Anastrozole Teva-Ratio 1 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Anastrozol Teva-ratio 1 mg film-coated tablets EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

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

1. What Anastrozol Teva-ratio is and what it is used for

Anastrozol contains a substance called anastrozol and belongs to a group of medicines known as "aromatase inhibitors". Anastrozol is used to treat breast cancer in women who are postmenopausal.

Anastrozol works by reducing the amount of hormones called estrogens produced by your body, through blocking a natural body substance (an enzyme) called "aromatase".

2. What you need to know before starting to take Anastrozol Teva-ratio

Do not take Anastrozol Teva-ratio

• If you are allergic (hypersensitive) to anastrozole or to any of the other ingredients of this medicine (listed in section 6).

• If you are pregnant or breastfeeding (see the section titled “Pregnancy and breastfeeding”).

Do not take Anastrozol Teva-ratio if you are in any of the situations described above. If you are unsure, consult your doctor or pharmacist before taking Anastrozol Teva-ratio.

Warnings and precautions

Talk to your doctor or pharmacist before taking Anastrozol Teva-ratio, and check with your doctor or pharmacist

• if you still have menstrual periods and have not reached menopause.

• if you are taking a medicine containing tamoxifen or medicines containing estrogen (see the section titled “Use of Anastrozol Teva-ratio with other medicines”).

• if you have ever had a condition affecting your bone strength (osteoporosis).

• if you have any liver or kidney problems.

If you are unsure whether any of these apply to you, consult your doctor or pharmacist before taking Anastrozol Teva-ratio.

If you are admitted to hospital, inform healthcare staff that you are taking Anastrozol Teva-ratio.

Children and adolescents

Anastrozol Teva-ratio must not be given to children or adolescents.

Use of Anastrozol Teva-ratio with other medicines

Tell your doctor or pharmacist if you are taking or using, have recently taken or used, or might need to take or use any other medicines, including those obtained without a prescription and herbal medicines. This is because Anastrozol Teva-ratio may affect the action of other medicines, and some medicines may affect Anastrozol Teva-ratio.

Do not take Anastrozol Teva-ratio if you are already being treated with any of the following medicines:

• Certain medicines used to treat breast cancer (selective estrogen receptor modulators), for example, medicines containing tamoxifen. This is because these medicines may cause Anastrozol Teva-ratio to stop working properly.

• Medicines containing 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 medicine known as an “LHRH analogue”. This includes gonadorelin, buserelin, goserelin, leuprorelin and triptorelin. These medicines are used to treat breast cancer, certain female (gynaecological) health disorders, and infertility.

Pregnancy and breastfeeding

Do not take Anastrozol Teva-ratio if you are pregnant or breastfeeding. Stop taking Anastrozol Teva-ratio if you become pregnant and consult your doctor.

Driving and using machines

It is unlikely that Anastrozol Teva-ratio will affect your ability to drive or use any tools or machines. However, occasionally some patients may experience weakness or drowsiness while taking Anastrozol Teva-ratio. If this happens to you, seek advice from your doctor or pharmacist.

Important information for athletes

Athletes are advised that this medicine contains a component that may result in a positive analytical finding in doping control tests.

Anastrozol Teva-ratio contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

Anastrozol Teva-ratio contains sodium

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

3. How to take Anastrozol Teva-ratio

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

• The recommended dose is one tablet daily.
• Try to take the tablet at the same time each day.
• Swallow the tablet whole with water.
• You may take Anastrozol Teva-ratio before, during, or after meals.

Continue taking Anastrozol Teva-ratio for as long as your doctor has instructed you. This is a long-term treatment and you may need to take it for several years.

If you take more Anastrozol Teva-ratio than you should

If you take more Anastrozol Teva-ratio than you should, contact a doctor immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Anastrozol Teva-ratio

If you forget to take a dose, simply take the next dose at the usual time.

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

If you stop taking Anastrozol Teva-ratio

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

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

Other adverse effects:

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

• Depression
• Headache
• Hot flushes
• Dizziness (nausea)
• Skin rash
• Joint pain or stiffness
• Inflammation of the joints (arthritis)
• Weakness
• Bone loss (osteoporosis)

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

• Loss of appetite
• Increased or elevated levels of a fatty substance in the blood known as cholesterol, which would be detected in a blood test
• Drowsiness
• Carpal tunnel syndrome (tingling, pain, cold sensation, weakness in areas of the hand)
• Tingling, numbness, or pins and needles of the skin, loss or lack of taste
• Diarrhea
• Vomiting
• Changes in liver function blood tests
• Hair thinning (hair loss)
• Allergic reactions (hypersensitivity), including of the face, lips, or tongue
• Bone pain
• Vaginal dryness
• Vaginal bleeding (usually during the first weeks of treatment – if bleeding continues, speak with your doctor)
• Muscle pain

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

• Changes in special blood tests showing how your liver is functioning (gamma-GT and bilirubin)
• Inflammation of the liver (hepatitis)
• Hives or welts
• Trigger finger (a condition in which one of the fingers of the hand remains bent)
• Increased levels of calcium in the blood. If you experience nausea, vomiting, and thirst, inform your doctor, pharmacist, or nurse, as you may need a blood test

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

• Rare skin inflammation that may include red spots or blisters
• Skin rash caused by hypersensitivity (this may be due to an allergic or anaphylactoid reaction)
• Inflammation of small blood vessels causing red or purple skin discoloration. Very rarely, symptoms such as joint, stomach, or kidney pain may occur; this is known as “Henoch-Schönlein purpura”

Adverse effects with unknown frequency (frequency cannot be estimated from available data):

• Dry eyes
• Lichenoid eruption (small red or purple itchy bumps on the skin)
• Inflammation of a tendon or tendinitis (connective tissues that join muscles to bones)
• Tendon rupture (connective tissues that join muscles to bones)
• Memory impairment

Effects on your bones

Anastrozol Teva-ratio reduces levels of hormones called estrogens in your body. This may reduce the mineral content of your bones. Bones may become weaker and more prone to fractures. Your doctor will monitor these risks according to treatment guidelines for bone health in postmenopausal women. You should discuss the risks and treatment options with your doctor.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Anastrozol Teva-ratio

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

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point located at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

• The active substance 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 carboxymethyl starch (type A) from potato

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

Appearance of the product and contents of the pack

• Anastrozol Teva-ratio 1 mg film-coated tablets are white to off-white, round tablets. One tablet face is marked with “93” and the other with “A10”.

• Anastrozol Teva-ratio 1 mg film-coated tablets are available in pack sizes of 1, 10, 14, 20, 28, 30 (3 x 10), 50, 56, 60, 84, 90, 98, 100 and 300 tablets. Hospital packs containing 84 tablets, as well as unit-dose hospital packs of 10 (10 x 1) and 50 (50 x 1) film-coated tablets are also available.

Only certain pack 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

Manufacturer

Teva Pharmaceutical Works Private Limited Company

Pallagi Street 13

H-4042 Debrecen

Hungary

or

Pharmachemie B. V.

Swensweg 5, Postbus 552, 2003 RN Haarlem

Netherlands

or

Teva Czech Industries s.r.o.

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

Czech Republic

Teva Pharma S.L.U.

C/ C, n° 4, Poligono Industrial Malpica,

50016 Zaragoza

Merckle GmbH

Ludwig-Merckle-Strasse 3, 89143 Blaubeuren

Germany

Date of the most recent revision of this leaflet: July 2025

“Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios - AEMPS) at: http://www.aemps.gob.es/”

You can access detailed and up-to-date information on this medicine by scanning with your mobile phone (smartphone) the QR code included in the outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/76081/P_76081.html