LETROZOLE TEVA-RATIOPHARM 2.5 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Letrozol Teva-ratiopharm 2.5mg 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.
• 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 experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Letrozol Teva-ratiopharm and what is it used for

What is Letrozol Teva-ratiopharm and how does it work

Letrozol Teva-ratiopharm 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 usually stimulated by estrogens, which are female sex hormones. Letrozol reduces the amount of estrogen by blocking an enzyme ("aromatase") involved in the production of estrogens and can therefore 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 Teva-ratiopharm used for

Letrozol Teva-ratiopharm 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 Teva-ratiopharm 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 Teva-ratiopharm works or why you have been prescribed this medicine, ask your doctor.

2. What you need to know before you take Letrozol Teva-ratiopharm

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

Do not take Letrozol Teva-ratiopharm

• 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 you are in any of these situations, do not take this medicine and consult your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Letrozol Teva-ratiopharm

• 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 Teva-ratiopharm" in section 3)

If you are in any of these situations, consult your doctor. Your doctor will take this into account during your treatment with Letrozol Teva-ratiopharm.

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 take this medicine.

Elderly patients (65 years and over)

People 65 years or older can take this medicine at the same dose as other adults.

Taking Letrozol Teva-ratiopharm with other medicines

Tell your doctor or pharmacist if 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 Teva-ratiopharm if you have passed the menopause. However, your doctor should discuss the use of effective contraception with you, as you could still become pregnant during treatment with Letrozol Teva-ratiopharm.

• Do not take Letrozol Teva-ratiopharm 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 machinery or tools until you feel better.

Important information for athletes

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

Letrozol Teva-ratiopharm contains lactose

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

Letrozol Teva-ratiopharm contains aluminum lake tartrazine

This medicine may cause allergic reactions because it contains aluminum lake tartrazine (E102).

Letrozol Teva-ratiopharm contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially "sodium-free".

3. How to take Letrozol Teva-ratiopharm

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

The recommended dose is one Letrozol Teva-ratiopharm tablet once a day. Taking Letrozol Teva-ratiopharm at the same time each day will help you remember when to take your 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 Teva-ratiopharm

Continue taking Letrozol Teva-ratiopharm every day for as long as your doctor tells you to. You may need to take it for months or even years. If you have any questions about how long you should keep taking Letrozol Teva-ratiopharm, ask your doctor.

Monitoring of treatment with Letrozol Teva-ratiopharm

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 Teva-ratiopharm 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 monitor osteoporosis) before, during, and after treatment.

If you take more Letrozol Teva-ratiopharm than you should

If you have taken too many Letrozol Teva-ratiopharm 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, indicating the medicine and the amount taken.

If you forget to take Letrozol Teva-ratiopharm

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

If you stop taking Letrozol Teva-ratiopharm

Do not stop taking Letrozol Teva-ratiopharm unless your doctor tells you to. See also the previous section "How long to take Letrozol Teva-ratiopharm”.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are mild or moderate and will 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 in your body.

Do not be alarmed by this list of possible side effects. You may not experience 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 (particularly 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)
• 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(may affect up to 1 in 1,000 people)

• 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)

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 symptoms during treatment with Letrozol Teva-ratiopharm:

• Swelling mainly of 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)

Other side effects

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 side effects gets serious, talk to your doctor.

Common(may affect up to 1 in 10 people)

• Skin rash
• Headache
• Dizziness
• General malaise
• Gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhea
• Increased or decreased appetite
• Muscle pain
• Thinning or weakening of bones (osteoporosis), which can cause bone fractures in some cases (see also "Monitoring of treatment with Letrozol Teva-ratiopharm" 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 side effects gets serious, talk to your doctor.

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 hands or wrists (carpal tunnel syndrome)
• Sensitivity disorders, especially touch
• Eyelid 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
• High blood levels of bilirubin (a product of red blood cell breakdown)
• Tendinitis or tendon inflammation (connective tissue that connects muscles to bones)

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

• Tendon rupture (connective tissue that connects muscles to bones)

Frequency not known(cannot be estimated from available data)

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

If any of these side effects gets serious, talk to your doctor.

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 Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Letrozol Teva-ratiopharm

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton after "EXP". The expiry date refers to the last day of the month shown.
• This medicine does not require any special storage conditions.
• Do not use this medicine if you notice visible signs of deterioration.

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. Container contents and additional information

Composition of Letrozol Teva-ratiopharm

• The active ingredient is letrozole. Each film-coated tablet contains 2.5 mg of letrozole.
• The other ingredients are microcrystalline cellulose, corn starch, magnesium stearate, lactose monohydrate, anhydrous colloidal silica, sodium starch glycolate (Type A), and Opadry II 85F32723 Yellow which contains: yellow iron oxide (E 172), macrogol 3350, titanium dioxide (E171), talc, aluminum indigo carmine lacquer (E132), polyvinyl alcohol, and aluminum tartrazine lacquer (E102).

Appearance of the product and container contents.

• Letrozol Teva-ratiopharm are film-coated tablets, dark yellow in color, round, convex, engraved with "93" on one side and "B1" on the other side.
• Letrozol Teva-ratiopharm is supplied in blisters in pack sizes of 1, 10, 14, 15, 20, 28, 30, 60, 90, 98, and 100 film-coated tablets; clinical packs of 50 film-coated tablets are also available.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11 Edificio Albatros B, 1ª planta

28108 Alcobendas, Madrid

Manufacturer

Pharmachemie B.V.

Swensweg 5, Postbus 552, 2003 RN Haarlem

Netherlands

or

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

or

TEVA Czech Industries s.r.o.

Ostravská 29, c.p. 305, 747 70 Opava -Komárov

Czech Republic

This medicinal product is registered in the EEA Member States with the following names:

Date of the last revision of this leaflet:October 2019

Detailed and updated 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/.

You can access detailed and updated information about this medicinal product by scanning the QR code included in the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/72500/P_72500.html