Egistrozol

Package leaflet: Information for the user

Egistrozol, 1 mg, film-coated tablets
Anastrozolum
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.
• Please contact your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for you personally. 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, tell your doctor. See section 4.

Contents of the leaflet

1. What Egistrozol is and what it is used for
2. What you need to know 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 Egistrozol is and what it is used for

Egistrozol 1 mg film-coated tablets contain an active substance called anastrozole. It belongs to a group of medicines known as aromatase inhibitors. Egistrozol is used in the treatment of breast cancer in postmenopausal women.
Egistrozol works by reducing the amount of a hormone produced by the body called estrogen. This occurs by inhibiting the action of a substance (an enzyme) called aromatase.

2. Important information before using Egistrozol

When not to take Egistrozol

• if the patient is allergic to anastrozole or any of the other ingredients of this medicine.
• if the patient is pregnant or breastfeeding (see "Pregnancy, breastfeeding and fertility").

If any of the situations listed above apply to the patient, Egistrozol must not be used.
If in doubt, consult a doctor or pharmacist before taking this medicine.

Warnings and precautions

Before taking Egistrozol, consult the treating doctor:

• if the patient is still menstruating (has not yet reached menopause),
• if the patient is taking a medicine containing tamoxifen or medicines containing estrogens (see "Egistrozol and other medicines"),
• if the patient has ever been diagnosed with a condition affecting bone strength (osteoporosis),
• if the patient has kidney or liver disease.

If the patient is unsure whether any of the above situations apply, she should consult a doctor or pharmacist before taking Egistrozol. If hospitalised, inform the medical staff that this medicine is being taken.

Egistrozol and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
This is because Egistrozol may affect the action of other medicines. Likewise, certain medicines may affect the action of Egistrozol.

Do not take Egistrozol if the patient is already taking any 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 this applies to the patient, consult a doctor or pharmacist.

Tell the doctor if:

• the patient is taking any medicine belonging to the group of LHRH analogues, e.g.: gonadorelin, buserelin, goserelin, leuprorelin, tryptorelin. These medicines are used in the treatment of breast cancer, certain gynaecological conditions, and infertility.

Pregnancy, breastfeeding and fertility

Egistrozol must not be used during pregnancy or while breastfeeding. Treatment with Egistrozol must be discontinued and a doctor consulted if pregnancy occurs.
Before taking any medicine, consult a doctor or pharmacist.

Driving and operating machinery

It is unlikely that Egistrozol impairs the ability to drive or operate machinery. However, weakness and drowsiness have been observed in some patients taking Egistrozol. If this applies to the patient, consult a doctor or pharmacist.

Egistrozol contains lactose and sodium

This medicine contains lactose (a type of sugar). If the patient has previously been diagnosed with an intolerance to certain sugars, she should consult her doctor before taking this medicine.

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

3. How to take Egistrozol

Egistrozol should always be taken as directed by the physician. In case of doubts, contact your doctor.

• The recommended dose is 1 tablet once daily.
• Tablets should be taken regularly, at the same time each day.
• The tablet should be swallowed whole with water.
• Egistrozol may be taken before, during, or after a meal.

Egistrozol should be taken for as long as prescribed by the doctor. Treatment is long-term and may last several years.

Use in children and adolescents
Egistrozol must not be used in children and adolescents.

Accidental overdose of Egistrozol
In case of an overdose, seek immediate medical advice from a physician.

Missed dose of Egistrozol
If a dose is missed, take the next dose at the usual time the following day. Do not take a double dose to make up for the missed dose.

Stopping treatment with Egistrozol
Do not stop taking Egistrozol without consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Egistrozol may cause adverse reactions, although not everyone experiences them.
Treatment with Egistrozol must be discontinued and medical advice must be sought immediately if the patient experiences any of the following severe but very rare adverse reactions
(may occur in up to 1 in 10,000 people):

• extremely severe skin reactions with skin ulceration or blistering, known as Stevens-Johnson syndrome.
• allergic (hypersensitivity) reactions with throat swelling, which may cause difficulty swallowing or breathing, known as angioedema.

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

• headache
• hot flushes
• nausea
• rash
• joint pain and stiffness
• arthritis
• fatigue
• bone demineralization (osteoporosis)

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

• loss of appetite
• increased serum cholesterol levels (shown in blood tests)
• drowsiness
• carpal tunnel syndrome (tingling, pain, coldness, weakness in part of the hand)
• skin tingling, numbness, or loss of taste sensation
• diarrhoea
• vomiting
• increased liver enzyme activity shown in blood tests
• hair thinning (hair loss)
• allergic (hypersensitivity) reactions affecting the face, mouth, or tongue
• bone pain
• vaginal dryness
• vaginal bleeding (observed mainly during the first weeks of treatment – if bleeding persists, contact your doctor)
• muscle pain

Uncommon (may affect up to 1 in 100 people):

• changes in blood test results indicating liver function (increased gamma-GT activity and increased serum bilirubin concentration)
• hepatitis
• urticaria
• trigger finger (difficulty bending and straightening fingers)
• increased blood calcium levels. If nausea, vomiting, and excessive thirst occur, contact your doctor, as blood tests may be required.

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

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

Frequency not known (frequency cannot be estimated from available data):

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

Effect on bones
Egistrozol reduces estrogen levels in the blood and may cause decreased bone density.

mineral density of bones. Therefore, due to weakening of the bones, in some patients the risk of fractures may increase. To reduce the risk of fractures, the treating physician will implement treatment according to guidelines for postmenopausal women. The risk and treatment options should be discussed with the physician.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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 .
Reporting adverse reactions enables further information on the safety of the medicine to be collected.

5. How to store Egistrozol

No special precautions for storage are required.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box following
EXP. The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via the sewage system or in household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures 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: monohydrate lactose, sodium carboxymethyl starch (type A), povidone (K-31) (E1201), magnesium stearate (E572).
• Coating: Opadry (Y-1-7000) white: polyethylene glycol, hypromellose (E464), titanium dioxide (E171).

What Egistrozol looks like and contents of the pack
White, round, biconvex coated tablets marked with "ANA" and "1" on one side.
Egistrozol is available in blister packs containing 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100 or 300 tablets, and in hospital packs containing 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
The 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