LETROZOLE MABO 2.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

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

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

What is LetrozolMABOand how does it work

This medicinal product 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 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 LetrozolMABOused for

This medicinal product is used to treat breast cancer in women who have passed 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 letrozole works or why you have been prescribed it, ask your doctor.

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

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

Do not take LetrozolMABO

• if you are allergic to letrozole or any of the other ingredients of this medicinal product (listed in section 6),
• if you still have menstrual periods, i.e., you have not reached menopause,
• if you are pregnant,
• if you are breast-feeding.

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

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

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Letrozol MABO

• 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 MABO 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 letrozole.

Children and adolescents (under 18 years)

Children and adolescents should not use this medicinal product.

Elderly patients (65 years and over)

People aged 65 and over can use this medicinal product at the same dose as the rest of adults.

Taking LetrozolMABOwith other medicines

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

Pregnancy, breast-feeding, and fertility

• You should only take letrozole if you have passed 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 this medicinal product 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.

LetrozolMABOcontains lactose

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

LetrozolMABOcontains sodium

This medicinal product contains less than 23 mg of sodium (1 mmol) per tablet, i.e., it is essentially "sodium-free".

Use in athletes:

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

3. How to take Letrozol MABO

Follow exactly the administration instructions of this medicinal product given by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

The normal dose is one letrozole tablet once a day. Taking the medicinal product at the same time every day 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 LetrozolMABO

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

Monitoring of LetrozolMABOtreatment

You should only take this medicinal product under strict medical supervision. Your doctor will periodically check your situation to ensure that the treatment has the desired 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 LetrozolMABOthan you should

If you have taken too many letrozole tablets, or if someone else has taken your tablets by mistake, contact your doctor or go to the hospital immediately. Show them the package of the tablets. You may need medical treatment. You can also call the Toxicological Information Service, Tel: 91 562 04 20, indicating the medicinal product and the amount taken.

If you forget to take LetrozolMABO

• 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 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 LetrozolMABO

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

4. Possible side effects

Like all medicines, this medicinal product 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:

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

• 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).
• Crushing 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).
• Blurred vision that persists.

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 that a blood clot has formed).
• 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 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 (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(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 Letrozol MABO 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(may affect up to 1 in 100 people)

• Nervous system disorders such as anxiety, nervousness, irritability, numbness, memory problems, sleepiness, insomnia
• Pain or burning sensation in the 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
• 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)
• Tendinitis or tendon inflammation (connective tissue that connects muscles to bones)

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 side effects affect you severely, inform your doctor.

Reporting of side effects

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

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

5. Storage of Letrozol MABO

• Keep this medicinal product out of the sight and reach of children.
• Do not use this medicinal product after the expiry date stated on the package after EXP. The expiry date refers to the last day of the month indicated.
• No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Return the packages and any unused medicinal products to the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of packages and unused medicinal products. This will help protect the environment.

6. Contents of the pack and further information

Composition of LetrozolMABO

• The active substance is letrozole. Each film-coated tablet contains 2.5 mg of letrozole.
• The other ingredients (excipients) are lactose monohydrate, croscarmellose sodium, povidone, colloidal anhydrous silica, and magnesium stearate. The coating consists of HPMC 2910/Hypromellose 6cP (E-464), macrogol 400, talc, yellow iron oxide (E-172), and titanium dioxide (E-171).

Appearance and packaging

• Letrozol MABO are yellow, round, slightly biconvex film-coated tablets with a beveled edge and a "5" mark on one side and an "H" mark on the other.
• Each package contains 30 tablets packaged in blisters.

Marketing authorisation holder

MABO-FARMA S.A.

Calle Vía de los Poblados 3,

Edificio 6, 28033, Madrid,

Spain.

Manufacturer

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park,

Paola PLA3000, Malta

Date of last revision of this leaflet: November 2019

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