Anastrozole Kern Pharma 1 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Anastrozol Kern Pharma 1 mg film-coated tablets EFG

Anastrozole

Read the entire 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 questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Anastrozol Kern Pharma is and what it is used for

2. What you need to know before taking Anastrozol Kern Pharma

3. How to take Anastrozol Kern Pharma

4. Possible side effects

5. How to store Anastrozol Kern Pharma

6. Contents of the pack and other information

1. What Anastrozol Kern Pharma is and what it is used for

Anastrozol Kern Pharma contains a substance called anastrozol and belongs to a group of medicines known as "aromatase inhibitors". Anastrozol is used to treat breast cancer in women who are postmenopausal.

Anastrozol 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 Kern Pharma

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).
• If you are pregnant or breastfeeding (see the section entitled “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 yet reached menopause.
• If you are taking a medicine containing tamoxifen or medicines containing estrogen (see the section entitled “Use of Anastrozol Kern Pharma with 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 these apply to you, consult your doctor or pharmacist before taking anastrozol.

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

Use of Anastrozol Kern Pharma with other medicines

Tell your doctor or pharmacist if you are using or have recently used, or might need to use, any other medicines. This is because anastrozol may affect the action of other medicines, and some medicines may affect anastrozol.

Do not take Anastrozol Kern Pharma if you are 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 gynecological conditions, and infertility.

Pregnancy, breastfeeding and fertility

Do not take anastrozol if you are pregnant or breastfeeding. Discontinue treatment with anastrozol if you become pregnant and consult your doctor.

Consult your doctor or pharmacist before using any medicine.

Driving and use of machines

It is unlikely that anastrozol will affect your ability to drive or operate tools or machinery. However, occasionally some patients may experience weakness or drowsiness while taking anastrozol. If this occurs, seek advice from your doctor or pharmacist.

Anastrozol Kern Pharma contains lactose

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

Important information for athletes

This medicine contains anastrozol, which may result in a positive doping test.

3. How to take Anastrozol Kern Pharma

Follow exactly the instructions given by your doctor for taking this medicine. 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 anastrozol for as long as your doctor has instructed you to. This is a long-term treatment and you may need to take it for several years.

Use in children

Anastrozol must not be given to children or adolescents.

If you take more Anastrozol Kern Pharma 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, pharmacist, or call the Toxicology Information Service immediately at: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Anastrozol Kern Pharma

If you forget to take a dose, simply take the next dose at your usual time.

Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

If you stop taking Anastrozol Kern Pharma

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, anastrozole can have adverse effects, although not everyone will experience 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
• Increased 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 indicating how well your liver is functioning
• Hair thinning (hair loss)
• Allergic reactions (hypersensitivity), including of the 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)
• Liver inflammation (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, 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 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 require urgent medical treatment.

Adverse effects with unknown frequency (frequency cannot be estimated from available data):

• Dry eye
• Lichenoid eruption (small red or purple itchy bumps on the skin)
• Tendon inflammation or tendinitis (connective tissues linking muscles to bones)
• Tendon rupture (connective tissues linking muscles to bones)
• Memory impairment

Effects on your bones

Anastrozole reduces levels of hormones called estrogens in your body. This may decrease the mineral content of your bones. Bones may become weaker, increasing the likelihood of fractures. Your doctor will monitor these risks according to treatment guidelines for bone status in postmenopausal women. You should discuss the risks and treatment options with your doctor.

If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. It is important to inform your doctor, as your dose may need to be reduced or treatment stopped, at least temporarily.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products, website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Anastrozol Kern Pharma

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. These tablets could harm them.

No special storage conditions are required.

Keep in the outer packaging.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Anastrozol Kern Pharma

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

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

Appearance of the product and contents of the pack

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

Anastrozol is available in calendar blister packs containing 28 film-coated tablets.

Marketing Authorization Holder

Kern Pharma, S.L.

Pol. Ind. Colón II

Venus, 72

08228 Terrassa - Barcelona

Spain

Manufacturer

Kern Pharma, S.L.

Pol. Ind. Colón II, C/ Venus, 72

08228 Terrassa - Barcelona

Spain

or

Haupt Pharma Münster GmbH

Schleebruggenkamp, 15

48159 Münster (Germany)

Date of the most recent revision of this leaflet: June 2025.

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/.