Atrozol

Package Leaflet: Information for the Patient

Atrozol, 1 mg, Film-Coated Tablets

Anastrozole

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Atrozol and What is it Used For
• 2. Important Information Before Taking Atrozol
• 3. How to Take Atrozol
• 4. Possible Side Effects
• 5. How to Store Atrozol
• 6. Contents of the Pack and Other Information

1. What is Atrozol and What is it Used For

Anastrozole, the active substance of Atrozol, belongs to a group of medicines called aromatase inhibitors. Anastrozole is used for the treatment of breast cancer in post-menopausal women. Anastrozole blocks the action of aromatase, an enzyme involved in the synthesis of female sex hormones, such as estrogens. This happens as a result of the inhibition of the action of the substance (enzyme) called aromatase.

2. Important Information Before Taking Atrozol

When Not to Take Atrozol

• if you are allergic to anastrozole or any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or breastfeeding (see section "Pregnancy and Breastfeeding").

If any of the above applies to you, do not take Atrozol. If you are in doubt, consult your doctor or pharmacist.

Warnings and Precautions

Before starting to take Atrozol, discuss it with your doctor, pharmacist, or nurse if:

• you are still having menstrual periods (have not yet reached menopause);
• you are taking a medicine that contains tamoxifen or medicines that contain estrogens (see "Atrozol and Other Medicines");
• you have ever been found to have a condition that affects bone density (osteoporosis);
• you have kidney or liver disease.

If you are in doubt about any of the above information, consult your doctor or pharmacist before taking Atrozol. If you are admitted to hospital, inform the medical staff that you are taking Atrozol.

Atrozol and Other Medicines

Tell your doctor about all the medicines you are taking now or have taken recently, and about any medicines you plan to take. This includes medicines that are available without a prescription and herbal preparations, as Atrozol may affect the way some medicines work, and some medicines may affect the way Atrozol works. Do not take Atrozol if you are already taking any of the following medicines:

• certain medicines used to treat breast cancer (selective estrogen receptor modulators), such as tamoxifen-containing medicines, as Atrozol may stop working properly;
• medicines that contain estrogen, such as hormone replacement therapy (HRT). If this applies to you, consult your doctor or pharmacist.

Tell your doctor if:

• you are taking any luteinizing hormone-releasing hormone (LHRH) analogues, such as gonadorelin, buserelin, goserelin, leuprorelin, or triptorelin. These are medicines used to treat breast cancer, certain gynecological conditions, and infertility.

Pregnancy and Breastfeeding

Do not take Atrozol if you are pregnant or breastfeeding. Stop taking Atrozol and consult your doctor if you become pregnant. Before taking any medicine, consult your doctor or pharmacist.

Driving and Using Machines

It is unlikely that Atrozol will affect your ability to drive or use machines. However, some people taking anastrozole have experienced weakness and drowsiness. If you experience these symptoms, consult your doctor or pharmacist.

Atrozol Contains Lactose Monohydrate

If you have been told that you have an intolerance to some sugars, consult your doctor before taking Atrozol.

Atrozol Contains Sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is considered to be essentially "sodium-free".

3. How to Take Atrozol

Take this medicine always exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

• The recommended dose of Atrozol is one tablet once a day.
• Take the medicine regularly, at the same time every day.
• Swallow the tablet whole with water.
• Atrozol can be taken before, during, or after food.

Take Atrozol for as long as your doctor has told you. Treatment with Atrozol is long-term and may last for several years. If you are in doubt, talk to your doctor or pharmacist.

Use in Children and Adolescents

Do not take Atrozol if you are under 18 years old.

Overdose

If you have taken more than the prescribed dose of Atrozol, contact your doctor immediately.

Missed Dose

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.

Stopping Treatment

Do not stop taking Atrozol without consulting your doctor. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Atrozol can cause side effects, although not everybody gets them.

If You Experience Any of the Following Serious but Very Rare Side Effects, Stop Taking Atrozol and Seek Urgent Medical Attention:

• severe skin reactions with blisters or peeling of the skin, known as Stevens-Johnson syndrome;
• allergic reactions (hypersensitivity) with swelling of the throat and tongue, which may cause difficulty in swallowing and breathing, known as angioedema.

Very Common (affects more than 1 in 10 people):

• headache
• hot flashes
• nausea
• rash
• joint pain or stiffness
• arthritis
• weakness
• bone thinning (osteoporosis)
• depression

Common (affects 1 to 10 people in 100):

• loss of appetite
• increased cholesterol levels (fats) in the blood (shown by blood tests)
• drowsiness
• carpal tunnel syndrome (tingling, pain, numbness, or weakness in the hand)
• tingling, numbness, or prickling sensation of the skin, loss of taste
• diarrhea
• vomiting
• changes in blood tests for liver function (liver enzyme levels)
• hair thinning (hair loss)
• allergic reactions (hypersensitivity) on the face, lips, tongue
• bone pain
• vaginal dryness
• vaginal bleeding (mainly in the first few weeks of treatment - if bleeding persists, consult your doctor)
• muscle pain

Uncommon (affects 1 to 10 people in 1,000):

• changes in blood tests for liver function (liver enzyme levels: gamma-glutamyltransferase [gamma-GT] and bilirubin levels);
• liver inflammation;
• hives;
• trigger finger (a condition where the finger or thumb clicks or locks when bent and is difficult to straighten);
• high levels of calcium in the blood; if you experience nausea, vomiting, and increased thirst, consult your doctor or pharmacist, as you may need to have blood tests.

Rare (affects 1 to 10 people in 10,000):

• inflammatory skin conditions where red patches or blisters appear
• skin rashes caused by hypersensitivity (allergic reactions or anaphylactoid reactions)
• inflammation of small blood vessels, causing red or purple discoloration of the skin. Very rarely, this may be associated with joint pain, stomach pain, and kidney pain, known as Henoch-Schönlein purpura.

Side Effects with Unknown Frequency (frequency cannot be estimated from the available data):

Dry eye syndrome
Lichenoid rash (small, red or purple, itchy bumps on the skin)
Tendinitis (inflammation of the tendon, the tissue that connects muscles to bones)
Tendon rupture (tearing of the tendon, the tissue that connects muscles to bones)
Memory impairment

Effects on Bone

Atrozol reduces the level of estrogen in the blood, which may lead to a reduction in bone mineral density. This may increase the risk of bone fractures. Your doctor will take appropriate preventive and therapeutic measures to minimize these risks, in line with therapeutic guidelines for the prevention and treatment of bone problems in post-menopausal women. Discuss these risks and the possibility of treating bone problems with your doctor.

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, you can help provide more information on the safety of this medicine. You can also report side effects to the marketing authorization holder.

5. How to Store Atrozol

Keep this medicine out of the sight and reach of children. Store in a temperature below 25°C. Do not use Atrozol after the expiry date stated on the packaging. The first two digits indicate the month, and the last four digits indicate the year. The expiry date refers to the last day of the month stated. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Pack and Other Information

What Atrozol Contains

• The active substance is anastrozole. One tablet contains 1 mg of anastrozole.
• The other ingredients are: lactose monohydrate, povidone, sodium carboxymethylcellulose, magnesium stearate. The coating contains: polyvinyl alcohol, titanium dioxide (E 171), talc, macrogol, quinoline yellow (E 104), iron oxide yellow (E 172).

What Atrozol Looks Like and Contents of the Pack

Atrozol is a yellow, film-coated tablet. The medicine is available in the following packs:

• 28 film-coated tablets in a plastic container, packaged in a cardboard box;
• 30 film-coated tablets in blisters, packaged in a cardboard box.

Marketing Authorization Holder and Manufacturer

Vipharm S.A.
ul. A. i F. Radziwiłłów 9
05-850 Ożarów Mazowiecki
tel.: +48 22 679 51 35
fax: +48 22 678 92 87
e-mail: [email protected]

Date of Last Revision of the Leaflet: 10.07.2025