Atrozol

Package leaflet: Information for the patient

Atrozol, 1 mg, film-coated tablets
Anastrozolum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

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

Anastrozole, the active substance in Atrozol, belongs to a group of medicines called aromatase inhibitors. Anastrozole is used in the treatment of breast cancer in postmenopausal women.
Anastrozole inhibits the action of aromatase – an enzyme involved in the synthesis of female sex hormones, such as estrogens. This occurs through inhibition of a substance (enzyme) called aromatase.

2. Important information before using Atrozol

When not to use Atrozol

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

If any of the situations listed above apply, Atrozol must not be used.
If in doubt, consult a doctor or pharmacist.
Warnings and precautions
Before starting treatment with Atrozol, discuss with a doctor, pharmacist, or
nurse if:

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

If in doubt about any of the information above, consult a doctor or
pharmacist before taking Atrozol.
If hospitalised, inform medical staff that Atrozol is being taken.
Atrozol and other medicines
Inform the doctor about all medicines currently used or
used recently, as well as any medicines planned for future use. This includes also medicines
available without prescription and herbal preparations, because Atrozol may affect the way
certain medicines work, and certain medicines may affect the action of Atrozol.
Do not take Atrozol 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, because Atrozol may become ineffective;
• medicines containing estrogen, such as hormone replacement therapy (HRT). If this applies to the patient, contact a doctor or pharmacist.

Inform the doctor if:

• the patient is taking any medicine belonging to the group of LHRH analogues, such as: gonadorelin, buserelin, goserelin, leuprorelin, and triptorelin. These medicines are used in the treatment of breast cancer, certain gynecological conditions, and infertility. Pregnancy and breastfeeding Atrozol must not be used during pregnancy or breastfeeding. Treatment with Atrozol 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 Atrozol affects the ability to drive or operate machinery. However,
weakness and drowsiness have been observed in some patients taking anastrozole. If these symptoms occur, contact a doctor or
pharmacist.
Atrozol contains lactose monohydrate
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should
consult a doctor before taking this medicine.
Atrozol contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Atrozol

This medicine should always be taken exactly as directed by the physician or pharmacist. If in doubt,
consult your physician or pharmacist.

• The recommended dose of Atrozol is 1 tablet once daily.
• The medicine should be taken regularly, at the same time each day.
• The tablet should be swallowed whole with water.
• Atrozol may be taken before, during, or after food.

Atrozol should be taken for as long as directed by the physician. Treatment with Atrozol is long-term
and may last for several years. In case of doubt, consult your physician or pharmacist.
Use in children and adolescents
Atrozol must not be used in children and adolescents.
Taking more Atrozol than recommended
If you take more Atrozol than recommended, consult your physician immediately.
If you forget to take Atrozol
If you miss a dose, take the next dose at your usual time the following day. Do not take a double dose
(two doses at the same time) to make up for a missed dose.
Stopping Atrozol
Do not stop taking Atrozol without consulting your physician.
If you have any further questions about the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in every patient.
If any of the following severe but very rare adverse reactions occur in the patient, administration of Atrozol must be discontinued immediately and the patient should urgently consult a doctor:

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

Very common (in more than 1 in 10 patients):

• headache
• hot flushes
• nausea
• rash
• joint pain or stiffness
• arthritis
• fatigue
• bone demineralization (osteopor游戏副本

5. How to store Atrozol

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

6. Contents of the packaging 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 carboxymethyl starch, magnesium stearate.
  Coating ingredients: polyvinyl alcohol, titanium dioxide (E 171), talc, macrogol, quinoline yellow, lac dye (E 104), yellow iron oxide (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 pack sizes:

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

Marketing authorisation 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]