Antabrest

Package leaflet: Information for the user

ANTABREST 1 mg film-coated tablets

anastrozole
Generic medicine
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, pharmacist or nurse.
• 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 effects, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What ANTABREST is and what it is used for

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

2. What you need to know before taking ANTABREST

Do not take ANTABREST:

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

• you still have menstrual periods and have not yet reached menopause. If you have osteoporosis, or if you have previously suffered from any condition affecting bone strength. ANTABREST lowers levels of female hormones, which may lead to loss of bone mineral content and reduced bone strength. During treatment, you may undergo a test to measure bone density. Your doctor may prescribe a medicine to prevent or treat bone loss.
• you are taking a medicine containing tamoxifen or medicines containing estrogens (see section "Other medicines and ANTABREST"). if you have ever had a condition that may affect the strength of your bones (osteoporosis).
• 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 ANTABREST.
If you are admitted to hospital, inform medical staff that you are taking
ANTABREST.
Children and adolescents
Do not give this medicine to children as it is unlikely to be safe.
For those engaged in sports: using this medicine without a medical need
constitutes doping and may result in a positive anti-doping test.
Other medicines and ANTABREST
Inform your doctor or pharmacist if you are taking, or have recently taken, any
other medicines. This includes medicines you can buy without a prescription and herbal
medicines. This is because ANTABREST may affect how some medicines work, and some medicines may affect ANTABREST.
You must not take ANTABREST if you are taking any of the following medicines:

• Certain medicines used to treat breast cancer (selective estrogen receptor modulators), e.g., medicines containing tamoxifene. This is because these medicines can block the action of ANTABREST.
• Medicines containing estrogens, such as hormone replacement therapy (HRT).

If this applies to you, ask your doctor or pharmacist for advice.
Inform your doctor or pharmacist if you are taking the following medicines:
A medicine known as an “LHRH analogue”. This includes gonadorelin,
buserelin, goserelin, leuprorelin and triptorelin. These medicines are used in the
treatment of breast cancer, certain gynecological conditions, or infertility.
ANTABREST with food and drink
Food does not affect the absorption of ANTABREST.
Pregnancy and breastfeeding
Do not take ANTABREST if you are pregnant or breastfeeding. Discontinue
anastrozole if you become pregnant and consult your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines:
It is unlikely that ANTABREST will affect your ability to drive or operate
machinery. However, some patients may experience weakness or drowsiness
while taking ANTABREST. If you experience these symptoms, consult your
doctor or pharmacist.
ANTABREST contains lactose
ANTABREST 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.
ANTABREST contains Sodium:
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e.
essentially “sodium-free”.

3. How to take ANTABREST

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

• The recommended dose is one tablet daily.
• Swallow the tablet whole with a little water.
• Try to take the tablet at the same time each day.
• It does not matter whether you take anastrozole before, during, or after meals.

Continue taking ANTABREST for as long as your doctor or pharmacist instructs you to do so. 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
ANTABREST must not be given to children and adolescents.
If you take more ANTABREST than you should
If you take more ANTABREST than you should, contact your doctor immediately. If you take more ANTABREST than prescribed, or if someone else has taken ANTABREST, contact the Emergency Department of the nearest hospital. Bring any remaining tablets or the empty packaging with you for easier identification.
If you forget to take ANTABREST
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 ANTABREST
Do not stop taking the tablets unless instructed by your doctor.
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

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

• A very severe skin reaction with ulcers and blisters on the skin. This is known as “Stevens-Johnson syndrome”.
• Allergic reactions (hypersensitivity) with swelling of the throat which may make swallowing or breathing difficult. This is known as “angioedema”.

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

• Hot flushes.
• Feeling of weakness.
• Joint pain or stiffness.
• Inflammation of the joints (arthritis).
• Skin rash.
• Feeling unwell (nausea).
• Headache.
• Bone loss (osteoporosis).
• Depression.

Common (may affect up to 1 in 10 people)

• Vaginal dryness.
• Vaginal bleeding (usually during the first weeks of treatment; if bleeding persists, consult your doctor).
• Thinning of the hair (hair loss).
• Diarrhea.
• Loss of appetite.
• Increased or high levels of fat substances in the blood known as cholesterol. This may be detected by a blood test.
• Feeling unwell (vomiting).
• Drowsiness.
• Carpal tunnel syndrome (tingling, pain, cold sensation and weakness in the hands).
• Itching, tingling or numbness of the skin, loss or absence of taste.
• Changes in blood tests indicating how well your liver is functioning.
• Bone pain.
• Allergic reactions (hypersensitivity) involving the face, lips or tongue.
• Muscle pain.

Uncommon (may affect up to 1 in 100 people)

• Trigger finger (a condition in which your finger or thumb locks in a bent position).
• Changes in certain blood tests showing how your liver is working (Gamma-GT and bilirubin).
• Inflammation of the liver (hepatitis).
• Hives (urticaria).
• Increased levels of calcium in the blood. If you experience nausea, vomiting or thirst, inform your doctor, pharmacist or nurse, as you may need blood tests.

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

• Rare skin inflammation which may include red patches or blisters.
• Inflammation of small blood vessels causing red or purple skin discolouration. Very rare symptoms may occur in joints, stomach, and kidney pain; this is known as “Henoch-Schönlein purpura”.

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

• Dry eyes.
• 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
ANTABREST lowers the levels of the hormone called estrogen in the blood.
This may lead to a loss of bone mineral content. Bones may become weaker and more prone to fractures. Your doctor will address these risks in accordance with guidelines for managing bone health in women entering menopause. Discuss with your doctor the risks and available treatment options.
If any of the side effects worsen, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.
Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. 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 ANTABREST

• 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. These tablets could harm children.
• This medicine does not require any special storage conditions.
• Always return any unused medicine to the pharmacist. Keep it only if your doctor instructs you to do so.
• Do not use ANTABREST after the expiry date stated on the carton and blister after "Exp". The expiry date refers to the last day of that month.
• Keep the tablets in the container in which they were supplied.
• 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 ANTABREST contains:
The active substance is anastrozole. Each film-coated tablet contains 1 mg of anastrozole.
The other components are:
Tablet core: monohydrate lactose (95.250 mg), povidone K30, sodium starch glycolate (type A), magnesium stearate.
Film coating: titanium dioxide (E171), Macrogol 300, hypromellose E5.

Description of the appearance of ANTABREST and pack contents:
ANTABREST are film-coated tablets, white to off-white, round, biconvex, with "AHI" engraved on one side and smooth on the other.
ANTABREST tablets are available in blisters in packs of 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100 or 300 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:
Marketing Authorization Holder
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50, 95-200 Pabianice,
Poland
Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
The Netherlands
Accord Healthcare Single Member S.A.
64th Km National Road Athens, Lamia, 32009,
Greece