Letrozole Tecnigen 2.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Letrozol TecniGen 2.5 mg film-coated tablets EFG

Letrozole

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these adverse effects are not listed in this leaflet.

Leaflet contents

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

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

What Letrozol TecniGen is and how it works

Letrozol TecniGen contains an active substance called letrozole. It belongs to a group of medicines known as 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 therefore can block the growth of breast cancers that require estrogen to grow. As a result, tumor cells grow more slowly, or their growth and/or spread to other parts of the body is halted.

What Letrozol TecniGen is used for

Letrozol TecniGen is used to treat breast cancer in women who have undergone menopause, that is, the cessation of menstrual periods.

It is used to prevent breast cancer from recurring. It may be used as initial treatment before breast cancer surgery, when immediate surgery is not appropriate, or as initial treatment after breast cancer surgery, or after five years of treatment with tamoxifen. Letrozol TecniGen is also used to prevent the spread of breast tumor to other parts of the body in patients with advanced breast cancer.

If you have any questions about how Letrozol TecniGen works or why this medicine has been prescribed for you, please consult your doctor.

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

Carefully follow all instructions given by your doctor. They may differ from the general information contained in this leaflet.

Do not take Letrozol TecniGen

• if you are allergic to letrozol or to any of the other ingredients of this medicine (listed in section 6),
• if you still have menstrual cycles, i.e. you have not yet 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 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 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 of age)

Children and adolescents must not use this medicine.

Elderly patients (aged 65 years and over)

Patients aged 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 if you are taking, have recently taken, or might need to take any other medicines, including medicines without a prescription.

Pregnancy, breastfeeding and fertility

• You should only take Letrozol TecniGen if you have passed the menopausal stage. However, your doctor should discuss with you the need to use effective contraception, as you could still become pregnant during treatment with Letrozol TecniGen.
• You must not take Letrozol TecniGen if you are pregnant or breastfeeding, as it may harm your baby.

Driving and using machines

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

Letrozol TecniGen contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

Letrozol TecniGen contains sodium

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

Use in athletes:

This medicine contains letrozol, which may result in a positive test in doping controls.

3. How to take Letrozol TecniGen

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

The usual dose is one tablet of Letrozol TecniGen once daily. Taking Letrozol TecniGen at the same time each day will help you remember when to take the tablet.

The tablet may 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 as long as 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 continue taking Letrozol TecniGen, consult your doctor.

Monitoring of treatment with Letrozol TecniGen

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

Letrozol TecniGen may cause a reduction in bone thickness or bone loss (osteoporosis) due to decreased estrogen levels 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 tablet packaging. You may require medical treatment. You can also call the Toxicology Information Service at phone number 915620420, stating the name of the medicine and the amount taken.

If you forget to take Letrozol TecniGen

• If it is almost time for your next dose (e.g. within 2 or 3 hours), do not take the missed dose and take the next dose at your usual time.
• Otherwise, take the missed dose as soon as you remember, and then take the next dose at your usual time.
• Do not take a double dose to make up for a missed dose.

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 adverse effects

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

Most of these adverse effects are mild to moderate and usually disappear after a few days or weeks of treatment.

Some of these adverse effects, such as hot flushes, hair loss, or vaginal bleeding, may be due to lack of oestrogens.

Do not be alarmed by this list of possible adverse effects. You may not experience any of them.

Some adverse effects may be serious:

Rare or uncommon adverse effects (i.e., may affect 1 to 100 in 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 (signs of a brain disorder, e.g., stroke).
• Sudden, crushing pain in the chest (signs of a heart disorder).
• Difficulty breathing, chest pain, fainting, rapid heartbeat, bluish skin colour, or sudden pain in the arm, leg, or foot (signs of a blood clot).
• Swelling and redness along a vein that is extremely tender and possibly painful to touch.
• Severe fever, cold, or mouth ulcers due to infections (lack of white blood cells).
• Severe, persistent blurred vision.

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 TecniGen:

• Swelling, mainly in the face and throat (signs of an allergic reaction).
• Yellowing of the skin and eyes, nausea, loss of appetite, darkening of urine (signs of hepatitis).
• Skin rash, redness of the skin, blisters on the lips, eyes or mouth, skin peeling, fever (signs of skin disorder).

Some adverse effects are very common. These adverse effects may affect more than 10 in every 100 patients.

• Hot flushes
• Elevated cholesterol levels (hypercholesterolaemia)
• Fatigue
• Increased sweating
• Bone and joint pain (arthralgia)

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

Some adverse effects are common. These adverse effects may affect 1 to 10 in every 100 patients.

• Skin rash
• Headache
• Dizziness
• General malaise
• Gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhoea
• Increased or decreased appetite
• Muscle pain
• Thinning or loss of bone (osteoporosis), which may lead to bone fractures in some cases (see also section “Monitoring of Letrozol TecniGen treatment” in section 3)
• Swelling of arms, hands, feet, ankles (oedema)
• Depression
• Weight gain
• Hair loss
• Increased 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.

Some adverse effects are uncommon. These adverse effects may affect 1 to 10 in every 1,000 patients.

• Nervous system disorders such as anxiety, nervousness, irritability, numbness, memory problems, drowsiness, insomnia
• Sensory disturbances, especially in touch
• Eye disorders such as blurred vision, eye irritation
• Skin disorders such as itching (urticaria)
• Vaginal dryness or discharge
• Joint stiffness (arthritis)
• Breast pain
• Fever
• Thirst, taste disturbance, dry mouth
• Dryness of mucous membranes
• Weight loss
• Urinary tract infection, increased frequency of urination
• Cough
• Increased levels of enzymes
• Yellowish discoloration of the skin and eyes
• Elevated blood levels of bilirubin (a breakdown product of red blood cells)
• Tendinitis or inflammation of a tendon (connective tissue linking muscles to bones)

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

Some adverse effects are rare. These adverse effects may affect 1 to 10 in every 10,000 patients.

• Rupture of a tendon (connective tissue linking muscles to bones)

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this 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 packaging after EXP. The expiry date refers to the last day of the month indicated.
• This medicine does not require any special storage conditions.
• Do not use any pack that is damaged or shows signs of tampering.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. 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 components (excipients) are:
  Core: Lactose monohydrate, microcrystalline cellulose, corn starch, colloidal anhydrous silica, sodium carboxymethyl starch from potato, magnesium stearate.
  Coating (OPADRY II 85F32444 yellow): Polyvinyl alcohol, talc, titanium dioxide (E-171), macrogol/PEG 3350, quinoline yellow aluminium lake, iron oxide red (E-172), iron oxide black (E-172).

Nature of the product and contents of the pack

• Letrozol TecniGen is presented as film-coated tablets. The tablets are round and dark yellow in colour.
• Each blister pack contains 10, 28, 30, 60, 90 or 100 tablets. Only certain pack sizes may be commercially available.

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 medicinal product is authorized in the European Economic Area member states under the following names:

Bulgaria: Letrofemin 2.5 mg Film-coated tablets
Germany: Letrozole Tecnimede 2.5 mg Filmtabletten
Greece: Letrozol Tecnimede 2.5 mg επικαλυμμένα με λεπτό υμένιο δισκία
Hungary: Letrozol Phace 2.5 mg Filmtabletta
Italy: Calantha 2.5 mg compresse rivestite 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

Date of the most recent review of this leaflet: November 2021

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