Patient Information Leaflet

Apo-Nastrol, 1 mg, film-coated tablets
Anastrozole
Please read this leaflet carefully before taking this medicine, because it contains important information for you.

Keep this leaflet so that you can read it again if needed.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

What Apo-Nastrol is and what it is used for
Important information before taking Apo-Nastrol
How to take Apo-Nastrol
Possible side effects
How to store Apo-Nastrol
Contents of the pack and other information

1. What Apo-Nastrol is and what it is used for

Apo-Nastrol contains an active substance called anastrozole. Anastrozole belongs to a group of medicines known as aromatase inhibitors. Apo-Nastrol is used in the treatment of breast cancer in postmenopausal women.
Apo-Nastrol reduces the amount of a female sex hormone called estrogen produced in the body. This occurs by inhibiting the action of a substance (enzyme) called aromatase.

2. Important information before using Apo-Nastrol

When not to use Apo-Nastrol

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

If any of the situations listed above apply to the patient, Apo-Nastrol must not be used.
If in doubt, consult a doctor or pharmacist.
Warnings and precautions
Before starting Apo-Nastrol, discuss this with a doctor or pharmacist:

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 "Apo-Nastrol and other medicines"),
if the patient has any bone disorders (osteoporosis),
if the patient has kidney or liver disease.

If in doubt, consult a doctor or pharmacist.
If admitted to hospital, inform the medical staff that you are taking Apo-Nastrol.
Apo-Nastrol and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take. This includes medicines obtained without a prescription and herbal medicines. Apo-Nastrol may affect the way some medicines work, and some medicines may affect Apo-Nastrol.
Do not take Apo-Nastrol if you are already taking any of the following medicines:

certain medicines used to treat breast cancer (selective estrogen receptor modulators), e.g. medicines containing tamoxifen. Apo-Nastrol may stop working properly.
medicines containing estrogen, such as hormone replacement therapy (HRT).

If any of the above situations apply to you, contact your doctor or pharmacist.
Tell your doctor if:

you are taking any medicine belonging to the group of LHRH analogues, such as: gonadorelin, buserelin, goserelin, leuprorelin, triptorelin. These medicines are used in the treatment of breast cancer, certain gynecological conditions, and infertility.

Pregnancy and breastfeeding
Do not use Apo-Nastrol during pregnancy or while breastfeeding. Discontinue use of Apo-Nastrol and consult your doctor if you become pregnant.
Before taking any medicine, consult your doctor or pharmacist.
Driving and operating machinery
It is unlikely that Apo-Nastrol will impair the ability to drive or operate machinery. However, weakness and drowsiness have been observed in some patients taking Apo-Nastrol. If this applies to you, contact your doctor or pharmacist.
Apo-Nastrol contains lactose
If you have been previously diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.
Apo-Nastrol contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is essentially "sodium-free".
3. How to use Apo-Nastrol
This medicine should always be used exactly as prescribed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose of Apo-Nastrol is 1 tablet once daily.
The medicine should be taken regularly at the same time each day.
Swallow the tablet whole with water.
Apo-Nastrol may be taken with or without food.

Continue taking Apo-Nastrol for as long as your doctor or pharmacist recommends. Treatment is long-term and may last several years. If in doubt, speak to your doctor or pharmacist.
Use in children and adolescents
Apo-Nastrol should not be used in children or adolescents.
Taking more than the recommended dose of Apo-Nastrol
If you take more than the recommended dose, contact your doctor immediately.
Missed dose of Apo-Nastrol
If you miss a dose, take the next tablet 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 Apo-Nastrol
Do not stop taking Apo-Nastrol without consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If the patient experiences any of the following severe but very rare adverse effects, treatment with Apo-Nastrol must be discontinued immediately and urgent medical advice must be sought:

Extremely severe skin reactions with blisters and skin peeling. These are known as "Stevens-Johnson syndrome".
Allergic reactions (hypersensitivity) with swelling of the throat, which may cause difficulty in swallowing and breathing. Known as "angioedema".

Very common adverse effects: may affect more than 1 in 10 people

Headache
Hot flushes
Nausea
Rash
Joint pain and stiffness
Joint inflammation (arthritis)
Weakness
Bone demineralization (osteopor游戏副本

6. Contents of the pack and other information

What Apo-Nastrol contains

The active substance is anastrozole. One coated tablet contains 1 mg of anastrozole.
The other ingredients are: monohydrate lactose, povidone K 30, sodium carboxymethyl starch type A, magnesium stearate, hypromellose, titanium dioxide (E171), macrogol 6000, talc.

What Apo-Nastrol looks like and contents of the pack
Round, white coated tablets. The medicine is available in blisters containing 28 or 30 coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa Street 13D, loc. 27
01-909 Warsaw
Poland
Manufacturers:
Doppel Farmaceutici S.R.L.
Via Martíri Delle Foibe 1
29016 Cortemaggiore (PC)
Italy
Genepharm S.A.
18 Marathonos Ave
15351 Pallini (Attiki)
Greece
For further information about this medicine and its names in the countries of the European Economic Area, please contact the Marketing Authorisation Holder.