PROSPECTO: INFORMATION FOR THE USER

Letrozol Teva-ratiopharm 2.5mg film-coated tablets EFG

Letrozol

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

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given 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, even if they are not listed in this prospectus. See section 4.

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

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

3. How to take Letrozol Teva-ratiopharm

4. Possible adverse effects

5. Storage of Letrozol Teva-ratiopharm

6. Contents of the pack and additional information

What is Letrozol Teva-ratiopharm and how it works

Letrozol Teva-ratiopharm contains an active ingredient called letrozol. It belongs to a group of medicines called aromatase inhibitors. It is a hormone (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 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 Teva-ratiopharm used for

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

Followcarefullyall instructions from your doctor. Theymay be differentfrom the general informationcontained inthis leaflet.

Do not take Letrozol Teva-ratiopharm

• if you are allergic to letrozol or any of the other ingredients of this medicine (listed in section 6)
• if you still have menstrual cycles, that is, you have not reached menopause,
• if you are pregnant,
• if you are breastfeeding.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Letrozol Teva-ratiopharm

• if you have a serious kidney disease,
• if you have a serious liver disease,
• if you have a history of osteoporosis or bone fractures (see also “Treatment control 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 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 18 years)

Children and adolescents should not take this medicine.

Older adults (65 years and over)

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

Taking Letrozol Teva-ratiopharm with other medicines

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

Pregnancy, breastfeeding and fertility

• You should only take Letrozol Teva-ratiopharm after menopause. However, your doctor will discuss with you the use of effective contraception, as you may still become pregnant during treatment with Letrozol Teva-ratiopharm.

-You should not take Letrozol Teva-ratiopharm if you are pregnant or breastfeeding, as it may harm your baby.

Driving and operating machines

If you feel dizzy, tired, drowsy, or generally unwell, do not drive or operate machines until you feel better again.

Important information for athletes

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

Letrozol Teva-ratiopharm contains lactose

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

Letrozol Teva-ratiopharm contains aluminium lake tartrazine

This medicine may cause allergic reactions because it contains aluminium 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”.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.In case of doubt, 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 every 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 the time 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 continue taking Letrozol Teva-ratiopharm, consult your doctor.

Monitoring treatment with Letrozol Teva-ratiopharm

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

Letrozol Teva-ratiopharm 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 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 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 Toxicology Information Service, Tf: 915620420, indicating the medication and the amount taken.

If you forget to take Letrozol Teva-ratiopharm

• If there is not much time left until the next dose (e.g. 2 or 3 hours), do not take the missed dose and take your next dose at the time it is 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 make up for the missed doses.

If you interrupt treatment with 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 other questions about using this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Most side effects are mild or moderate in nature 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 a lack of estrogen 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:

Rare(may affect up to 1 in 100 people)

• 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).
• Oppressive and sudden chest pain (sign of heart alteration).
• Swelling and redness along 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.

Very rare(may affect up to 1 in 1000 people)

• 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).

Inform your doctor immediately if you experience any of the following:

Also, inform 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).
• Yellow color in the skin and eyes, nausea, loss of appetite, darkening of urine color (signs of hepatitis).
• Rash, skin redness, blisters on the lips, eyes, or mouth, skin peeling, fever (signs of skin alteration).

Other side effects

Very common(may affect more than 1 in 10 people)

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

Consult your doctor if any of these effects affect you severely.

Common(may affect up to 1 in 10 people)

• Skin rash
• Headache
• Dizziness
• General discomfort
• Gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhea
• Increased or decreased appetite
• Muscle pain
• Osteoporosis, which can cause bone fractures in some cases (see also the "Letrozol Teva-ratiopharm treatment control" section in section 3)
• Swelling of arms, hands, feet, ankles (edema)
• Depression
• Weight gain
• Hair loss
• High blood pressure (hypertension)
• Abdominal pain
• Skin dryness
• Vaginal bleeding
• Palpitations, rapid heart rate
• Joint stiffness (arthritis)
• Chest pain

Consult your doctor if any of these effects affect you severely.

Rare(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 in 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
• Membrane mucosa dryness
• Weight loss
• Urinary tract infection, increased frequency to urinate
• Cough
• Elevated enzyme levels
• Yellow discoloration of the skin and eyes
• Elevated bilirubin levels (a product of red blood cell breakdown).
• Tendinitis or inflammation of a tendon (connective tissue that connects muscles to bones).

Very rare(may affect up to 1 in 1000 people)

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

Frequency not known(cannot be estimated from available data)

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

Consult your doctor if any of these effects affect you severely.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, 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 Pharmacovigilance of Medicines for Human Use:https://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 this medication 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 special conditions for conservation.
• Do not use this medication if you observe visible signs of deterioration.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Letrozol Teva-ratiopharm Composition

• The active ingredient is letrozol. Each film-coated tablet contains 2.5 mg of letrozol.
• The other components are microcrystalline cellulose, maize starch, magnesium stearate, lactose monohydrate, anhydrous colloidal silica, sodium starch glycolate (Type A) and Opadry II 85F32723 Yellow which contains: yellow iron oxide (E172), macrogol 3350, titanium dioxide (E171), talc, aluminium lake of indigo carmine (E132), polyvinyl alcohol and aluminium lake of tartrazine (E102).

Appearance of the product and contents of the pack.

• Letrozol Teva-ratiopharm are film-coated tablets, dark yellow in color, round, convex, engraved with “93” on one face and “B1” on the other face.
• 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; there are also clinical packs of 50 film-coated tablets.

Only some pack sizes may be commercially available.

Marketing Authorization Holder and Responsible for Manufacturing

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11 Edificio Albatros B, 1st floor

28108 Alcobendas, Madrid

Responsible for Manufacturing

Pharmachemie B.V.

Swensweg 5, Postbus 552, 2003 RN Haarlem

Holland

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 Member States of the EEA with the following names:

Last revision date of this leaflet:October 2019

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.

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