Prospecto: information for the patient

Anastrozol NORMON 1 mg film-coated tablets EFG

Anastrozol

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

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others, 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, even if they are not listed in this prospect. See section 4.

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

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

3.How to take Anastrozol NORMON

4.Possible adverse effects

5Storage of Anastrozol NORMON

6. Contents of the pack and additional information

Anastrozol NORMON 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 in menopause.

Anastrozole works 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 NORMON

• if you are allergic to anastrozol or any of the other components of this medication (listed in section 6).
• if you are pregnant or breastfeeding (see the section called “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 or pharmacist before starting to take anastrozol

• if you still have menstrual periods and have not reached menopause.
• if you are taking a medication that contains tamoxifeno or medications that contain estrogen (see the section called “Use of 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 affects you, consult your doctor or pharmacist before taking anastrozol.

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

Other medications and anastrozol

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This includes medications you purchase without a prescription and herbal remedies. This is because anastrozol may affect the activity of other medications, and some medications may have an effect on anastrozol.

Do not take anastrozol if 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 ineffective.
• 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 analog”. This includes gonadorelina, buserelina, goserelina, leuprorelina, and triptorelina. These medications are used to treat breast cancer, certain gynecological health conditions, and infertility.

Pregnancy, breastfeeding, and fertility

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

This medicationcontainslactose. If your doctor has told you that you have alactose intolerance, consult with them before taking this medication.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially “sodium-free”.

Important information for athletes

Warning to athletes: this medication contains anastrozol, a component that may result in a positive analytical result for doping control.

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

• The recommended dose is one daily tablet.
• Try to take the tablet at the same time every day.
• Swallow the tablet whole with the help of water.
• You can take anastrozol before, during, or after meals.

Continue taking anastrozol 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. In case of 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 NORMON than you should

If you take more anastrozol than you should, contact your doctor or pharmacist immediately.

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

If you forget to take Anastrozol NORMON

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 the missed doses.

If you interrupt treatment with Anastrozol NORMON

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 or pharmacist.

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

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

• A severe skin reaction with blisters or ulcers on the skin, known as “Stevens-Johnson syndrome”.
• Allergic reactions (hypersensitivity) with swelling of the throat that can cause difficulty swallowing or breathing, known as “angioedema”.

Very common side effects may 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 may affect up to 1 in 10 people

• Loss of appetite.
• Increased or high 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/taste of taste
• Diarrhea.
• Vomiting.
• Changes in blood tests that show how well your liver is functioning.
• Thinning of hair (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

Rare side effects may affect up to 1 in 100 people

• Changes in special blood tests 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).
• Increased levels of calcium in the blood. If you experience nausea, vomiting, and thirst, report to your doctor, pharmacist, or nurse as you may need a blood test.

Rare side effects may 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. 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 prospectus, report to your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist or nurse, even if it is a possible side effect not listed in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use: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 use this medication after the expiration date that appears on the packagingafter CAD.The expiration date is the last day of the month indicated.

No special storage conditions are required.

Store in the outer packaging.

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

Composition of Anastrozol NORMON

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

The other components (excipients) are:

Tablet core: lactose monohydrate (lactose), povidone (E1201), carboxymethylcellulose sodium from potato (Type A) and magnesium stearate (E572).

Components of the tablet coating: hypromellose (E464), macrogol 6.000, titanium dioxide (E171) and talc.

Appearance of the product and contents of the packaging

Film-coated tablets, round, biconvex, white or almost white.

Anastrozol NORMON is presented in a blister pack containing 28 tablets.

Holder of the authorization and responsible for manufacturing

Holder of the authorization

LABORATORIOS NORMON, S.A,

Ronda de Valdecarrizo, 6 –Tres Cantos 28760- Madrid (SPAIN)

Date of the last review of this leaflet: August 2021

The detailed information of this medicine is available on the website ofthe Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/