Package Leaflet: Information for the User

Anastrozol Viatris 1 mg Film-Coated Tablets EFG

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 pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Anastrozol Viatris is and what it is used for

2. What you need to know before you start taking Anastrozol Viatris

3. How to take Anastrozol Viatris

4. Possible side effects

5. Storage of Anastrozol Viatris

6. Contents of the pack and additional information

AnastrozolViatriscontains a substance called anastrozol and belongs to a group of medicines called “aromatase inhibitors”. Anastrozol is used to treat breast cancer in women who are in menopause.

Anastrozol works 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 Viatris:

• 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 anastrozol if you are in any of the situations described above. If you are unsure, consult your doctor or pharmacist before taking anastrozol.

Warnings and precautions

Consult your doctor or pharmacist before starting to takeAnastrozol Viatris.

• 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 Viatris ”).
• 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 whether this affects you, consult your doctor or pharmacist before taking anastrozol.

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

Other medications and Anastrozol Viatris

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

This includes medications obtained 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), for example, medications that contain tamoxifeno.
• Medications that contain estrogens, such as hormone replacement therapy (HRT).

This is because these medications may make anastrozol not work properly.

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

Consult 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 gynecological health conditions, and infertility.

Pregnancy and breastfeeding

Do not takeanastrozolif you are pregnant or breastfeeding. Stopanastrozolif you become pregnant and consult your doctor.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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

Anastrozol Viatris contains lactose and sodium

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

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

Follow exactly the administration instructions for anastrozol as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• The recommended dose is one daily tablet (1 mg of anastrozol).
• Try to take the tablet at the same time every day.
• Swallow the tablet whole with water.
• You can take anastrozol before, during, or after meals.

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

Use in children and adolescents

Anastrozol should not be administered to children and adolescents.

If you take more Anastrozol Viatris than you should

If you have taken 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 5620420, indicating the medication and the amount taken.

If you forget to take Anastrozol Viatris

If you forget to take a dose, simply take the next dose normally.

Do not take a double dose (two doses at the same time) to make up for a missed dose.

If you interrupt treatment with Anastrozol Viatris

Do not stoptaking the tablets unless your doctor tells you to.

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

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

If any of the following side effects occur, do not take any more anastrozole. Inform your doctor immediately or go to the nearest hospital emergency department:

Rare (may affect up to 1 in 100 people):

• Liver inflammation (hepatitis) with nausea, vomiting, loss of appetite, fever, itching, yellowing of the skin and eyes, light-colored stools or dark-colored urine.

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

• Skin eruption 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 pain, and kidney pain may occur; this is known as "Henoch-Schönlein purpura".

Very rare (may affect up to 1 in 10,000 people):

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

Other side effects include:

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

• Headache.
• Hot flashes.
• Sensation of dizziness (nausea).
• Skin eruption.
• Pain or stiffness in the joints.
• Joint inflammation (arthritis).
• Weakness.
• Bone loss (osteoporosis).
• Depression.

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

• Loss of appetite.
• Increased or elevated 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).
• 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, talk to your doctor).
• Muscle pain.

Rare (may affect up to 1 in 100 people):

• Changes in special blood tests that show how well your liver is functioning (gamma-GT and bilirubin).
• Hives or welts.
• Elevated levels of calcium in the blood. If you have nausea, vomiting, and thirst, you should inform your doctor or pharmacist as you may need blood tests.
• Trigger finger (alteration in which one of the fingers of the hand stays bent).

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

• Rare inflammation of the skin that may include red patches or blisters, known as erythema multiforme.

Effects on your bones

Anastrozole reduces 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 talk to 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 leaflet. 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 out of the sight and reach of children.

This medication does not require special storage conditions.

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

Medications should not be disposed of through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Anastrozol Viatris Composition

The active ingredient is anastrozole. One tablet contains 1 mg of anastrozole.

The other components of the tablet core are lactose monohydrate (see section 2 “Anastrozol Viatris contains lactose and sodium”), potato starch carboxymethyl sodium, povidone (E1201), and magnesium stearate (E572).

The components of the tablet coating are macrogol, hypromellose (E464), and titanium dioxide (E171).

Appearance of Anastrozol Viatris and packaging contents

Anastrozol Viatris 1 mg is a film-coated, round tablet marked with the inscription “ANA” and “1” on one face.

Anastrozole is marketed in blisters of 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100, or 300 tablets and in hospital blisters of 28, 50, 84, 98, 300, or 500 tablets.

Only some packaging sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer:

Synthon Hispania, S.L.

C/ Castelló, 1 - Polígono Las Salinas

08830 Sant Boi de Llobregat (Barcelona)

Spain

or

Synthon BV

Microweg 22

6545 CM Nijmegen

Netherlands

or

McDermott Laboratories Ltd. t/a Gerard Laboratories

35/36 Baldoyle Industrial Estate, Grange Road

Dublin 13,

Ireland

or

Mylan Hungary Kft.

H-2900, Komárom

Mylan utca 1

Hungary

or

Mylan UK Healthcare Limited

Building 20 Station Close

Potters Bar

EN6 1TL

UK

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine is authorized in the European Economic Area with the following names:

AustriaAnastrozol Arcana 1 mg Filmtabletten

SpainAnastrozol Viatris1 mg film-coated tablets EFG

FranceAnastrozole Mylan 1 mg, coated tablet

IrelandAgerdex 1 mg film-coated tablets

ItalyAnastrozolo Mylan Generics

NetherlandsAnastrozol Mylan 1 mg, film-coated tablets

PortugalAnastrozol Mylan

UKAnastrozole 1 mg Film-coated Tablet

Czech RepublicAnastrozol Mylan

Last review date of this leaflet:March 2021

More detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)https://www.aemps.gob.es/