LETROZOLE EDIGEN 2.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Letrozol Edigen 2.5 mg film-coated tablets EFG

Letrozol

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 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 Edigen and what is it used for
2. What you need to know before you take Letrozol Edigen
3. How to take Letrozol Edigen
4. Possible side effects

5 Conservation of Letrozol Edigen

1. Contents of the pack and further information

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

What is Letrozol Edigen and how does it work

Letrozol Edigen contains an active substance called 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 usually stimulated by estrogens, which are female sex hormones. Letrozol Edigen reduces the amount of estrogen by blocking an enzyme ("aromatase") involved in estrogen production and can therefore 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 Letrozol Edigen used for

Letrozol Edigen 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 five years of treatment with tamoxifen. Letrozol Edigen 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 Letrozol Edigen works or why you have been prescribed this medicine, ask your doctor.

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

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

Do not takeLetrozol Edigen

• 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 menopause
• if you are pregnant
• if you are breast-feeding

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Letrozol Edigen

• if you have severe kidney disease
• if you have severe liver disease

if you have a history of osteoporosis or bone fractures (see also "Control of treatment 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 medicine.

Older people (from 65 years)

People from 65 years of age can use this medicine at the same dose as for adults.

Taking Letrozol Edigen 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

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

Important information about some of the ingredients ofLetrozol Edigen

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

Use in athletes

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

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

3. How to take Letrozol Edigen

Follow exactly the administration instructions of this medicine given to you by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is one Letrozol Edigen tablet once a day. If you take Letrozol Edigen at the same time every day, it will help you remember when you should 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 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 doubts about how long you should take Letrozol Edigen, consult your doctor.

Control of treatment with Letrozol Edigen

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

Letrozol Edigen may cause a decrease in bone density or bone loss (osteoporosis) due to the decrease in estrogens in the body. Your doctor may decide to perform bone density measurements (a way to check for osteoporosis) before, during, and after treatment.

If you take more Letrozol Edigen than you should

If you have taken too many Letrozol Edigen tablets, or if someone else has taken your tablets, 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 Toxicology Information Service, Phone: 915620420, indicating the medicine and the amount taken.

If you forget to takeLetrozol Edigen

• If it is almost time for your next dose (e.g., 2 or 3 hours are missing), 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 dose as you normally would.
• Do not take a double dose to make up for missed doses.

If you stop takingLetrozol Edigen

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

If you have any further questions about 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 estrogens.

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 very rare side effects (may affect 1 to 10 out of 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 disorder, e.g., stroke)
• Chest pain (sign of heart disorder)
• 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)
• 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)

Very rare side effects (may affect less than 1 in 10,000 patients):

• Severe blurred vision.
• Tendon rupture (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 Letrozol Edigen:

• 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).

Very common side effects(may affect more than 10 out of 100 patients):

• Hot flashes.
• High 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 out of 100 patients):

• Skin rash.
• Headache.
• Dizziness.
• General malaise.
• 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 section "Control of treatment with Letrozol Edigen" 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, inform your doctor.

Uncommon side effects(may affect 1 to 10 out of 1,000 patients):

• Nervous system disorders such as anxiety, nervousness, irritability, numbness, memory problems, sleepiness, insomnia.
• 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 (tissue that connects muscles to bones).

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

Reporting of side effects:

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Letrozol Edigen

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

Do not use Letrozol Edigen after the expiration date stated on the package after EXP:. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Keep in the original packaging to protect from moisture.

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

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition ofLetrozol Edigen

• The active substance is letrozole. Each film-coated tablet contains 2.5 mg of letrozole.
• The other ingredients (excipients) are:

Core excipients: Lactose monohydrate, corn starch, microcrystalline cellulose, sodium starch glycolate (Type A) 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 contents of the pack

Letrozol Edigen is available in packs containing 30 and 100 tablets. The film-coated tablets are round, biconvex, and yellow.

Marketing authorization holder

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

Manufacturer

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

Date of last revision of this leaflet: October 2019

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