Anastrozole Tarbis Farma 1 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Anastrozol Tarbis Farma 1 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because 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 you should not give it 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 Tarbis Farma is and what it is used for
2. What you need to know before taking Anastrozol Tarbis Farma
3. How to take Anastrozol Tarbis Farma
4. Possible side effects
5. How to store Anastrozol Tarbis Farma
6. Contents of the pack and other information

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

This medicine contains a substance called anastrozole and belongs to a group of medicines known as "aromatase inhibitors". Anastrozole is used to treat breast cancer in women who are postmenopausal.

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

2. What you need to know before starting to take Anastrozol Tarbis Farma

Do not take Anastrozol Tarbis Farma

• 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 this medicine if you are in any of the situations described above. If you are unsure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to take this medicine:

• if you still have menstrual periods and have not yet reached menopause.
• if you are taking a medicine containing tamoxifen or medicines containing estrogen (see the section entitled “Other medicines and Anastrozol Tarbis Farma”).
• if you have ever had a condition affecting the strength of your bones (osteoporosis).
• if you have any liver or kidney problems.

If you are unsure whether any of these apply to you, consult your doctor or pharmacist before taking this medicine.

If you are admitted to hospital, inform healthcare staff that you are taking this medicine.

Other medicines and Anastrozol Tarbis Farma

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines. This includes medicines you purchase 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 Anastrozol Tarbis Farma if you are already being treated with any of the following medicines:

• Certain medicines used to treat breast cancer (selective estrogen receptor modulators), e.g. medicines containing tamoxifen. This is because these medicines may prevent Anastrozol Tarbis Farma 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.

Tell 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 gynecological conditions, and infertility.

Pregnancy and breastfeeding

Do not take this medicine if you are pregnant or breastfeeding. Stop taking this medicine if you become pregnant and consult your doctor.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

Use in athletes

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

Anastrozol Tarbis Farma contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with your doctor before taking this medicine.

Anastrozol 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 Anastrozol Tarbis Farma

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• The recommended dose is one tablet daily.
• Try to take the tablet at the same time each day.
• Swallow the tablet whole with water.
• You may take this medicine before, during, or after meals.

Continue taking this medicine 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

This medicine must not be given to children and adolescents.

If you take more Anastrozol Tarbis Farma than you should

If you take more Anastrozol Tarbis Farma 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 at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Anastrozol Tarbis Farma

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 forgotten doses.

If you stop taking Anastrozol Tarbis Farma

Do not stop taking your tablets unless instructed by your doctor.

If you have any further questions about the use of this medicine, ask 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 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 swallowing or breathing. This is known as “angioedema”.

Very common adverse effects may affect more than 1 in 10 people

• Headache.
• Hot flushes.
• Dizziness (nausea).
• Skin rash.
• Joint pain or stiffness.
• Inflammation of the joints (arthritis).
• Weakness.
• Bone loss (osteoporosis).
• Depression.

Common adverse effects may affect up to 1 in 10 people

• Loss of appetite.
• Increased or high levels of a fatty substance in the blood known as cholesterol, which would be detected in a blood test.
• Drowsiness.
• Carpal tunnel syndrome (tingling, pain, cold sensation, weakness in areas of the hand).
• Tingling, numbness, or pins and needles of the skin, loss or lack of taste.
• Diarrhea.
• Vomiting.
• Changes in blood tests showing how well your liver is functioning.
• Hair thinning (hair loss).
• Allergic reactions (hypersensitivity), including of the face, lips, or tongue.
• Bone pain.
• Vaginal dryness.
• Vaginal bleeding (usually during the first weeks of treatment – if bleeding continues, speak with your doctor).
• Muscle pain.

Uncommon adverse effects may affect up to 1 in 100 people

• Changes in special blood tests showing how your liver is functioning (gamma-GT and bilirubin).
• Inflammation of the liver (hepatitis).
• Hives or welts.
• Trigger finger (a condition in which one of the fingers of the hand remains bent).
• 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 adverse effects may affect up to 1 in 1,000 people

• Rare skin inflammation which may include red spots or blisters.
• Skin rash caused by hypersensitivity (this may be due to an allergic or anaphylactoid reaction).
• 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”.

Effects on your bones

Anastrozole reduces the levels of hormones called estrogens in your body. This may reduce the mineral content of your bones. Bones may become weaker and more prone to fractures. 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, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can 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 Tarbis Farma

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

Do not use this medicine after the expiry date stated on the packaging and on the blister after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and waste materials, including packaging, should be returned to the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Anastrozol Tarbis Farma

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

Appearance of the product and contents of the pack

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

Anastrozol 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

The Netherlands

Date of the most recent review 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/