Anastrozole Aurobindo

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

Anastrozole Aurobindo 1 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. (See section 4.)

Contents of this leaflet:

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

1. What Anastrozole Aurobindo is and what it is used for

Anastrozole Aurobindo contains a substance called anastrozole, which belongs to a group
of medicines known as "aromatase inhibitors". Anastrozole Aurobindo is used for the treatment
of breast cancer in postmenopausal women.
Anastrozole Aurobindo works by reducing the amount of hormones called oestrogens produced
by the body. This occurs by blocking a natural substance (enzyme) in your body called "aromatase".

2. What you need to know before taking Anastrozole Aurobindo

Do not take Anastrozole Aurobindo

• if you are allergic to anastrozole or to any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant or breastfeeding (see section "Pregnancy and breastfeeding").

Do not take Anastrozole Aurobindo if any of the above apply to you. If in doubt,
consult your doctor or pharmacist before taking Anastrozole Aurobindo.
Warnings and precautions
Talk to your doctor or pharmacist before taking Anastrozole Aurobindo:

• if you still have menstrual periods and have not yet reached menopause.
• if you are taking a medicine containing tamoxifen or medicines containing oestrogens (see section "Other medicines and Anastrozole Aurobindo").
• if you have or have ever had a condition affecting bone strength (osteoporosis).
• if you have liver or kidney problems.

If you are unsure whether any of the above apply to you, consult your doctor or pharmacist before
taking Anastrozole Aurobindo.
If you are admitted to hospital, inform medical staff that you are taking Anastrozole
Aurobindo.
Other medicines and Anastrozole Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. This includes prescription and over-the-counter medicines and herbal
products. Anastrozole Aurobindo may affect how some medicines work, and some medicines may affect Anastrozole Aurobindo.
Do not take Anastrozole Aurobindo if you are already taking any of the following medicines:

• Certain medicines used to treat breast cancer (selective oestrogen receptor modulators), for example medicines containing tamoxifen. These medicines may interfere with the proper action of Anastrozole Aurobindo.
• Medicines containing oestrogens, for example hormone replacement therapy (HRT). If either of these applies to you, ask your doctor or pharmacist for advice.

Inform your doctor or pharmacist if you are taking the following:

• A medicine known as an “LHRH analogue”, such as gonadorelin, buserelin, goserelin, leuprorelin or triptorelin. These medicines are used to treat breast cancer, certain gynaecological conditions and infertility.

Pregnancy and breastfeeding
Do not take Anastrozole Aurobindo if you are pregnant or breastfeeding.
Stop taking Anastrozole Aurobindo if you become pregnant and speak to your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Anastrozole Aurobindo is unlikely to affect your ability to drive or use tools or machines. However, some people may occasionally feel weak or drowsy while taking Anastrozole Aurobindo. If this occurs, consult your doctor or pharmacist.
Anastrozole Aurobindo contains lactose
If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Anastrozole Aurobindo

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

• The recommended dose is one tablet once daily.
• Try to take the tablet at the same time each day.
• Swallow the tablet whole with a glass of water.
• It does not matter whether you take Anastrozole Aurobindo before, with, or after food.

Continue taking Anastrozole Aurobindo for the length of time prescribed by your doctor. This is a long-term treatment and may need to be taken for several years.
Use in children and adolescents
Anastrozole Aurobindo must not be given to children and adolescents.
If you take more Anastrozole Aurobindo than you should
If you take more Anastrozole Aurobindo than you should, inform your doctor immediately.
If you forget to take Anastrozole Aurobindo
If you forget to take a dose, take the next dose at the usual time.
Do not take a double dose (two doses at the same time) to make up for forgotten doses.
If you stop taking Anastrozole Aurobindo
Do not stop taking the tablets unless instructed by your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects:
If you experience any of the following serious side effects, call an ambulance or see a doctor immediately – you may need urgent medical treatment:

• A very severe skin reaction with the appearance of ulcers or blisters on the skin. This is known as ‘Stevens-Johnson syndrome’. Very rare (may affect fewer than 1 in 10,000 people);
• Allergic reaction (hypersensitivity) with swelling of the throat which may cause difficulty swallowing or breathing. This is known as ‘angioedema’. Very rare (may affect fewer than 1 in 10,000 people);

Other side effects:
Very common side effects (may affect more than 1 in 10 people)
Headache,
Hot flushes,
Feeling unwell (nausea),
Skin rash,
Pain or stiffness in the joints,
Inflammation of the joints (arthritis),
Feeling weak,
Loss of bone (osteoporosis).

Common side effects (may affect from 1 to 10 in 100 people)

• Loss of appetite.
• Increase or elevated levels in the blood of a fatty substance known as cholesterol, detectable by a blood test.
• Feeling drowsy.
• Carpal tunnel syndrome (tingling, pain, cold sensation in parts of the hand).
• Diarrhoea.
• Feeling unwell (vomiting).
• Changes in blood tests related to liver function.
• Thinning of hair (hair loss).
• Allergic reactions (hypersensitivity), including of the face, lips and tongue.
• Bone pain.
• Vaginal dryness.
• Vaginal bleeding (usually during the first weeks of treatment – if bleeding continues, talk to your doctor).

Uncommon side effects (may affect from 1 to 10 in 1,000 people)

• Changes in certain specific blood tests indicating liver function (gamma-GT and bilirubin).
• Inflammation of the liver (hepatitis).
• Urticaria (hives).
• Trigger finger (a condition in which a finger or thumb locks or catches in a bent position).

Rare side effects (may affect from 1 to 10 in 10,000 people)

• Unusual skin inflammation which may include red spots or blisters.
• Skin redness caused by hypersensitivity (this may be due to an allergic or anaphylactic reaction).
• Inflammation of small blood vessels causing red or purple skin discolouration. Joint, stomach and kidney pain may very rarely occur; this is known as “Henoch-Schönlein purpura”.

Effects on bones
Anastrozole reduces the amount of hormones called oestrogens in the body. This may reduce the mineral content of bones; therefore, bones may become weaker and more prone to fractures. Your doctor will monitor these risks in accordance with treatment guidelines for managing bone health in postmenopausal women. Please consult your doctor regarding these risks and treatment options.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at
http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Anastrozolo Aurobindo

Keep this medicine out of the sight and reach of children. Store the tablets in a safe place where children cannot see or reach them. The tablets may be dangerous for them.
This medicine does not require any special storage conditions.
Do not take Anastrozolo Aurobindo after the expiry date stated on the carton and blister pack 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 dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Anastrozolo Aurobindo contains

• The active substance is anastrozole. Each film-coated tablet contains 1 mg of anastrozole.
• The other excipients in the tablet core are monohydrate lactose, sodium starch glycolate, povidone (E1201) and magnesium stearate (E572). The excipients in the tablet coating are macrogol, hypromellose (E464) and titanium dioxide (E171).

Description of the appearance of Anastrozolo Aurobindo 1 mg and package contents
Anastrozolo Aurobindo 1 mg is a white, film-coated, round tablet marked with the characters
“ANA” and “1” on one side.
Anastrozolo Aurobindo is available in blisters containing 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100, 120
or 300 tablets, and in hospital blisters containing 28, 50, 84, 98, 300 or 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
AUROBINDO PHARMA (ITALIA) – Via San Giuseppe 102 – 21047 Saronno (Varese)

Manufacturer:
Synthon BV
Microweg 22
6545 CM Nijmegen (Netherlands)
Synthon Hispania, S.L.
C/Castelló, 1
Polígono Las Salinas
08830 Sant Boi de Llobregat
Barcelona (Spain)

This medicinal product is authorised in the European Economic Area countries under the
following names:
Austria Anastrozol Aurobindo 1 mg Filmtabletten
Belgium Anastrozol Aurobindo 1 mg tabletten
Czech Republic Anastrozol Aurobindo 1 mg
Denmark Anastrozol Aurobindo
Estonia Anastrozole Aurobindo
Finland Anastrozol Aurobindo 1 mg
Germany Anastrozol-Aurobindo 1 mg Filmtabletten
Greece Ansyn
Hungary Anaromat
Iceland Anastrozol Aurobindo
Ireland Anastrozole 1mg Film-coated Tablets
Italy Anastrozolo Aurobindo
Lithuania Anastrozole Aurobindo 1 mg plėvele dengtos tabletės
Luxembourg Anastrozol Aurobindo
Latvia Anastrozole Aurobindo 1 mg apvalkotās tabletes
Netherlands Anastrozol Aurobindo 1 mg
Poland Ansyn
Portugal Anastrozol Aurobindo 1 mg comprimidos revestidos por película
Romania Anaromat
Slovenia Ansyn 1 mg filmsko obložene tablete
Slovakia Ansyn 1 mg
Spain Anastrozol Aurobindo 1 mg comprimidos recubiertos con pelicula EFG
Sweden Anastrozol Aurobindo
United Kingdom Anastrozole 1mg Tablets

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