ANASTROZOL TARBIS FARMA 1 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Anastrozole Tarbis Farma 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, 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

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

1. What Anastrozole Tarbis Farma is and what it is used for

This medicine contains the active substance 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. It does this by blocking a natural substance (an enzyme) in your body called 'aromatase'.

2. What you need to know before you take Anastrozole Tarbis Farma

Do not take Anastrozole Tarbis Farma

• 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 on 'Pregnancy and breast-feeding').

Do not take this medicine if you are in any of the above situations. If you are not sure, talk to your doctor or pharmacist before taking Anastrozole Tarbis Farma.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Anastrozole Tarbis Farma.

• if you are still having menstrual periods and have not yet gone through the menopause.
• if you are taking a medicine that contains tamoxifen or medicines that contain estrogen (see the section on 'Other medicines and Anastrozole Tarbis Farma').
• if you have ever had a condition that affects the strength of your bones (osteoporosis).
• if you have any problems with your liver or kidneys.

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

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

Other medicines and Anastrozole Tarbis Farma

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 way other medicines work, and some medicines can affect the way anastrozole works.

Do not take Anastrozole Tarbis Farma 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 Tarbis Farma 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.

Tell your doctor or pharmacist if you are taking:

• A medicine called an 'LHRH analogue'. This includes goserelin, buserelin, goserelin, leuprorelin, and triptorelin. These medicines are used to treat breast cancer, some gynecological conditions, and infertility.

Pregnancy and breast-feeding

Do not take this medicine if you are pregnant or breast-feeding. Stop taking this medicine if you become pregnant and talk to your doctor.

Ask your doctor or pharmacist for advice 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.

Use in athletes

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

Anastrozole Tarbis Farma contains lactose

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

Anastrozole Tarbis Farma contains sodium

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

3. How to take Anastrozole Tarbis Farma

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, talk to your doctor or pharmacist.

• The recommended 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 this medicine before, during, or after food.

Keep taking this medicine for as long as your doctor or pharmacist tells you to. This is a long-term treatment and you may need to take it for several years. If you are not sure, talk to your doctor or pharmacist.

Use in children and adolescents

This medicine should not be given to children and adolescents.

If you take more Anastrozole Tarbis Farma than you should

If you take more Anastrozole Tarbis Farma than you should, talk to a doctor straight away.

In case of overdose or accidental ingestion, talk to your doctor or pharmacist or contact the Poisons Information Service on 91 562 04 20, quoting the medicine and the amount taken.

If you forget to take Anastrozole Tarbis Farma

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 Tarbis Farma

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

If you have any further questions on the use of this medicine, 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 Tarbis Farma 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, which 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.
• Inflammation of the joints (arthritis).
• Weakness.
• Bone loss (osteoporosis).
• Depression.

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

• Lack of appetite.
• Increased or high levels of a fatty substance in the blood called cholesterol, which would be seen in a blood test.
• Drowsiness.
• Carpal tunnel syndrome (tingling, pain, numbness, or weakness in parts of the hand).
• Tingling, numbness, or prickling of the skin, loss of taste.
• Diarrhea.
• 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 your fingers gets 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)

• A rare skin condition with redness and blisters on the skin.
• A skin rash caused by an allergic reaction (this may be due to an allergic or anaphylactoid reaction).
• Inflammation of small blood vessels, which may cause red or purple spots on the skin. Very rarely, this can cause joint pain, stomach pain, and kidney problems; this is known as 'Henoch-Schönlein purpura'.

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 bone conditions in post-menopausal women. You should talk to your doctor about the risks and treatment options.

If you notice any side effects not listed 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 and Health Products Agency (AEMPS) 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 Tarbis Farma

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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 Tarbis Farma contains

• The active substance is anastrozole. Each film-coated tablet contains 1 mg of anastrozole.
• The other ingredients are lactose monohydrate, povidone, sodium starch glycolate type A (from potato), magnesium stearate, hypromellose (E464), macrogol 400, and titanium dioxide (E171).

Appearance and packaging

White, round, and biconvex film-coated tablets, marked with a '1' on one face and 'H' on the other.

Anastrozole Tarbis Farma is available in blister packs containing 28 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028-Barcelona

Spain

Manufacturer

Amarox Pharma B.V.

Rouboslaan 32

2252 TR Voorschoten

Netherlands

Date of last revision of this leaflet: November 2021

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