PATIENT INFORMATION LEAFLET

Anastrozol Liderfarm 1 mg Film-Coated Tablets

Anastrozol

Read this leaflet carefully before you start taking this medicine.

- Keep this leaflet, as you may need to read it again.

- If you have any questions, ask your doctor or pharmacist.

- This medicine has been prescribed for you. Do not pass it on to others even if their symptoms are the same. It may harm them.

- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

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

2. Before taking Anastrozol Liderfarm

3. How to take Anastrozol Liderfarm

4. Possible side effects

5. Storage of Anastrozol Liderfarm

6. Further information

Anastrozol Liderfarm contains a substance called anastrozole and belongs to a group of medicines known as “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 Liderfarm

• if you are allergic (hypersensitive) to anastrozol or to any of the other components of Anastrozol Liderfarm (see section 6: Additional information).
• 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.

Be especially careful with Anastrozol Liderfarm

Before taking Anastrozol Liderfarm, 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 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.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those obtained 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.

Consult 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 and breastfeeding

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 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.

Important information about some of the components of Anastrozol Liderfarm

This medication contains lactose, which is a type of sugar. If your doctor has told you that you have a intolerance to certain 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. Consult your doctor or pharmacist if you have any doubts.

- The usual 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 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 Liderfarm 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 at telephone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Anastrozol Liderfarm

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 Liderfarm

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

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

Like all medications, Anastrozol Liderfarm 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 less 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 any of these occur, call an ambulance or seek medical attention immediately. You may need urgent medical treatment.

Effects on your bones

Anastrozol 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 consider any of the side effects you experience to be severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

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.

This medication does not require special storage conditions.

Store in the outer packaging.

Medications should not be thrown down the drain or in the trash. Dispose of the packaging 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 packaging and medications you no longer need. By doing so, you will help protect the environment.

Anastrozol Liderfarm Composition

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 K29-32, sodium starch glycolate Type A potato starch (potato starch), magnesium stearate (E572)

Tablet coating:Opadry White Y-1-70001(hypromellose (E464), macrogol 400 and titanium dioxide (E171)), hypromellose (E464)

Product Appearance and Packaging Content

White to off-white, round, biconvex tablets with the imprint “A 1” on one face.

Anastrozol Liderfarm is presented in packaging containing 28 film-coated tablets.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Farmaldier, S.A

C/ Aragoneses, 15

28108 Pol. Ind. Alcobendas

Madrid (Spain)

Responsible Manufacturer

Toll Manufacturing Services, S.L.,

Aragoneses, nº2

28108 Alcobendas (Madrid)

This leaflet was approved in 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/