LETROZOLE SUN 2.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Letrozol SUN 2.5 mg film-coated tablets EFG

Letrozol

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you experience any side effects, consult your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack

1. What is Letrozol SUN and what is it used for
2. What you need to know before you take Letrozol SUN
3. How to take Letrozol SUN
4. Possible side effects
5. Storage of Letrozol SUN
6. Contents of the pack and further information

1. What is Letrozol SUN and what is it used for

What is Letrozol SUNand how does it work

Letrozol SUN contains the active substance letrozole. It belongs to a group of medicines called aromatase inhibitors. It is a hormonal (or "endocrine") treatment for breast cancer. The growth of breast cancer is often stimulated by estrogens, which are female sex hormones. Letrozol SUN reduces the amount of estrogen by blocking an enzyme ("aromatase") involved in estrogen production and can therefore 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 is Letrozol SUN used for

Letrozol SUN is used to treat breast cancer in women who have gone through the 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, if 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 SUN 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 SUN works or why you have been prescribed this medicine, ask your doctor.

2. What you need to know before you take Letrozol SUN

Follow carefully all instructions given by your doctor. They may differ from the general information contained in this leaflet.

Do not takeLetrozol SUN

• if you are allergic to letrozole or any of the other ingredients of this medicine (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 apply to you, do not take this medicine and tell your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Letrozol SUN

• 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 treatment with Letrozol SUN" in section 3).

If any of these apply to you, tell your doctor. Your doctor will take this into account during your treatment with Letrozol SUN.

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 medicine.

Elderly patients (65 years and over)

People 65 years and over can use this medicine at the same dose as for adults.

Taking Letrozol SUN with other medicines

Tell your doctor or pharmacist that you are taking, have recently taken, or might take any other medicines, including those without a prescription.

Pregnancy and breastfeeding

• You should only take Letrozol SUN if you have gone through the menopause. However, your doctor should discuss with you the use of effective contraception, as you could still become pregnant during treatment with Letrozol SUN.
  • Do not take Letrozol SUN 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.

Letrozol SUNcontains lactose(milk sugar)

If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

Use in athletes:

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

3. How to take Letrozol SUN

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The usual dose is one Letrozol SUN tablet once a day. If you take Letrozol SUN 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 SUN

Continue taking Letrozol SUN every day for as long as your doctor tells you. You may need to take it for months or even years. If you are unsure how long you should take Letrozol SUN, consult your doctor.

Monitoring of treatment with Letrozol SUN

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

Letrozol SUN may cause a decrease in bone density 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 SUN than you should

If you have taken too many Letrozol SUN tablets, or if someone else has taken your tablets, contact your doctor or go to the hospital immediately. Show them the pack of tablets. You may need medical treatment. You can also call the Toxicology Information Service, Tel: 915620420, stating the medicine and the amount taken.

If you forget to take Letrozol SUN

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

If you stop taking Letrozol SUN

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody 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 any 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 (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 that a blood clot has formed).
• Swelling and redness in 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.

If you experience any of these, tell your doctor immediately.

You should also tell your doctor immediately if you experience any of the following symptoms during treatment with Letrozol SUN:

• 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
• Pain in bones and joints (arthralgia)

If any of these 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 treatment with Letrozol SUN" 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 affect you severely, tell 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, sleepiness, insomnia
• Pain or burning sensation in hands or wrists (carpal tunnel syndrome) Sensitivity disorders, especially touch
• Eye disorders such as blurred vision, eye irritation
• Skin disorders such as itching (urticaria)

• Vaginal discharge or dryness
  • Chest 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
  • High 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 affect you severely, tell your doctor.

Rare.May affect up to 1 in 1,000 patients.

• Tendon rupture (connective tissue that connects muscles to bones).

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

Trigger finger, a condition where your finger or thumb gets stuck in a bent position.

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

5. Storage of Letrozol SUN

Keep this medicine out of the sight and reach of children.

Do not use Letrozol SUN after the expiry date stated on the pack after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. This will help protect the environment.

6. Contents of the pack and further information

Composition of Letrozol SUN

• The active substance is letrozole. Each film-coated tablet contains 2.5 mg of letrozole.
• The other ingredients in the tablet core are lactose monohydrate, microcrystalline cellulose, maize starch, povidone, sodium carboxymethyl starch, colloidal anhydrous silica, magnesium stearate.
• The tablet coating contains hypromellose (E464), yellow iron oxide (E172), titanium dioxide (E171), polyethylene glycol 4000, talc, polyethylene glycol 400.

Appearance and packaging

Letrozol SUN 2.5 mg is presented as film-coated tablets. The tablets are dark yellow, round, biconvex, and smooth on both sides.

Each pack contains 28, 30, 60, 84, or 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

Local representative:

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 - Barcelona

Spain

Tel.: 93 342 78 90

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

France: Letrozole CRISTERS PHARMA 2.5 mg, film-coated tablet

Germany: Letrozol SUN 2.5 mg film-coated tablets

Italy: Letrozolo SUN 2.5 mg film-coated tablets

Spain: Letrozol SUN 2.5 mg film-coated tablets EFG

Netherlands: Letrozol SUN 2.5 mg film-coated tablets

United Kingdom (Northern Ireland): Letrozole 2.5 mg film-coated tablets

Date of last revision of this leaflet: April 2024

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.