Anastrozol sun 1mg comprimidos recubiertos con pelicula efg

PROSPECTO: INFORMATION FOR THE USER

Anastrozol SUN 1 mg film-coated tablets EFG

Anastrazole

Read this prospectus carefully before starting to take this medication, as it contains important information for you.

??Keep this prospectus, as you may need to read it again.

??If you have any doubts, consult your doctor or pharmacist or nurse.

??This medication has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

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

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

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

3. How to take Anastrozol SUN.

4. Possible adverse effects.

5. Storage of Anastrozol SUN.

6. Contents of the package and additional information.

Anastrozol SUN contains a substance called anastrozole andbelongs to a group of medications known as “aromatase inhibitors”. Anastrozole is used to treat breast cancer in women who are in menopause.

Anastrozoleacts by reducing the amount of hormones called estrogens that are produced by your body, by blocking a natural bodily substance (an enzyme) called “aromatase”.

Do not take Anastrozol SUN:

If you areallergic to anastrozol or to any of the other componentsof this medication (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

Consult your doctor, pharmacist, or nurse before starting to take Anastrozol SUN:

??if you still have menstrual periods andhave not yet reached menopause.

?if you are taking a medication that contains tamoxifeno or medications that contain estrogen (see the section titled “Taking Anastrozol SUN with other medications”).

?if you have ever had any condition that affects the strength of your bones (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.

Inform hospital staff that you are taking anastrozol if you are admitted to the hospital.

Taking Anastrozol SUN with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. This is because Anastrozol SUN may affect the activity of other medications, and some medications may have an effect on Anastrozol SUN.

Do not take Anastrozol SUNif you are already being treated with any of the following medications:

- Certain medications used to treat breast cancer (selective estrogen receptor modulators), such as medications that contain tamoxifeno. This is because these medications may make anastrozol less effective.

-Medications that contain estrogens, such as hormone replacement therapy (HRT).

If you are in any of these situations, seek advice from your doctor or pharmacist.

Inform your doctor or pharmacist if you are taking the following:

- A medication known as an “LHRH analogue”. This includes gonadorelina, buserelina, goserelina, leuprorelina, and triptorelina. These medications are used to treat breast cancer, certain gynecological conditions, and infertility.

Pregnancy and breastfeeding

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

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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

Anastrozol SUN contains lactose

Anastrozol SUN contains lactose, a type of sugar.If your doctor has told you that you have an intolerance tocertain sugars, consult with them before taking this medication.

Use in athletes

This medication contains anastrozol, which may produce a positive result in doping control tests.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

- The recommended dose is one tablet per day.

- Try to take the tablet at the same time every day.

- Swallow the tablet whole with the help of water.

- You can take Anastrozol SUN before, during, or after meals.

Continue taking Anastrozol SUN for the time your doctor or pharmacist tells you to. 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:

Anastrozol should not be administered to children and adolescents

If you take more Anastrozol SUN than you should:

If you take more Anastrozol SUN than you should, contact your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Anastrozol SUN:

If you forget to take a dose, simply take the next dose normally.

Do not take a double dose (two doses at the same time) to compensate for a missed dose.

If you interrupt treatment with Anastrozol SUN:

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

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking anastrozol and seek urgent medical attention if you experience any of the following severe but rare side effects:

• Extremely severe skin reaction with blisters or ulcers on the skin. This is known as "Stevens-Johnson syndrome".
• Allergic reactions (hypersensitivity) with throat swelling that can cause difficulty swallowing or breathing. This is known as "angioedema".

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

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

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

- Loss of appetite

- Elevated levels of a fatty compound in the blood known as cholesterol, which would be observed in a blood test.

- Drowsiness

- Carpal tunnel syndrome (tingling, pain, sensation of coldness, weakness in areas of the hand).

-Itching, tingling or numbness of the skin, loss / lack of taste.

- Diarrhea

- Vomiting

-Blood test changes that show how well your liver is functioning.

- Hair thinning (hair loss)

- Allergic reactions (hypersensitivity) including face, lips or tongue.

- Bone pain

- Vaginal dryness

- Vaginal bleeding (usually in the first weeks of treatment - if bleeding continues, talk to your doctor).

- Muscle pain

Uncommon side effects (can affect up to 1 in 100 people)

-Blood test changes that show how well your liver is functioning (gamma-GT and bilirubin).

- Liver inflammation (hepatitis).

- Hives or welts.

-Trigger finger (alteration in which one of the fingers of the hand stays bent).

-Elevated levels of calcium in the blood. If you experience nausea, vomiting and thirst, inform your doctor or pharmacist or nurse as you may need to have a blood test.

Rare side effects (can affect up to 1 in 1,000 people)

- Rare skin inflammation that may include red patches or blisters.

- Skin rash caused by hypersensitivity (this may be due to an allergic reaction or anaphylactoid reaction).

- Inflammation of small blood vessels causing red or purple discoloration of the skin. Very rarely, symptoms of joint pain, stomach and kidney pain may occur; this is known as "Henoch-Schönlein purpura".

Effects on your bones:

Anastrozol reduces the levels of hormones called estrogens present in your body. This can reduce the mineral content of your bones. These may be less strong and make fractures more likely. Your doctor will monitor these risks according to the treatment guidelines for bone health in postmenopausal women. You should talk to your doctor about the risks and treatment options.

If you consider any of the side effects you are experiencing to be severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consulta your doctor,pharmacist or nurse,even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication 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 usethis medicationafter the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Store in the original packaging.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Anastrozol SUN

- The active ingredient is anastrozol. Each tablet contains 1 mg of anastrozol.

- The other components (excipients) are:

Tablet core:

Lactose monohydrate, cornstarch, povidone, microcrystalline cellulose, sodium carboxymethyl starch, anhydrous colloidal silica, magnesium stearate, talc.

Tablet coating:

Hypromellose, macrogol 400), titanium dioxide (E-171), talc.

Appearance of the product and contents of the packaging

Anastrozol SUN 1 mgis presented as coated tablets with a film coating, round, white.

Each blister contains 10 or 14 tablets.

Packaging sizes: 20, 28, 30, 60, or 100 coated tablets.

Not all packaging sizes may be marketed

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp, Netherlands

Responsible manufacturer

Remedica Ltd

Limassol Industrial Estate, Aharnon Street

P.O.Box 51706, 3508, Limassol

Cyprus

Local representative

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 Barcelona. Spain

Tel.: +34 93 342 78 90

Last review date of this leaflet: March 2021

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