PATIENT INFORMATION LEAFLET

Letrozol ratiopharm 2.5 mg film-coated tablets

Letrozol

Read this 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking Letrozol ratiopharm

3. How to take Letrozol ratiopharm

4. Possible side effects

5. Storage of Letrozol ratiopharm

6. Contents of the pack and additional information

What is Letrozol ratiopharm and how it works

Letrozol ratiopharm contains an active ingredient called letrozol. 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 usually stimulated by estrogens, which are the female sex hormones. Letrozol reduces 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 ratiopharm used for

Letrozol ratiopharm is 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 as the first treatment before breast cancer surgery, if immediate surgery is not suitable, or it can be used as the first treatment after breast cancer surgery, or after five years of treatment with tamoxifen. Letrozol ratiopharm 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 ratiopharm works or the reason why you have been prescribed this medicine, consult your doctor.

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

Do not take Letrozol ratiopharm

• 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 ratiopharm

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

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 ratiopharm 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, breastfeeding, and fertility

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

Driving and operating machines

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

Important information for athletes

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

Letrozol ratiopharm contains lactose

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.

Letrozol ratiopharm contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially “sodium-free”.

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 recommended dose is one Letrozol ratiopharm tablet once a day. If you take Letrozol ratiopharm 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 ratiopharm

Continue taking Letrozol ratiopharm 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 ratiopharm, consult your doctor.

Monitoring treatment with Letrozol ratiopharm

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 ratiopharm 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 ratiopharm

If you have taken too many Letrozol ratiopharm tablets, or if someone else has accidentally taken the tablets, 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, phone: 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Letrozol ratiopharm

- If it is almost time for your next tablet (e.g. 2 or 3 hours), do not take the missed dose and take the next dose at the time it is due.

- 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 dose.

If you interrupt treatment with Letrozol ratiopharm

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

If you have any other questions about using this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

Some 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(may affect up to 1 in 100 people):

• 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).
• Oppressive and sudden chest pain (sign of a heart alteration).
• 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 and continuous blurred vision.

Uncommon(may affect up to 1 in 1000 people)

• Difficulty breathing, chest pain, fainting, rapid heart rate, blue discoloration of the skin, or sudden pain in the arm, leg, or foot (signs that a blood clot has formed).

Inform your doctor immediately if you experience any of the following:.

Also, inform your doctor immediately if you experience any of the following symptoms during treatment with Letrozol ratiopharm

• Swelling mainly in the face and throat (signs of an 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 the lips, eyes, or mouth, skin peeling, fever (signs of skin alteration).

Very common(may affect more than 1 in 10 people)

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

Consult your doctor if any of these effects affect you severely.

Common(may affect up to 1 in 10 people)

• Rash on the skin
• Headache
• Dizziness
• General discomfort
• Gastrointestinal disturbances such as nausea, vomiting, indigestion, constipation, diarrhea
• Increased or decreased appetite
• Muscle pain
• Weight loss or bone loss (osteoporosis), which may cause bone fractures in some cases (see also the "Letrozol ratiopharm treatment control" section 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

Inform your doctor if any of these affect you severely.

Rare(may affect up to 1 in 100 people)

• Nervous system disorders such as anxiety, nervousness, irritability, numbness, memory problems, drowsiness, insomnia
• Pain or burning sensation in the hands or wrists (carpal tunnel syndrome)
• Sensitivity problems, especially in 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
• Membrane mucosa dryness
• Weight loss
• Urinary tract infection, increased frequency to urinate
• Cough
• Elevated 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)

Rare(may affect up to 1 in 1000 people)

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

Unknown frequency(cannot be estimated from available data)

• Trigger finger, a situation in which your finger or thumb gets stuck in a bent position.

Inform your doctor if any of these affect you severely.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of reach and sight of children.

Store in the original packaging to protect it from moisture.

Do not use Letrozol ratiopharm after the expiration date that appears on the packaging after the abbreviation CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Letrozol ratiopharm Composition

-The active ingredient is letrozol. Each tablet contains 2.5 mg of letrozol.

-The other components are lactose monohydrate, cornstarch, microcrystalline cellulose, sodium starch glycolate (Type A) from potato, hydroxypropylmethyl cellulose, hydroxypropyl cellulose, magnesium stearate, talc, cottonseed oil, yellow iron oxide (E-172), red iron oxide (E-172), titanium dioxide (E-171).

Product appearance and packaging contents

Letrozol ratiopharm is presented as film-coated tablets, round in shape, yellow in color, and with both surfaces convex. The tablets are packaged in blisters containing 10, 30, and 100 tablets.

Only some packaging sizes may be commercially marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B 1st floor

28108 Alcobendas, Madrid (Spain)

Manufacturer:

MERCKLE GMBH

Ludwig Merckle Strasse 3

89143 Blaubeuren

Germany

This leaflet was approved in October 2019

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/