Apo-nastrol

Package Leaflet: Information for the Patient

Apo-Nastrol, 1 mg, Coated Tablets

Anastrozole

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

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

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

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

2. Important information before taking Apo-Nastrol

When not to take Apo-Nastrol

If any of the above situations apply to the patient, they should not take Apo-Nastrol. In case of doubts, consult a doctor or pharmacist.

Warnings and precautions

Before starting to take Apo-Nastrol, the patient should discuss it with their doctor or pharmacist:

In case of doubts, consult a doctor or pharmacist.
In case of hospitalization, the patient should inform the medical staff that they are taking Apo-Nastrol.

Apo-Nastrol and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This includes medicines that are available without a prescription and herbal medicines. Apo-Nastrol may affect the way some medicines work, and some medicines may affect Apo-Nastrol.
The patient should not take Apo-Nastrol if they are already taking one of the following medicines:

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

If the above situation applies to the patient, they should contact their doctor or pharmacist.
The patient should tell their doctor if:

• they are taking any medicine from the group of LHRH analogues, such as: gonadorelin, buserelin, goserelin, leuprorelin, tryptorelin. These are medicines used to treat breast cancer, certain gynecological diseases, and infertility.

Pregnancy and breastfeeding

Apo-Nastrol should not be taken during pregnancy and breastfeeding. The patient should stop taking Apo-Nastrol and consult their doctor if they become pregnant.
Before taking any medicine, the patient should consult their doctor or pharmacist.

Driving and using machines

It is unlikely that Apo-Nastrol will affect the patient's ability to drive or use machines. However, in patients taking Apo-Nastrol, cases of weakness and drowsiness have been observed. If this situation applies to the patient, they should contact their doctor or pharmacist.

Apo-Nastrol contains lactose

If the patient has been diagnosed with an intolerance to some sugars, they should contact their doctor before taking the 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 take Apo-Nastrol

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, consult a doctor or pharmacist.

• The recommended dose of Apo-Nastrol is one tablet once a day.
• The medicine should be taken regularly at the same time every day.
• The tablet should be swallowed whole and washed down with water.
• Apo-Nastrol can be taken with or without food.

Apo-Nastrol should be taken for as long as the doctor or pharmacist recommends. The treatment is long-term and may last for several years. In case of doubts, consult a doctor or pharmacist.

Use in children and adolescents

Apo-Nastrol should not be used in children and adolescents.

Overdose

In case of an overdose, the patient should immediately consult their doctor.

Missed dose

In case of a missed dose, the patient should take the next dose the following day at the usual time.
The patient should not take a double dose (two doses at the same time) to make up for the missed dose.

Stopping treatment

The patient should not stop taking Apo-Nastrol without consulting their doctor.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Apo-Nastrol can cause side effects, although not everybody gets them.

If the patient experiences any of the following serious but very rare side effects, they should stop taking Apo-Nastrol and immediately consult their doctor:

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

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

• Headache.
• Hot flashes.
• Nausea.
• Rash.
• Pain and stiffness in the joints.
• Arthritis (joint inflammation).
• Weakness.
• Osteoporosis (bone thinning)
• Depression.

Common side effects: may affect up to 1 in 10 people

• Loss of appetite.
• Increased cholesterol levels in the blood, as shown by blood tests.
• Drowsiness.
• Carpal tunnel syndrome (tingling, pain, coldness, weakness in the hand).
• Pins and needles, tingling, or numbness in the skin, loss of taste
• Diarrhea.
• Vomiting.
• Increased liver enzyme activity, as shown by blood tests.
• Thinning and hair loss.
• Allergic reactions (hypersensitivity) on the face, lips, tongue.
• Bone pain.
• Vaginal dryness.
• Vaginal bleeding (mainly observed in the first weeks of treatment - if bleeding persists, consult a doctor).
• Muscle pain.

Uncommon side effects: may affect up to 1 in 100 people

• Changes in blood test results related to liver function (increased gamma-GT and bilirubin levels in the blood).
• Hepatitis.
• Hives or rash.
• Trigger finger (difficulty bending and straightening fingers).
• Increased calcium levels in the blood. If nausea, vomiting, and thirst occur, the patient should inform their doctor, pharmacist, or nurse, as blood tests may be necessary.

Rare side effects: may affect up to 1 in 1000 people

• Inflammatory skin conditions, which may include red spots or peeling.
• 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, abdominal pain, kidney pain, known as Henoch-Schönlein purpura, may occur.

Effects on bones

Apo-Nastrol reduces estrogen levels in the blood and may cause a decrease in bone mineral density. Therefore, some patients may be at increased risk of bone fractures. The treating doctor will assess the existing risk in accordance with the guidelines for bone health in postmenopausal women. The patient should discuss the existing risk and possible treatment with their doctor.
If any of the side effects worsen or if the patient experiences any side effects not listed in the leaflet, they should inform their doctor or pharmacist.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: +48 22 49-21-301, fax: +48 22 49-21-309, website: https://smz.ezdrowie.gov.pl .
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Apo-Nastrol

The medicine should be stored out of 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 the month.
Store in a temperature below 25°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Apo-Nastrol contains

• The active substance of the medicine is anastrozole. One coated tablet contains 1 mg of anastrozole.
• The other ingredients are: lactose monohydrate, povidone K 30, sodium carboxymethylcellulose 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 authorization holder and manufacturer

Marketing authorization holder:
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lok. 27
01-909 Warsaw
Poland
Manufacturer:
Doppel Farmaceutici S.R.L.
Via Martíri Delle Foibe 1
29016 Cortemaggiore (PC)
Italy
Genepharm S.A.
18 Marathonos Ave
15351 Pallini (Attiki)
Greece
To obtain more detailed information on the medicine and its names in the Member States of the European Economic Area, the patient should contact the marketing authorization holder.

Date of last revision of the leaflet: 04.2021