Egistrozol

Package Leaflet: Information for the User

Egistrozol, 1 mg, coated tablets

Anastrozole

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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 any not listed in this leaflet, please tell your doctor. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Egistrozol and what is it used for

Egistrozol 1 mg coated tablets contain the active substance anastrozole. It belongs to a group of medicines called aromatase inhibitors. Egistrozol is used for the treatment of breast cancer in postmenopausal women.
Egistrozol works by reducing the amount of the hormone estrogen produced by the body. This is achieved by blocking the action of an enzyme called aromatase.

2. Important information before taking Egistrozol

When not to take Egistrozol

If any of the above applies to you, do not take Egistrozol. If you are in doubt, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Before taking Egistrozol, consult your doctor:

Egistrozol and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about any medicines you plan to take.
This is because Egistrozol may affect the action of other medicines. Also, some medicines may affect the action of Egistrozol.
Do not take Egistrozol if you are already taking one of the following medicines:

• certain medicines used to treat breast cancer (selective estrogen receptor modulators), e.g. medicines containing tamoxifen, as Egistrozol may stop working properly;
• medicines containing estrogen, such as hormone replacement therapy (HRT). If the above applies to you, consult your doctor or pharmacist.

Tell your doctor if:

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

Pregnancy, breastfeeding and fertility

Do not take Egistrozol during pregnancy and breastfeeding. Stop taking Egistrozol 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 Egistrozol will affect your ability to drive or use machines. However, some people taking Egistrozol have experienced weakness and drowsiness. If this applies to you, consult your doctor or pharmacist.

Egistrozol contains lactose and sodium

The medicine contains lactose (a type of sugar). If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which is considered to be essentially "sodium-free".

3. How to take Egistrozol

Always take Egistrozol exactly as your doctor has told you. If you are in doubt, consult your doctor.

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

Take Egistrozol for as long as your doctor has told you. The treatment is long-term and may last for several years.

Use in children and adolescents

Egistrozol should not be used in children and adolescents.

If you take more Egistrozol than you should

If you have taken more than the prescribed dose, consult your doctor immediately.

If you forget to take Egistrozol

If you miss a dose, take the next dose the following day at the usual time.
Do not take a double dose to make up for the missed dose.

If you stop taking Egistrozol

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

4. Possible side effects

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

Stop taking Egistrozol and immediately contact your doctor if you experience any of the following serious but very rare side effects (may affect up to 1 in 10,000 people):

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

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

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

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

• loss of appetite
• increased cholesterol levels in the blood (shown by blood tests)
• drowsiness
• carpal tunnel syndrome (tingling, pain, coldness, weakness in the hand)
• tingling, numbness or prickling sensation of the skin, loss of taste
• diarrhea
• vomiting
• increased liver enzyme activity shown by blood tests
• 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 (may affect up to 1 in 100 people):

• changes in blood test results showing liver function (increased gamma-GT and bilirubin levels in the blood)
• liver inflammation
• hives
• trigger finger (difficulty bending and straightening fingers)
• high levels of calcium in the blood. If you experience nausea, vomiting, and increased thirst, consult your doctor, as blood tests may be necessary.

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

• inflammatory skin conditions, which may include red spots or blisters
• skin rashes caused by hypersensitivity (due to allergy or anaphylactoid reaction)
• inflammation of small blood vessels, causing purple discoloration of the skin. Very rarely, joint pain, stomach pain, kidney pain, known as Henoch-Schönlein purpura, may occur.

Frequency not known (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)
• Tendon rupture (tear in the tendon)
• Memory impairment

Effect on bones

Egistrozol reduces the level of estrogen in the blood and may cause a decrease in bone mineral density. This may increase the risk of fractures in some patients. To reduce the risk of fractures, your doctor will treat you according to the guidelines for postmenopausal women. Discuss the risk and treatment options with your doctor.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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.

5. How to store Egistrozol

No special precautions for storage are necessary.
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Egistrozol contains

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

• tablet core: lactose monohydrate, sodium carboxymethylcellulose (type A), povidone (K-31) (E1201), magnesium stearate (E572).
• coating: Opadry (Y-1-7000) white: macrogol, hypromellose (E464), titanium dioxide (E171).

What Egistrozol looks like and contents of the pack

White, round, biconvex coated tablets marked "ANA" and "1" on one side.
Egistrozol is available in blisters of 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100 or 300 tablets and hospital blisters of 28, 50, 84, 98, 300 or 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Egis Pharmaceuticals PLC
Keresztúri út 30-38.
1106 Budapest
Hungary

Manufacturers:

Synthon BV
Microweg 22
6545 CM Nijmegen
Netherlands
Synthon Hispania, S.L.
C/Castelló, 1
Polígono Las Salinas
08830 Sant Boi de Llobregat
Barcelona
Spain
Egis Pharmaceuticals PLC
Bökényföldi út 118-120.
1165 Budapest
Hungary

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Bulgaria
Egistrozol 1 mg film-coated tablets
Егистрозол 1 mg филмирани таблетки
Czech Republic
Egistrozol
Netherlands
Egistrozol 1 mg, filmomhulde tabletten
Poland
Egistrozol
Slovakia
Egistrozol 1 mg filmom obalené tablety
Hungary
Anabrest filmtabletta
Date of last revision of the package leaflet:01.07.2025