Package Leaflet: Information for the User

Anastrozole Sandoz 1 mg Film-Coated Tablets

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, ask 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, talk to your doctor, pharmacist or nurse. See section 4.

Anastrozol Sandoz contains a substance called anastrozole. It belongs 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 Sandoz

• if you are allergic to anastrozol or any of the other ingredients of this medication (listed in section 6),
• if you are pregnant or breastfeeding (see section “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 Sandoz.

• 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 Anastrozol Sandoz with 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 whether this affects you, consult your doctor or pharmacist before taking Anastrozol Sandoz.

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

Taking Anastrozol Sandoz with other medications

Inform your doctor or pharmacist if you are taking or have recently taken or may need to take any other medication. 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), for example, medications that contain tamoxifeno. This is because these medications may make anastrozol not work 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.

Consult 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 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 taking 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.

Anastrozol Sandoz contains sodium

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

Anastrozol Sandoz contains lactose,which is a type of sugar

If your doctor has told you that you have an intolerance to certain sugars, 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 or pharmacist. 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 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 Sandoz than you should

If you have taken more anastrozol than you should, consult 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 Sandoz

If you forget to take a dose, take the next dose as you normally do.

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 Sandoz

Do not stop taking your tablets unless your doctor tells you to.

If you have any doubts about the use of this medication, ask your doctor or pharmacist.

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

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

• Asevere skin reactionwith blisters or ulcers on the skin. This is known as “Stevens-Johnson syndrome”.
• Allergic reactions (hypersensitivity) with swelling of the throat that may causedifficulty swallowing or breathing. This is known as “angioedema”.

Other possible side effects:

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

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

Common side effects(may affect up to 1 in 10 people)

• 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, speak with 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 levels of calcium in the blood. If you experience nausea, vomiting and thirst, you should consult your doctor, pharmacist or nurse, as you may need blood tests.

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. 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 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 speak with 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 national notification system: 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 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 blister/pack and carton packaging after CAD/EXP. The expiration date is the last day of the month indicated.

Alu/PVC Blister

This medication does not require any special storage conditions.

HDPE Bottles

Do not store at a temperature above 30°C

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

Composition of Anastrozol Sandoz

Theactive ingredientisanastrozole.

Each film-coated tablet contains 1 mg of anastrozole.

The other components (excipients) are:

Tablet core:lactose monohydrate, microcrystalline cellulose, sodium carboxymethyl starch (type A) from potato, magnesium stearate, anhydrous colloidal silica, hydroxypropyl cellulose.

Coating:

Opadry II white: lactose monohydrate, hypromellose, macrogol 4000, and titanium dioxide (E171).

Appearance of the product and contents of the package

White, round, biconvex tablets with the inscription “A1” on one side.

The film-coated tablets are available in Alu/PVC blister packs or HDPE bottles with a screw cap.

Blister pack: 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100 film-coated tablets.

HDPE bottle: 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer

Lek Pharmaceuticals d.d.

Verovskova 57

1526 Ljubljana

Slovenia

Or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

This medicine is authorized in the member states of the European Economic Area with the following names:

United Kingdom: Anastrozole 1 mg film-coated tablet

Austria: Anastrozol Sandoz 1 mg – Filmtabletten

Belgium: Anastrozol Sandoz 1 mg filmomhulde tabletten

Denmark: Anastrozol Sandoz

Finland: Anastrozol Sandoz

France: Anastrozole Biostabilex 1 mg, comprimé pelliculé

Germany: Anastrozol SP 1 mg Filmtabletten

Hungary: Anastrozol Hexal filmtabletta

Italy: Anastrozolo Sandoz 1 mg compresse rivestite con film

Netherlands: Anastrozol Sandoz tablet 1 mg, filmomhulde tabletten

Norway: Anastrozol Sandoz

Poland: Anastrozol Jacobsen

Romania: Anastraze 1 mg comprimate filmate

Slovenia: Anastrozol Sandoz 1 mg filmsko obložene tablete

Spain: Anastrozol Sandoz 1 mg comprimidos recubiertos con película EFG

Sweden: Anastrozol Sandoz

Last review date of this prospectus:April 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/