver effects

The signs may include yellowing of your skin or eyes, dark coloured urine, a loss of appetite and a general feeling of being unwell (an uncommon side effect). If this happens to you, immediatley see a doctor - you may need medical tests or treatment.

Very common:

•    headache

•    hot flushes

•    feeling sick (nausea)

•    rash

•    pain or stiffness of the joints, inflammation of the joints (arthritis)

•    feeling weak or lack of energy Common:

•    thinning of the hair

•    vaginal dryness

•    vaginal bleeding (usually in the first few weeks of treatment - if the bleeding continues talk to your doctor)

•    loss of appetite

•    raised or high levels of fatty substance known as cholesterol in your blood. This would be seen in a blood test

•    sleepiness

•    Carpal Tunnel syndrome (tingling, pain, coldness, weakness in parts of the hand)

•    diarrhoea

•    being sick (vomiting)

•    changes in blood test that show how well your liver is working

•    skin and subcutaneous allergic reactions

•    bone pain

Uncommon:

•    hives (urticaria)

•    trigger finger (a condition in which your finger or thumb catches in a bend position)

Rare:

•    severe rash with spots that look like small targets (erythema multiforme)

Anastrozole lowers the levels of female hormones and this may lead to a loss of the mineral content of bones, which might decrease their strength (see section 2, Take special care with Anastrozole Actavis 1 mg). This can lead to bone fractures e.g. fractures of the spine, hip or wrist.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

J HOW TO STORE ANASTROZOLE ACTAVIS 1 MG

Keep out of the reach and sight of children.

This medicinal product does not require any special storage conditions.

Do not use anastrozole 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.

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.

FURTHER INFORMATION

What Anastrozole Actavis 1 mg contains

•    The active substance is anastrozole. One tablet contains 1 mg of anastrozole.

•    The other ingredients in the tablet core are lactose monohydrate, sodium starch glycolate, povidone (E1201), and magnesium stearate (E572).

The ingredients in the tablet coating are macrogol, hypromellose (E464), and titanium dioxide (E171).

What Anastrozole Actavis 1 mg looks like and contents of the pack

Anastrozole is a white film-coated round 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, 120 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:

Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjordur Iceland

Manufacturers:

Synthon BV Microweg 22 6545 CM Nijmegen The Netherlands

Synthon Hispania, S.L.

C/Castello, 1

Poligono Las Salinas

08830 Sant Boi de Llobregat

Barcelona

Spain

is authorised in the Member the following names:

Anastrozol Actavis 1 mg Filmtabletten Anastrozol Actavis 1 mg tabletten

Anastrozol Actavis 1 mg Anastrozol Actavis Anastrozole Actavis Anastrozol Actavis 1 mg Anastrozol-Actavis 1 mg Filmtabletten Ansyn Anaromat Anastrozol Actavis Anastrozole 1mg Film-coated Tablets Anastrozolo Actavis Anastrozole Actavis 1 mg plevele dengtos tabletes Anastrozol Actavis Anastrozole Actavis 1 mg apvalkotas tabletes Anastrozol Actavis 1 mg Anastrozol Actavis Ansyn

Anastrozol Actavis 1 mg comprimidos revestidos por pelicula Anaromat Ansyn 1 mg filmsko oblozene tablete Ansyn 1 mg

Anastrozol Actavis 1 mg comprimidos recubiertos con pelicula EFG Anastrozol Actavis Anastrozole 1mg Tablets

This leaflet was last revised in March 2011

Actavis