Letrozole Sun

Package leaflet: Information for the user

Letrozole SUN 2.5 mg film-coated tablets

Letrozole
Generic medicine
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Letrozole SUN is and what it is used for

What Letrozole SUN is and how it works
Letrozole SUN contains an active substance called 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. Letrozole SUN reduces the amount of estrogen by blocking an enzyme ("aromatase") involved in estrogen production; therefore, it can block the growth of breast tumors that require estrogen to grow. As a result, the growth of cancer cells and/or their spread to other parts of the body is slowed down or stopped.

What Letrozole SUN is used for
Letrozole SUN is used for the treatment of breast cancer in postmenopausal women, that is, women who no longer have menstrual periods.
It is used to prevent the recurrence of breast cancer. It may be used as initial treatment before breast surgery when immediate surgery is not possible, or as initial treatment after breast surgery, or after five years of treatment with tamoxifen. Letrozole SUN is also used to prevent the spread of breast cancer to other parts of the body in patients with advanced-stage breast cancer.

If you have any questions about how Letrozole SUN works or why this medicine has been prescribed for you, consult your doctor.

2. What you need to know before taking Letrozole SUN

Follow your doctor's instructions carefully. They may differ from the general information
provided in this leaflet.
Do not take Letrozole SUN

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

If any of these conditions applies to you, do not take this medicine and inform your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking Letrozole SUN

• 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 SUN" in section 3). If any of these conditions applies to you, inform your doctor. This will be taken into account by your doctor during treatment with Letrozole SUN.

For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive doping test.
Children and adolescents (under 18 years of age)
Children and adolescents must not use this medicine.
Elderly (65 years of age and over)
Women aged 65 years and over can take this medicine at the same dose as adult women.
Other medicines and Letrozole SUN
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
Pregnancy and breastfeeding

• You should only take Letrozole SUN after you have entered menopause. However, your doctor will discuss with you the need to use an effective method of contraception, as you could potentially become pregnant during treatment with Letrozole SUN.
• You must not take Letrozole SUN if you are pregnant or breastfeeding, as it may harm the baby.

Driving and using machines
If you feel dizzy, tired, drowsy, or generally unwell, do not drive or operate machinery until you feel well again.
Letrozole SUN contains lactose
Letrozole SUN contains lactose (milk sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Letrozole SUN

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure,
consult your doctor or pharmacist.
The usual dose is one Letrozole SUN tablet taken once daily. Taking Letrozole SUN
at the same time each day will help you remember when to take the tablet.
The tablet should be taken with or without food and must be swallowed whole with a glass of water or
another beverage.

How long to take Letrozole SUN
Continue taking Letrozole SUN every day for the duration prescribed by your doctor. You may need to
take it for months or even years. If you have any questions about how long to take Letrozole SUN, speak
with your doctor.

Monitoring during treatment with Letrozole SUN
You must take this medicine under close medical supervision. Your doctor will regularly monitor your
health to ensure the treatment is having the intended effect.
Letrozole SUN may cause bone fragility or loss of bone mass (osteoporosis) due to reduced estrogen levels
in the body. Your doctor may decide to measure your bone density (a way to monitor
osteoporosis) before, during, and after treatment.

If you take more Letrozole SUN than you should
If you have taken too much Letrozole SUN, or if someone else has accidentally taken your tablets,
contact your doctor or hospital immediately for advice. Show them the medicine pack.
Medical treatment may be necessary.

If you forget to take Letrozole SUN

• If it is nearly time for your next dose (for example, within 2 or 3 hours), skip the missed dose and take the next dose at the usual time.
• Otherwise, take the missed dose as soon as you remember, then continue with your regular dosing schedule.
• Do not take a double dose to make up for a forgotten dose.

If you stop taking Letrozole SUN
Do not stop taking Letrozole SUN unless your doctor tells you to. See also the section above titled “How long to take Letrozole SUN”.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most of the side effects are mild to moderate and usually disappear within a few days to a few weeks of treatment.
Some of these side effects, such as hot flushes, hair loss or vaginal bleeding, may be caused by low levels of oestrogen in the 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 or uncommon side effects (may affect up to 1 in 1,000 people):

• Weakness, paralysis or loss of sensation in any part of the body (especially arm or leg), loss of coordination, nausea, or difficulty speaking or breathing (symptoms of a brain disorder, for example stroke).
• Sudden chest pain with a feeling of tightness (symptom of a heart disorder).
• Difficulty breathing, chest pain, fainting, rapid heartbeat, bluish skin colouration, or sudden pain in the arm, leg or foot (symptoms of possible blood clot formation).
• Swelling and redness along a vein that is very tender and painful to touch.
• High fever, chills or mouth ulcers due to infections (caused by lack of white blood cells).
• Severe and persistent blurred vision.

If any of these effects occur, inform your doctor immediately.
You must also inform your doctor immediately if any of the following symptoms occur during treatment with Letrozole SUN:

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

Some side effects are very common. May affect more than 1 in 10 people.

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

If any of these effects occur severely, inform your doctor.
Some side effects are common. May affect up to 1 in 10 people.

• Skin rash
• Headache
• Dizziness
• Malaise (usually a general feeling of being unwell)
• Gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhoea
• Increased or decreased appetite
• Muscle pain
• Fragility or loss of bone mass (osteoporosis), which in some cases leads to bone fractures (see also “Monitoring during treatment with Letrozole SUN” 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
• Palpitations, tachycardia
• Joint stiffness (arthritis)
• Chest pain

If any of these effects occur severely, inform your doctor.
Other side effects are uncommon. May affect up to 1 in 100 people.

• Nervous system disorders such as anxiety, nervousness, irritability, drowsiness, memory problems, somnolence, insomnia
• Pain or burning sensation in the hands or wrist (carpal tunnel syndrome)
• Impaired sensation, especially to touch
• Eye disorders such as blurred vision, eye irritation
• Skin disorders such as itching (urticaria)
• Vaginal dryness or discharge
• Breast pain
• Fever
• Thirst, taste disturbances, dry mouth
• Dryness of mucous membranes
• Weight loss
• Urinary tract infections, increased frequency of urination
• Cough
• Increased levels of liver enzymes
• Yellowing of the skin and eyes
• Elevated blood levels of bilirubin (a breakdown product of red blood cells).

Side effects with unknown frequency (frequency cannot be estimated from the available data)

• Trigger finger, a condition in which one of the fingers of the hand becomes locked in a bent position.

If any of these effects occur severely, inform your doctor.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Letrozole SUN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "EXP". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Letrozolo SUN contains

• The active substance is letrozole. Each film-coated tablet contains 2.5 mg of letrozole.
• The other components of the tablet core are monohydrate lactose, microcrystalline cellulose (E460), maize starch, povidone (K-30), sodium starch glycolate type A, anhydrous colloidal silica, magnesium stearate (E572).
• The tablet coating contains: hypromellose (E464), yellow iron oxide (E172), titanium dioxide (E171), polyethylene glycol-4000, talc, polyethylene glycol-400.

Description of the appearance of Letrozolo SUN and contents of the package
Letrozolo SUN 2.5 mg film-coated tablets are dark yellow, round, biconvex, film-coated and smooth on both sides.
The tablets are available in transparent PVC/aluminum blisters containing 28, 30, 84 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

Representative in Italy:
Ranbaxy Italia S.p.A.
Viale Giulio Richard, 1 – 20143 Milano
Italy

Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
France: Letrozole SUN 2.5 mg comprimés pelliculés
Germany: Letrozol SUN 2.5 mg Filmtabletten
Italy: Letrozolo SUN 2,5 mg compresse rivestite con film
Spain: Letrozol SUN 2.5 mg comprimidos recubiertos de película EFG
The Netherlands: Letrozol SUN 2.5 mg filmomhulde tabletten
United Kingdom: Letrozole 2.5 mg film-coated tablets