Anastrozole Zentiva

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PATIENT LEAFLET: INFORMATION FOR THE USER

Anastrozole Zentiva 1 mg film-coated tablets

Equivalent 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Anastrozolo Zentiva is and what it is used for

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

2. What you should know before taking Anastrozole Zentiva

Do not take Anastrozole Zentiva:

• 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, breastfeeding and fertility").

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

• if you are still having menstrual periods and have not yet reached menopause;

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• if you are taking a medicine containing tamoxifen or medicines containing estrogens (see section "Other medicines and Anastrozole Zentiva");
• 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 Zentiva. If you are admitted to hospital, inform medical staff that you are taking Anastrozole Zentiva.

For individuals engaged in sports, using this medicine without a therapeutic need constitutes doping and
may lead to a positive anti-doping test.
Other medicines and Anastrozole Zentiva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines. This includes medicines purchased without a prescription and
herbal medicines. Anastrozole Zentiva may affect how some medicines work, and some medicines may affect Anastrozole Zentiva.
Do not take Anastrozole Zentiva 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 proper action of Anastrozole Zentiva.
• 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 gynaecological conditions and infertility.

Pregnancy, breastfeeding and fertility
Do not take Anastrozole Zentiva if you are pregnant or breastfeeding.
Stop taking Anastrozole Zentiva if you become pregnant and speak to your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
It is unlikely that Anastrozole Zentiva will affect your ability to drive or operate
machinery. However, some people may occasionally experience weakness or
drowsiness while taking Anastrozole Zentiva. If this occurs, consult your
doctor or pharmacist.
Anastrozole Zentiva contains lactose and sodium
Anastrozole Zentiva contains lactose, a type of sugar. If your doctor has diagnosed you
with an intolerance to certain sugars, consult your doctor before taking this medicine.
Anastrozole Zentiva contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially “sodium-free”.

3. How to take Anastrozole Zentiva

Take this medicine exactly as your doctor or pharmacist has told you.
If you are unsure, consult your doctor or pharmacist.
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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 Zentiva before, with or after food.

Continue taking Anastrozole Zentiva for the duration indicated by your doctor or pharmacist.
This is a long-term treatment and you may need to take it for several years.
Use in children and adolescents
Anastrozole Zentiva must not be given to children and adolescents.
If you take more Anastrozole Zentiva than you should
If you take more Anastrozole Zentiva than you should, inform your doctor immediately.
If you forget to take Anastrozole Zentiva
If you forget to take a dose, take the next dose as usual.
Do not take a double dose (two doses at the same time) to make up for a forgotten tablet.
If you stop taking Anastrozole Zentiva
Do not stop taking the tablets, even if you feel well, 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.
Stop taking Anastrozole Zentiva and seek urgent medical attention
if you experience any of the following serious but very rare side effects:

• A very severe skin reaction, with ulcers or blisters appearing on the skin. This is known as “Stevens-Johnson syndrome”.
• An allergic reaction (hypersensitivity) with swelling of the throat, which may cause difficulty swallowing or breathing. This is known as “angioedema”.

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

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

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

• Loss of appetite
• Increase or high 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)
• Tingling, numbness of the skin, loss or altered sense of taste
• Diarrhoea
• Feeling unwell (vomiting)
• Changes in blood tests related to liver function
• Hair thinning (hair loss)
• Allergic reactions (hypersensitivity) affecting the face, lips and tongue
• Bone pain
• Muscle pain
• Vaginal dryness
• Vaginal bleeding (usually during the first weeks of treatment – if bleeding continues, speak to your doctor)

Uncommon (may affect up to 1 in 100 people):

• High levels of calcium in the blood (hypercalcaemia)
• Changes in specific blood tests indicating liver function (gamma-GT and bilirubin)
• Inflammation of the liver (hepatitis)
• Skin redness or hives (urticaria)
• Trigger finger (a condition in which one of your fingers or your thumb locks in a bent position)

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

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

Effects on bones
Anastrozole Zentiva 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 assess these risks according to 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 www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Anastrozole Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack following the term
“Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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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 Zentiva contains

• The active substance is anastrozole. Each film-coated tablet contains 1 mg of anastrozole.
• The other components are in the tablet core: monohydrate lactose, sodium starch glycolate, povidone (E1201) and magnesium stearate (E572); in the tablet coating: macrogol 6000, hypromellose (E464), titanium dioxide (E171) and talc (E553b).

Description of the appearance of Anastrozolo Zentiva and pack sizes
Anastrozolo Zentiva is a white, round, film-coated tablet with the imprints “ANA” and “1” on one side and a diameter of 6.0 mm ± 0.3 mm.
Anastrozolo Zentiva is available in blisters in packs of 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100 or 300 tablets, and in hospital packs of 28, 50, 84, 98, 300 or 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturers
Marketing Authorisation Holder
Zentiva Italia S.r.l.
Via P. Paleocapa 7,
20121 Milano, Italy

Manufacturer:
Pharmacare Premium Limited
HHF003 Hal Far Industrial Estate
Birzebbugia, Malta, BBG 3000

This medicinal product is authorised in the European Economic Area Member States under the following names:
Italy: Anastrozolo Zentiva 1 mg film-coated tablets
Germany: Anastrozol Winthrop 1 mg filmtabletten
France: Anastrozole Zentiva 1 mg comprimé pelliculé
United Kingdom: Anastrozol 1 mg, film coated tablet