ANASTROZOL ACCORD 1 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet: Information for the User

Anastrozole Accord 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.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.

• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

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

Anastrozole Accord contains a substance called anastrozole. This belongs to a group of medicines called aromatase inhibitors. It is used to treat breast cancer in women who have gone through the menopause.

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

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

Do not take Anastrozole Accord:

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

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

Warnings and precautions

Consult your doctor, pharmacist or nurse before taking Anastrozole Accord:

• if you are still having menstrual periods and have not yet gone through the menopause. You have osteoporosis or have had a condition that affects the strength of your bones. Anastrozole reduces the levels of female hormones, which may lead to a loss of bone mineral density, making your bones weaker. Your bone density may also be measured during treatment. Your doctor may prescribe other medicines to prevent or treat bone loss.
• if you are taking a medicine that contains tamoxifen or medicines that contain estrogen (see section "Other medicines and Anastrozole Accord").
• if you have ever had a condition that affects the strength of your bones (osteoporosis).
• if you have liver or kidney problems.

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

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

Children and adolescents

Do not give this medicine to children because it is unlikely to be safe.

Other medicines and Anastrozole Accord

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Anastrozole Accord can affect the action of other medicines, and some medicines can affect Anastrozole Accord.

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

• Certain medicines used to treat breast cancer (selective estrogen receptor modulators), e.g. medicines that contain tamoxifen. This is because these medicines may stop Anastrozole Accord from working properly.
• Medicines that contain estrogen, 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 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, some gynaecological conditions (e.g. endometriosis, fibroids) and infertility.

Using Anastrozole Accord with food and drink:

There are no effects on the absorption of Anastrozole Accord when taken with food.

Pregnancy, breast-feeding:

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

Consult your doctor or pharmacist before taking this medicine.

Driving and using machines:

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

Anastrozole Accord contains lactose

This medicine contains lactose, which is a type of sugar. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

Anastrozole Accord contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet, which is essentially "sodium-free".

3. How to take Anastrozole Accord

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 for adults is one tablet once a day.
• The tablets should be swallowed whole with water.
• Try to take a tablet at the same time each day.

You can take Anastrozole Accord before, during or after meals.

Keep taking Anastrozole Accord 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 are not sure, consult your doctor or pharmacist.

Use in children and adolescents

Anastrozole Accord should not be given to children and adolescents.

If you take more Anastrozole Accord than you should

If you have taken more Anastrozole Accord than you should, contact a doctor immediately.

If you forget to take Anastrozole Accord

If you miss a dose, just take the next dose at the usual time. Do not take a double dose (two doses at the same time) to make up for a missed dose. Just carry on with the next dose as normal.

If you stop taking Anastrozole Accord

Do not stop taking this medicine unless your doctor tells you to. If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.

4. Possible side effects

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

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

• A severe skin rash with ulcers or blisters in the skin. This is known as "Stevens-Johnson syndrome".
• Allergic reactions (hypersensitivity) with swelling of the throat which may cause difficulty in swallowing or breathing. This is known as "angioedema".

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

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

Common (may affect up to 1 in 10 people)

• Vaginal dryness
• Vaginal bleeding (usually in the first few weeks of treatment - if bleeding continues, talk to your doctor)
• Thinning of hair (hair loss)
• Diarrhea
• Lack of appetite
• Increased or high levels of a lipid compound in the blood known as cholesterol, which would be seen in a blood test
• Vomiting
• Feeling sleepy
• Carpal tunnel syndrome (tingling, pain, numbness or weakness in the hand)
• Tingling, numbness or prickling of the skin, loss of taste
• Changes in blood tests that show how your liver is working
• Bone pain
• Allergic reactions (hypersensitivity) including face, lips or tongue
• Muscle pain

Uncommon (may affect up to 1 in 100 people)

• Trigger finger (a condition in which one of your fingers gets stuck in a bent position)
• Changes in special blood tests that show how your liver is working (gamma-GT and bilirubin)
• Inflammation of the liver (hepatitis)
• Hives or itchy skin

High levels of calcium in the blood. If you experience nausea, vomiting and thirst, tell your doctor, pharmacist or nurse as you may need a blood test.

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

• A rare inflammation of the skin that may include red patches or blisters.
• Inflammation of small blood vessels which can cause red or purple spots on the skin. Very rarely, symptoms of joint pain, stomach pain and kidney pain may occur; this is known as "Henoch-Schönlein purpura".

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

• Dry eyes
• Lichenoid rash (small, itchy, red or purple bumps on the skin)
• Inflammation of a tendon or tendonitis (tissues that connect muscles to bones)
• Tendon rupture (tissues that connect muscles to bones)
• Memory loss

Effects on your bones

Anastrozole reduces the levels of hormones such as estrogen in your body, which may lead to a loss of bone mineral density, making your bones weaker and increasing the risk of fractures. Your doctor will monitor these risks according to the treatment guidelines for the state of bones in postmenopausal women. You should discuss the risks and treatment options with your doctor.

If you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects:

If you get any side effects, talk to your doctor, pharmacist or nurse. 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: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Anastrozole Accord

• Keep this medicine 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.
• No special storage conditions are required.
• Always return any leftover medicine to your pharmacist. Only keep it if your doctor tells you to.
• Do not use Anastrozole Accord after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
• Store in the original package.

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 further information

What Anastrozole Accord contains

The active substance is anastrozole. Each film-coated tablet contains 1 mg of anastrozole.

The other ingredients are:

Core of the tablet: lactose monohydrate (92.250 mg), povidone K-30, sodium starch glycolate (Type A) and magnesium stearate.

Coating: titanium dioxide (E171), macrogol 300 and hypromellose E-5.

Appearance of Anastrozole Accord and packaging:

Anastrozole Accord are white to off-white, round, biconvex, film-coated tablets marked with 'AHI' on one face and plain on the other face.

Anastrozole Accord is packaged in blister packs of 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100 or 300 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Accord Healthcare S.L.U., World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona

Manufacturer:

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50, 95-200 Pabianice,

Poland

Or

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht,

Netherlands

Or

Accord Healthcare Single Member S.A.

64th Km National Road Athens, Lamia, 32009,

Greece

This medicine is authorised in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet: 07/2025

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