Prospect: information for the patient

Letrozol SUN 2.5 mg film-coated tablets

Letrozol

Read this prospect carefully before starting to take this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect.

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

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

3.How to take Letrozol SUN

4.Possible adverse effects

5.Storage of Letrozol SUN

6.Contents of the package and additional information

What is Letrozol SUNand how it works

Letrozol SUN contains an active ingredient called letrozol. It belongs to a group of medicines called aromatase inhibitors. It is a hormone therapy (or "endocrine") for breast cancer.The growth of breast cancer is usually stimulated by estrogens, which are the female sex hormones.Letrozol SUNreduces the amount of estrogen by blocking an enzyme ("aromatase") involved in estrogen production and therefore 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 is Letrozol SUN used for

Letrozol SUNis used to treat breast cancer in women who have gone through menopause, that is, the cessation of menstrual periods.

It is used to prevent breast cancer from recurring. It can be used asthe first treatment before breast cancer surgery, in cases where immediate surgery is not suitable, or it can be used asfirst treatment after breast cancer surgery, or after five years of treatment with tamoxifen. Letrozol SUN is also used to prevent breast cancer from spreading to other parts of the body in patients with advanced breast cancer.

If you have any questions about how Letrozol SUN works orthe reasonwhyyouhave been prescribed this medication, consult your doctor.

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

Do not takeLetrozol SUN

• if you are allergic to letrozol or any of the other components of this medication (listed in section 6),
• if you still have menstrual cycles, that is, 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 SUN

• if you have a severe kidney disease,
• if you have a severe liver disease,
• if you have a history of osteoporosis or bone fractures (see also “Treatment control with Letrozol SUN” 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 SUN.

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

Children and adolescents (under 18 years)

Children and adolescents should not use this medication.

Older adults (65 years and older)

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

Taking Letrozol SUN with other medications

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

Pregnancy, and breastfeeding

-You should only take Letrozol SUN after menopause. However, your doctor should discuss with you the use of effective contraception, as you may still become pregnant during treatment with Letrozol SUN.

• You should not take Letrozol SUN if you are pregnant or breastfeeding as it may harm your baby.

Driving and operating machinery

If you feel dizzy, tired,if you havesleepiness or do not feel well, do not drive or operatetools ormachinery until you feel well again.

Letrozol SUNcontains lactose(milk sugar)

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

Use in athletes:

This medication contains letrozol which may produce a positive result in doping control tests.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, 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 the time your doctor tells you to. You may need to take it for months or even years. If you have any doubts about how long you should take Letrozol SUN, consult your doctor.

Monitoring treatment with Letrozol SUN

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

Letrozol SUN 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 too much Letrozol SUN

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

If you forget to take Letrozol SUN

• If it is almost time for your next tablet (e.g., 2 or 3 hours away), do not take the missed dose and take the next dose at the usual time.
• Otherwise, take the missed 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 interrupt treatment with Letrozol SUN

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

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

Some of these side effects, such as hot flashes, hair loss, or vaginal bleeding, may be due to a 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 of every 10,000 patients):

• Weakness, paralysis, or loss of sensation in some part of the body (particularly arm or leg), loss of coordination, nausea, or difficulty speaking or breathing (sign of a brain alteration, e.g., stroke).

• Crushing chest pain and sudden onset (sign of heart alteration).
• Difficulty breathing, chest pain, fainting, rapid heart rate, 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.
• Severe fever, cold, or mouth ulcers due to infections (lack of white blood cells).
• Severe blurred vision continuously.

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

You must also inform 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).
• Yellow discoloration of the skin and eyes, nausea, loss of appetite, darkening of urine color (signs of hepatitis).
• Rash, skin redness, blisters on lips, eyes, or mouth, skin peeling, fever (signs of skin alteration).

Some side effects are very frequent..These side effects can affect more than 10 of every 100 patients.

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

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

Some side effects are frequent.These side effects can affect 1 to 10 of every 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 “Treatment control with Letrozol SUN in section 3”)
• Swelling of arms, hands, feet, ankles (edema)
• Depression
• Weight gain
• Hair loss
• High blood pressure (hypertension)
• Abdominal pain
• Skin dryness
• Vaginal bleeding
• Palpitations, rapid heart rate
• Joint stiffness (arthritis)
• Chest pain.

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

Some side effects are uncommon..These side effects can affect 1 to 10 of every 1,000 patients.

• Nervous disorders such as anxiety, nervousness, irritability, numbness, memory problems, drowsiness, insomnia
• Pain or burning sensation in the hands or wrists (carpal tunnel syndrome)Sensory problems, especially tactile
• 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
• Membrane mucosa dryness
• Weight loss
• Urinary tract infection, increased frequency to urinate
• Cough
• Increased enzyme levels
• Yellow discoloration of the skin and eyes
• Elevated bilirubin levels in the blood (a product of red blood cell breakdown).
• Tendinitis or inflammation of a tendon (connective tissue that connects muscles to bones).

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

Rare.May affect up to 1 of every 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 situation in which your finger or thumb stays locked in a bent position.

If you experience side effects, consult your doctor or pharmacist, even if it is side effects that do not appear in this prospectus.

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

Do not use Letrozol SUN 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.

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

Letrozole SUN Composition

• The active ingredient isletrozole. Eachfilm-coated tablet contains 2.5 mg of letrozole.
• The other components in the tablet core arelactose monohydrate, microcrystalline cellulose, cornstarch, povidone, sodium carboxymethylstarch, anhydrous colloidal silica, magnesium stearate.
• Thefilm coating contains hydroxypropylmethylcellulose (E464),yellow iron oxide (E172), titanium dioxide (E171), polyethylene glycol-4000, talc, polyethylene glycol-400.

Appearance of the product and contents of the package

Letrozole SUN2.5mg is presented as film-coated tablets. The tablets are dark yellow, round, biconvex, and smooth on both sides.

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

Only some package sizes may be commercially available.

Marketing authorization 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

Phone: 93 342 78 90

This medication is authorized 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 Filmtabletten

Italy:Letrozolo SUN 2.5 mg compresse rivestite con film

Spain:Letrozol SUN 2,5 mg film-coated tablets EFG

Netherlands:Letrozol SUN 2,5 mg filmomhulde tabletten

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

Last review date of this leaflet: April 2024

For detailed and updated information on this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.