PATIENT INFORMATION LEAFLET

Anastrozole 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 give it to others, even if they have the same symptoms, 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.

Anastrozol pensacontains a substance called anastrozoland belongs to a group of medications known as “aromatase inhibitors”. Anastrozol is used to treat breast cancer in women who are in menopause.

Anastrozol 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 think

• 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 find yourself 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 take anastrozol:

• if you still have menstrual periods and have not yet reached menopause.
• if you are taking a medication that contains tamoxifeno or medications that contain estrogen (see the section “Use of Anastrozol think 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 whether any of 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.

Use of Anastrozol think with other medications

Inform your doctor or pharmacist if you are taking, have recently taken, 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), such as medications that contain tamoxifeno. This is because these medications may make anastrozol ineffective.
• Medications that contain estrogens, such as hormone replacement therapy (HRT).

If you find yourself 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 gynecological health conditions, and infertility.

Pregnancy and breastfeeding

Do not take anastrozol if you are pregnant or breastfeeding

Stop taking anastrozol 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 tool or machine. However, some patients may occasionally feel weakness or drowsiness while taking anastrozol. If this happens to you, seek advice from your doctor or pharmacist.

Anastrozol think contains lactose

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

Anastrozol think contains sodium

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

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

• The usual 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 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 pensa 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 at telephone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Anastrozol pensa

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 the missed dose.

If you interrupt treatment with Anastrozol pensa

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 or pharmacist.

Like all medications, anastrozol can produce side effects, although not everyone will experience them.

Stop taking anastrozol and seek urgent medical treatment if you experience any of the following severe but very rare side effects:

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

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

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

Common side effects (may 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 hand areas).
• Itching, tingling, or numbness of the skin, loss 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, talk to your doctor).
• Muscle pain.

Rare 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).
• Liver inflammation (hepatitis).
• Hives or welts.
• 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, 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 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 skin discoloration or purpura. Very rarely, symptoms of joint pain, stomach, and kidney pain may occur; this is known as “Henoch-Schönlein purpura”.

Effects on your bones

Anastrozol 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.

If you consider any of the side effects you are experiencing to be severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es.By reporting side effects, you can contribute to providing more information about the safety of this medication.

No special storage conditions are required. Store in the outer packaging.

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 may harm them.

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.

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

Composition of Anastrozol pensa

The active ingredient is anastrozol. Each coated tablet contains 1 mg of anastrozol.

The other components (excipients) are:

• Tablet core:lactose monohydrate, lactose, carboxymethylcellulose sodium from potato, microcrystalline cellulose (E460), anhydrous colloidal silica, and magnesium stearate.

• Tablet coating:Opadry 04F58804 White/Vivacoat PC-1P-573(hypromellose (E464), titanium dioxide (E171), and macrogol 6000).

Appearance of the product and contents of the packaging

White, biconvex, cylindrical tablet.

Anastrozol pensa is presented in a blister pack, in containers holding 28 tablets.

Holder of the authorization

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing:

SAG Manufacturing, S.L.U.

Ctra. N-I, Km 36

28750 San Agustín de Guadalix,

Madrid, Spain

Last review date of this leaflet: March 2021

The detailed information about this medication is available on the website ofthe Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/