Prospecto: information for the patient

Letrozol TecniGen 2.5 mg film-coated tablets

Letrozol

Read this prospectus carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospectus, 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 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 prospectus.

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

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

3.How to take Letrozol TecniGen

4.Possible adverse effects

5.Storage of Letrozol TecniGen

6.Contents of the package and additional information

What is Letrozol TecniGen and how it works

Letrozol TecniGen contains an active ingredient called letrozol. It belongs to a group of medicines called aromatase inhibitors. It is a hormone (endocrine) treatment for breast cancer. The growth of breast cancer is usually stimulated by estrogens, which are the female sex hormones. Letrozol TecniGen 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 Letrozol TecniGen used for

Letrozol TecniGen 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 TecniGen 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 TecniGen works or 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 take Letrozol TecniGen

• if you are allergic to letrozol or 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.

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 TecniGen

• 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 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 TecniGen 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.

Children and adolescents (under 18 years)

Children and adolescents should not use this medicine.

Older patients (65 years and over)

Patients 65 years and over may use this medicine at the same dose as adults.

Taking Letrozol TecniGen with other medicines

Inform your doctor or pharmacist that you are taking, have taken recently, or may need to take any other medicine, including over-the-counter medicines.

Pregnancy, breastfeeding and fertility

• You should only take Letrozol TecniGen after menopause. However, your doctor will discuss with you the use of effective contraception, as you may still become pregnant during treatment with Letrozol TecniGen.
• You should not take Letrozol TecniGen if you are pregnant or breastfeeding, as it may harm your baby.

Driving and operating machines

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

Letrozol TecniGen contains lactose

If your doctor has told you that you are intolerant to certain sugars, consult with him 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 letrozol, which may produce a positive result in doping control tests.

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

The usual 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 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 Letrozol TecniGen, consult your doctor.

Monitoring treatment with Letrozol TecniGen

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

Letrozol TecniGen 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 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 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 forget to take Letrozol TecniGen

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

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

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 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(i.e., 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 brain alteration, e.g., stroke).
• Oppressive and sudden chest pain (sign of heart alteration).
• Difficulty breathing, chest pain, fainting, rapid heart rate, bluish discoloration of the skin, or sudden pain in the arm, leg, or foot (signs of blood clot formation).
• Swelling and redness along a very soft and possibly painful vein.
• Severe fever, cold, or mouth ulcers due to infections (lack of white blood cells).
• Severe and continuous blurred vision.

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 TecniGen:

• 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).

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

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

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

Some side effects are common.These side effects can 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
• Osteoporosis, which causes bone fractures in some cases (see also the "Control of Letrozol TecniGen treatment" 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.

Some side effects are infrequent.These side effects can 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
• Joint stiffness (arthritis)
• Chest pain
• Fever
• Thirst, taste disorder, dry mouth
• Membrane mucosa dryness
• Weight loss
• Urinary tract infection, increased frequency of urination
• 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.

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

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

If you experience side effects, consult your doctor or pharmacist, even if they do not appear in this prospectus.

• Keep this medication out of the sight and reach of children.
• Do not use Letrozol TecniGen after the expiration date that appears on the packaging after CAD. The expiration date refers to the last day of the month indicated.
• This medication does not require special storage conditions.
• Do not use any packaging that is damaged or shows signs of manipulation.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Letrozol TecniGen Composition

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

-The other components (excipients) are:Core:Lactose monohydrate, microcrystalline cellulose, cornstarch, anhydrous colloidal silica, sodium carboxymethylstarch from potato, magnesium stearate.Coating(OPADRY II 85F32444 yellow): Polyvinyl alcohol, talc, titanium dioxide (E-171), macrogol/PEG 3350, yellow quinoline aluminum lacquer, red iron oxide (E-172), black iron oxide (E-172).

Appearance of the product and contents of the package

-Letrozol TecniGen is presented as film-coated tablets. The tablets are round, dark yellow in color.

-Each package with blisters contains 10, 28, 30, 60, 90, or 100 tablets. Some package sizes may only be marketed.

Marketing Authorization Holder and Responsible for Manufacturing:

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) ESPAÑA

Responsible for Manufacturing:

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 with the following names:

Bulgaria:Letrofemin 2.5 mg Film-coated tablets

Germany:Letrozole Tecnimede 2.5 mg Filmtabletten

Greece:Letrozol Tecnimede 2.5 mg επικαλυμμ?να με λεπτ? υμ?νιο δισκ?α

Hungary:Letrozol Phace 2.5 mg Filmtabletta

Italy:Calantha 2.5 mg compresse revestite con film

Poland:Letrozole Tecnimede

Portugal:Letrozol Tecnimede

Slovakia:Lidiozol

Spain:Letrozol TecniGen 2.5 mg comprimidos recubiertos con película EFG

United Kingdom:Letrozole 2.5 mg Film-coated tablets

Last review date of this leaflet:November 2021

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