Package Leaflet: Information for the User

Anastrozol Tarbis Farma 1 mg Film-Coated Tablets EFG

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do 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, pharmacist or nurse, even if they are not listed in this package leaflet. See section 4.

This medication contains a substance called anastrozol and belongs to a group of medications known as “aromatase inhibitors”. Anastrozol is used to treat breast cancer in postmenopausal women.

Anastrozol acts 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 Farma

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take this medication.

• 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 Tarbis Farma”).
• 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 affects you, consult your doctor or pharmacist before taking this medication.

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

Other medications and Anastrozol Tarbis Farma

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. This includes medications you buy 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 Tarbis Farma if you are already being treated with any of the following medications:

• Certain medications used to treat breast cancer (selective estrogen receptor modulators), e.g. medications that contain tamoxifeno. This is because these medications may make Anastrozol Tarbis Farma 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.

Inform 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 female health conditions (gynecological), and infertility.

Pregnancy and breastfeeding

Do not take this medication if you are pregnant or breastfeeding. Stop taking this medication 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, some patients may occasionally feel weakness or drowsiness while taking anastrozol. If this happens, seek advice from your doctor or pharmacist.

Use in athletes

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

Anastrozol Tarbis Farma contains lactose

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

Anastrozol Tarbis Farma contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per coated 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.

• 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 this medication before, during, or after meals.

Continue taking this medication for the time 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

This medication should not be administered to children and adolescents.

If you take more Anastrozol Tarbis Farma than you should

If you take more Anastrozol Tarbis Farma 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 Tarbis Farma

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 doses.

If you interrupt treatment with Anastrozol Tarbis Farma

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, pharmacist, or nurse.

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

Stop taking Anastrozol Tarbis Farma 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".
• Allergic reactions (hypersensitivity) with swelling of the throat 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 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 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 red or purple discoloration of the skin. 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 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.

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 leaflet, inform your doctor or pharmacist.

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 leaflet. 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 medicine.

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 and in the blister pack 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 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 Farma

• The active ingredient is anastrozol. Each film-coated tablet contains 1 mg of anastrozol.
• The other components are lactose monohydrate, povidone, carboxymethylcellulose sodium type A (from potato), magnesium stearate, hypromellose (E464), macrogol 400, and titanium dioxide (E171).

Appearance of the product and contents of the packaging

White, round, biconvex film-coated tablets, marked with a “1” on one face and 'H' on the other.

Anastrozol Tarbis Farma is presented in blister packs containing 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028-Barcelona

Spain

Responsible for manufacturing

Amarox Pharma B.V.

Rouboslaan 32

2252 TR Voorschoten

Netherlands

Last review date of this leaflet: November 2021

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