Package Insert: Information for the User

Anastrozol Tarbis 1 mg Film-Coated Tablets

Anastrozol

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Anastrozol Tarbis contains a substance called anastrozole and belongs to a group of medicines known as “aromatase inhibitors”. Anastrozole is used to treat breast cancer in postmenopausal women.

Anastrozole works by reducing the amount of hormones called estrogens produced by your body, by blocking a natural bodily substance (an enzyme) called “aromatase”.

Do not take Anastrozol Tarbis

• if you are allergic to anastrozol or any of the other components of Anastrozol Tarbis (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

Before taking Anastrozol Tarbis, check with your doctor or pharmacist

• 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 “Use of other medications”).
• 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 about any of this, consult your doctor or pharmacist before taking anastrozol.

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

Taking Anastrazol Tarbis with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those obtained without a prescription and herbal remedies. This is because anastrozol may affect the activity of other medications, and some medications may affect 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 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 conditions, and infertility.

Pregnancy and breastfeeding

Do not take anastrozol if you are pregnant or breastfeeding. Discontinue anastrozol treatment 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, seek advice from your doctor or pharmacist.

Anastrazol Tarbis contains lactose

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

Use in athletes

This medication contains anastrozol, which may produce a positive result in doping control tests.

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

• The usual dose is one tablet per day.
• 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 Tarbis 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 Tarbis

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 Tarbis

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 medication may cause side effects, although not everyone will experience them.

Very common side effects (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 (affect between 1 and 10 people in every 100)

• 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).
• Diarrhea.
• Vomiting.
• Changes in blood tests that show how well your liver is functioning.
• Thinning of the 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).

Rare side effects (affect between 1 and 10 people in every 1,000)

• 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).

Very rare side effects (affect between 1 and 10 people in every 10,000)

• 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".

Extremely rare side effects (affect fewer than 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".

If you experience any of these, call an ambulance or see a doctor immediately. You may need urgent medical treatment.

Effects on your bones

Anastrozole 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 talk to 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,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. Store the tablets in a safe place where children cannot see or reach them. Your tablets could 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.

No special storage conditions are required

Store in the outer packaging.

Medications should not be disposed of through drains or in the trash. Dispose of the 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 the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Anastrozol Tarbis

The active ingredient is anastrozol. Each film-coated tablet contains 1 mg of anastrozol. The other components (excipients) are: lactose monohydrate (lactose), sodium carboxymethyl starch from potato (potato starch), povidone, magnesium stearate. The components of the coating are: hydroxypropylmethyl cellulose, macrogol, cottonseed oil, cornstarch, titanium dioxide.

Appearance of the product and content of the packaging

White, round, biconvex tablet. Anastrozol Tarbis is presented in a blister pack, in containers that contain 28 tablets.

Holder of the marketing authorization and manufacturer responsible

Holder of the marketing authorization

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Manufacturer responsible

HAUPT PHARMA MÜNSTER GMBH

Scheebrüggenkamp 15

48159 Münster (Germany)

or

TECNIMEDE-SOCIEDADE TECNICO MEDICINAL, S.A.

Quinta da Cerca, Caixaria (Dois Portos)

2565-187 – Portugal

Last review date of this leaflet: February 2021

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