Letrozole Mabo 2.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Letrozol MABO 2.5 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as 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, and you must not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

What Letrozol MABO is and how it works

This medicine contains an active substance called letrozole. It belongs to a group of medicines known as aromatase inhibitors. It is a hormonal (or "endocrine") treatment for breast cancer. The growth of breast cancer is usually stimulated by estrogens, which are female sex hormones. Letrozole reduces the amount of estrogen by blocking an enzyme ("aromatase") involved in estrogen production, and therefore can block the growth of breast cancers that require estrogens to grow. As a result, tumor cells grow more slowly, or their growth and/or spread to other parts of the body is stopped.

What Letrozol MABO is used for

This medicine is used to treat breast cancer in women who have been through menopause, that is, the cessation of menstrual periods.

It is used to prevent breast cancer from recurring. It may be used as the initial treatment before breast cancer surgery, when immediate surgery is not appropriate, or as initial treatment after breast cancer surgery, or after five years of treatment with tamoxifen. Letrozole is also used to prevent breast tumors 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 it has been prescribed for you, please consult your doctor.

2. What you need to know before taking Letrozol MABO

Carefully follow all instructions provided by your doctor. These may differ from the general information contained in this leaflet.

Do not take Letrozol MABO

• if you are allergic to letrozol or to any of the other ingredients of this medicine (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.

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 immediately.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting 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 treatment with Letrozol MABO" in section 3).

If any of these situations apply to you, inform your doctor. Your doctor will take this into account during your treatment with letrozol.

Children and adolescents (under 18 years of age)

Children and adolescents must not use this medicine.

Elderly patients (aged 65 years and over)

Patients aged 65 years and over can use this medicine at the same dose as other adults.

Taking Letrozol MABO with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including medicines without a prescription.

Pregnancy, breastfeeding and fertility

• You should only take letrozol if you have passed the menopausal stage. However, your doctor should discuss with you the need to use an effective method of contraception, as you may still be able to become pregnant during treatment with letrozol.
• You must not take this medicine if you are pregnant or breastfeeding, as it may harm your baby.

Driving and use of machines

If you feel dizzy, tired, drowsy, or unwell, do not drive or operate tools or machinery until you feel well again.

Letrozol MABO contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, consult with him or her before taking this medicine.

Letrozol MABO contains sodium

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

Use in athletes:

This medicine contains letrozol, which may lead to a positive result in doping control tests.

3. How to take Letrozole MABO

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The usual dose is one tablet of letrozole once daily. Taking the medicine at the same time each day will help you remember when to take the tablet.

The tablet may be taken with or without food and should be swallowed whole with a glass of water or other liquid.

How long to take Letrozole MABO

Continue taking Letrozole MABO every day for as long as your doctor has instructed. You may need to take it for months or even years. If you have any doubts about how long you should take this medicine, consult your doctor.

Monitoring of treatment with Letrozole MABO

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

Letrozole may cause a reduction in bone thickness or bone loss (osteoporosis) due to decreased estrogen levels 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 MABO than you should

If you have taken too many letrozole tablets, or if someone else has accidentally taken your tablets, contact your doctor or go to the hospital immediately. Show them the tablet packaging. You may require medical treatment. You may also call the Toxicology Information Service at phone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Letrozole MABO

• If it is almost time for your next dose (e.g., 2 or 3 hours before), 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 dose at your usual time.
• Do not take a double dose to make up for the missed dose.

If you stop taking Letrozole MABO

Do not stop taking this medicine unless your doctor tells you to. See also the section “How long to take Letrozole MABO”.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everybody will experience them.

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

Some of these adverse effects, such as hot flushes, hair loss, or vaginal bleeding, may be due to low estrogen levels.

Do not be alarmed by this list of possible adverse effects. You may not experience any of them.

Some adverse effects may be serious:

Uncommon effects (may affect up to 1 in 100 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 (signs of a brain disorder, e.g., stroke).
• Sudden, pressing chest pain (sign of a heart disorder).
• Swelling and redness in a vein that is extremely soft and possibly painful to touch.
• High fever, chills, or mouth ulcers due to infections (due to low white blood cell count).
• Persistent blurred vision.

Rare (may affect up to 1 in 1000 patients):

• Difficulty breathing, chest pain, fainting, rapid heartbeat, bluish skin discoloration, or sudden pain in the arm, leg, or foot (signs of a blood clot).
• Tendon rupture (connective tissue linking muscles to bones).

If you experience any of the above conditions, 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 an allergic reaction).
• Yellowing of the skin and eyes, nausea, loss of appetite, darkening of urine (signs of hepatitis).
• Skin rash, redness of the skin, blisters on the lips, eyes, or mouth, skin peeling, fever (signs of skin disorder).

Some adverse effects are very common (may affect more than 1 in 10 patients):

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

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

Some adverse effects are common (may affect up to 1 in 10 patients):

• Skin rash
• Headache
• Dizziness
• General malaise
• Gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhea
• Increased or decreased appetite
• Muscle pain
• Bone thinning or bone loss (osteoporosis), which may lead to bone fractures in some cases (see also section “Monitoring of Letrozol MABO treatment” in section 3)
• Swelling of arms, hands, feet, ankles (edema)
• Depression
• Weight gain
• Hair loss
• Increased blood pressure (hypertension)
• Abdominal pain
• Dry skin
• Vaginal bleeding
• Palpitations, rapid heart rate
• Joint stiffness (arthritis)
• Chest pain

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

Some adverse effects are uncommon (may affect up to 1 in 100 patients):

• 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)

• Sensory disturbances, especially to touch

• Eye disorders such as blurred vision, eye irritation

• Skin disorders such as itching (urticaria)

• Vaginal dryness or discharge

• Breast pain

• Fever

• Thirst, taste disturbances, 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

• Elevated blood levels of bilirubin (a product of red blood cell breakdown)

• Tendinitis or inflammation of a tendon (connective tissue linking muscles to bones)

Adverse effects with unknown frequency (cannot be estimated from 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, inform your doctor.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is an effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Letrozole MABO

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts,
ask your pharmacist how to properly dispose of unused medicines and their containers.
This will help protect the environment.

6. Contents of the package and other information

Composition of LetrozolMABO

• The active substance is letrozole. Each film-coated tablet contains 2.5 mg of letrozole.
• The other components (excipients) are monohydrate lactose, sodium croscarmellose, povidone, anhydrous colloidal 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 of the product and contents of the pack

• Letrozol MABO are film-coated tablets, dark yellow in colour, round, slightly biconvex, with bevelled edges, marked with "5" on one side and "H" on the other.
• Each pack contains 30 tablets in a blister pack.

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 the most recent revision of this leaflet: November 2019

Detailed and up-to-date 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/