Anastrozole Eugia

Package Leaflet: Information for the Patient

Anastrozole Eugia, 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.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• 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, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

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

1. What is Anastrozole Eugia and what is it used for

Anastrozole Eugia contains the active substance anastrozole. Anastrozole belongs to a group of medicines called aromatase inhibitors. Anastrozole Eugia is used to treat breast cancer in post-menopausal women.
Anastrozole Eugia works by blocking the enzyme aromatase, which is involved in the production of female sex hormones, such as estrogen. This leads to a reduction in estrogen levels in the body.

2. Important information before taking Anastrozole Eugia

When not to take Anastrozole Eugia

• If you are allergic (hypersensitive) to anastrozole or any of the other ingredients of this medicine (listed in section 6)
• If you are pregnant or breastfeeding (see section "Pregnancy and breastfeeding").

If any of the above applies to you, do not take Anastrozole Eugia. If you are in doubt, consult your doctor or pharmacist.

Warnings and precautions

• If you are still having menstrual periods and have not yet reached menopause
• If you are taking a medicine that contains tamoxifen or estrogen (see section "Anastrozole Eugia and other medicines")
• If you have a history of osteoporosis (a condition that affects bone density)
• If you have liver or kidney disease.

If you are in doubt about any of the above, consult your doctor or pharmacist before taking Anastrozole Eugia.
If you are admitted to hospital, tell the medical staff that you are taking Anastrozole Eugia.

Anastrozole Eugia and other medicines

Tell your doctor about all the medicines you are taking, or have recently taken, including those obtained without a prescription and herbal products, as Anastrozole Eugia may affect the way some medicines work, and some medicines may affect the way Anastrozole Eugia works.
Do not take Anastrozole Eugia if you are already taking one of the following medicines:

• certain medicines used to treat breast cancer (selective estrogen receptor modulators), such as tamoxifen, as Anastrozole Eugia may not work properly
• medicines that contain estrogen, such as hormone replacement therapy (HRT). If this applies to you, consult your doctor or pharmacist.

Tell your doctor if:

• you are taking any medicine that belongs to the group of LHRH analogues, such as gonadorelin, buserelin, goserelin, leuprorelin, or triptorelin. These medicines are used to treat breast cancer, certain gynecological conditions, and infertility.

Pregnancy and breastfeeding

Do not take Anastrozole Eugia if you are pregnant or breastfeeding.
Stop taking Anastrozole Eugia and consult your doctor if you become pregnant.
Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines

Anastrozole Eugia is unlikely to affect your ability to drive or use machines. However, some people taking Anastrozole Eugia have experienced weakness and drowsiness. If you experience these symptoms, consult your doctor or pharmacist.

Anastrozole Eugia contains lactose

The medicine contains sugar (lactose monohydrate). If you have been told that you have an intolerance to some sugars, consult your doctor before taking Anastrozole Eugia.

Anastrozole Eugia contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per coated tablet, which is essentially "sodium-free".

3. How to take Anastrozole Eugia

Always take Anastrozole Eugia exactly as your doctor has told you. If you are in doubt, consult your doctor or pharmacist.

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

Take Anastrozole Eugia for as long as your doctor tells you to. The treatment is long-term and may last for several years. If you are in doubt, consult your doctor or pharmacist.

Use in children and adolescents

Anastrozole Eugia should not be used in children and adolescents.

Overdose of Anastrozole Eugia

If you take more Anastrozole Eugia than you should, contact your doctor immediately.

Missed dose of Anastrozole Eugia

If you miss a dose of Anastrozole Eugia, take the next dose at the usual time the next day.
Do not take a double dose (two doses at the same time) to make up for a missed dose.

Stopping treatment with Anastrozole Eugia

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

4. Possible side effects

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

If you experience any of the following serious but very rare side effects, stop taking Anastrozole Eugia and contact your doctor immediately:

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

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

• headache
• hot flashes
• nausea
• skin rash
• joint pain or stiffness
• arthritis
• weakness
• osteoporosis (bone thinning)
• depression.

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

• loss of appetite
• increased cholesterol levels in the blood (which may be seen in blood tests),
• drowsiness
• carpal tunnel syndrome (tingling, pain, numbness, or weakness in the hand)
• tingling, numbness, or prickling sensation in the skin, loss of taste
• diarrhea
• vomiting
• changes in liver function tests (liver enzyme levels)
• 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 liver function tests (liver enzyme levels: gamma-glutamyltransferase [gamma-GT] and bilirubin levels)
• hepatitis
• hives
• trigger finger (a condition where the finger or thumb catches or snaps when bent)
• increased calcium levels in the blood; if you experience nausea, vomiting, and increased thirst, consult your doctor or pharmacist, as blood tests may be necessary.

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

• inflammatory skin conditions with red patches or blisters
• skin rashes due to hypersensitivity (allergic reactions or anaphylactoid reactions)
• inflammation of small blood vessels, which can cause red or purple discoloration of the skin. Very rarely, this may be associated with joint pain, abdominal pain, kidney problems, known as Henoch-Schönlein purpura.

If you experience any of the above side effects, contact your doctor as soon as possible.

Effect on bones

Anastrozole Eugia reduces the levels of estrogen in the blood and may cause a reduction in bone mineral density. This can lead to a decrease in bone strength and an increased risk of bone fractures. Your doctor will take appropriate preventive and therapeutic measures to minimize these risks, in accordance with therapeutic guidelines for the prevention and treatment of bone problems in post-menopausal women. Discuss these risks and possible treatments for bone problems with your doctor.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product 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.
Side effects can also be reported to the marketing authorization holder.

5. How to store Anastrozole Eugia

Keep the medicine out of the sight and reach of children.
Do not take Anastrozole Eugia after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of the month.
There are no special storage requirements for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Anastrozole Eugia contains

• The active substance is anastrozole. Each coated tablet contains 1 mg of anastrozole.
• The other ingredients are: Core:lactose monohydrate, sodium carboxymethylcellulose (type A), povidone (K-30), magnesium stearate Coating (White colour):hypromellose 2910 (6mPas), titanium dioxide (E 171), macrogol
• 400.

What Anastrozole Eugia looks like and contents of the pack

Coated tablet
Anastrozole Eugia, 1 mg, coated tablets
White, biconvex, coated tablets with "A1" engraved on one side and smooth on the other side. The tablet size is approximately 6.1 mm
Anastrozole Eugia, coated tablets are available in blisters of transparent PVC/Aluminum, in a cardboard box.
Pack sizes:10, 28, 30, 50, 56, 60, 84, 90, 98, and 100 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Eugia Pharma (Malta) Ltd.
Vault 14, level 2
Valletta Waterfront
Floriana, FRN1914
Malta

Manufacturer/Importer:

APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A
Rua Jo ã o De Deus 19, Venda Nova
2700-487 Amadora
Portugal
Arrow Génériques
26 Avenue Tony Garnier
69007 Lyon
France

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

Portugal:
Anastrozol Generis
France:
ANASTROZOLE ARROW LAB 1 mg, comprimé pelliculé
Germany:
AnastroPUREN 1 mg Filmtabletten
Italy:
Anastrozolo Aurobindo Italia
Poland:
Anastrozole Eugia
Spain:
Anastrozol Aurovitas 1 mg comprimidos recubiertos con película EFG

Date of last revision of the leaflet: 10/2022