LETROZOLE CINFA 2.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

letrozole cinfa 2.5 mg film-coated tablets EFG

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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is letrozole cinfa and what is it used for

What is letrozole cinfa and how does it work

This medicine 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. Letrozole cinfa reduces the amount of estrogen by blocking an enzyme (aromatase) involved in estrogen production, 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 is letrozole cinfa used for

Letrozole 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 5 years of treatment with tamoxifen. Letrozole 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 this medicine works or why you have been prescribed it, ask your doctor.

2. What you need to know before you take letrozole cinfa

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

Do not take letrozole cinfa

• 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 the menopause,
• if you are pregnant,
• if you are breast-feeding.

If any of these apply to you, do not take this medicine and tell your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking letrozole cinfa

• 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 letrozole cinfa" in section 3).

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

Letrozole 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 aged 65 and over can use this medicine at the same dose as adults.

Taking letrozole cinfa with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You should only take letrozole 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 letrozole.

Do not take letrozole if you are pregnant or breast-feeding, 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.

letrozole cinfa contains lactose

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

letrozole cinfa contains tartrazine

This medicine may cause allergic reactions because it contains tartrazine (E102). It can cause asthma, especially in patients allergic to acetylsalicylic acid.

letrozole cinfa contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

Use in athletes

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

3. How to take letrozole cinfa

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

The usual dose is one tablet once a day. If you take letrozole cinfa at the same time each 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 letrozole cinfa

Keep taking this medicine 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 to take this medicine, ask your doctor.

Monitoring of treatment with letrozole cinfa

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

Letrozole 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 letrozole cinfa than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take letrozole cinfa

• 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 letrozole cinfa

Do not stop taking this medicine unless your doctor tells you to. See also the section "How long to take letrozole cinfa".

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Most side effects are mild or 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 get any of them.

Some side effects can be serious:

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

• Weakness, paralysis, or loss of sensation in a part of the body (especially 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).
• 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.
• Tendinitis or tendon inflammation (connective tissue that connects muscles to bones).

Rare(may affect up to 1 in 1,000 people):

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

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

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

• 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(may affect more than 1 in 10 people):

• Hot flashes.
• High cholesterol levels (hypercholesterolemia).
• Fatigue
• Increased sweating.
• Pain in bones and joints (arthralgia).

If any of these affect you severely, talk to your doctor.

Some side effects are common(may affect up to 1 in 10 people):

• Skin rash.
• Headache.
• Dizziness.
• General malaise.
• Gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhea.
• Increased or decreased appetite.
• Muscle pain.
• Thinning or bone loss (osteoporosis), which can cause bone fractures in some cases (see also the section "Monitoring of treatment with letrozole cinfa" 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(may affect up to 1 in 100 people):

• Nervous disorders such as anxiety, nervousness, irritability, numbness, memory problems, sleepiness, insomnia.
• Pain or burning sensation in hands or wrists (carpal tunnel syndrome)
• Sensitivity problems, 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.
• High blood levels of bilirubin (a product of red blood cell breakdown).

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

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

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) via their website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of letrozole cinfa

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help to protect the environment.

6. Contents of the pack and further information

Composition of letrozole cinfa

• The active substance is letrozole. Each film-coated tablet contains 2.5 mg of letrozole.
• The other ingredients are: lactose monohydrate, sodium carboxymethyl starch (type A) (potato), microcrystalline cellulose, hypromellose, anhydrous colloidal silica, and magnesium stearate. The ingredients of the tablet coating, Opadry Yellow, are: hypromellose, macrogol 6000, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), and tartrazine (E102).

Appearance and packaging

letrozole cinfa are yellow, biconvex, film-coated tablets, cylindrical in shape and marked with the letter "L" on one side.

Each blister pack contains 30 or 100 (clinical pack) tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta.

31620 Huarte (Navarra) - Spain

Date of last revision of this leaflet:October 2019

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

You can access detailed and up-to-date information on this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/72125/P_72125.html

QR code to: https://cima.aemps.es/cima/dochtml/p/72125/P_72125.html