LETROZOLE TARBIS 2.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Letrozol Tarbis 2.5 mg film-coated tablets EFG

Letrozol

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.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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. This includes any possible side effects not listed in this leaflet.

Contents of the pack

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

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

What is Letrozol Tarbis and how does it work

Letrozol Tarbis contains the active substance letrozole. It belongs to a group of medicines called aromatase inhibitors. It is a hormonal (or "endocrine") treatment for breast cancer. The growth of breast cancer is often 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 thus 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 used for

Letrozol Tarbis is used to treat breast cancer in women who have passed the menopause, i.e., the cessation of menstrual 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 immediately possible, or it can be used as the first treatment after breast cancer surgery, or after five years of treatment with tamoxifen. Letrozol Tarbis is also used to prevent the breast tumor 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, ask your doctor.

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

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

Do not take Letrozol Tarbis

• if you are allergic to letrozole or any of the other ingredients of this medicine (listed in section 6),
• if you still have menstrual cycles, i.e., you have not reached menopause,
• if you are pregnant,
• if you are breast-feeding.

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

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with 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.

Letrozol may cause tendon inflammation or tendon damage (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 65 years and over can use this medicine at the same dose as for adults.

Taking Letrozol Tarbis with other medicines

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

Pregnancy, breast-feeding, and fertility

• You should only take Letrozol Tarbis if you have passed the menopause. However, your doctor should discuss with you the use of effective contraception, as you could still become pregnant during treatment with Letrozol Tarbis.
• Do not take Letrozol Tarbis if you are pregnant or breast-feeding, as it may harm your baby.

Driving and using machines

If you feel dizzy, tired, sleepy, or unwell, do not drive or use tools or machines until you feel better.

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

Use in athletes:

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

3. How to take Letrozol Tarbis

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

The normal dose is one Letrozol Tarbis tablet once a day. If you take Letrozol Tarbis at the same time each 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

Continue taking Letrozol Tarbis every day for as long as your doctor tells you. You may need to take it for months or even years. If you are in doubt about how long to take Letrozol Tarbis, consult your doctor.

Monitoring of treatment with Letrozol Tarbis

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

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

If you have taken too many Letrozol Tarbis 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

• 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

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

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 estrogens.

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 or uncommon side effects(i.e., may affect 1 to 10 out of every 10,000 patients):

• 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).
• Chest pain (sign of heart disorder).
• Difficulty breathing, chest pain, fainting, rapid heartbeat, bluish discoloration of the skin, or sudden pain in the arm, leg, or foot (signs of blood clots).
• Swelling and redness along 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.
• Rare - tendon rupture (connective tissue that connects muscles to bones)

If you experience any of these, tell your doctor immediately.

You should also tell 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 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.These side effects may affect more than 10 out of every 100 patients.

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

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

Some side effects are common.These side 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 bones (osteoporosis), which can cause bone fractures in some cases (see also the section "Monitoring of treatment with Letrozol Tarbis" 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.These side effects may affect 1 to 10 out of every 1,000 patients.

• Nervous system disorders such as anxiety, nervousness, irritability, numbness, memory problems, sleepiness, insomnia
• Sensitivity disorders, 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 the mucous membranes
• Weight loss
• Urinary tract infection, increased frequency of urination
• Cough
• Increased enzyme levels
• Yellowing of the skin and eyes
• High blood levels of bilirubin (a product of red blood cell breakdown)
• Tendinitis or tendon inflammation (connective tissue that connects muscles to bones)

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

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Health Products Agency (AEMPS) 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

• Keep this medicine out of the sight and reach of children.
• Do not use Letrozol Tarbis after the expiry date stated on the pack after EXP. The expiry date refers to the last day of the month stated.
• 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. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 ingredients (excipients) are lactose monohydrate (lactose), cornstarch, microcrystalline cellulose, sodium starch glycolate (Type A) potato starch, talc, magnesium stearate. The coating is composed of Aquopolish yellow, which is formed by: hydroxypropyl methylcellulose, hydroxypropyl cellulose, talc, cottonseed oil, yellow iron oxide (E172), red iron oxide (E172), titanium dioxide (E171).

Appearance and packaging of the product

• Letrozol Tarbis is presented as film-coated tablets. The tablets are round, biconvex, and yellow in color.
• The blister pack contains 30 tablets or 100 tablets (clinical 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 last revision of this leaflet: October 2019

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