Package Leaflet: Information for the User

Anastrozole Aurovitas 1 mg Film-Coated Tablets

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist. Even if they are not listed in this leaflet. See section 4.

This medication contains a substance called anastrozol and belongs to a group of medications known as “aromatase inhibitors”. This medication is used to treat breast cancer in women who are in menopause.

This medication acts by reducing the amount of hormones called estrogens that are produced by your body, by blocking a natural bodily substance (an enzyme) called “aromatase”.

Do not take Anastrozol Aurovitas

• If you are allergic to anastrozol or any of the other components of this medication (listed in section 6).
• If you are pregnant or breastfeeding (see the section called “Pregnancy and breastfeeding”).

Do not take this medication if you are in any of the situations described above. If you are unsure, consult your doctor or pharmacist before taking this medication.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take this medication.

• If you still have menstrual periods and have not reached menopause.
• If you are taking a medication that contains tamoxifeno or medications that contain estrogen (see the section called “Other medications and Anastrozol Aurovitas”).
• If you have ever had any condition that affects the strength of your bones (osteoporosis).
• If you have any liver or kidney problems.

If you are unsure if any of this affects you, consult your doctor or pharmacist before taking this medication.

Inform hospital staff that you are taking this medication if you are admitted to the hospital.

Other medications and Anastrozol Aurovitas

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.This includes medications you purchase without a prescription and herbal remedies.This is because anastrozol may affect the activity of other medications, and some medications may have an effect on anastrozol.

Do not take anastrozol if you are already being treated with any of the following medications:

• Certain medications used to treat breast cancer (selective estrogen receptor modulators), e.g., medications that contain tamoxifeno. This is because these medications may make this medication not work properly.
• Medications that contain estrogens, such as hormone replacement therapy (HRT).

If you are in any of these situations, seek advice from your doctor or pharmacist.

Inform your doctor or pharmacist if you are taking the following:

• A medication known as an “LHRH analog”. This includes gonadorelina, buserelina, goserelina, leuprorelina, and triptorelina. These medications are used to treat breast cancer, certain female health conditions (gynecological), and infertility.

Pregnancy and breastfeeding

Do not take this medication if you are pregnant or breastfeeding. Stop taking this medication if you become pregnant and consult your doctor.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

It is unlikely thatthis medicationwill affect your ability to drive or use any tool or machine. However, occasionally some patients may feel weakness or drowsiness while takingthis medication. If this happens, seek advice from your doctor or pharmacist.

Anastrozol Aurovitas contains lactose

This medication containslactose, which is a type of sugar. If your doctor has told you that you have alactose intolerance, consult with them before taking this medication.

Anastrozol Aurovitas contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

• The recommended dose is one tablet per day.
• Try to take the tablet at the same time every day.
• Swallow the tablet whole with the help of water.
• You can take this medication before, during, or after meals.

Continue taking this medication for the time your doctor or pharmacist tells you to. This is a long-term treatment and you may need to take it for several years.Continue taking this medication for the time your doctor or pharmacist tells you to. This is a long-term treatment and you may need to take it for several years.

Use in children and adolescents

This medication should not be administered to children and adolescents.

If you take more Anastrozol Aurovitas than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Anastrozol Aurovitas

If you forget to take a dose, take the next dose normally. Do not take a double dose (two doses at the same time) to make up for the missed doses.

If you interrupt treatment with Anastrozol Aurovitas

Do not stop taking the tablets unless your doctor tells you to.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking Anastrozol Aurovitas and seek urgent medical treatment if you experience any of the following severe but rare side effects.

• A severe skin reaction with blisters or ulcers on the skin, known as “Stevens-Johnson syndrome”.
• Allergic reactions (hypersensitivity) with swelling of the throat that can cause difficulty swallowing or breathing, known as “angioedema”.

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

• Headache.
• Hot flashes.
• Dizziness (nausea).
• Skin rash.
• Pain or stiffness in the joints.
• Joint inflammation (arthritis).
• Weakness.
• Bone loss (osteoporosis).
• Depression.

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

• Loss of appetite.
• Increased or high levels of a fatty compound in the blood known as cholesterol, which would be observed in a blood test.
• Drowsiness.
• Carpal tunnel syndrome (tingling, pain, sensation of coldness, weakness in areas of the hand).
• Itching, tingling, or numbness of the skin, loss/tastelessness of taste.
• Diarrhea.
• Vomiting.
• Changes in blood tests that show how well your liver is functioning.
• Thinning of hair (hair loss).
• Allergic reactions (hypersensitivity) including face, lips, or tongue.
• Bone pain.
• Vaginal dryness.
• Vaginal bleeding (usually in the first weeks of treatment - if bleeding continues, speak with your doctor).
• Muscle pain.

Rare side effects can affect up to 1 in 100 people

• Changes in special blood tests that show how well your liver is functioning (gamma-GT and bilirubin).
• Liver inflammation (hepatitis).
• Hives or urticaria.
• Trigger finger (alteration in which one of the fingers of the hand stays bent).
• Increased calcium levels in the blood. If you experience nausea, vomiting, and thirst, report to your doctor, pharmacist, or nurse as you may need a blood test.

Rare side effectscan affect up to 1 in 1,000 people

• Rare skin inflammation that may include red patches or blisters.
• Skin rash caused by hypersensitivity (this may be due to an allergic reaction or anaphylactoid reaction).
• Inflammation of small blood vessels causing red or purple discoloration of the skin. Very rarely, symptoms of joint pain, stomach, and kidney pain may occur; this is known as “Henoch-Schönlein purpura”.

Effects on your bones

This medicinereduces the levels of hormones called estrogens present in your body. This can reduce the mineral content of your bones. These may be less strong and make fractures more likely. Your doctor will monitor these risks according to the treatment guidelines for bone health in postmenopausal women. You should speak with your doctor about the risks and treatment options.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Anastrozol Aurovitas Composition

• The active ingredient is anastrozole. Each film-coated tablet contains 1 mg of anastrozole.
• The other components are:

Core:monohydrate lactose, sodium glycolate starch type A (from potato), povidone (K30), and magnesium stearate.

Coating: hypromellose 2910 (6mPas), titanium dioxide (E171), and macrogol.

Product appearance and packaging content

Film-coated tablet.

Anastrozole is a film-coated, biconvex, white tablet, marked with “A1” on one face and smooth on the other. The tablet size is approximately 6.1 mm.

This medication is available in PVC/Aluminum blisters.

Packaging size: 10, 28, 30, 50, 56, 60, 84, 90, 98, and 100 film-coated tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder and manufacturer

Marketing authorization holder

Eugia Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront

Floriana, FRN 1914

Malta

Manufacturer

APL Swift Services (Malta) Ltd

HF26, Hal Far Industrial Estate,

Hal Far, BBG 3000,

Birzebbugia, Malta.

O

Generis Farmacêutica S.A.

Rua Joao De Deus, nº 19

Venda Nova, 2700-487,

Amadora, Portugal.

O

Arrow Generiques S.A.S.

26 Avenue Tony Garnier

69007, Lyon, France.

For more information about this medication, please contact the local representative of the marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

This medication is authorized in the European Economic Area member states with the following names:

PortugalAnastrozol Generis

FranceANASTROZOLE ARROW LAB 1 mg, comprimé pelliculé

GermanyAnastroPUREN 1 mg Filmtabletten

ItalyAnastrozolo Aurobindo Italia

PolandAnastrozole Eugia

SpainAnastrozol Aurovitas 1 mg comprimidos recubiertos con película EFG

Last review date of this prospectus:April 2021

For detailed information about this medication, please visit the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es)