Package Leaflet: Information for the User

Anastrozole VIR 1 mg Film-Coated Tablets

Anastrozole

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

about the medicine

- Keep this leaflet, as you may need to read it again.

- If you have any questions, ask your doctor, pharmacist or nurse.

- This medicine has been prescribed for you personally and you should not give it to others, even if they have the same symptoms, as it may harm them.

-If you experience any side effects, talk to your doctor, pharmacist or nurse. See section 4.

Contents of the pack and additional information

Anastrozol VIR contains a substance called anastrozol. It 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 VIR

- If you are allergic (hypersensitive) to anastrozol or any of the other components of anastrozol (listed in section 6).

- If you are pregnant or breastfeeding (see the section called “Pregnancy and breastfeeding”).

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

Warnings and precautions

Consult your doctor, pharmacist or nurse before taking Anastrozol Vir:

- 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 “Taking Anastrozol Vir with other medications”).

- If you have ever suffered from any condition that affects the strength of your bones (osteoporosis).

- If you have any liver or kidney problems.

If you are unsure if this affects you, consult your doctor or pharmacist before taking Anastrozol Vir.

Inform hospital staff that you are taking Anastrozol Vir in case of hospital admission.

Use of other medications and Anastrazol VIR

Inform your doctor or pharmacist that you are using, have used recently or may need to use any other medication.This includes medications you obtain without a prescription and herbal remedies. This is because anastrozol can affect the activity of other medications, and some medications may have an effect on anastrozol.

Do not take Anastrozol VIR 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. This is because these medications may make Anastrozol Vir ineffective.

- 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.

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 analogue”. 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 take Anastrozol Vir if you are pregnant or breastfeeding. Discontinue treatment with Anastrozol Vir if you become pregnant and consult your doctor.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

It is unlikely that anastrozol will affect your ability to drive or use any tools or machinery. However, occasionally some patients may feel weakness or drowsiness while taking Anastrozol Vir. If this happens, seek advice from your doctor or pharmacist.

Anastrozol contains lactose

Anastrozol Vir 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.

Anastrozol contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

- The recommended dose is one daily tablet.

- Try to take the tablet at the same time every day.

- Swallow the tablet whole with the help of water.

- You can take Anastrozol Vir before, during, or after meals.

Continue taking Anastrozol Vir for the time period indicated by your doctor or pharmacist. This is a long-term treatment and you may need to take it for several years. In case of doubt, consult your doctor or pharmacist.

Use in children and adolescents.

Anastrozol Vir should not be administered to children and adolescents.

If you take more Anastrozol VIR than you should

If you have taken more Anastrozol VIR 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 VIR

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 compensate for a missed dose.

If you interrupt treatment with Anastrozol VIR

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

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

Stop taking Anastrozol VIR 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".
• Severe allergic reactions (hypersensitivity) with swelling of the throat that may cause difficulty swallowing or breathing, known as "angioedema".

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

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

Common side effects (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.
• Somnolence.
• Carpal tunnel syndrome (tingling, pain, sensation of coldness, weakness in areas of the hand).
• Itching, tingling, or numbness of the skin, loss/taste of flavor
• Dyspepsia.
• 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 bleeding (usually in the first weeks of treatment - if bleeding continues, speak with your doctor).
• Muscle pain

Uncommon side effects (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).
• Inflammation of the liver (hepatitis).
• Hives or welts.
• Trigger finger (alteration in which one of the fingers of the hand remains in a bent position)

• Trigger finger (alteration in which one of the fingers of the hand remains in a bent position).
• Increased levels of calcium in the blood. If you experience nausea, vomiting, and thirst, inform your doctor, pharmacist, or nurse as you may need a blood test.

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

• Rare inflammation of the skin 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".

Very rare side effects (affect less than 1 in 10,000 people)

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

If you experience any of these, call an ambulance or seek immediate medical attention. You may need urgent medical treatment.

Effects on your bones

Anastrozol reduces the levels of hormones called estrogens present in your body. This may 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, pharmacist, or nurse, 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 of 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 medication.

Keep out of the sight and reach of children. Store the tablets in a safe place where children cannot see or reach them. Your tablets could harm them.

This medication does not require special storage conditions

Do not use Anastrozol VIR 1 mg after the expiration date that appears on the packaging after CAD. The first two digits indicate the month and the last four digits indicate the year. The expiration date is the last day of the month indicated

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

Composition of Anastrozol VIR

- The active ingredient is anastrozole. Each film-coated tablet contains 1 mg of anastrozole.

- The other components are in the tablet core lactose monohydrate, carboxymethylstarch sodium salt (type A), povidone (E1201), and magnesium stearate (E572)

The components of the coating are macrogol 400, hypromellose (E464) and titanium dioxide (E171)

Appearance of the product and contents of the packaging

Anastrozole is a round, film-coated tablet with the inscriptions “ANA” and “1” on one face

Anastrozole is available in packs of 28 tablets.

Holder of the marketing authorization and Responsible for manufacturing

Holder of the marketing authorization:

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II, 28923 Alcorcón (Madrid) – Spain

Responsible for manufacturing:

Synthon Hispania, S.L.

C/ Castelló, 1.Polígono Las Salinas

08830 Sant Boi de Llobregat (Barcelona)

Spain

O

Synthon BV

Microweg 22

6545 CMNijmegen

Netherlands

O

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

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

NetherlandsStrakir 1 mg, filmomhulde tabletten

SpainAnastrozol VIR 1 mg, comprimidos recubiertos con película EFG

UKAnastrozole 1 mg, Film-coated Tablets

Last review date of this leaflet: June 2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)www.aemps.gob.es