Letrozole eugia

Package leaflet: Information for the patient

Letrozole Eugia, 2.5 mg, film-coated tablets
Letrozole
Please read all of this leaflet carefully before 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, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

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

What Letrozole Eugia is and how it works
Letrozole Eugia contains an active substance called letrozole. It belongs to a group of medicines known as aromatase inhibitors. It is used in hormonal (endocrine) treatment of breast cancer. The growth of breast cancer is often stimulated by estrogens, which are female sex hormones. Letrozole Eugia reduces the amount of estrogen by inhibiting the activity of an enzyme (aromatase) involved in estrogen production. Therefore, it can slow down the growth of estrogen-dependent malignant breast tumours. As a result of this action, cancer cells stop growing or grow more slowly and (or) stop spreading to other parts of the body.

For what purpose is Letrozole Eugia used
Letrozole Eugia is used to treat breast cancer in postmenopausal women, that is, women who have stopped menstruating.
This medicine is used to prevent recurrence of breast cancer. It may be used as initial treatment before breast surgery when immediate surgery is not recommended, or as initial treatment after breast surgery, or after five years of tamoxifen therapy. Letrozole Eugia is also used to prevent the spread of breast tumour to other parts of the body in patients with advanced breast cancer.
If you have any questions about how Letrozole Eugia works or why it has been prescribed for you, please consult your doctor.

2. Important information before using Letrozole Eugia

Follow your doctor's instructions. These may differ from the general information contained
in this leaflet.
When not to use Letrozole Eugia

• if the patient is allergic to letrozole or any of the other ingredients of this medicine (listed in section 6),
• if the patient is still menstruating, i.e. is still premenopausal,
• if the patient is pregnant,
• if the patient is breastfeeding.

Do not use the medicine if any of these points apply to the patient – consult a doctor.
Warnings and precautions
Before starting treatment with Letrozole Eugia, discuss this with your doctor or pharmacist

• if the patient has severe kidney disease,
• if the patient has severe liver disease,
• in case of osteoporosis or if the patient has previously experienced bone fractures (see "Monitoring during treatment with Letrozole Eugia" in section 3).

Letrozole may cause inflammation or damage to tendons (see section 4). If the patient
experiences pain or swelling in a tendon, the affected area should be rested and the doctor should be contacted.
If any of these points apply to the patient, inform the doctor. The doctor
will take these factors into account during treatment with Letrozole Eugia.
Children and adolescents (under 18 years of age)
This medicine should not be used in children and adolescents.
Elderly patients (65 years of age and older)
Patients aged 65 years and older may take the medicine at the same dosage as other adult
patients.
Letrozole Eugia and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have
a child, she should consult her doctor or pharmacist before using this medicine.

• Letrozole Eugia should only be used when the patient is postmenopausal. However, the doctor will discuss with the patient the need for an effective method of contraception, as the patient may still become pregnant during treatment with Letrozole Eugia.
• Letrozole Eugia must not be used if the patient is pregnant or breastfeeding, as treatment may harm the unborn or nursing child.

Driving and operating machinery
If the patient experiences dizziness, fatigue, drowsiness or general malaise,
she must not drive or operate tools and machinery until her condition
returns to normal.
Letrozole Eugia contains lactose
Letrozole Eugia contains lactose (milk sugar). If the patient has previously been diagnosed with
intolerance to certain sugars, she should consult her doctor before taking
this medicine.
Letrozole Eugia contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Letrozole Eugia

This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, consult
the doctor or pharmacist.
The usual dose is one coated tablet of Letrozole Eugia taken once daily. Taking Letrozole Eugia at the same time each day will help you remember to take the 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 Letrozole Eugia
You should take Letrozole Eugia every day for as long as your doctor has instructed. Treatment may need to continue for several months or even years. If you have any questions about how long you should continue taking Letrozole Eugia, consult your doctor.

Monitoring during treatment with Letrozole Eugia
This medicine must always be used under strict medical supervision. Your doctor will regularly monitor your health condition to ensure that the treatment is effective and appropriate.
Letrozole Eugia may cause thinning or loss of bone tissue (osteoporosis) due to reduced estrogen levels in the body. Your doctor may recommend measuring your bone density (osteoporosis screening test) before starting treatment, during treatment, and after treatment has ended.

Taking more Letrozole Eugia than prescribed
If you have taken more Letrozole Eugia than prescribed, or if someone accidentally swallows the tablets, contact your doctor or go to hospital immediately. Show the medicine packaging. Treatment may be necessary.

Missed dose of Letrozole Eugia

• If it is almost time for the next dose (e.g. only 2 to 3 hours remain), 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 taking the next tablet at your regular time.
• Do not take a double dose to make up for a missed dose.

Stopping Letrozole Eugia treatment
Do not stop taking Letrozole Eugia without consulting your doctor. See also section "How long to take Letrozole Eugia".
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Most of the observed adverse reactions are mild to moderate in severity and generally appear within a few days to a few weeks of starting treatment.
Some of these, such as hot flushes, hair loss or vaginal bleeding, may be consequences of estrogen deficiency in the body.
Do not be alarmed by all the possible adverse reactions of this medicine listed below. They may not occur at all.
Some adverse reactions may be serious:
Uncommon (may affect up to 1 in 100 people):

• weakness, numbness or loss of sensation in any part of the body (especially in the arm or leg), loss of coordination, nausea or difficulty speaking or breathing (symptoms of brain disorders, e.g. stroke)
• sudden, pressing chest pain (symptom of heart disorders)
• swelling and redness along a vein, extremely tender and painful to touch
• high fever, chills or oral ulcers due to infections (lack of white blood cells)
• severe, persistent visual disturbances
• tendon inflammation (soft tissue connecting muscles and bones).

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

• difficulty breathing, chest pain, fainting, rapid heartbeat, bluish skin discoloration or sudden pain in the arm, leg or foot (symptoms indicating blood clot formation)
• tendon rupture (soft tissue connecting muscles and bones).

If any of the above symptoms occur, inform your doctor immediately.
You should also inform your doctor immediately if any of the following symptoms occur during treatment with Letrozole Eugia:

• swelling, mainly of the face and throat (symptoms of allergic reaction)
• yellowing of the skin and eyes, nausea, loss of appetite, dark urine (symptoms of hepatitis)
• skin rash, redness of the skin, formation of blisters on the lips, eyes or in the mouth, skin peeling, fever (symptoms of skin disorders).

Other adverse reactions
Very common (may affect more than 1 in 10 people):

• hot flushes
• increased cholesterol levels (hypercholesterolemia)
• feeling of fatigue
• excessive sweating
• bone and joint pain.

If any of these symptoms occur severely in the patient, inform the doctor.
Common (may affect up to 1 in 10 people):

• skin rash
• headache
• dizziness
• general malaise
• gastrointestinal disorders such as: nausea, vomiting, indigestion, constipation, diarrhoea
• increased appetite or loss of appetite
• muscle pain
• thinning or loss of bone tissue (osteoporosis), which in some cases may lead to bone fractures (see "Monitoring during treatment with Letrozole Eugia" in section 3)
• swelling of arms, hands, feet and ankles (oedema)
• depression
• weight gain
• hair loss
• increased blood pressure (hypertension)
• abdominal pain
• dry skin
• vaginal bleeding
• palpitations, rapid heartbeat
• joint stiffness (arthritis)
• chest pain.

If any of these symptoms occur severely in the patient, inform the doctor.
Uncommon (may affect up to 1 in 100 people):

• nervous system disorders such as anxiety, nervousness, irritability, drowsiness, memory problems, feeling of sleepiness, insomnia
• pain or burning in the hands or wrist (carpal tunnel syndrome)
• sensory disturbances, especially touch
• eye disorders such as blurred vision, eye irritation
• skin disorders such as itching (urticaria)
• vaginal discharge or vaginal dryness
• breast pain
• fever
• thirst, taste disturbances, dry mouth
• inflammation of the mouth and lips
• dryness of mucous membranes
• weight loss
• urinary tract infection, more frequent urination
• cough
• increased enzyme activity
• yellowing of the skin and whites of the eyes
• high bilirubin levels in the blood (a breakdown product of red blood cells).

Frequency not known (frequency cannot be estimated from available data):

• triggering of tendon inflammation – a condition in which a finger or thumb locks in a bent position.

If any of these symptoms occur severely in the patient, inform the doctor.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Letrozole Eugia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister after:
EXP. The expiry date refers to the last day of the stated month.
No special storage conditions apply for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.

6. Contents of the package and other information

What Letrozole Eugia contains

• The active substance is letrozole. Each coated tablet contains 2.5 mg of letrozole.
• The other ingredients are:
  Tablet core: monohydrate lactose, microcrystalline cellulose, sodium carboxymethyl starch (type A), corn starch, anhydrous colloidal silicon dioxide, magnesium stearate.
  Tablet coating: hypromellose 2910, yellow iron oxide (E 172), titanium dioxide (E 171), macrogol 3350, talc.

What Letrozole Eugia looks like and contents of the pack
Coated tablet
Dark yellow, coated, round, slightly biconvex tablet with bevelled edges, imprinted with the code "L2.5" on one side and smooth on the other.
Letrozole Eugia coated tablets are available in blister packs.
Pack sizes:
Blister packs: 30, 60, 100 and 120 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Eugia Pharma (Malta) Ltd.
Vault 14, level 2
Valletta Waterfront
Floriana, FRN1914
Malta
e-mail: [email protected]

Manufacturer/Importer:
APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus 19, Venda Nova
2700-487 Amadora
Portugal
Arrow Génériques
26 Avenue Tony Garnier
69007 Lyon
France

This medicinal product is authorised in the European Economic Area countries under the following names:
France: Letrozole Arrow Lab 2.5 mg, comprimé pelliculé
Spain: Letrozol Aurovitas 2.5 mg comprimidos recubiertos con película EFG
Germany: LetroPUREN 2.5 mg Filmtabletten
Poland: Letrozole Eugia
Portugal: Letrozol Loxoprel
Italy: Letrozolo Aurobindo Italia