Anastrozole eugia

Package leaflet: Information for the patient

Anastrozole Eugia, 1 mg, coated tablets
Anastrozolum
Please read this entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are identical.
• If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

1. What Anastrozole Eugia is and what it is 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 Anastrozole Eugia is and what it is used for
Anastrozole Eugia contains an active substance called anastrozole. Anastrozole belongs to a group of medicines known as aromatase inhibitors. Anastrozole Eugia is used in the treatment of breast cancer in postmenopausal women.
Anastrozole Eugia 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 taking Anastrozole Eugia

When not to take Anastrozole Eugia

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

Do not take Anastrozole Eugia if any of the situations listed above apply to you. If in doubt, consult your doctor or pharmacist.
Warnings and precautions

• If you are still menstruating and have not yet reached menopause
• If you are taking a medicine containing tamoxifen or estrogen-containing medicines (see section "Anastrozole Eugia with other medicines")
• If you have ever had conditions affecting bone strength (osteoporosis)
• If you have liver or kidney disease.

If you are unsure about any of the information above, consult your doctor or pharmacist before taking Anastrozole Eugia.
If you are admitted to hospital, inform the medical staff that you are taking Anastrozole Eugia.
Anastrozole Eugia with other medicines
Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. This includes medicines available without a prescription and herbal products, because Anastrozole Eugia may affect the way some medicines work, and some medicines may affect the action of Anastrozole Eugia.
Do not take Anastrozole Eugia 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, because Anastrozole Eugia may stop working properly
• Medicines containing estrogen, such as those used in hormone replacement therapy (HRT). If this applies to you, contact your doctor or pharmacist.

Tell your doctor if:

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

Pregnancy and breastfeeding
Do not take Anastrozole Eugia during pregnancy or while breastfeeding.
Stop taking Anastrozole Eugia 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 Anastrozole Eugia will impair your ability to drive or operate machinery. However, weakness and drowsiness have been observed in some patients taking Anastrozole Eugia. If you experience these symptoms, consult your doctor or pharmacist.
Anastrozole Eugia contains lactose
This medicine contains the sugar lactose monohydrate. If you have previously been diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.
Anastrozole Eugia contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per coated tablet, which means it is essentially "sodium-free".

3. How to take Anastrozole Eugia

Anastrozole Eugia must always be taken exactly as directed by your doctor. If you are unsure,
consult your doctor or pharmacist.

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

Anastrozole Eugia should be taken for as long as directed by your doctor or pharmacist. Treatment with this
medicine is long-term and may last for several years. If you have any doubts, consult your
doctor or pharmacist.
Use in children and adolescents
Anastrozole Eugia must not be used in children and adolescents.
If you take more Anastrozole Eugia than you should
If you take more than the prescribed dose, contact your doctor immediately.
If you forget to take Anastrozole Eugia
If you miss a dose of Anastrozole Eugia, take the next dose the following day at your usual time.
Do not take a double dose (two doses at the same time) to make up for a missed dose.
Stopping Anastrozole Eugia
Do not stop taking Anastrozole Eugia 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, Anastrozole Eugia may cause adverse reactions, although ̇ they do not occur in all patients.

If any of the following severe but very rare adverse reactions occur, treatment with Anastrozole Eugia must be discontinued immediately and medical advice must be sought urgently:

• extremely severe skin reactions with ulceration or blistering of the skin, 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 (may affect more than 1 in 10 people):

• headaches
• hot flushes
• nausea
• skin rash
• joint pain or stiffness
• arthritis
• fatigue
• bone demineralization (osteoporosis)
• depression

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

• loss of appetite
• increased blood cholesterol levels (a fatty substance in the blood), as shown by blood tests
• drowsiness
• carpal tunnel syndrome (tingling, pain, cold sensation, weakness in part of the hand)
• skin tingling, numbness, or prickling, loss or absence of taste
• diarrhoea
• vomiting
• changes in blood test results related to liver function (liver function parameters)
• hair thinning (hair loss)
• allergic reactions (hypersensitivity) affecting the face, lips, 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 related to liver function (liver function parameters: gamma-glutamyl transferase [gamma-GT] and serum bilirubin levels)
• hepatitis
• urticaria (hives)
• trigger finger (a condition in which a finger or thumb locks in a bent position and straightening it is difficult)
• increased calcium levels in the blood; if nausea, vomiting, and increased thirst occur, contact your doctor, pharmacist, or nurse, as blood tests may be necessary.

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

• skin inflammation with red spots or blisters
• skin rashes due to hypersensitivity (caused by allergy or anaphylactoid reaction)
• inflammation of small blood vessels causing red or purple 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)
• tendonitis (inflammation of the connective tissue linking muscles to bones)
• tendon rupture (rupture of the connective tissue linking muscles to bones)
• memory impairment

If any of the adverse reactions listed above occur, contact your doctor or go to the nearest hospital as soon as possible.

Effect on bones
Anastrozole Eugia reduces estrogen levels in the blood and may cause a decrease in bone mineral content. This may result in reduced bone strength and an increased risk of bone fractures. Your doctor will take appropriate preventive and therapeutic measures to reduce these risks, in accordance with therapeutic guidelines for the prevention and treatment of bone problems in postmenopausal women. Discuss these risks and available treatment options for bone problems with your doctor.

Reporting of adverse reactions
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions at 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 helps to provide more information on the safety of this medicine.
Adverse reactions can also be reported to the marketing authorization holder.

5. How to store Anastrozole Eugia

Keep this medicine out of the sight and reach of children.
Do not use Anastrozole Eugia after the expiry date stated on the blister pack and carton after EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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.
• Excipients:
  Tablet core: monohydrate lactose, sodium carboxymethyl starch (type A), povidone (K-30), magnesium stearate
  Tablet coating (White colour): hypromellose 2910 (6 mPa·s), 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, embossed with "A1" on one side and smooth on the other side. Tablet size is approximately 6.1 mm.
Anastrozole Eugia coated tablets are available in blisters made of transparent PVC/Aluminium foil, packed in cardboard cartons.
Pack sizes: 10, 28, 30, 50, 56, 60, 84, 90, 98 and 100 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 João De Deus 19, Venda Nova
2700-487 Amadora
Portugal
Arrow Génériques
26 Avenue Tony Garnier
69007 Lyon
France

This medicinal product is authorised 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