ANASTROZOL KERN PHARMA 1 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Anastrozole Kern Pharma 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 is Anastrozole Kern Pharma and what is it used for
2. What you need to know before you take Anastrozole Kern Pharma
3. How to take Anastrozole Kern Pharma
4. Possible side effects
5. Storing Anastrozole Kern Pharma

1. Contents of the pack and other information

1. What is Anastrozole Kern Pharma and what is it used for

Anastrozole Kern Pharma 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 estrogens that are produced by your body, by blocking a natural substance (an enzyme) called 'aromatase'.

2. What you need to know before you take Anastrozole Kern Pharma

Do not take Anastrozole Kern Pharma

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

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

Warnings and precautions

Consult your doctor or pharmacist before taking Anastrozole Kern Pharma.

• If you are still having menstrual periods and have not yet reached the menopause.
• If you are taking a medicine that contains tamoxifen or medicines that contain estrogen (see the section called “Using Anastrozole Kern Pharma with other medicines”).
• If you have ever had a condition that affects the strength of your bones (osteoporosis).
• If you have any liver or kidney problems.

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 that you are taking anastrozole.

Using Anastrozole Kern Pharma with other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This is because anastrozole can affect the action of other medicines, and some medicines can affect anastrozole.

Do not take Anastrozole Kern Pharma if you are being treated with any of the following medicines:

• Certain medicines used to treat breast cancer (selective estrogen receptor modulators), e.g. tamoxifen. This is because these medicines may stop anastrozole 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 any of the following:

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

Pregnancy, breast-feeding and fertility

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

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Anastrozole 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. If this happens to you, ask your doctor or pharmacist for advice.

Anastrozole Kern Pharma contains lactose

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

Important information for athletes

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

3. How to take Anastrozole Kern Pharma

Follow exactly the instructions of your doctor and do not take more or less than prescribed.

• The usual 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 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.

Use in children

Anastrozole should not be given to children and adolescents.

If you take more Anastrozole Kern Pharma than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service on +34 91 562 04 20, stating the name of the medicine and the amount taken.

If you forget to take Anastrozole Kern Pharma

If you forget to take 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 forgotten dose.

If you stop taking Anastrozole Kern Pharma

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

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

4. Possible side effects

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

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

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

Common side effects (affect between 1 and 10 people in 100)

• Lack of appetite.
• High levels of a fatty substance called cholesterol in the blood, which would be seen in a blood test.
• Feeling tired.
• Carpal tunnel syndrome (tingling, pain, numbness, weakness in parts of the hand).
• 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).

Uncommon side effects (affect between 1 and 10 people in 1,000)

• Changes in special blood tests that show how 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).

Rare side effects (affect between 1 and 10 people in 10,000)

• Rare inflammation of the skin that can include red patches or blisters.
• 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”.

Very rare side effects (affect less than 1 in 10,000 people)

• 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, which can cause difficulty in swallowing or breathing. This is known as “angioedema”.

If any of these happen, call an ambulance or see a doctor straight away. You may need urgent medical treatment.

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

• Dry eye
• Lichenoid rash (small red or purple bumps on the skin that itch)
• Tendinitis (inflammation of tendons, which connect muscles to bones)
• Tendon rupture (tear in tendons, which connect muscles to bones)
• Memory problems

Effects on your bones

Anastrozole lowers the levels of female sex hormones (estrogens) in your body, which may cause your bones to become thinner and weaker. This may increase the risk of fractures. Your doctor will monitor these risks according to treatment guidelines for the management of osteoporosis in post-menopausal women. You should talk to your doctor about the risks and treatment options.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

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 (www.notificaRAM.es). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Anastrozole Kern Pharma

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.

Store in the outer carton.

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.

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

What Anastrozole Kern Pharma contains

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

• The other ingredients are: lactose monohydrate, sodium carboxymethyl starch (type A) potato starch, povidone, magnesium stearate, hypromellose, macrogol, hydrogenated cottonseed oil, pregelatinised maize starch and titanium dioxide (E-171).

Appearance and packaging

Anastrozole Kern Pharma 1 mg is presented as white, round, biconvex film-coated tablets.

Anastrozole is available in a calendar pack (blister pack) containing 28 film-coated tablets.

Marketing authorisation holder

Kern Pharma, S.L.

Pol. Ind. Colón II

Venus, 72

08228 Terrassa - Barcelona

Spain

Manufacturer

Kern Pharma, S.L.

Pol. Ind. Colón II, C/ Venus, 72

08228 Terrassa - Barcelona

Spain

or

Haupt Pharma Münster GmbH

Schleebruggenkamp, 15

48159 Münster (Germany)

Date of last revision of this leaflet:June 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/.