Anastrozole Accord 1 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Anastrozol Accord 1 mg film-coated tablets EFG

Anastrozole

Read the entire leaflet carefully before you start taking this medicine, as 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, pharmacist or nurse.

• 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 could harm them.

• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Anastrozol Accord contains a substance called anastrozol. This belongs to a group of medicines known as aromatase inhibitors. It is used to treat breast cancer in women who have been through the menopause.

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

2. What you need to know before taking Anastrozol Accord

Do not take Anastrozol Accord:

• If you are allergic 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 entitled “Pregnancy and breastfeeding”).

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to take Anastrozol Accord:

• If you still have menstrual periods and have not reached menopause.
• If you have osteoporosis or have previously had a condition affecting the strength of your bones. Anastrozole reduces levels of female hormones, which may lead to a loss of bone mineral density, thereby reducing bone strength. Your bone density should also be monitored during treatment. Your doctor may prescribe medication to prevent or treat bone density loss.
• If you are taking a medicine containing tamoxifen or medications containing estrogen (see the section entitled “Other medicines and Anastrozol Accord”).
• If you have ever had a condition affecting the strength of your bones (osteoporosis).
• If you have liver or kidney problems.

If you are unsure whether any of the above apply to you, consult your doctor or pharmacist before taking Anastrozol Accord.

If you are admitted to hospital, inform healthcare staff that you are taking Anastrozol Accord.

Children and adolescents

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

Other medicines and Anastrozol Accord

Inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines. This includes medicines you have purchased without a prescription and herbal remedies. This is because anastrozole may affect the action of other medicines, and some medicines may affect anastrozole.

Do not take Anastrozol Accord 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 prevent anastrozole from 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.

Talk to your doctor or pharmacist if you are taking the following:

• A medicine known as an “LHRH analogue”, such as gonadorelin, buserelin, goserelin, leuprorelin, or triptorelin. These medicines are used to treat breast cancer and certain female health conditions (gynecological conditions and infertility).

Use of Anastrozol Accord with food and drink:

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

Pregnancy and breastfeeding:

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

Consult your doctor or pharmacist before taking this medicine.

Driving and using machines:

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

Anastrozol Accord contains lactose

This medicine contains lactose, a type of sugar. If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.

Anastrozol Accord contains sodium

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

3. How to take Anastrozol Accord

Follow exactly the instructions for taking Anastrozol Accord as given by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

• The recommended dose for adults is one tablet once daily.
• Tablets should be swallowed whole with water.
• Try to take one tablet at the same time every day.

You may take Anastrozol Accord before, during, or after meals.

Continue taking Anastrozol for as long as your doctor or pharmacist has instructed you. This is a long-term treatment and you may need to take it for several years. If in doubt, consult your doctor or pharmacist.

Use in children and adolescents

Anastrozol Accord must not be given to children and adolescents.

If you take more Anastrozol Accord than you should

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

If you forget to take Anastrozol Accord

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 a missed dose. Simply resume your regular dosing schedule.

If you stop taking Anastrozol Accord

Do not stop treatment with this medicine unless instructed by your doctor.

If you have any questions about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

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

Stop taking Anastrozol Accord and seek urgent medical attention if you experience any of the following serious but very rare adverse effects:

• A very severe skin reaction with skin ulcers or blisters. 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”.

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

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

Common (may affect up to 1 in 10 people)

• Vaginal dryness
• Vaginal bleeding (usually during the first weeks of treatment – if bleeding continues, speak with your doctor)
• Hair thinning (hair loss)
• Diarrhea
• Loss of appetite
• Increased or elevated levels of a lipid compound in the blood known as cholesterol, which would be observed in a blood test
• Vomiting
• Drowsiness
• Carpal tunnel syndrome (tingling, pain, cold sensation, weakness in areas of the hand)
• Tingling, numbness or skin prickling, loss or absence of taste
• Changes in blood tests showing how your liver is functioning
• 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 the fingers of the hand remains bent)
• Changes in special blood tests showing how your liver is functioning (gamma-GT and bilirubin)
• Inflammation of the liver (hepatitis)
• Hives or wheals

Increase in the amount 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 (may affect up to 1 in 1,000 people)

• Rare skin inflammation which may include red spots or blisters.
• Inflammation of small blood vessels causing red or purple skin discolouration. 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 the available data)

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

Effects on your bones

Anastrozol reduces the levels of hormones called oestrogens in your body, and this may reduce the mineral content of your bones, which can decrease their strength and make fractures more likely. 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.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may 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 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. The tablets could harm them.
• No special storage conditions are required.
• Always return any leftover tablets to your pharmacist. Keep them only if your doctor instructs you to do so.
• Do not use Anastrozol Accord after the expiry date stated on the packaging, following (EXP). The expiry date refers to the last day of the month indicated.
• Store in the original packaging.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Anastrozol Accord

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

The other components are:

Tablet core: 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.

Presentation of Anastrozol Accord and contents of the pack:

Anastrozol Accord are film-coated tablets, white to off-white in colour, round, biconvex, marked with ‘AHI’ on one side and plain on the other.

Anastrozol Accord is packed in blister packs containing 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100 or 300 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder:

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

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,

The Netherlands

OR

Accord Healthcare Single Member S.A.

64th Km National Road Athens, Lamia, 32009,

Greece

This medicinal product is authorized in the European Economic Area member states under the following names:

Date of the most recent review of this leaflet: 07/2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es