Package Insert: Information for the User

Anastrozol Kern Pharma 1 mg Film-Coated Tablets

Anastrozol

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

• Keep this package insert, 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 must 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 package insert. See section 4.

6.Contents of the pack and additional information

Anastrozol Kern Pharma contains a substance called anastrozol and belongs to a group of medicines called “aromatase inhibitors”. Anastrozol is used to treat breast cancer in women who are in menopause.

Anastrozol 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 Anastrozol Kern Pharma

• If you are allergic (hypersensitive) to anastrozol or to any of the other components of Anastrozol Kern Pharma (listed in section 6).of Anastrozol Kern Pharma (including in the section 6).
• If you are pregnant or breastfeeding (see the section called “Pregnancy, fertility 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 Kern Pharma.

• 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 Anastrozol Kern Pharma 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 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.

Use of Anastrozol Kern Pharma with other medications

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

Do not take Anastrozol Kern Pharma if you are being treated with any of the following medications:

• Certain medications used to treat breast cancer (selective estrogen receptor modulators), for example, medications that contain tamoxifeno. This is because these medications may make anastrozol not work 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 “LHRH analogue”. This includes gonadorelina, buserelina, goserelina, leuprorelina, and triptorelina. These medications are used to treat breast cancer, certain female health conditions (gynecological) and infertility.

Pregnancy, breastfeeding and fertility

Do not take anastrozol if you are pregnant or breastfeeding. Stop taking anastrozol 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 tool or machine. However, occasionally some patients may feel weakness or drowsiness while taking anastrozol. If this happens, seek advice from your doctor or pharmacist.

Anastrozol Kern Pharma 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.

Important information for 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. In case of doubt, consult your doctor or pharmacist again.

• The usual 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 tells you to. This is a long-term treatment and you may need to take it for several years.

Use in children

Anastrozol should not be administered to children and adolescents.

If you take more Anastrozol Kern Pharma than you should

If you take more anastrozol 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, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Anastrozol Kern Pharma

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 Kern Pharma

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, anastrozole may cause side effects, although not everyone will experience them.

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

• Headache.
• Hot flashes.
• Sensation of dizziness (nausea).
• Skin rash.
• Pain or stiffness in the joints.
• Joint inflammation (arthritis).
• Weakness.
• Bone loss (osteoporosis).
• Depression

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

• 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).
• Diarrhea.
• Vomiting.
• Changes in blood tests that show how well the liver is functioning.
• Thinning of the 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, speak with your doctor).

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

• Changes in special blood tests that show how well the 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).

Very rare side effects (affect between 1 and 10 people in every 10,000)

• 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".

Extremely rare side effects (affect fewer than 1 person in every 10,000)

• A 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 that 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 need urgent medical treatment.

Effects on your bones

Anastrozole reduces the levels of hormones called estrogens present in your body. This may 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 speak with your doctor about the risks and treatment options.

If you experience side effects, consult your doctor or pharmacist, even if they are side effects that do not appear in this prospectus. It is essential to inform your doctor, as they may need to lower your dose or suspend treatment, at least temporarily.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is side effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for human use, website: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.

No special storage conditions are required.

Store in the outer packaging.

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.

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

Anastrozol Kern Pharma Composition

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

• The other components (excipients) are: lactose monohydrate, carboxymethylcellulose sodium (type A) from potato (potato starch), povidone, magnesium stearate, hypromellose, macrogol, hydrogenated cottonseed oil, pregelatinized cornstarch (cornstarch) and titanium dioxide (E-171).

Product appearance and packaging contents

Anastrozol Kern Pharma 1 mg is presented as white, round, biconvex film-coated tablets.

Anastrozol is available in a calendar-type blister pack containing 28 film-coated tablets.

Marketing Authorization Holder

Kern Pharma, S.L.

Colón II Industrial EstateVenus, 72

08228 Terrassa - Barcelona

Spain

Responsible for Manufacturing

Kern Pharma, S.L.

Colón II Industrial Estate, C/Venus, 72

08228 Terrassa - Barcelona

Spain

or

Haupt Pharma Münster GmbH

Schleebruggenkamp, 15

48159 Münster (Germany)

Last review date of this leaflet: 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/.