LETROZOLE TECNIGEN 2.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Letrozol TecniGen 2.5 mg film-coated tablets EFG

Letrozol

Read the package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package 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.

Contents of the package leaflet

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

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

What is Letrozol TecniGen and how does it work

Letrozol TecniGen 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 TecniGen 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 Letrozol TecniGen is used for

Letrozol TecniGen 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 TecniGen 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 TecniGen works or why you have been prescribed this medicine, ask your doctor.

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

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

Do not take LetrozolTecniGen

• 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

Talk to your doctor or pharmacist before starting to take Letrozol TecniGen

• 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 TecniGen" 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 TecniGen.

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

Children and adolescents (under 18 years)

Children and adolescents should not use this medicine.

Elderly patients (65 years and over)

People aged 65 and over can use this medicine at the same dose as for adults.

Taking Letrozol TecniGen with other medicines

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

Pregnancy, breast-feeding, and fertility

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

Letrozol TecniGen contains lactose

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

Letrozol TecniGen contains sodium

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

Use in athletes:

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

3. How to take Letrozol TecniGen

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

The normal dose is one Letrozol TecniGen tablet once a day. If you take Letrozol TecniGen 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.

How long to take Letrozol TecniGen

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

Monitoring of treatment with Letrozol TecniGen

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 TecniGen 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 Letrozol TecniGen than you should

If you have taken too many Letrozol TecniGen 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 take Letrozol TecniGen

• 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 usual time.
• Otherwise, take the dose as soon as you remember, and then take the next tablet as you would normally.
• Do not take a double dose to make up for the missed doses.

If you stop taking Letrozol TecniGen

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

4. Possible side effects

Like all medicines, this medicine 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 get any of them.

Some side effects can be serious:

Rare or uncommon side effects(i.e., may affect 1 to 10 out of every 10,000 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 (sign of a brain disorder, e.g., stroke).
• Chest pain (sign of heart disorder).
• Difficulty breathing, chest pain, fainting, rapid heartbeat, blue discoloration of the skin, or sudden pain in the arm, leg, or foot (signs of blood clots).
• Swelling and redness along 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).
• Severe blurred vision.

If you experience any of these, tell your doctor immediately.

You should also tell your doctor immediately if you experience any of the following symptoms during treatment with Letrozol TecniGen:

• Swelling mainly in the face and throat (signs of allergic reaction).
• Yellow color in 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 disorder).

Some side effects are very common.These side effects may affect more than 10 out of every 100 patients.

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

If any of these side effects affect you severely, talk to your doctor.

Some side effects are common.These side effects may affect 1 to 10 out 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
• Thinning or loss of bones (osteoporosis), which can cause bone fractures in some cases (see also the section "Monitoring of treatment with Letrozol TecniGen" 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, tell your doctor.

Some side effects are uncommon.These side effects may affect 1 to 10 out of every 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
• Joint stiffness (arthritis)
• 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 breakdown product of red blood cells).
• Tendinitis or tendon inflammation (connective tissue that connects muscles to bones)

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

Some side effects are rare.These side effects may affect 1 to 10 out of every 10,000 patients.

• Tendon rupture (connective tissue that connects muscles to bones)

If you experience side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet.

5. Storage of Letrozol TecniGen

• Keep this medicine out of the sight and reach of children.
• Do not use Letrozol TecniGen after the expiry date stated on the package after EXP. The expiry date refers to the last day of the month indicated.
• This medicine does not require special storage conditions.
• 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 medicine in the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Letrozol TecniGen

• The active substance is letrozole. Each film-coated tablet contains 2.5 mg of letrozole.
• The other ingredients (excipients) are: Core: Lactose monohydrate, microcrystalline cellulose, corn starch, anhydrous colloidal silica, sodium starch glycolate (type A), magnesium stearate. Coating (OPADRY II 85F32444 yellow): Polyvinyl alcohol, talc, titanium dioxide (E-171), macrogol/PEG 3350, yellow quinoline aluminum lake, iron oxide red (E-172), iron oxide black (E-172).

Appearance and packaging of the product

• Letrozol TecniGen is presented as film-coated tablets. The tablets are round, dark yellow in color.
• Each blister pack contains 10, 28, 30, 60, 90, or 100 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Marketing authorization holder:

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid) SPAIN

Manufacturer:

Tecnimede – Sociedade Técnico Medicinal, S.A.

Quinta da Cerca, Caixaria

2565-187 Dois Portos

Portugal

This medicine is authorized in the Member States of the European Economic Area under the following names:

Bulgaria:Letrofemin 2.5 mg film-coated tablets

Germany:Letrozole Tecnimede 2.5 mg film-coated tablets

Greece:Letrozol Tecnimede 2.5 mg film-coated tablets

Hungary:Letrozol Phace 2.5 mg film-coated tablets

Italy:Calantha 2.5 mg film-coated tablets

Poland:Letrozole Tecnimede

Portugal:Letrozol Tecnimede

Slovakia:Lidiozol

Spain:Letrozol TecniGen 2.5 mg film-coated tablets EFG

United Kingdom:Letrozole 2.5 mg film-coated tablets

Date of last revision of this package leaflet:November 2021

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