ANASTROZOL TARBIS 1 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

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

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

Anastrozole Tarbis 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 Tarbis

Do not take Anastrozole Tarbis

• if you are allergic to anastrozole or any of the other ingredients of Anastrozole Tarbis (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 above situations. If you are not sure, consult your doctor or pharmacist before taking anastrozole.

Warnings and precautions

Before taking Anastrozole Tarbis, check with your doctor or pharmacist

• 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 “Use of 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.

Taking Anastrozole Tarbis with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription and herbal medicines. This is because anastrozole may affect the action of other medicines, and some medicines may affect anastrozole.

Do not take Anastrozole Tarbis 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 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, certain 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 Tarbis 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, consult them before taking this medicine.

Use in athletes

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

3. How to take Anastrozole Tarbis

Follow exactly the instructions of your doctor for taking 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 meals.

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 Tarbis 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 medicine and the amount taken.

If you forget to take Anastrozole Tarbis

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

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

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

4. Possible side effects

Like all medicines, this medicine 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.
• Increased or high levels of a fatty substance called cholesterol in the blood, which would be seen in a blood test.
• Feeling sleepy.
• 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 well 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)

• A rare skin condition that may include red patches or blisters.
• 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, symptoms of joint pain, stomach pain and kidney problems may occur; 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 may cause difficulty in swallowing or breathing. This is known as “angioedema”.

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

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.

Reporting of side effects

If you experience 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 Pharmacovigilance System for Human Use Medicines, www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Anastrozole Tarbis

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.

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.

No special storage conditions are required.

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 is in Anastrozole Tarbis

The active substance is anastrozole. Each film-coated tablet contains 1 mg of anastrozole. The other ingredients are: lactose monohydrate (lactose), potato starch, povidone, magnesium stearate. The coating contains: hypromellose, macrogol, cottonseed oil, maize starch, titanium dioxide.

Appearance and packaging

White, round, biconvex tablet. Anastrozole Tarbis is available in blister packs, in packs containing 28 tablets.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Manufacturer

HAUPT PHARMA MÜNSTER GMBH

Scheebrüggenkamp 15

48159 Münster (Germany)

or

TECNIMEDE-SOCIEDADE TECNICO MEDICINAL, S.A.

Quinta da Cerca, Caixaria (Dois Portos)

2565-187 – Portugal

Date of last revision of this leaflet: February 2021

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/