Prospect: information for the patient

Letrozol MABO 2.5 mg film-coated tablets

Read this prospect carefully before starting to take this medicine, 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 medicine has been prescribed to you alone, and you must 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. See section 4.

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

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

3. How to take Letrozol MABO

4. Possible adverse effects

5. Storage of Letrozol MABO

6. Contents of the package and additional information

What is LetrozolMABOand how it works

This medication contains an active ingredient called letrozol.It belongs to a group of medications 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 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 LetrozolMABO used for

This medication 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 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 works or why you have been prescribed it, 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 MABO

• if you are allergic to letrozol or any of the other components of this medication (including those 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 pain or tendon inflammation, rest the affected area and contact your doctor.

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 MABO

• 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” 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.

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 the rest of the adults.

Taking Letrozol MABO 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 if you have passed the menopause stage. However, your doctor should discuss with you the use of effective contraception, as you may still become pregnant during treatment with letrozol.
• You should not take this medication if you are pregnant or breastfeeding, as it may harm your baby.

Driving and operating machinery

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

Letrozol MABO contains lactose

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

Letrozol MABO contains sodium

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

Use in athletes:

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The usual dose is one tablet of letrozol once a day.Taking the medication 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 Letrozol MABO

Continue taking Letrozol MABO 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 this medication, consult your doctor.

Control of treatment with Letrozol MABO

You should only take this medication under strict medical supervision. Your doctor will periodically monitor your situation to check that the treatment has the desired effect.

Letrozol 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 control osteoporosis) before, during, and after treatment.

If you take more Letrozol MABO than you should

If you have taken too many tablets of letrozol, 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 Toxicological Information Service, Tel: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Letrozol MABO

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

If you interrupt treatment with Letrozol MABO

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

Like all medicines, this medicine can 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 side effects (may affect up to 1 in 100 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).
• Oppressive and sudden chest pain (sign of 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).
• Continuous blurred vision.

Rare (may affect up to 1 in 1000 patients)

• 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).
• Roture of a tendon (connective tissue that connects muscles to bones).

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:

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

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

Consult your doctor if any of these affect you severely.

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

• Rash on the skin
• Headache
• Dizziness
• General discomfort
• Gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhea
• Increased or decreased appetite
• Muscle pain
• Osteoporosis, which causes bone fractures in some cases (see also the "Letrozol MABO 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
• Rigidity of the joints (arthritis)
• Chest pain

Inform your doctor if any of these affect you severely.

Some side effects are infrequent (may affect up to 1 in 100 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)
• Sensitivity problems, especially in 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
• Membrane mucosa dryness
• Weight loss
• Urinary tract infection, increased frequency of urination
• Cough
• Elevated blood levels of enzymes
• Yellow discoloration 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 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.

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 not listed in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

-Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date refers to the last day of the month indicated.

-No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and

medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt,

ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Letrozole Composition MABO

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

Appearance of the product and content of the container

- Letrozole MABO are film-coated tablets of dark yellow color, round, slightly biconvex, beveled edges, and with a mark “5” on one face and “H” on the other.

- Each container contains 30 tablets conditioned in blister pack.

Marketing Authorization Holder

MABO-FARMA S.A.

Calle Rejas 2, planta 1

28821 Coslada (Madrid)

Spain

Responsible for Manufacturing

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park,

Paola PLA3000, Malta

Last review date of this leaflet: November 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/