Letrozole Sandoz 2.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Letrozole Sandoz 2.5 mg film-coated tablets EFG

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 symptoms 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. See section 4.

Contents of this leaflet

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

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

What Letrozol Sandoz is and how it works

Letrozol Sandoz 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 Sandoz reduces the amount of estrogen by blocking an enzyme ("aromatase") involved in estrogen production, and thus can block the growth of breast cancers that require estrogen to grow. As a result, tumor cells grow more slowly, or tumor growth and/or spread to other parts of the body is prevented.

What Letrozol Sandoz is used for

Letrozol is used to treat breast cancer in women who have gone through menopause, i.e. the cessation of menstrual periods.

It is used to prevent breast cancer from recurring. It can 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 Sandoz 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 Sandoz works or why this medicine has been prescribed for you, consult your doctor.

2. What you need to know before taking Letrozol Sandoz

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

Do not take Letrozol Sandoz

• 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, that is, you 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 Sandoz

• 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 Sandoz” 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 Sandoz.

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)

Children and adolescents must not use this medicine.

Elderly patients (aged 65 years and over)

Patients aged 65 years and over may use this medicine at the same dose as adults.

Taking Letrozol Sandoz 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 Sandoz if you have passed the menopausal stage. However, your doctor should discuss with you the use of effective contraception, as you could still become pregnant during treatment with Letrozol Sandoz.
• You must not take Letrozol Sandoz if you are pregnant or breastfeeding, as it may harm your baby.

Driving and using machines

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

Letrozol Sandoz contains lactose

Letrozol Sandoz contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

Letrozol Sandoz contains less than 23 mmol of sodium (1 mmol) per film-coated tablet; this is essentially “sodium-free”.

3. How to take Letrozol Sandoz

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

The usual dose is one Letrozol Sandoz tablet once daily. Taking Letrozol Sandoz 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 other liquid.

How long to take Letrozol Sandoz

Continue taking Letrozol Sandoz 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 doubts about how long you should take Letrozol Sandoz, consult your doctor.

Monitoring of treatment with Letrozol Sandoz

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

Letrozol Sandoz 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 of monitoring osteoporosis) before, during, and after treatment.

If you take more Letrozol Sandoz than you should

If you have taken too many Letrozol Sandoz tablets, or if someone else has accidentally taken them, contact your doctor or go to the hospital immediately. Show them the medicine’s packaging. You may need medical treatment. If you have taken more Letrozol Sandoz than you should, contact your doctor, pharmacist, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Letrozol Sandoz

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

If you stop taking Letrozol Sandoz

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

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 will experience them.

Most 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 lack of oestrogens.

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 adverse effects (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, pressing chest pain (signs of heart disorder),

• swelling and redness along a vein which is extremely tender and possibly painful to touch,
• severe fever, chills, or mouth ulcers due to infections (lack of white blood cells),
• persistent blurred vision.

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

• difficulty breathing, chest pain, fainting, rapid heartbeat, bluish skin colouration, 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 Sandoz:

• 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, redness of the skin, blisters on the lips, eyes or mouth, skin peeling, fever (signs of skin disorder).

Some adverse effects are very common (may affect more than 1 in 10 people):

• hot flushes,

• elevated cholesterol levels (hypercholesterolaemia),

  • fatigue,

• increased sweating,

• bone and joint pain (arthralgia).

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

Some adverse effects are common (may affect up to 1 in 10 people):

• palpitations, rapid heartbeat,
• joint stiffness (arthritis),
• chest pain,
• skin rash,
• headache,
• dizziness,
• general malaise,
• gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhoea,
• 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 Sandoz treatment” in section 3”),
• swelling of arms, hands, feet, ankles (oedema),
• depression,
• weight gain,
• hair loss,
• increased blood pressure (hypertension),
• abdominal pain,
• dry skin,
• vaginal bleeding.

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

Other adverse effects are 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 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 disturbances, 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,
• elevated blood levels of bilirubin (a product of red blood cell breakdown),
• tendinitis or inflammation of a tendon (connective tissue connecting muscles to bones).

Other adverse effects are rare (may affect up to 1 in 1,000 people):

• tendon rupture (connective tissue connecting muscles to bones).

Adverse effects with unknown frequency (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 affect you severely, inform your doctor.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Letrozole Sandoz

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and cardboard package following EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

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 you are 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 Letrozol Sandoz

• The active substance is letrozol. Each film-coated tablet contains 2.5 mg of letrozol.
• The other components are: lactose monohydrate, microcrystalline cellulose (E460), pregelatinized maize starch, sodium carboxymethyl starch (type A) (from potato), magnesium stearate (E572), colloidal silicon dioxide (E551).
• Components of the tablet coating: macrogol (PEG 8000), talc (E553b), hypromellose (E464), titanium dioxide (E171), yellow iron oxide (E172).

Appearance of Letrozol Sandoz and contents of the pack

Letrozol Sandoz 2.5 mg is presented as yellow, round, biconvex film-coated tablets, marked with "L9OO" on one side and "2.5" on the other.

Letrozol Sandoz is available in PVC-aluminum blisters containing 10, 28, 30, 50, 60, 84, 90, 98 or 100 tablets per box.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Synthon Hispania S.L.

Castelló 1

Polígono Las Salinas

08830 Sant Boi de Llobregat

Spain

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

or

Synthon BV

Microweg 22

6545 CM Nijmegen

Netherlands

or

Rottendorf Pharma GmbH

Ostenfelder Strasse 51-61

59320 Ennigerloh

Germany

or

Lek Pharmaceuticals d.d.

Verovskova 57

1526 Ljubljana

Slovenia

This medicinal product is authorized in the European Economic Area member states under the following names:

Slovakia: Letrozol Sandoz 2.5 mg filmsko obalené tablety
Czech Republic: Letrozol Sandoz 2.5 mg
Hungary: Letrozol Sandoz 2.5 mg filmyabletta
Netherlands: Letrozol Sandoz 2.5 mg finlomhulde tabletten

Date of the most recent review of this leaflet: November 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/