PATIENT INFORMATION LEAFLET

Amenur 1 mg film-coated tabletsEFG

Anastrozole

Read this 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 doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

1. What is Amenur and what it is used for.
2.What you need to knowbeforestarting totake Amenur
3. How to take Amenur
4. Possible side effects.
5. Storage of Amenur
6. Contents of the pack and additional information

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

Anastrozole acts 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 Amenur

• If you are allergic (hypersensitive) to anastrozole 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 anastrozole if you are in any of the situations described above. If you are unsure, consult your doctor or pharmacist before taking anastrozole.

Be especially careful with Amenur

Before taking Amenur, check with your doctor or pharmacist

• If you still have menstrual periods and have not reached menopause.
• If you are taking a medication that contains tamoxifen or medications that contain estrogen (see the section called “Other medications and Amenur”).
• 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 anastrozole.

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

Other medications and Amenur

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription and herbal remedies. This is because anastrozole may affect the activity of other medications, and some medications may have an effect on anastrozole.

Do not take anastrozole 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 tamoxifen. This is because these medications may make anastrozole stop working properly.
• 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.

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

• A medication known as an “LHRH analog”. This includes gonadorelin, buserelin, goserelin, leuprorelin, and triptorelin. These medications are used to treat breast cancer, certain gynecological health conditions, and infertility.

Pregnancy and breastfeeding

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

Important information about some of the components of Amenur

Amenur contains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Amenur contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor. 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 anastrozole before, during, or after meals.

Continue taking anastrozole for the time 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 administered to children and adolescents.

If you take more Amenur than you should

If you take more anastrozole than you should, contact your doctor 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 forgot to take Amenur

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 the treatment with Amenur

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 Amenur and seek urgent medical treatment if you experience any of the following severe but very rare side effects:

• A severe skin reaction with blisters or ulcers on the skin. This is known as “Stevens-Johnson syndrome”.
• Allergic reactions (hypersensitivity) with swelling of the throat 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.
• Pain or stiffness in the joints.
• Joint inflammation (arthritis).
• Weakness.
• Bone loss (osteoporosis).
• Depression.

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

• Loss of appetite.
• Increased or 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/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(can 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(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.
• Rarely, symptoms of joint, stomach, and kidney pain may occur; this is known as “Henoch-Schönlein purpura”.

Effects on your bones

Anastrozole 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.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano,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 packaging after 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. Deposit the containers and medications you no longer need at the SIGRE collection point at 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 Amenur

The active principle is anastrozole. Each film-coated tablet contains 1 mg of anastrozole.

The other components (excipients) of the core are: lactose monohydrate (lactose), povidone (E1201), sodium starch glycolate (potato starch), magnesium stearate (E572); the components (excipients) of the coating are: hypromellose (E464), macrogol 6000, titanium dioxide (E171) and talc.

Appearance of the product and contents of the packaging

Round, biconvex, white or almost white film-coated tablet.

Amenur is presented in a blister pack, in containers that contain 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

GP-Pharm, S.A.

Pol.Ind. Els Vinyets – Els Fogars C244, Km 22

08777 Sant Quintí de Mediona (Barcelona)

SPAIN

Responsible for manufacturing

Genepharm S.A.

18 KmMarathon Avenue

15351 Pallini

Greece

Revision date of this prospectus: May 2021

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