PACKAGE LEAFLET: INFORMATION FOR THE USER

LETROZOLE EG 2.5 mg film-coated tablets

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 their symptoms
are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist.
See section 4.
Contents of this leaflet

What LETROZOLE EG is and what it is used for
What you need to know before taking LETROZOLE EG
How to take LETROZOLE EG
Possible side effects
How to store LETROZOLE EG
Contents of the pack and other information

1. What LETROZOLO EG is and what it is used for

What LETROZOLO EG is and how it works
LETROZOLO EG 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 often stimulated by estrogens, which are female sex hormones. LETROZOLO EG reduces the amount of estrogen by blocking an enzyme ("aromatase") involved in estrogen production, and therefore can inhibit 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 LETROZOLO EG is used for
LETROZOLO EG 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 can be used as initial treatment before breast surgery when immediate surgery is not possible, or as initial treatment following breast surgery, or after a five-year treatment with tamoxifen. LETROZOLO EG 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 LETROZOLO EG works or why this medicine has been prescribed for you, please consult your doctor.

2. What you need to know before taking LETROZOLO EG

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

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 periods, i.e. if you are not yet in 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 LETROZOLO EG

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 LETROZOLO EG" in section 3). If any of these conditions applies to you, inform your doctor. This will be taken into consideration by your doctor during treatment with LETROZOLO EG.

Children and adolescents (under 18 years of age)
Children and adolescents must not use this medicine.
Elderly (65 years of age and older)
Women aged 65 years and older can use this medicine at the same dose as adult women.
Other medicines and LETROZOLO EG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding and fertility

You should take LETROZOLO EG only 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 still be at risk of becoming pregnant during treatment with LETROZOLO EG.
You must not take LETROZOLO EG if you are pregnant or breastfeeding, as it may harm the baby.

If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding with breast milk, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
If you feel dizzy, tired, drowsy or generally unwell, do not drive and do not operate machinery until you feel well again.
LETROZOLO EG contains lactose
LETROZOLO EG contains lactose (milk sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take LETROZOLO EG

Take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one LETROZOLO EG tablet to be taken once daily.
Taking LETROZOLO EG at the same time each day will help you remember when to take the tablet.
The tablet can be taken with or without food and must be swallowed whole with a glass of water or another beverage.

How long to take LETROZOLO EG
Continue taking LETROZOLO EG 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 you should take LETROZOLO EG, speak with your doctor.

Monitoring during treatment with LETROZOLO EG
You must take this medicine under close medical supervision. Your doctor will regularly monitor your health to ensure the treatment is having the desired effect.
LETROZOLO EG 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 of monitoring osteoporosis) before, during, and after treatment.

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

If you forget to take LETROZOLO EG

If it is almost 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 normal dosing schedule.
Do not take a double dose to make up for the missed dose.

If you stop taking LETROZOLO EG
Do not stop taking LETROZOLO EG unless instructed by your doctor. See also the section above titled “How long to take LETROZOLO EG.”
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Most of the side effects are mild to moderate and usually disappear after a period of treatment ranging from a few days to a few weeks.
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 (i.e. may affect between 1 and 100 people in 10,000):

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 (symptoms of a brain disorder, for example stroke).
Sudden chest pain with a feeling of tightness (symptoms 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 extremely tender and painful to touch.
High fever, chills, or mouth ulcers due to infections (due to lack of white blood cells).
Severe and persistent blurred vision. If any of these effects occur, inform your doctor immediately.

You must inform your doctor immediately if any of the following symptoms occur during treatment with LETROZOLO EG:

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. These side effects 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. These side effects 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 may lead to bone fractures (see also “Monitoring during treatment with LETROZOLO EG” 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 occur severely, inform your doctor.

Other side effects are uncommon. These side effects may affect up to 1 in 100 people.

Nervous system disorders such as anxiety, nervousness, irritability, drowsiness, memory problems, somnolence, insomnia
Pain and burning sensation in hands and wrists (carpal tunnel syndrome)
Impaired sensation, especially to touch
Eye disorders such as blurred vision, eye irritation
Palpitations, rapid heartbeat
Skin disorders such as itching (urticaria)
Vaginal dryness or discharge
Joint stiffness (arthritis)
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

Side effects with unknown frequency. Frequency cannot be estimated from the available data.
Trigger finger, a condition in which a finger or thumb locks 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/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store LETROZOLE EG

Keep this medicine out of the sight and reach of children.
Store the medicine in its original packaging to protect it from moisture.
Do not use this medicine after the expiry date stated on both the blister and the packaging. The expiry date refers to the last day of that month.
Do not dispose of any medicine 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 LETROZOLE EG contains
Description of the appearance of LETROZOLE EG and pack contents
LETROZOLE EG film-coated tablets are round, yellow tablets with convex surfaces on both sides. The tablets are available in blister packs containing 10, 30, and 100 tablets.
Marketing Authorization Holder
EG S.p.A., Via Pavia, 6 – 20136 Milan, Italy
Manufacturers
Haupt Pharma Munster GmbH, Schleebruggenkamp 15, 48159 Münster, Germany
cell pharm GmbH, Feodor-Lynen-Str. 35, 30625 Hannover, Germany
STADA Arzneimittel AG, Stadastrasse 2 – 18, 61118 Bad Vilbel, Germany
Stada Arzneimittel GmbH, Muthgasse 36, 1190 Vienna, Austria
Eurogenerics N.V., Heizel Esplanade B22, 1020 Brussels, Belgium
Clonmel Healthcare Ltd., Waterford Road, Clonmel, Co. Tipperary, Ireland