Letrozole Tarbis 2.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Letrozole Tarbis 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 such effects are not listed in this leaflet.

Leaflet contents

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

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

What Letrozol Tarbis is and how it works

Letrozol Tarbis 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 Tarbis 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 estrogens to grow. As a result, tumor cells grow more slowly, or their growth and/or spread to other parts of the body is stopped.

What Letrozol Tarbis is used for

Letrozol Tarbis is used to treat breast cancer in women who have been through menopause, that is, who have stopped menstruating.

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

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

2. What you need to know before taking Letrozol Tarbis

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

Do not take Letrozol Tarbis

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

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Letrozol Tarbis

• 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” in section 3).

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

Letrozole may cause tendon inflammation or tendon injury (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)

This medicine must not be used in children and adolescents.

Elderly patients (aged 65 years and over)

Patients aged 65 years and over can take this medicine at the same dose as adults.

Taking Letrozol Tarbis 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 obtained without a prescription.

Pregnancy, breastfeeding and fertility

• You should only take Letrozol Tarbis if you have passed the menopausal stage. However, your doctor should discuss with you the use of an effective method of contraception, as you may still be able to become pregnant during treatment with Letrozol Tarbis.
• You must not take Letrozol Tarbis 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 contains lactose (milk sugar). If your doctor has informed you that you have an intolerance to certain sugars, consult with your doctor before taking this medicine.

Use in athletes:

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

3. How to take Letrozol Tarbis

Follow exactly the instructions for using this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The usual dose is one Letrozol Tarbis tablet once daily. Taking Letrozol Tarbis 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 another liquid.

How long to take Letrozol Tarbis

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

Monitoring of treatment with Letrozol Tarbis

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 Tarbis 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 Tarbis than you should

If you have taken too many Letrozol Tarbis 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 915620420, stating the name of the medicine and the amount taken.

If you forget to take Letrozol Tarbis

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

If you stop taking Letrozol Tarbis

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

4. Possible adverse effects

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

Most of the 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 estrogen deficiency.

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

Some adverse effects can be serious:

Rare or uncommon adverse effects (i.e., may affect 1 to 100 out of 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, oppressive chest pain (sign of heart disorder).
• Difficulty breathing, chest pain, fainting, rapid heartbeat, bluish skin coloration, or sudden pain in the arm, leg, or foot (signs of blood clot formation).
• Swelling and redness along 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.
• Rare - tendon rupture (connective tissue linking muscles to bones).

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 Tarbis:

• Swelling, mainly in the face and throat (signs of allergic reaction).
• Yellowing of the skin and eyes, nausea, loss of appetite, darkening of urine (signs of hepatitis).
• Rash, skin redness, blisters on 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 out of every 100 patients.

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

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

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

• Skin rash
• Headache
• Dizziness
• General malaise
• Gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhea
• 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 Tarbis treatment” 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. These adverse effects may affect 1 to 10 out of every 1,000 patients.

• Nervous system disorders such as anxiety, nervousness, irritability, numbness, memory problems, drowsiness, insomnia
• Sensory disturbances, especially related to 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 levels of liver enzymes
• Yellowish discoloration of the skin and eyes
• Elevated blood levels of bilirubin (a product of red blood cell breakdown)
• Tendinitis or inflammation of a tendon (connective tissue linking muscles to bones)

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

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, 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

• Keep this medicine out of the sight and reach of children.
• Do not use Letrozol Tarbis 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 should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at a SIGRE collection point at your pharmacy. If you are 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 Tarbis

• The active substance is letrozole. Each film-coated tablet contains 2.5 mg of letrozole.
• The other components (excipients) are monohydrate lactose (lactose), corn starch, microcrystalline cellulose, sodium starch glycolate (Type A) from potato (potato starch), talc, magnesium stearate. The coating consists of Aquopolish® yellow, composed of: hypromellose, hydroxypropyl cellulose, talc, cottonseed oil, yellow iron oxide (E172), red iron oxide (E172), titanium dioxide (E171).

Appearance of the medicinal product and contents of the pack

• Letrozol Tarbis is presented as film-coated tablets. The tablets are round, biconvex, and yellow in colour.
• The blister pack contains 30 tablets or 100 tablets (hospital pack).

Marketing Authorization Holder

Tarbis Farma, S.L.

Gran Via Carlos III, 94

08028– Barcelona

(Spain)

Manufacturer

Haupt Pharma Münster GmbH

Schleebrüggenkamp 15

D-48159 Münster

Germany

Or

TECNIMEDE-SOCIEDADE TECNICO MEDICINAL, S.A.,

Quinta Da Cerca, Caixaria, Dois Portos

PORTUGAL

Date of the most recent revision of this package leaflet: October 2019

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