Prospect: Information for the User

Anastrozol STADA 1 mg Film-Coated Tablets

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

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

-If you have any doubts, consult your doctor, pharmacist, or nurse.

-This medicine has been prescribed only for you and should not be given 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, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

1.What Anastrozol Stada is and for what it is used

2.What you need to know before starting to take Anastrozol Stada

3.How to take Anastrozol Stada

4.Possible adverse effects

5.Storage of Anastrozol Stada

6.Contents of the package and additional information

AnastrozolStada contains a substance called anastrozole andbelongs to a group of medicines called “aromatase inhibitors”. Anastrozole is used to treat breast cancer in women who are in menopause.

Anastrozole 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 Stada

-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 are 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, pharmacist, or nurse before starting to take Anastrozol Stada.

• 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 Stada”).
• 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 anastrozol.

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

Other medications and Anastrozol Stada

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 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), e.g., medications containing tamoxifeno.This is because these medications may make anastrozol stop working properly.
• 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 pharmacistif 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 if you arepregnant or breastfeeding. Stop taking anastrozol if you become pregnant and consult your doctor.

Consult your doctor or pharmacist before using this 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.

Anastrozol Stada 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 Stada contains sodium

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

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 or pharmacist. If in doubt, consult your doctor or pharmacist again.

• The recommended 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 indicated by your doctor or pharmacist. This is a long-term treatment and you may need to take it for several years.If in doubt, consult your doctor or pharmacist.

Use in children and adolescents

Anastrozol should not be administered to children and adolescents.

If you take more Anastrozol Stada 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 Telephone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Anastrozol Stada

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 Stada

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 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. This is known as “Stevens-Johnson syndrome.”
• Allergic reactions (hypersensitivity) with swelling of the throat that can cause difficulty swallowing or breathing. This is known as “angioedema.”

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

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

Common side effects(can 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 / lack 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.

Uncommon side effects(can 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(can 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).

Small blood vessel inflammation causing red or purple discoloration of the skin. Very rarely, symptoms of joint, 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 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 not listed in this leaflet. 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 medicine.

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.

This medication does not require special storage conditions.

Do not use this medication 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.

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

Composition of Anastrozol Stada:

• The active ingredient is anastrozol. Each film-coated tablet contains 1 mg of anastrozol.
• The other components (excipients) are: in the tablet core lactose monohydrate (lactose), carboxymethylcellulose sodium (type A) (from potato), 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 content of the packaging

White, round, biconvex film-coated tablet with the inscriptions “ANA” and “1” on one face.

Anastrozol Stada is presented in blister packaging, in containers that contain 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA Laboratory, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

Synthon Hispania, S.L.

Castelló, 1.

Polígono Las Salinas 08830

Sant Boi de Llobregat (Barcelona)

Spain

or

Synthon BV

Microweg 22

6545 CM Nijmegen

Netherlands

Last review date of this leaflet:March 2021

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