ANASTROZOL PENSA 1 mg FILM-COATED TABLETS

Introduction

PATIENT INFORMATION LEAFLET

Anastrozole pensa 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, 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:

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

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

Anastrozole pensa 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 in the menopause.

Anastrozole works by reducing the amount of hormones called oestrogens that are produced by your body, by blocking a natural substance (an enzyme) in your body called “aromatase”.

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

Do not take Anastrozole pensa

• 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 the section called “Pregnancy and breast-feeding”).

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take anastrozole:

• if you still have menstrual periods and have not yet reached the menopause.
• if you are taking a medicine that contains tamoxifen or medicines that contain oestrogen (see the section “Using Anastrozole pensa 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 or nurse that you are taking anastrozole.

Taking Anastrozole pensa with other medicines

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 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.

Tell your doctor or pharmacist if you are taking:

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

Pregnancy and breast-feeding

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 pensa 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.

Anastrozole pensa contains sodium

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

3. How to take Anastrozole pensa

Follow exactly the instructions of your doctor to take this medicine. If you are not sure, consult your doctor or pharmacist again.

• The usual dose is one tablet per day.
• 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 and adolescents

Anastrozole should not be given to children and adolescents.

If you take more Anastrozole pensa 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 Toxicological Information Service on +34 91 562 04 20, stating the name of the medicine and the amount taken.

If you forget to take Anastrozole pensa

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 pensa

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.

Stop taking anastrozole 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 in swallowing or breathing. This is known as “angioedema”.

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

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

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

• Loss of appetite.
• Increased or high levels of a fatty substance in the blood called cholesterol, which would be seen in a blood test.
• Feeling tired.
• Carpal tunnel syndrome (tingling, pain, numbness or a cold sensation in parts of the hand).
• Pins and needles, tingling or numbness 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 where one of the fingers of the hand becomes stuck in a bent position).
• 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 side effects (may affect up to 1 in 1,000 people)

• Rare inflammation of the skin that can include redness or blisters.
• Severe skin rash caused by hypersensitivity (this may be due to an allergic reaction or anaphylactoid reaction).
• Inflammation of small blood vessels which can cause red or purple discoloration of the skin. Very rarely, this can be accompanied by 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 eye
• Lichenoid rash (small red or purple bumps on the skin that are itchy)
• Tendon inflammation or tendinitis (connective tissue that joins muscles to bones)
• Tendon rupture (connective tissue that joins muscles to bones)
• Memory problems

Effects on your bones

Anastrozole lowers the levels of female sex hormones (oestrogens) in your body. This may reduce the mineral content of your bones. This means they may become weaker and there is a greater risk they may break. Your doctor will check the risks according to treatment guidelines for the management of osteoporosis in postmenopausal women. You should talk to your doctor about the risks and treatment options.

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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaram.es. By reporting side effects you can help provide more information on the safety of this medicine.

5. Storage of Anastrozole pensa

No special storage conditions are required. Store in the outer carton.

Keep 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.

Do not use this medicineafter 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 further information

What is in Anastrozole pensa

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

The other ingredients are:

• Core of the tablet: lactose monohydrate, lactose, sodium starch glycollate (type A), microcrystalline cellulose (E460), anhydrous colloidal silica and magnesium stearate.

• Coating of the tablet: Opadry 04F58804 White/Vivacoat PC-1P-573(hypromellose (E464), titanium dioxide (E171) and macrogol 6000).

Appearance and packaging

White, biconvex, cylindrical tablet.

Anastrozole pensa is available in blister packs, in packs containing 28 tablets.

Marketing authorisation holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

SAG Manufacturing, S.L.U.

Ctra. N-I, Km 36

28750 San Agustín de Guadalix,

Madrid, Spain

Date of last revision of this leaflet: May 2025

Detailed information on this medicine is available on the website of the Spanish Medicines and Healthcare Products Agency (AEMPS) http://www.aemps.gob.es/