Letrozole Teva-Ratiopharm 2.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Letrozole Teva-ratiopharm 2.5 mg film-coated tablets EFG

Letrozole

Read the entire leaflet carefully before you start taking this medicine, as 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 must not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

What Letrozol Teva-ratiopharm is and how it works

Letrozol Teva-ratiopharm 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. Letrozole 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 stop growing and/or spreading to other parts of the body.

What Letrozol Teva-ratiopharm is 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 may be used as the initial treatment before breast cancer surgery, when immediate surgery is not appropriate, or as initial treatment after breast cancer surgery, or after five years of treatment with tamoxifen. Letrozol Teva-ratiopharm is also used to 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 Teva-ratiopharm works or why you have been prescribed this medicine, please consult your doctor.

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

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

Do not take Letrozole Teva-ratiopharm

• if you are allergic to letrozole or to any of the other ingredients of this medicine (listed in section 6),
• if you still have menstrual cycles, i.e. 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

Talk to your doctor or pharmacist before starting to take Letrozole 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 Letrozole 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 Letrozole Teva-ratiopharm.

Letrozole 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 of age)

Children and adolescents must not take this medicine.

Elderly patients (aged 65 years and over)

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

Taking Letrozole Teva-ratiopharm 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 without a prescription.

Pregnancy, breastfeeding and fertility

• You should only take Letrozole Teva-ratiopharm if you have passed the menopausal stage. However, your doctor should discuss with you the use of effective contraception, as you may still become pregnant during treatment with Letrozole Teva-ratiopharm.

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

Driving and use of machines

If you feel dizzy, tired, drowsy or generally unwell, do not drive or operate machinery or tools until you feel well again.

Important information for athletes

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

Letrozole Teva-ratiopharm contains lactose

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

Letrozole Teva-ratiopharm contains tartrazine aluminium lake

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

Letrozole Teva-ratiopharm contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; essentially “sodium-free”.

3. How to take Letrozol Teva-ratiopharm

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

Continue taking Letrozol Teva-ratiopharm every day for as long as your doctor has instructed. 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 of treatment with Letrozol Teva-ratiopharm

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 Teva-ratiopharm may cause a decrease in bone thickness or bone loss (osteoporosis) due to reduced 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 Teva-ratiopharm than you should

If you have taken too many Letrozol Teva-ratiopharm tablets, or if someone else has accidentally taken them, contact your doctor or go to the hospital immediately. Show them the medicine packaging. You may require medical treatment. You can also call the Toxicology Information Service at telephone number 915620420, stating the name of 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. only 2 or 3 hours remaining), do not take the missed dose and take your next dose at the usual time.
• Otherwise, take the dose as soon as you remember, and then take the following tablet at your normal time.
• Do not take a double dose to make up for forgotten 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 adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. Most of these adverse effects are mild or moderate in nature 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 low estrogen levels in your body.

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

Some adverse effects may be serious:

Uncommon (may affect up to 1 in 100 people)

• 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, crushing chest pain (signs of a heart disorder).
• 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 cells).
• Severe, persistent blurred vision.

Rare (may affect up to 1 in 1000 people)

• Difficulty breathing, chest pain, fainting, rapid heartbeat, bluish skin coloration, or sudden pain in the arm, leg, or foot (signs of blood clot formation).

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 Teva-ratiopharm:

• Swelling, mainly of the face and throat (signs of an allergic reaction).
• Yellowing of the skin and eyes, nausea, loss of appetite, darkening of urine (signs of hepatitis).
• Skin rash, redness of the skin, blisters on the lips, eyes, or mouth, skin peeling, fever (signs of skin disorder).

Other adverse effects

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

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

If any of these effects affect you severely, consult 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 may lead to bone fractures in some cases (see also section “Monitoring of Letrozol Teva-ratiopharm 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 effects affect you severely, consult 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 the hands or wrists (carpal tunnel syndrome)
• Sensory disturbances, especially related to touch
• Eye disorders such as blurred vision, eye irritation
• Skin disorders such as itching (urticaria)
• Vaginal discharge or dryness
• Breast pain
• Fever
• Thirst, taste disturbance, dry mouth
• Dryness of mucous membranes
• Weight loss
• Urinary tract infection, increased frequency of urination
• Cough
• Increased enzyme levels
• 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 that connects muscles to bones)

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 condition in which your finger or thumb becomes locked in a bent position.

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

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 through 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 Letrozole Teva-ratiopharm

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine 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 this medicine if you notice any visible signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Letrozole Teva-ratiopharm

• The active substance is letrozole. Each film-coated tablet contains 2.5 mg of letrozole.
• The other components are microcrystalline cellulose, corn starch, magnesium stearate, lactose monohydrate, colloidal anhydrous silica, sodium starch glycolate (potato starch, type A), and Opadry II 85F32723 Yellow, which contains: yellow iron oxide (E 172), 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

• Letrozole Teva-ratiopharm are film-coated tablets, dark yellow in colour, round, biconvex, engraved with "93" on one side and "B1" on the other.
• Letrozole 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, 1st floor

28108 Alcobendas, Madrid

Manufacturer

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

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

Date of the most recent review of this leaflet: October 2019

Detailed and up-to-date information on this medicine 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 up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/72500/P_72500.html