Anastrozole Alter

Package leaflet: Information for the user

Anastrozolo Alter 1 mg film-coated tablets

Generic medicine
anastrozole
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, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

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

Do not take Anastrozolo Alter:

• 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 Anastrozolo Alter if any of the above apply to you. If in doubt,
consult your doctor or pharmacist before taking Anastrozolo Alter.
Warnings and precautions
Talk to your doctor or pharmacist before taking Anastrozolo Alter

• 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 Anastrozolo Alter").
• 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 Anastrozolo Alter.
If you are admitted to hospital, inform medical staff that you are taking Anastrozolo Alter.
For those engaged in sports activities
Using the medicine without therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.
Other medicines and Anastrozolo Alter
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines you can buy without a prescription and herbal remedies. Anastrozolo Alter may affect how some medicines work, and some medicines may affect Anastrozolo Alter.
Do not take Anastrozolo Alter 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 tamoxifene. This is because these medicines may prevent Anastrozolo Alter from working properly.
• medicines containing estrogens, for example, hormone replacement therapy (HRT). If you are taking any of these, ask your doctor or pharmacist for advice.

Tell 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, breastfeeding and fertility
Do not take Anastrozolo Alter if you are pregnant or breastfeeding.
Stop taking Anastrozolo Alter 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 Anastrozolo Alter will affect your ability to drive or operate tools or machinery. However, some people may occasionally feel weakness or drowsiness while taking Anastrozolo Alter. If this occurs, consult your doctor or pharmacist.
Anastrozolo Alter contains lactose
Anastrozolo Alter contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
Anastrozolo contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Anastrozole Alter

Take this medicine exactly as directed by your doctor or
pharmacist. 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 Alter before, with, or after food. Continue taking Anastrozole Alter for the entire period indicated 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 Alter must not be given to children or adolescents.
If you take more Anastrozole Alter than you should
If you take more Anastrozole Alter than prescribed, inform your doctor immediately.
If you forget to take Anastrozole Alter
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
dose.
If you stop taking Anastrozole Alter
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.
Stop taking Anastrozolo Alter and seek immediate medical attention
if you experience any of the following serious but very rare side effects:

• Severe skin reaction, with ulcers or blisters appearing on the skin. Known as “Stevens-Johnson syndrome”.
• Allergic reaction (hypersensitivity) with swelling of the throat, which may cause difficulty in swallowing or breathing. Known as “angioedema”.

Very common side effects (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 side effects (may affect up to 1 in 10 people)

• Loss of appetite
• Increase or elevated levels in the blood of a fatty substance known as cholesterol, detectable by a blood test
• Drowsiness
• Carpal tunnel syndrome (tingling, pain, cold sensation, weakness in parts of the hand)
• Itching, tingling or numbness of the skin, loss or absence of taste
• 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, pharmacist or nurse, 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 caused by hypersensitivity (this may be due to an allergic or anaphylactic reaction)
• Inflammation of the capillaries causing red or purple skin discolouration. Very rarely, joint, stomach and kidney pain may occur; known as “Henoch-Schönlein purpura”

Effects on bones
Anastrozolo Alter 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.
If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Reporting of side effects
If you experience any side effects, 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 Alter

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.
Do not use this medicine after the expiry date stated on the carton after "Exp".
The expiry date refers to the last day of the stated month.
Keep the tablets in the original packaging.
Do not dispose of any medicine 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 Alter contains

• The active substance is anastrozole. Each film-coated tablet contains 1 mg of anastrozole.
• The other components are: Tablet core: monohydrate lactose, maize starch, povidone K-30, microcrystalline cellulose pH102, sodium starch glycolate Type A, anhydrous colloidal silicon dioxide, magnesium stearate (E572), talc. Film coating: hypromellose 5cp (E464), macrogol 400, titanium dioxide (E171), talc.

Description of the appearance of Anastrozolo Alter and contents of the pack
Anastrozolo Alter tablets are white, round, film-coated tablets with a diameter of approximately 6.6 mm.
The tablets are available in blisters of 10 and 14 tablets.
Packs: 28 and 30 tablets.
Marketing Authorization Holder and Manufacturer:
Marketing Authorization Holder:
Laboratori Alter s.r.l.
via Egadi, 7
20144 Milano
Italy
Manufacturer:
Remedica Ltd.
Limassol Industrial Estate
Aharnon Street
P.O Box 51706
3508 Limassol
Cyprus