Anastrozole Aurobindo Italia

• Package leaflet: Information for the user

Anastrozole Aurobindo Italia 1 mg film-coated tablets

Generic medicine
Please read all of 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, contact your doctor or pharmacist (see section 4).
Contents of this leaflet:

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

1. What Anastrozolo Aurobindo Italia is and what it is used for

Anastrozolo Aurobindo Italia contains a substance called anastrozole, which belongs to a group of medicines known as "aromatase inhibitors". Anastrozolo Aurobindo Italia is used for the treatment of breast cancer in postmenopausal women.
Anastrozolo Aurobindo Italia 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 Aurobindo Italia

Do not take Anastrozole Aurobindo Italia

• 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 Italia if any of the above apply to you. If in doubt, consult your doctor or pharmacist before taking Anastrozole Aurobindo Italia.

Warnings and precautions

Talk to your doctor or pharmacist before taking Anastrozole Aurobindo Italia:

• 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 Aurobindo Italia");
• 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 Italia.

If you are admitted to hospital, inform medical staff that you are taking Anastrozole Aurobindo Italia.

Other medicines and Anastrozole Aurobindo Italia

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines without a prescription and herbal medicines. Anastrozole Aurobindo Italia may affect how some medicines work, and some medicines may affect Anastrozole Aurobindo Italia.

Do not take Anastrozole Aurobindo Italia 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, as they may interfere with the effectiveness of Anastrozole Aurobindo Italia.
• Medicines containing estrogens, for example hormone replacement therapy (HRT). If you are taking any of these, consult your doctor or pharmacist.

Tell your doctor or pharmacist if you are taking any of the following:

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

Pregnancy and breastfeeding

Do not take Anastrozole Aurobindo Italia if you are pregnant or breastfeeding. If you become pregnant while taking Anastrozole Aurobindo Italia, stop taking it immediately 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 Aurobindo Italia will affect your ability to drive or operate machinery. However, some people may occasionally experience weakness or drowsiness while taking Anastrozole Aurobindo Italia. If this occurs, consult your doctor or pharmacist.

Anastrozole Aurobindo Italia contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

Anastrozole Aurobindo Italia contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "sodium-free".

For athletes: Using this medicine without a therapeutic need constitutes doping and may lead to a positive anti-doping test.

3. How to take Anastrozole Aurobindo Italia

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Anastrozole Aurobindo Italia and seek urgent medical attention if you experience any of the following serious but very rare side effects:

• A very severe skin reaction with the appearance of ulcers or blisters on the skin. This is known as Stevens-Johnson syndrome.
• Allergic reaction (hypersensitivity) with swelling of the throat which may cause difficulty in swallowing or breathing. This is known as 'angioedema'.

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 of weakness
• Bone loss (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 sleepy
• Carpal tunnel syndrome (tingling, pain, cold sensation in parts of the hand)
• Itching, tingling or numbness of the skin, loss or absence of taste
• Diarrhoea
• Malaise (vomiting)
• Changes in blood tests relating to liver function
• Hair thinning (hair loss)
• Allergic reactions (hypersensitivity) affecting the face, lips and tongue
• Bone pain
• Vaginal dryness
• Vaginal bleeding (usually during the first weeks of treatment – if bleeding continues, speak to your doctor)
• Muscle pain

Uncommon (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).
• Hives (urticaria)
• Trigger finger (a condition in which a finger or thumb becomes locked in a bent position)
• Increased levels of calcium in the blood. If you experience nausea, vomiting and thirst, inform your doctor, pharmacist or nurse, as a blood test may be needed.

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

• Unusual skin inflammation which may include red spots or blisters
• Skin erythema caused by hypersensitivity (this may be due to 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 is known as “Henoch-Schönlein purpura”.

Not known (frequency cannot be estimated from the available data):

• Dry eye
• Lichenoid eruption (small itchy red or purple bumps on the skin)
• Inflammation of a tendon or tendinitis (connective tissue joining muscles to bones)
• Tendon rupture (connective tissue joining muscles to bones)
• Memory impairment.

Effects on bones
Anastrozole Aurobindo Italia reduces the amount of hormones called oestrogens in the body.
This may reduce the mineral content of bones. 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 available 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 https://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 Aurobindo Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister 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 Anastrozolo Aurobindo Italia contains

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

Tablet core: monohydrate lactose, sodium starch glycolate (type A), povidone (K-30) and
magnesium stearate.
Tablet coating: hypromellose 2910 (6 mPa·s), titanium dioxide (E171), macrogol 400

Description of the appearance of Anastrozolo Aurobindo Italia and pack contents
Film-coated tablet
Anastrozolo Aurobindo Italia 1 mg film-coated tablets
White, biconvex, film-coated tablet, marked “A1” on one side and smooth on the other.
The tablet size is 6.1 mm.
Anastrozolo Aurobindo Italia film-coated tablets are available in PVC-aluminum
blister packs.
Pack sizes: 10, 28, 30, 50, 56, 60, 84, 90, 98 and 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Eugia Pharma (Malta) Limited
Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1914, Malta

Manufacturer
APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000, Malta
Generis Farmacêutica, S.A.
Rua João de Deus, 19, Venda Nova, 2700-487 Amadora, Portugal
Arrow Generiques
26 Avenue Tony Garnier, 69007 Lyon, France

This medicinal product is authorized in the European Economic Area Member States under the following names:
France: Anastrozole Arrow Lab 1 mg, comprimé pelliculé
Germany: AnastroPUREN 1 mg Filmtabletten
Italy: Anastrozolo Aurobindo Italia
Poland: Anastrozole Eugia
Portugal: Anastrozol Generis
Spain: Anastrozol Aurovitas 1 mg comprimidos recubiertos con película EFG