Anastrozole Teva

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Anastrozole Teva 1 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before taking this medicine because 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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Anastrozole Teva contains a substance called anastrozole, which belongs to a group of medicines known as "aromatase inhibitors". Anastrozole Teva is used for the treatment of breast cancer in postmenopausal women.
Anastrozole Teva works by reducing the amount of hormones called estrogens 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 Teva

Do not take Anastrozole Teva

• if you are allergic (hypersensitive) 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 Teva if any of the above apply to you. If in doubt,
consult your doctor or pharmacist before taking Anastrozole Teva.
Warnings and precautions
Talk to your doctor or pharmacist before taking Anastrozole Teva

• if you are still having menstrual periods and have not yet reached menopause.
• if you are taking a medicine containing tamoxifen or medicines containing estrogens (see section “Other medicines and Anastrozole Teva”).
• 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 Teva.
If you are admitted to hospital, inform medical staff that you are taking Anastrozole Teva.
For athletes: using this medicine without therapeutic need constitutes doping
and may lead to a positive anti-doping test.

Other medicines and Anastrozole Teva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines. This includes medicines that can be purchased without a prescription and herbal remedies. This is because Anastrozole Teva may affect how some medicines work, and some medicines may affect Anastrozole Teva.
Do not take Anastrozole Teva if you are already taking any of the following medicines:

• Certain medicines used to treat breast cancer (selective estrogen receptor modulators), for example medicines containing tamoxifen. This is because these medicines may interfere with the effectiveness of Anastrozole Teva.
• Medicines containing estrogens, for example hormone replacement therapy (HRT). If any of these apply 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”. This includes gonadorelin, buserelin, goserelin, leuprorelin and triptorelin. These medicines are used to treat breast cancer, certain gynecological conditions, and infertility.

Pregnancy and breastfeeding
Do not take Anastrozole Teva if you are pregnant or breastfeeding.
Stop taking Anastrozole Teva if you become pregnant and speak to your doctor.
Driving and using machines
It is unlikely that Anastrozole Teva will affect your ability to drive or operate
tools, machines or equipment. However, some people may occasionally feel weakness
or drowsiness while taking Anastrozole Teva. If this occurs, consult your doctor or pharmacist.
Anastrozole Teva contains lactose
Lactose is a type of sugar. If your doctor has diagnosed you with an intolerance to certain
sugars, contact him or her before taking this medicine.

3. How to take Anastrozole Teva

Take this medicine exactly as your doctor or
pharmacist has told you. If you are not sure, 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 Teva before, with or after food.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Very common side effects (may affect more than 1 in 10 people):

• Headache
• Hot flushes
• Feeling unwell (nausea)
• Skin rash
• Joint pain or stiffness
• Joint inflammation (arthritis)
• Feeling weak
• Loss of bone density (osteoporosis)

Common side effects (may affect up to 1 in 10 people):

• Loss of appetite
• Increase or elevated blood levels of a fatty substance known as cholesterol, detectable by a blood test
• Drowsiness
• Carpal tunnel syndrome (tingling, pain, cold sensation in parts of the hand)
• Diarrhoea
• Feeling unwell (vomiting)
• Changes in blood tests relating to liver function
• Hair thinning (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, discuss this with your doctor)
• Muscle pain

Uncommon side effects (may affect up to 1 in 100 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 in a bent position)
• Increased levels of calcium in the blood. If nausea, vomiting and thirst occur, inform your doctor or pharmacist, as blood tests may be needed.

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

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

Very rare side effects (may affect up to 1 in 10,000 people):

• Severe skin reaction, with ulcers or blisters appearing on the skin. This is known as “Stevens-Johnson syndrome”
• Allergic reaction (hypersensitivity) with swelling of the throat, which may cause difficulty swallowing or breathing. This is known as “angioedema”. If you experience any of these effects, call an ambulance or consult a doctor immediately – urgent medical treatment may be required.

Effects on bones
Anastrozolo Teva 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 Anastrozole Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer packaging after "EXP". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 Anastrozole Teva contains

• The active substance is anastrozole. Each film-coated tablet contains 1 mg of anastrozole.
• The other components are:

Description of the appearance of Anastrozole Teva and contents of the pack:

• Anastrozole Teva 1 mg film-coated tablets are round, white to off-white tablets. One side of the tablet is marked with the number “93”, the other side with “A10”.
• Anastrozole Teva 1 mg film-coated tablets are available in packs of 1, 14, 20, 28, 30 (3 x 10), 56, 60, 84, 90, 98, 100 and 300 tablets. Hospital packs of 84 tablets and hospital unit dose packs of 10 (10 x 1) and 50 (50 x 1) film-coated tablets are also available. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Italia S.r.l. – Via Messina 38 - 20154 Milano
Manufacturers
Teva Pharmaceutical Works Private Limited Company - Pallagi st. 13 - H-4042 Debrecen
(Hungary)
Teva Pharmaceutical Works Private Limited Company - Tàncsics Mihàly st. 82 –H- 2100
Gödöllő (Hungary)
Teva UK Ltd. - Brampton Road - Hampden Park – BN 22 9AG Eastbourne – East Sussex (United Kingdom)
Pharmachemie B.V. - Swensweg 5 – P.O. Box 552 - 2003 RN Haarlem (The Netherlands)
Teva Santé SA – Rue Bellocier – BP 713 – 89107 Sens Cedex (France)
Teva Czech Industries s.r.o. - Ostravská 29, č.p. 305, 74770 Opava-Komárov (Czech Republic)
Merckle GmbH - Ludwig-Merckle-Straße, 3 - 89143 Blaubeuren (Germany)
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