Letrozole Tarbis Farma 2.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Letrozol Tarbis Farma 2.5 mg film-coated tablets EFG

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, consult your doctor, pharmacist, or nurse.

• This medicine has been prescribed for you only, and you must not give it to other people, even if they have the same symptoms as you, because it could harm them.

• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if these adverse reactions are not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Letrozol Tarbis Farma is and what it is used for

What Letrozol Tarbis Farma is and how it works

This medicine 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. This medicine reduces the amount of estrogen by blocking an enzyme called aromatase, which is involved in estrogen production. Therefore, it can block the growth of breast cancers that require estrogen to grow. As a result, tumor cells grow more slowly or stop growing and/or spreading to other parts of the body.

What Letrozol Tarbis Farma is used for

This medicine is used to treat breast cancer in women who have gone through menopause, that is, whose menstrual periods have stopped.

It is used to prevent breast cancer from recurring. It may be used as the first 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. This medicine is also used to prevent breast tumors from spreading to other parts of the body in patients with advanced breast cancer.

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

2. What you need to know before starting Letrozol Tarbis Farma

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

Do not take Letrozol Tarbis Farma

• 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. have not yet reached menopause,
• if you are pregnant,
• if you are breastfeeding.

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

Warnings and precautions

Consult your doctor or pharmacist before starting Letrozol Tarbis Farma

• 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 Tarbis Farma” in section 3).

If any of these situations apply to you, inform your doctor. Your doctor will take this into account during your treatment with letrozol.

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 immediately.

Children and adolescents (under 18 years of age)

This medicine must not be used in children and adolescents.

Elderly patients (aged 65 years and older)

Patients aged 65 years and older may use this medicine at the same dosage as adults.

Other medicines and Letrozol Tarbis Farma

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including medicines not requiring a prescription.

Pregnancy, breastfeeding and fertility

• You should only take letrozol if you have passed the menopausal stage. However, your doctor should discuss with you the need for effective contraception, as you may still be able to become pregnant during treatment with letrozol.
• You must not take letrozol 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 Tarbis Farma contains lactose

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

Letrozol Tarbis Farma contains sodium

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

Use in athletes:

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

3. How to take Letrozol Tarbis Farma

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

The usual dose is one Letrozol Tarbis Farma tablet once daily. Taking letrozol 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 Tarbis Farma

Continue taking letrozol every day for as long as your doctor has instructed. You may need to take it for months or even years. If you have any doubts about how long you should continue taking letrozol, consult your doctor.

Monitoring of treatment with Letrozol Tarbis Farma

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

Letrozol may cause a decrease in bone thickness or bone loss (osteoporosis) due to reduced 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 Tarbis Farma than you should

If you have taken too many Letrozol Tarbis Farma tablets, or if someone else has accidentally taken the tablets, contact your doctor or go to the hospital immediately. Show them the medicine packaging. You may require medical treatment. You may also call the Toxicology Information Service at telephone number 915620420, stating the name of the medicine and the amount taken.

If you forget to take Letrozol Tarbis Farma

• If it is almost time for your next dose (e.g., only 2 or 3 hours remain), 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 following dose at your usual time.
• Do not take a double dose to make up for the missed doses.

If you stop taking Letrozol Tarbis Farma

Do not stop taking Letrozol Tarbis Farma unless instructed by your doctor. See also the section "How long to take Letrozol Tarbis Farma?" above.

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 low estrogen levels.

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

Some adverse effects may be serious:

Uncommon (may affect up to 1 in 100 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, pressing chest pain (signs of a heart disorder).
• Swelling and redness in a vein that is extremely tender and possibly painful to touch.
• Severe fever, chills, or mouth ulcers due to infections (due to low white blood cell count).
• Persistent, severe blurred vision.
• Tendinitis or inflammation of a tendon (connective tissue that connects muscles to bones).

Rare (may affect up to 1 in 1,000 patients):

• Difficulty breathing, chest pain, fainting, rapid heartbeat, bluish skin discoloration, or sudden pain in the arm, leg, or foot (signs of blood clot formation).
• Rupture of a tendon (connective tissue that connects muscles to bones).

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

You should also inform your doctor immediately if you experience any of the following symptoms during treatment with Letrozol Tarbis Farma:

• 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).
• Rash, skin redness, blisters on the lips, eyes, or mouth, skin peeling, fever (signs of skin disorder).

Some adverse effects are very common (may affect more than 1 in 10 patients):

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

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

Some adverse effects are common (may affect up to 1 in 10 patients):

• Skin rash
• Headache
• Dizziness
• General malaise
• Gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhea
• Increased or decreased appetite
• Muscle pain
• Bone thinning or bone loss (osteoporosis), which may lead to bone fractures in some cases (see also section “Monitoring of treatment with Letrozol Tarbis Farma” in section 3)
• Swelling of arms, hands, feet, ankles (edema)
• Depression
• Weight gain
• Hair loss
• Increased blood pressure (hypertension)
• Abdominal pain
• Dry skin
• Vaginal bleeding
• Palpitations, rapid heart rate
• Joint stiffness (arthritis)
• Chest pain

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

Some adverse effects are uncommon (may affect up to 1 in 100 patients):

• Nervous system disorders such as anxiety, nervousness, irritability, numbness, memory problems, drowsiness, insomnia
• Pain or burning sensation in the hands or wrists (carpal tunnel syndrome)
• Sensory disturbances, especially in touch
• Eye disorders such as blurred vision, eye irritation
• Skin disorders such as itching (urticaria)
• Vaginal dryness or discharge
• Breast pain
• Fever
• Thirst, taste disturbance, dry mouth
• Dryness of mucous membranes
• Weight loss
• Urinary tract infection, increased frequency of urination
• Cough
• Increased enzyme levels
• Yellowish discoloration of the skin and eyes
• Elevated blood levels of bilirubin (a product of red blood cell breakdown)

Adverse effects with unknown frequency (cannot be estimated from available data):

• Trigger finger, a condition in which your finger or thumb locks in a bent position.

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

Reporting of adverse effects

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

5. Storage of Letrozol Tarbis Farma

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

Do not use Letrozol Tarbis Farma 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 packaging that is damaged or shows signs of tampering.

Medicines must not be disposed of via wastewater or household waste. Return unused or expired containers and medicines to the SIGRE collection point at your pharmacy. If you have any doubts, 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 Tarbis Farma

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

The other components (excipients) are monohydrate lactose, sodium croscarmellose,
povidone K-30, colloidal anhydrous silica, magnesium stearate, yellow iron oxide, hypromellose, polyethylene glycol 400, titanium dioxide, talc.

Appearance of the product and contents of the pack

Film-coated tablets, dark yellow, round, slightly biconvex with bevelled edges, marked with "5" on one side and "H" on the other side (approximately 6.0 mm in diameter).

Each blister pack contains 30 tablets.

Marketing Authorization Holder

TARBIS FARMA, S.L.
Gran Vía Carlos III, 94
08028-Barcelona
Spain

Manufacturer

Pharmadox Healthcare Ltd
KW20A Kordin Industrial Park
Paola, PLA3000
Malta

Amarox Pharma B.V.
Rouboslaan 32
2252 TR, Voorschoten
The Netherlands

Date of the most recent revision of this leaflet: March 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/