Prospect: information for the patient

Letrozol Edigen 2.5 mg film-coated tablets

Letrozol

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 only for you and should not be given 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 isLetrozol Edigenand for what it is used

2.What you need to know before starting to takeLetrozol Edigen

3.How to takeLetrozol Edigen

4.Possible adverse effects

5Storage ofLetrozol Edigen

6.Contents of the package and additional information

What is Letrozol Edigen and how it works

Letrozol Edigencontains 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.LetrozolEdigenreduces 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.

For what Letrozol Edigen is used

LetrozolEdigenis used to treat breast cancer in women who have passed 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 tamoxifenLetrozol Edigenis 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 howLetrozol Edigenworks or the reason why you have been prescribed this medicine, consult your doctor.

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

Do not takeLetrozol Edigen

- if you are allergic to letrozol or to 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 Edigen

- 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 Edigen” 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 Edigen.

Children and adolescents

Children and adolescents should not use this medication.

Older adults (65 years and older)

People 65 years and older can use this medication at the same dose as adults.

Taking Letrozol Edigen with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Pregnancy, breastfeeding, and fertility

• You should only take Letrozol Edigen 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 Edigen.
• You should not take Letrozol Edigen 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.

Important information about some of the components of Letrozol Edigen

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

Use in athletes

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

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.

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

The recommended dose is one tablet of Letrozol Edigen once a day. If you take Letrozol Edigen 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.

For how long to take Letrozol Edigen

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

Control of treatment with Letrozol Edigen

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 Edigen 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 Edigen than you should

If you have taken too many tablets of Letrozol Edigen, 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, Tf: 915620420, indicating the medication and the amount taken.

If you forgot to take Letrozol Edigen

- 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 missed doses.

If you interrupt treatment with Letrozol Edigen

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

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

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

The majority of 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 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 or uncommon side effects (may affect 1 to 100 of every 10,000 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)

-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).

-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 blurred vision.

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

If you experience any of the above, inform your doctor immediately.

You must also inform your doctor immediately if you experience any of the following symptoms during treatment with Letrozol Edigen:

-Swelling mainly in the face and throat (signs of 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).

Frequent side effects(may affect more than 10 of every 100 patients):

-Hot flashes.

-Elevated cholesterol levels (hypercholesterolemia).

-Increased sweating.

-Bone and joint pain (arthralgia).

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

Common side effects(may affect 1 to 10 of every 100 patients):

-Skin rash.

-Headache.

-Dizziness.

-General discomfort.

-Gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhea.

-Increased or decreased appetite.

-Muscle pain.

-Weight loss or bone loss (osteoporosis), which can cause bone fractures in some cases (see also the "Treatment control with Letrozol Edigen" 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.

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

Rare side effects(may affect 1 to 10 of every 1,000 patients):

-Nervous system disorders such as anxiety, nervousness, irritability, numbness, memory problems, drowsiness, insomnia.

-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 to urinate.

-Cough.

-Increased enzyme levels.

-Yellow discoloration of the skin and eyes.

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

-Tendinitis or inflammation of a tendon (connective tissue that connects muscles to bones).

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

Reporting 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 prospectus. You can also report them directly through the Spanish System for 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 this medication out of the sight and reach of children.

Do not useLetrozolEdigenafter the expiration date that appears on the packaging after CAD:. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Store in the original packaging to protect it from moisture.

Do not use any packaging that is damaged or shows signs of manipulation.

Medications should not be thrown down the drain or in the trash.Deposit the containers and medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need.This will help protect the environment.

Composition ofLetrozol Edigen

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

-The other components (excipients) are:

Core excipients: Lactose monohydrate, cornstarch, microcrystalline cellulose, sodium starch glycolate (Type A) from potato (potato starch), talc, magnesium stearate

Coating excipients: Aquopolish®yellow formed by:Hydroxypropyl methylcellulose, hydroxypropyl cellulose, talc, cottonseed oil, yellow iron oxide, red iron oxide, titanium dioxide.

Appearance of the product and content of the container

LetrozolEdigenis presented in containers containing 30 and 100 tablets. The film-coated tablets are round, biconvex, and yellow in color.

Holder of the marketing authorization

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid. Spain

Responsible for manufacturing

Haupt Pharma Münster GmbH

Schleebrüggenkamp 15

D-48159 Münster

Germany

or

Tecnimede – Sociedade Técnico-Medicinal, S.A.

Quinta da Cerca, Caixaria, Dois Portos – 2565-187

Portugal

Last review date of this leaflet: October 2019

The 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/