LETROZOLE KERN PHARMA 2.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Letrozol Kern Pharma 2.5 mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Letrozol Kern Pharma and what is it used for
2. What you need to know before taking Letrozol Kern Pharma
3. How to take Letrozol Kern Pharma
4. Possible side effects
5. Storage of Letrozol Kern Pharma
6. Package Contents and Additional Information

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

What is Letrozol Kern Pharma and how it works

Letrozol Kern Pharma contains an active ingredient called letrozole. It belongs to a group of medications called aromatase inhibitors. It is a hormonal (or "endocrine") treatment for breast cancer. The growth of breast cancer is usually stimulated by estrogens, which are female sex hormones. Letrozol Kern Pharma reduces the amount of estrogen by blocking an enzyme ("aromatase") involved in the production of estrogens, and thus can block the growth of breast cancers that need estrogens to grow. As a result, tumor cells grow more slowly or stop growing and/or spreading to other parts of the body.

What Letrozol Kern Pharma is used for

Letrozol Kern Pharma is used to treat breast cancer in women who have gone through menopause, i.e., the cessation of menstrual periods.

It is used to prevent breast cancer from coming back. It can be used as the first treatment before breast cancer surgery, in case surgery is not immediately possible, or it can be used as the first treatment after breast cancer surgery, or after five years of treatment with tamoxifen. Letrozol Kern Pharma is also used to prevent the breast tumor from spreading to other parts of the body in patients with advanced breast cancer.

If you have any questions about how Letrozol Kern Pharma works or why you have been prescribed this medication, consult your doctor.

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

Follow your doctor's instructions carefully. They may be different from the general information contained in this package leaflet.

Do not take Letrozol Kern Pharma

• if you are allergic to letrozole or any of the other ingredients of this medication (listed in section 6),
• if you still have menstrual cycles, i.e., you have not reached menopause,
• if you are pregnant,
• if you are breastfeeding.

If any of these cases apply to you, do not take this medication and inform your doctor.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Letrozol Kern Pharma

• if you have severe kidney disease,
• if you have severe liver disease,
• if you have a history of osteoporosis or bone fractures (see also "Monitoring of Letrozol Kern Pharma treatment" in section 3).

If any of these cases apply to you, inform your doctor. Your doctor will take this into account during your treatment with Letrozol Kern Pharma.

Letrozol may cause tendon inflammation or tendon damage (see section 4). If you experience any signs of pain or inflammation of the tendons, rest the affected area and contact your doctor.

Children and Adolescents (under 18 years)

Children and adolescents should not use this medication.

Elderly Patients (65 years and older)

People 65 years and older may use this medication at the same dose as for adults.

Taking Letrozol Kern Pharma with other medications

Tell your doctor or pharmacist that you are taking, have recently taken, or may need to take any other medication, including over-the-counter medications.

Pregnancy, Breastfeeding, and Fertility

• You should only take Letrozol Kern Pharma if you have gone through menopause. However, your doctor should discuss the use of effective contraception with you, as you may still become pregnant during treatment with Letrozol Kern Pharma.
• Do not take Letrozol Kern Pharma if you are pregnant or breastfeeding, as it may harm your baby.

Driving and Using Machines

If you feel dizzy, tired, sleepy, or unwell, do not drive or operate tools or machines until you feel better.

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

Athletes:

This medication contains letrozole, which may produce a positive result in doping tests.

3. How to take Letrozol Kern Pharma

Follow your doctor's or pharmacist's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

The usual dose is one Letrozol Kern Pharma tablet once a day. If you take Letrozol Kern Pharma at the same time every day, it will help you remember when to take the tablet.

The tablet can be taken with or without food and should be swallowed whole with a glass of water or other liquid.

How long to take Letrozol Kern Pharma

Continue taking Letrozol Kern Pharma every day for the time your doctor tells you. You may need to take it for months or even years. If you have any questions about how long you should take Letrozol Kern Pharma, consult your doctor.

Monitoring of Letrozol Kern Pharma treatment

You should only take this medication under strict medical supervision. Your doctor will periodically check your condition to ensure that the treatment has the desired effect.

Letrozol may cause a decrease in bone thickness or bone loss (osteoporosis) due to the decrease in estrogen in the body. Your doctor may decide to perform bone density measurements (a way to monitor osteoporosis) before, during, and after treatment.

If you take more Letrozol Kern Pharma than you should

If you have taken too many Letrozol Kern Pharma tablets, or if someone else has taken the tablets by accident, contact your doctor or go to the hospital immediately. Show them the package of tablets. You may need medical treatment. You can also call the Toxicology Information Service, phone: 915620420, indicating the medication and the amount taken.

If you forget to take Letrozol Kern Pharma

• If it is almost time for the next tablet (e.g., 2 or 3 hours), do not take the missed dose and take the next dose at the scheduled time.
• Otherwise, take the dose as soon as you remember, and then take the next tablet as you normally would.
• Do not take a double dose to make up for the missed doses.

If you stop taking Letrozol Kern Pharma

Do not stop taking Letrozol Kern Pharma unless your doctor tells you to. See also the section "How long to take Letrozol Kern Pharma".

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

Most side effects are mild to moderate and usually disappear after a few days or weeks of treatment.

Some of these side effects, such as hot flashes, hair loss, or vaginal bleeding, may be due to the lack of estrogen.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Some side effects can be serious:

Rare or uncommon side effects(i.e., may affect 1 to 100 out of 10,000 patients):

• Weakness, paralysis, or loss of sensation in a part of the body (particularly arm or leg), loss of coordination, nausea, or difficulty speaking or breathing (sign of a brain disorder, e.g., stroke).
• Chest pain or sudden onset (sign of heart disorder).
• Difficulty breathing, chest pain, fainting, rapid heartbeat, bluish discoloration of the skin, or sudden pain in the arm, leg, or foot (signs of blood clots).
• Swelling and redness along a vein that is extremely soft and possibly painful to the touch.
• High fever, cold, or mouth ulcers due to infections (lack of white blood cells).
• Severe blurred vision.
• Rare - tendon rupture (connective tissue that connects muscles to bones).

If you experience any of the above, inform your doctor immediately.

You should also inform your doctor immediately if you experience any of the following symptoms during treatment with Letrozol Kern Pharma:

• Swelling mainly in the face and throat (signs of allergic reaction).
• Yellowing of the skin and eyes, nausea, loss of appetite, darkening of urine color (signs of hepatitis).
• Rash, redness of the skin, blisters on the lips, eyes, or mouth, skin peeling, fever (signs of skin disorder).

Some side effects are very common.These side effects may affect more than 10 out of 100 patients.

• Hot flashes
• High cholesterol (hypercholesterolemia)
• Fatigue
• Increased sweating
• Bone and joint pain (arthralgia)

If any of these side effects affect you severely, consult your doctor.

Some side effects are common.These side effects may affect 1 to 10 out of 100 patients.

• Skin rash
• Headache
• Dizziness
• General discomfort
• Gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhea
• Increased or decreased appetite
• Muscle pain
• Weight loss or bone loss (osteoporosis), which can cause bone fractures in some cases (see also the section "Monitoring of Letrozol Kern Pharma treatment" in section 3)
• Swelling of arms, hands, feet, ankles (edema)
• Depression
• Weight gain
• Hair loss
• High blood pressure (hypertension)
• Abdominal pain
• Dry skin
• Vaginal bleeding
• Palpitations, rapid heartbeat
• Joint stiffness (arthritis)
• Chest pain

If any of these side effects affect you severely, inform your doctor.

Some side effects are uncommon.These side effects may affect 1 to 10 out of 1,000 patients.

• Nervous system disorders such as anxiety, nervousness, irritability, numbness, memory problems, drowsiness, insomnia
• Sensitivity disorders, especially touch
• Eye disorders such as blurred vision, eye irritation
• Skin disorders such as itching (urticaria)
• Vaginal discharge or dryness
• Breast pain
• Fever
• Thirst, taste disorder, dry mouth
• Dryness of mucous membranes
• Weight loss
• Urinary tract infection, increased frequency of urination
• Cough
• Increased enzyme levels
• Yellowing of the skin and eyes
• Elevated blood levels of bilirubin (a product of red blood cell breakdown)
• Tendinitis or tendon inflammation (connective tissue that connects muscles to bones)

If any of these side effects affect you severely, inform your doctor.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Letrozol Kern Pharma

• Keep this medication out of the sight and reach of children.
• Do not use Letrozol Kern Pharma after the expiration date stated on the package after CAD. The expiration date refers to the last day of the month indicated.
• No special storage conditions are required.
• Store in the original packaging to protect it from moisture.
• Do not use any packaging that is damaged or shows signs of tampering.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If you have any questions, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Letrozol Kern Pharma

• The active ingredient is letrozole. Each film-coated tablet contains 2.5 mg of letrozole.
• The other ingredients are: lactose monohydrate (lactose), sodium starch glycolate (potato starch), anhydrous colloidal silica, microcrystalline cellulose, crospovidone, pregelatinized corn starch (corn starch), and magnesium stearate (E-470b). The ingredients of the tablet coating are: hypromellose (E-464), polyethylene glycol 400, titanium dioxide (E-171), and yellow iron oxide (E-172).

Appearance of the product and package contents

Letrozol Kern Pharma is presented as film-coated tablets. The tablets are yellow and round. Each blister pack contains 30 tablets.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the last revision of this package leaflet: October 2019

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/