Leaflet: information for the user

Anastrozole Cinfa 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, and you must not give it to others even if they have the same symptoms as 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.

anastrozol cinfacontains a substance called anastrozoland 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 cinfa

• if you are allergic to anastrozol or any of the other ingredients of this medicine (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 cinfa

• if you still have menstrual periods and have not yet reached menopause.
• if you are taking a medicine that contains tamoxifeno or medicines that contain estrogen (see the section called “Other medicines and anastrozol cinfa”).
• 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 any of this applies to you, consult your doctor or pharmacist before taking anastrozol.

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

Other medicines and anastrozol cinfa

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

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

• Certain medicines used to treat breast cancer (selective estrogen receptor modulators), such as medicines that contain tamoxifeno. This is because these medicines may make anastrozol less effective.
• Medicines that contain estrogens, such as hormone replacement therapy (HRT). If you find yourself in either of these situations, ask your doctor or pharmacist for advice.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Driving and operating machinery

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

anastrozol cinfa contains lactose

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

anastrozol cinfa contains sodium

This medicine 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. In case of doubt, consult your doctor or pharmacist again.

Continue taking anastrozol 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. In case of doubt, consult your doctor or pharmacist again.

Use in children and adolescents

Anastrozol should not be administered to children and adolescents.

If you take more anastrozol cinfa 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 cinfa

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 the missed doses.

If you interrupt treatment with anastrozol cinfa

Do not stop taking your 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 medications,this medicationcan cause side effects, although not everyone will experience them.

Stop taking anastrozol and seek urgent medical attention 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 patients)

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

Common side effects (can affect up to 1 in 10 patients)

• 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).
• Itching, tingling, or numbness of the skin, loss/taste 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 (can affect up to 1 in 100 patients)

• 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 amount 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 (can affect up to 1 in 1,000 patients)

• 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

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.

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 medication.

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.

This medication does not require special conditions for conservation.

Medications should not be thrown down the drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Anastrozole Cinfa Composition

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

-Tablet core: lactose monohydrate, lactose anhydrous, carboxymethylcellulose sodium (type A) (from potato), microcrystalline cellulose (E-460), anhydrous colloidal silica, and magnesium stearate.

-Tablet coating: Opadry white (hypromellose (E-464), titanium dioxide (E-171), and macrogol 6000).

Product appearance and packaging contents

White, cylindrical, biconvex tablets, coated with a film, and with the logo “1” on one face.

Presented in PVC/PVDC/Aluminum blisters. Each package contains 28 or 100 (clinical package) tablets.

Only some package sizes may be commercially marketed.

Marketing authorization holder and manufacturer responsible

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:July 2021.

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/69384/P_69384.html

QR code link to:https://cima.aemps.es/cima/dochtml/p/69384/P_69384.html