Prospect: information for the patient

Letrozol Tarbis Farma 2.5mg film-coated tablets EFG

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

• Keep this prospect, as you may need to read it again.
  If you have any questions, consult your doctor or pharmacist or nurse.

• 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 or nurse, even if they are not listed in this prospect. See section 4.

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

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

3.How to take Letrozol Tarbis Farma

4.Possible adverse effects

5.Storage of Letrozol Tarbis Farma

6.Contents of the package and additional information

What is Letrozol Tarbis Farma and how it works

This medication contains an active ingredient called letrozol. It belongs to a group of medications called aromatase inhibitors. It is a hormonal or endocrine cancer treatment for breast cancer. The growth of breast cancer is usually stimulated by estrogens, which are the female sex hormones. This medication reduces the amount of estrogen by blocking an aromatase enzyme 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 Tarbis Farma used for

This medication 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. This medication 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 this medication works or the reason why you have been prescribed this medication, consult your doctor.

Follow carefully all instructions from your doctor. They may be different from the general information contained in this prospectus.

Do not take Letrozol Tarbis Farma

• if you are allergic to letrozol or to any of the other components of this medication (including those listed in section6),
• 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 medication and inform your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Letrozol Tarbis Farma

• 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 Tarbis Farma” in section3).

If any of these cases 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.

Children and adolescents (under 18years)

Children and adolescents should not use this medication.

Older adults (65years and older)

People 65years and older may use this medication at the same dose as adults.

Other medications and Letrozol Tarbis Farma

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

Pregnancy, breastfeeding, and fertility

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

Driving and operating machinery

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

Letrozol Tarbis Farma contains lactose

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

Letrozol Tarbis Farma contains sodium

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

Use in athletes:

This medication contains letrozol, which may produce a positive result in doping control tests.

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

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

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

Control of treatment with Letrozol Tarbis Farma

You should only take this medication under strict medical supervision. Your doctor will periodically monitor your situation to check that the treatment has the desired effect.

Letrozol 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 control 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 packaging of the tablets. You may need medical treatment. You can also call the Toxicological Information Service, Tf: 915620420, indicating the medication and the amount taken.

If you forget to take Letrozol Tarbis Farma

• If it is almost time for your next tablet (e.g. 2 or 3 hours), do not take the dose you missed and take the next dose at the time it was due.
• Otherwise, take the dose as soon as you remember, and then take the next tablet as you normally would.
• Do not take a double dose to compensate for the doses you missed.

If you interrupt treatment with 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?.

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 a few 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(may affect up to 1 in 100patients):

• 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 a brain alteration, e.g. stroke).
• Crushing chest pain and sudden onset (sign of heart alteration).
• Swelling and redness in a vein that is extremely soft and possibly painful to the touch.
• Severe fever, cold, or mouth ulcers due to infections (lack of white blood cells).
• Severe blurred vision.
• Tendinitis or inflammation of a tendon (connective tissue that connects muscles to bones).

Very rare(may affect up to 1 in 1000patients):

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

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 Tarbis Farma:

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

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

• 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(may affect up to 1 in 10patients):

• Rash on the skin
• 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 section “Control 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 heart rate
• Joint stiffness (arthritis)
• Chest pain

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

Some side effects are rare(may affect up to 1 in 100patients):

• Nervous 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 in touch
• Eye problems such as blurred vision, eye irritation
• Skin problems 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
• Elevated enzyme levels
• Yellow discoloration of the skin and eyes
• Elevated bilirubin levels in the blood (a product of red blood cell breakdown)

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

• Trigger finger, a situation in which your finger or thumb stays locked in a bent position.

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

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: httpss://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use Letrozol Tarbis Farma after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require any special storage conditions.

Do not use any packaging that is damaged or shows signs of manipulation.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and the

medicines you do not need at the SIGRE collection point of the pharmacy. If in doubt

ask your pharmacist how to dispose of the packaging and the medicines you do not

need. In this way, you will help protect the environment.

Letrozole Tarbis Farma Composition

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

The other components (excipients) are lactose monohydrate, sodium croscarmellose,

povidone K-30, colloidal anhydrous silica, magnesium stearate, yellow iron oxide, hypromellose, macrogol 400, titanium dioxide, talc.

Product appearance and packaging content

Film-coated tablets, dark yellow, round, slightly biconvex with beveled edges and engraved on one face with “5” and with “H” on the other face (approximately 6.0 mm).

Each package with blisters contains 30 tablets

Marketing Authorization Holder

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028-Barcelona

Spain

Responsible for Manufacturing

Pharmadox Healthcare Ltd

KW20A Kordin Industrial Park

Paola, PLA3000

Malta

Amarox Pharma B.V.

Rouboslaan 32

2252 TR, Voorschoten

Netherlands

Last review date of this leaflet: March 2021

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