ANASTROZOL TEVA 1 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Anastrozole Teva 1 mg Film-Coated Tablets EFG

anastrozole

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What Anastrozole Teva is and what it is used for
2. What you need to know before you take Anastrozole Teva
3. How to take Anastrozole Teva
4. Possible side effects
5. Storing Anastrozole Teva
6. Contents of the pack and other information

1. What Anastrozole Teva is and what it is used for

Anastrozole 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 post-menopausal.

Anastrozole works by reducing the amount of hormones called oestrogens that your body makes, by blocking a natural substance (an enzyme) called ‘aromatase’.

2. What you need to know before you take Anastrozole Teva

Do not take Anastrozole Teva

• If you are allergic (hypersensitive) to anastrozole or any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant or breast-feeding (see the section called “Pregnancy and breast-feeding”).

Do not take Anastrozole Teva if you are in any of the above situations. If you are not sure, consult your doctor or pharmacist before taking Anastrozole Teva.

Warnings and precautions

Consult your doctor or pharmacist before taking Anastrozole Teva

If you are not sure if any of these apply to you, consult your doctor or pharmacist before taking anastrozole.

If you are going to have an operation, tell the doctor or nurse that you are taking anastrozole.

Use in children and adolescents

Anastrozole should not be given to children and adolescents.

Using Anastrozole Teva with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription and herbal medicines. This is because anastrozole can affect the action of other medicines, and some medicines can affect anastrozole.

Do not take anastrozole if you are already taking any of the following medicines:

• Certain medicines used to treat breast cancer (selective oestrogen receptor modulators), e.g. medicines that contain tamoxifen. This is because these medicines may stop anastrozole from working properly.
• Medicines that contain oestrogen, such as hormone replacement therapy (HRT).

If you are in any of these situations, ask your doctor or pharmacist for advice.

Consult your doctor or pharmacist if you are taking any of the following:

• A medicine called an “LHRH analogue”. This includes gonadorelin, buserelin, goserelin, leuprorelin and triptorelin. These medicines are used to treat breast cancer, some gynaecological conditions and infertility.

Pregnancy and breast-feeding

Do not take Anastrozole Teva if you are pregnant or breast-feeding. Stop taking Anastrozole Teva if you become pregnant and consult your doctor.

Driving and using machines

Anastrozole Teva is unlikely to affect your ability to drive or use any tools or machines. However, occasionally some patients may feel weak or sleepy while taking Anastrozole Teva. If this happens to you, ask your doctor or pharmacist for advice.

Use in athletes

This medicine contains anastrozole, which may produce a positive result in anti-doping tests.

Anastrozole Teva contains lactose

Lactose is a type of sugar. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Anastrozole Teva contains sodium

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

3. How to take Anastrozole Teva

Follow exactly the instructions given to you by your doctor or pharmacist. If you are not sure, consult your doctor or pharmacist.

• The recommended dose is one tablet daily.
• Try to take your tablet at the same time each day.
• Swallow the tablet whole with a glass of water.
• You can take Anastrozole Teva before, during or after food.

Keep taking anastrozole for as long as 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 Anastrozole Teva than you should

If you take more Anastrozole Teva than you should, contact a doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the National Poison Information Service on 91 562 04 20, quoting the medicine and the amount taken.

If you forget to take Anastrozole Teva

If you forget to take a dose, just take the next dose as normal.

Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

If you stop taking Anastrozole Teva

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

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Anastrozole Teva and seek urgent medical attention if you experience any of the following serious but very rare side effects:

• A very severe skin rash with ulcers or blisters in the skin. This is known as “Stevens-Johnson syndrome”.
• Allergic reactions (hypersensitivity) with swelling of the face, lips, tongue or throat that may cause difficulty in swallowing or breathing. This is known as “angioedema”.

Other side effects:

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

• Depression

• Headache
• Hot flushes
• Feeling sick (nausea)
• Rash
• Pain or stiffness in the joints
• Inflammation of the joints (arthritis)
• Weakness
• Bone loss (osteoporosis)

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

• Lack of appetite
• High levels of a fatty substance called cholesterol in the blood. This would be seen in a blood test.
• Drowsiness
• Carpal tunnel syndrome (tingling, pain, numbness or weakness in the hand)
• Pins and needles, numbness or tingling of the skin, loss of taste
• Diarrhoea
• Vomiting
• Changes in blood tests that show how well your liver is working.
• Thinning of hair (hair loss)
• Allergic reactions (hypersensitivity) including face, lips or tongue.
• Bone pain
• Vaginal dryness
• Vaginal bleeding (usually in the first few weeks of treatment – if bleeding continues, talk to your doctor)
• Muscle pain

Uncommon side effects (may affect up to 1 in 100 people)

• Changes in special blood tests that show how well your liver is working (gamma-GT and bilirubin).
• Inflammation of the liver (hepatitis)
• Hives or itching
• Trigger finger (a condition in which one of your fingers gets stuck in a bent position)
• High levels of calcium in the blood. If you get nausea, vomiting and thirst, you should tell your doctor, pharmacist or nurse as you may need to have a blood test.

Rare side effects (may affect up to 1 in 1,000 people)

• A rare skin condition with redness and blisters on the skin.
• A skin rash caused by an allergic reaction (this can be due to an allergic or anaphylactoid reaction).
• Inflammation of small blood vessels which can cause red or purple spots on the skin. Very rarely, this can be associated with joint pain, stomach pain and kidney problems; this is known as “Henoch-Schönlein purpura”.

Side effects with frequency not known (frequency cannot be estimated from the available data)

• Dry eyes
• Lichenoid rash (small red or purple bumps on the skin that can be itchy)
• Tendonitis (inflammation of tendons, which connect muscles to bones)
• Tendon rupture (tearing of tendons, which connect muscles to bones)
• Memory loss

Effects on your bones

Anastrozole lowers the levels of female sex hormones (oestrogens) in your body, which may cause your bones to become thinner and weaker. This may increase the risk of fractures. Your doctor will check the risks and treatment options for your bone health as part of your treatment for breast cancer.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Agency’s website at https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Anastrozole Teva

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

• The active substance is anastrozole. Each tablet contains 1 mg of anastrozole.
• The other ingredients 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 and packaging

• Anastrozole Teva 1 mg film-coated tablets are white to off-white, round tablets. Engraved with the number “93” on one side of the tablet and the number “A10” on the other side of the tablet.
• Anastrozole Teva 1 mg film-coated tablets are available in blister packs and are available in pack 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 unit dose hospital packs of 10 (10 x 1) and 50 (50 x 1) film-coated tablets are also available.

Not all pack sizes may be marketed.

Marketing authorisation holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1º Planta

28108 Alcobendas, Madrid

Spain

Manufacturer

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

Ludwig-Merckle-Strasse, 3

Blaubeuren-D-89143, Germany

Date of last revision of this leaflet: July 2025

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“Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/”