Anastrozole Tarbis 1 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Anastrozol Tarbis 1 mg film-coated tablets EFG

Anastrozol

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only; do not give it to others, even if they have the same symptoms as yours, because it could harm them.

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Anastrozol Tarbis 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 have undergone menopause.

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

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

Do not take Anastrozol Tarbis

• if you are allergic to anastrozol or to any of the other components of Anastrozol Tarbis (listed in section 6).
• if you are pregnant or breastfeeding (see the section titled “Pregnancy and breastfeeding”).

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

Warnings and precautions

Before taking Anastrozol Tarbis, check with your doctor or pharmacist

• 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 titled “Use of other medicines”).
• if you have ever had a condition affecting bone strength (osteoporosis).
• if you have any liver or kidney problems.

If you are unsure whether any of this applies to you, consult your doctor or pharmacist before taking anastrozol.

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

Taking Anastrozol Tarbis with other medicines

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

Do not take Anastrozol if you are already being treated with any of the following medicines:

• Certain medicines used to treat breast cancer (selective estrogen receptor modulators), for example, medicines containing tamoxifen. This is because these medicines may prevent anastrozol 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.

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 female (gynecological) health disorders, and infertility.

Pregnancy and breastfeeding

Do not take anastrozol if you are pregnant or breastfeeding. Stop treatment with anastrozol 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 anastrozol will affect your ability to drive or use tools or machines. However, occasionally some patients may experience weakness or drowsiness while taking anastrozol. If this happens to you, seek advice from your doctor or pharmacist.

Anastrozol Tarbis contains lactose

This medicine contains lactose, which is a type of sugar. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Use in athletes

This medicine contains anastrozol, which may lead to a positive result in doping control tests.

3. How to take Anastrozol Tarbis

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

• The usual 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 anastrozole before, during, or after meals.

Continue taking anastrozole for as long as your doctor has instructed you. This is a long-term treatment and you may need to take it for several years.

Use in children and adolescents

Anastrozole must not be given to children and adolescents.

If you take more Anastrozol Tarbis than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Anastrozol Tarbis

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 a missed dose.

If you stop taking Anastrozol Tarbis

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

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone gets them.

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

• Headache
• Hot flushes
• Dizziness (nausea)
• Skin rash
• Joint pain or stiffness
• Joint inflammation (arthritis)
• Weakness
• Bone loss (osteoporosis)
• Depression

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

• Loss of appetite
• Increase or elevated levels of a fatty substance in the blood known as cholesterol, which would be observed in a blood test
• Drowsiness
• Carpal tunnel syndrome (tingling, pain, cold sensation, weakness in areas of the hand)
• Diarrhea
• Vomiting
• Changes in blood tests showing how well your liver is functioning
• Hair weakening (hair loss)
• Allergic reactions (hypersensitivity) including face, lips or tongue
• Bone pain
• Vaginal dryness
• Vaginal bleeding (usually during the first weeks of treatment – if bleeding continues, speak with your doctor)

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

• Changes in special blood tests showing how your liver is functioning (gamma-GT and bilirubin)
• Inflammation of the liver (hepatitis)
• Hives or wheals
• Trigger finger (a condition in which one of the fingers of the hand remains bent)

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

• Rare skin inflammation that may include red spots or blisters
• Skin rash due to hypersensitivity (this may be due to an allergic or anaphylactoid reaction)
• Inflammation of small blood vessels causing red or purple skin discoloration. Very rarely, symptoms such as joint, stomach or kidney pain may occur; this is known as “Henoch-Schönlein purpura”

Very rare adverse effects (affect fewer 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 swallowing or breathing. This is known as “angioedema”

If you experience any of these, call an ambulance or see a doctor immediately. You may require urgent medical treatment.

Effects on your bones

Anastrozol reduces levels of hormones called estrogens in your body. This may reduce the mineral content of your bones. They 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.

Reporting of adverse effects

If you experience any adverse effects, 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, www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Anastrozol 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. The tablets could harm them.

Do not use this medicine after the expiry date stated on the packaging after EXP.

The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Store in the original outer packaging.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of any unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Anastrozol Tarbis

The active substance is anastrozol. Each film-coated tablet contains 1 mg of anastrozol. The other components (excipients) are: lactose monohydrate (lactose), sodium carboxymethyl starch from potato (potato starch), povidone, magnesium stearate. The components of the coating are: hypromellose, macrogol, cottonseed oil, corn starch, titanium dioxide.

Appearance of the product and contents of the container

White, round, biconvex tablet. Anastrozol Tarbis is presented in blisters, in 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

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 the most recent revision of this leaflet: February 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/