Package Insert: Information for the Patient

Anastrozole Teva 1 mg Film-Coated Tablets

Anastrozole

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 only for you and should not be given to others even if they have the same symptoms, 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 Teva contains a substance called anastrozole and 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 Teva

• If you are allergic (hypersensitive) to anastrozole or to 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 Teva if you find yourself in any of the situations described above. If you are unsure, consult your doctor or pharmacist before taking Anastrozol Teva.

Warnings and precautions

Consult your doctor or pharmacist before taking Anastrozol Teva

• If you still have menstrual periods and have not reached menopause.
• If you are taking a medication that contains tamoxifen or medications that contain estrogen (see the section called “Use of Anastrozol Teva 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 about whether anything affects you, consult your doctor or pharmacist before taking anastrozole.

In case you are admitted to the hospital, inform the healthcare staff that you are taking anastrozole.

Use in children and adolescents

Anastrozole should not be administered to children and adolescents.

Use of Anastrozol Teva with other medications

Inform your doctor or pharmacist if you are using/taking, have used/taken recently, or may need to use/take any other medication, including those acquired without a prescription and herbal remedies. This is because anastrozole may affect the activity of other medications, and some medications may have an effect on anastrozole.

Do not take anastrozole 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 tamoxifen. This is because these medications may make anastrozole stop working properly.
• Medications that contain estrogens, such as hormone replacement therapy (HRT).

If you find yourself 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 gonadorelin, buserelin, goserelin, leuprorelin, and triptorelin. These medications are used to treat breast cancer, certain gynecological health conditions, and infertility.

Pregnancy and breastfeeding

Do not take Anastrozol Teva if you are pregnant or breastfeeding. Discontinue Anastrozol Teva if you become pregnant and consult your doctor.

Driving and operating machines

It is unlikely that Anastrozol Teva will affect your ability to drive or use any tool or machine. However, occasionally some patients may feel weakness or drowsiness while taking Anastrozol Teva. If this happens, seek advice from your doctor or pharmacist.

Use in athletes

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

Anastrozol Teva contains lactose

Lactose 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.

Anastrozol Teva 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 Anastrozol Teva 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.

If you take more Anastrozol Teva than you should

If you take more Anastrozol Teva 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 Teva

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 Teva

Do not stop taking your medication 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 medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking Anastrozol Teva 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”.

Other side effects:

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

• Depression

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

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 hand areas).
• 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.

Rare 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, you should inform your doctor, pharmacist or nurse as it may be necessary to perform a blood test

Very 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).
• 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 lessstrong and make fractures more likely. Your doctor will monitor these risks according to the treatment guidelines for bone state 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 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 after “CAD”. The expiration date is the last day of the month indicated

This medication does not require special storage conditions

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

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

Tablet core: lactose monohydrate, magnesium stearate (E572),

povidone K-30, sodium starch glycolate type A potato.

Coating: hypromellose (E464), macrogol 400 and 6000, and titanium dioxide (E171).

Appearance of the product and contents of the package.

• Anastrozole Teva 1 mg film-coated tablets are white to off-white, round tablets. Engraved with the number “93” on one face of the tablet and with the number “A10” on the other face of the tablet.
• Anastrozole Teva 1 mg film-coated tablets are available in blisters and are available in package sizes of 1, 14, 20, 28, 30 (3 x 10), 56, 60, 84, 90, 98, 100, and 300 tablets. Hospital packs of 84 tablets and hospital packs with unit doses of 10 (10 x 1) and 50 (50 x 1) film-coated tablets are also available.

Only some package sizes may be marketed.

Marketing authorization holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1st Floor

28108 Alcobendas, Madrid

Spain

Responsible for manufacturing

Teva Pharmaceutical Works Company Ltd

Pallagi Street 13

H-4042 Debrecen

Hungary

Or

Pharmachemie B. V.

Swensweg 5, Postbus 552, 2003 RN Haarlem

Netherlands

Or

Teva Pharmaceutical Works Private Limited Company

Táncsics Mihály út 82, H-2100 Gödöllo

Hungary

or

Teva Czech Industries s.r.o.

Ostravská 29, c.p. 305, 747 70 Opava -Komárov

Czech Republic

or

Merckle GmbH

Ludwing-Merckle-Strasse, 3

Blaubeuren-D-89143, Hungary

Last review date of this prospectus: March 2021

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“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/ ”