Letrozole Aurobindo Italia

Package leaflet: Information for the user

Letrozole Aurobindo Italia 2.5 mg film-coated tablets

Generic medicine
Please read 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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet

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

1. What is Letrozole Aurobindo Italia and what is it used for

What is Letrozole Aurobindo Italia and how does it work
Letrozole Aurobindo Italia 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 Aurobindo Italia reduces the amount of estrogen by blocking an enzyme ("aromatase") involved in estrogen production, and therefore can block the growth of breast tumors that require estrogen to grow.
As a result, the growth of tumor cells and/or their spread to other parts of the body is slowed down or stopped.
What Letrozole Aurobindo Italia is used for
Letrozole Aurobindo Italia is used for the treatment of breast cancer in postmenopausal women, i.e. 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 Aurobindo Italia 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 Aurobindo Italia works or why this medicine has been prescribed for you, please consult your doctor.

2. What you need to know before taking Letrozole Aurobindo Italia

Follow your doctor's instructions carefully. They may differ from the general information
provided in this leaflet.
Do not take Letrozole Aurobindo Italia
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, that is, if you have not yet reached menopause,
if you are pregnant,
if you are breastfeeding.
If any of these conditions apply to you, do not take this medicine and inform your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking Letrozole Aurobindo Italia
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 Aurobindo Italia” in section 3).
Letrozole may cause tendon inflammation or injury (see section 4). If you experience signs of tendon pain or
swelling, rest the affected area and contact your doctor.
If any of these conditions apply to you, inform your doctor. This will be taken into consideration by your doctor
during treatment with Letrozole Aurobindo Italia.
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 use this medicine at the same dose as adult women.
Other medicines and Letrozole Aurobindo Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines, including those not requiring a prescription.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding,
consult your doctor or pharmacist before taking this medicine.
You must only take Letrozole Aurobindo Italia 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 Aurobindo Italia.
You must not take Letrozole Aurobindo Italia 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 Aurobindo Italia contains lactose (milk sugar). If your doctor has diagnosed you with an
intolerance to certain sugars, contact them before taking this medicine.
Letrozole Aurobindo Italia contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially ‘sodium-free’.
For those engaged in sports activities: using this medicine without therapeutic need constitutes doping and
may lead to a positive anti-doping test.

3. How to take Letrozole Aurobindo Italia

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 tablet of Letrozole Aurobindo Italia to be taken once daily.
Taking Letrozole Aurobindo Italia 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 drink.

How long to take Letrozole Aurobindo Italia
Continue taking Letrozole Aurobindo Italia 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 Letrozole
Aurobindo Italia, speak with your doctor.

Monitoring during treatment with Letrozole Aurobindo Italia
You must take this medicine under close supervision of your doctor. Your doctor will regularly monitor your
health to ensure the treatment is having the desired effect.
Letrozole Aurobindo Italia 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 Aurobindo Italia than you should
If you have taken too much Letrozole Aurobindo Italia, 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 Letrozole Aurobindo Italia
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, and then take the next tablet as usual.
Do not take a double dose to make up for a forgotten dose.

If you stop taking Letrozole Aurobindo Italia
Do not stop taking Letrozole Aurobindo Italia unless your doctor tells you to.
See also the section above, “How long to take Letrozole Aurobindo Italia”.
If you have any further questions about the use of 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:

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 (symptoms of a brain disorder, e.g. stroke).
Sudden chest pain with a feeling of tightness (symptom of a heart condition).
Swelling and redness along a vein which is extremely tender and also painful to touch.
High fever, chills or mouth ulcers due to infections (lack of white blood cells).
Severe and persistent blurred vision.
Inflammation of tendons or tendinitis (connective tissues linking muscles to bones).

Rare (may affect up to 1 in 1,000 people):
Difficulty breathing, chest pain, fainting, rapid heartbeat, bluish skin discolouration, or sudden pain in the arm, leg or foot (symptoms of possible blood clot formation).
Rupture of a tendon (connective tissues linking muscles to bones).

If you experience any of these effects, inform your doctor immediately.

You must contact your doctor immediately if any of the following symptoms occur during treatment with Letrozole Aurobindo Italia:
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.
Pain in bones and joints (arthralgia).
If any of these effects become severe, 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.
Reduced bone strength or loss of bone mass (osteoporosis), which in some cases may lead to bone fractures (see also “Monitoring during treatment with Letrozole Aurobindo Italia” 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 become severe, inform your doctor.

Other uncommon side effects (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).
Reduced 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 remains locked in a bent position.
If any of these effects become severe, 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Letrozole Aurobindo Italia

Keep out of the sight and reach of children.
Do not use Letrozole Aurobindo Italia after the expiry date which is stated on the carton or blister after
Exp. The expiry date refers to the last day of the month.
This medicinal product requires no special storage conditions.
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 Letrozolo Aurobindo Italia contains
The active substance is letrozole.
Each film-coated tablet contains 2.5 mg of letrozole.
The other components are:
Tablet core: monohydrate lactose, microcrystalline cellulose, sodium starch glycolate (type A), maize starch, anhydrous colloidal silicon dioxide, magnesium stearate.
Tablet coating: hypromellose 2910, iron oxide yellow (E 172), titanium dioxide (E 171), macrogol 3350, talc.

Description of the appearance of Letrozolo Aurobindo Italia and package contents
Film-coated tablet.
Film-coated tablet, dark yellow, round, slightly biconvex with bevelled edges, imprinted with 'L2.5' on one side and smooth on the other side.
Letrozolo Aurobindo Italia film-coated tablets are available in blister packs.
Pack sizes:
Blister packs: 30, 60, 100 and 120 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Eugia Pharma (Malta) Limited
Vault 14, Level 2, Valletta Waterfront,
Floriana FRN 1914, Malta

Manufacturers
APL Swift Services (Malta) Limited
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 Generiques S.A.S.
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
Germany: LetroPUREN 2.5 mg Filmtabletten
Italy: Letrozolo Aurobindo Italia
Poland: Letrozole Aurovitas
Portugal: Loxoprel
Spain: Letrozol Aurovitas 2.5 mg comprimidos recubiertos con película EFG