LETROZOLE TARBIS FARMA 2.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Letrozol Tarbis Farma 2.5mg Film-Coated Tablets EFG

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 or nurse.

• 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

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

What is Letrozol Tarbis Farma and how does it work

This medicine contains the active substance letrozole. It belongs to a group of medicines called aromatase inhibitors. It is a hormonal (endocrine) treatment for breast cancer. The growth of breast cancer is often 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, and can therefore block the growth of breast cancers that need estrogens to grow. As a result, the tumor cells grow more slowly or may stop growing altogether.

What is Letrozol Tarbis Farma used for

This medicine is used to treat breast cancer in women who have gone through the menopause (i.e., have stopped having 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 appropriate immediately, or it can be used as the first treatment after breast cancer surgery, or after 5 years of treatment with tamoxifen. This medicine is also used to prevent the spread of breast cancer to other parts of the body in patients with advanced breast cancer.

If you have any questions about how this medicine works or why you have been prescribed it, ask your doctor.

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

Follow carefully all instructions given to you 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 letrozole or any of the other ingredients of this medicine (listed in section 6),
• if you are still having periods, i.e., you have not yet reached the menopause,
• if you are pregnant,
• if you are breast-feeding.

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

Warnings and precautions

Tell your doctor or pharmacist before you start taking 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 apply to you, tell your doctor. Your doctor will take this into account when treating you with letrozole.

Letrozole may cause inflammation of the tendons or tendon injury (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.

Other medicines and Letrozol Tarbis Farma

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

Pregnancy, breast-feeding, and fertility

• You should only take letrozole if you have gone through the menopause. However, your doctor should discuss with you the use of effective contraception, as you could still become pregnant during treatment with letrozole.
• Do not take letrozole if you are pregnant or breast-feeding, 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 machines until you feel better.

Letrozol Tarbis Farma contains lactose

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

Letrozol Tarbis Farma contains sodium

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

Use in athletes:

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

3. How to take Letrozol Tarbis Farma

Follow exactly the instructions of your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The usual dose is one Letrozol Tarbis Farma tablet once a day. If you take letrozole 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 Tarbis Farma

Keep taking letrozole every day for as long as your doctor tells you to. You may need to take it for months or even years. If you are unsure how long to take letrozole, ask your doctor.

Monitoring of treatment with Letrozol Tarbis Farma

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

Letrozole 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 check for 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 taken your tablets, contact your doctor or go to the hospital immediately. Show them the pack of tablets. You may need medical treatment. You can also call the Toxicology Information Service, Tel: 915620420, stating 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., 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 dose as you would normally.
• Do not take a double dose to make up for a forgotten dose.

If you stop taking Letrozol Tarbis Farma

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

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:

Uncommon(may affect up to 1 in 100 people)

• Weakness, paralysis, or loss of sensation in a part of the body (especially arm or leg), loss of coordination, nausea, or difficulty speaking or breathing (sign of a brain disorder, e.g., stroke).
• Severe chest pain (sign of heart disorder).
• 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).
• Severe blurred vision.
• Tendinitis or tendon inflammation (tissue that connects muscles to bones).

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

• Difficulty breathing, chest pain, fainting, rapid heartbeat, blue discoloration of the skin, or sudden pain in the arm, leg, or foot (signs that a blood clot has formed)
• Tendon rupture (tissue that connects muscles to bones).

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

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

• 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).

Some side effects are very common(may affect more than 1 in 10 people):

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

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

Some side effects are common(may affect up to 1 in 10 people):

• Skin rash
• Headache
• Dizziness
• General feeling of being unwell
• Gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhea
• Increased or decreased appetite
• Muscle pain
• Thinning or loss of bone (osteoporosis), which can cause bone fractures in some cases (see also the section “Monitoring of treatment with Letrozol Tarbis Farma” 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, tell your doctor.

Some side effects are uncommon(may affect up to 1 in 100 people):

• 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)
• Sensitivity problems, 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
• Elevated blood levels of bilirubin (a product of red blood cell breakdown)

Side effects with unknown frequency(cannot be estimated from the available data)

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

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) via their website: https://www.notificaram.es. By reporting side 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 pack after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

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

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. They will dispose of it in an environmentally friendly way.

6. Contents of the pack and other information

Composition of Letrozol Tarbis Farma

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

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

Appearance of the product and pack contents

Film-coated tablets, dark yellow, round, slightly biconvex with beveled edges and engraved on one side with “5” and with “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

Netherlands

Date of last revision of this leaflet: March 2021

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