Letrix

PACKAGE LEAFLET: INFORMATION FOR THE USER

LETRIX 2.5 mg film-coated tablets

Letrozole
Equivalent 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, pharmacist, or nurse.
• 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 may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. WHAT LETRIX IS AND WHAT IT IS USED FOR

What LETRIX is and how it works
LETRIX contains a 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. LETRIX 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 cancer cells and/or their spread to other parts of the body is slowed down or stopped.

What LETRIX is used for
LETRIX 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.
LETRIX 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 LETRIX works or why this medicine has been prescribed for you, please consult your doctor.

2. WHAT YOU NEED TO KNOW BEFORE TAKING LETRIX

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

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6),
• if you still have menstrual periods, i.e. 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, pharmacist or nurse before taking LETRIX

• 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 LETRIX treatment” 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 LETRIX.

Letrozole may cause inflammation of the tendons or tendon injury (see section 4). At the first sign of tendon pain or swelling, 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 (aged 65 years and over)
Women aged 65 years and over can take this medicine at the same dose as adult women.
Other medicines and LETRIX
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding and fertility

• You should take LETRIX 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 become pregnant during treatment with LETRIX.
• You must not take LETRIX if you are pregnant or breastfeeding, as it may harm the baby.

Driving and use of machines
If you feel dizzy, tired, drowsy or generally unwell, do not drive or operate machinery until you feel normal again.
LETRIX contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.
For those engaged in sports: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

3. HOW TO TAKE LETRIX

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 LETRIX tablet taken once daily. Taking LETRIX 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 LETRIX
Continue taking LETRIX every day for as long as your doctor has instructed. You may need to take it for months or even years. If you have any questions about how long you should take LETRIX, speak with your doctor.

Monitoring during treatment with LETRIX
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.
LETRIX 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 LETRIX than you should
If you have taken too much LETRIX, 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 LETRIX

• If it is almost time for your next dose (e.g., 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 take the next tablet at your usual time.
• Do not take a double dose to make up for a forgotten tablet.

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

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Most of the adverse reactions are mild to moderate and usually disappear after a period of treatment ranging from a few days to a few weeks.
Some of these adverse reactions, such as hot flushes, hair loss, or vaginal bleeding, may be caused by the lack of estrogen in the body.
Do not be alarmed by this list of possible adverse reactions. You may not experience any of them.

Some adverse reactions can be serious:

Uncommon side 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.
• Sudden chest pain with a feeling of tightness (symptom of a heart condition).
• Swelling and redness along a vein that is extremely tender and painful to touch.
• High fever, chills, or mouth ulcers due to infections (caused by low white blood cell counts).
• Severe and persistent blurred vision.
• Inflammation of a tendon or tendinitis (connective tissues linking muscles to bones).

Rare side effects (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 of possible blood clot formation).
• Tendon rupture (connective tissues linking muscles to bones).
• Difficulty speaking or breathing (symptom of a brain disorder, such as stroke).

If any of these effects occur, inform your doctor immediately.
You must contact your doctor immediately if you experience any of the following symptoms during treatment with LETRIX:

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

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

• Hot flushes
• Increased cholesterol levels (hypercholesterolemia)
• Fatigue
• Increased sweating
• Bone and joint pain (arthralgia)
  If any of these effects become severe, inform your doctor.

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

• Skin rash
• Headache
• Dizziness
• Malaise (usually a feeling of discomfort)
• Gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhea
• 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 LETRIX” in section 3)
• Swelling of the arms, hands, feet, or ankles (edema)
• 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 adverse reactions are uncommon (may affect up to 1 in 100 people):

• Nervous system disorders such as anxiety, nervousness, irritability, drowsiness, somnolence, memory problems, insomnia
• Pain or burning sensation in the hands or wrist (carpal tunnel syndrome)
• Impaired sensation, especially touch
• Eye disorders such as blurred vision, eye irritation
• Skin changes 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 liver enzyme levels
• Yellowing of the skin and eyes
• Elevated blood levels of bilirubin (a breakdown product of red blood cells).

Adverse reactions 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 become severe, inform your doctor.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE LETRIX

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
Do not store above 30°C.
Keep in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What LETRIX 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, maize starch, anhydrous colloidal silica, sodium starch glycolate (type A), magnesium stearate; and (film coating): polyvinyl alcohol, talc, titanium dioxide (E171), macrogol 3350, quinoline yellow aluminum lake, red iron oxide (E172) and black iron oxide (E172).

Description of the appearance of LETRIX and contents of the pack
LETRIX is available as film-coated tablets. The tablets are round with a white core and a dark yellow coating.
Each pack contains 30 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Sophos Biotech S.r.l.
Via Modica 6
20143 Milano, Italy

Manufacturer
Tecnimede – Sociedade Técnico Medicinal, S.A.
Quinta da Cerca, Caixaria, 2565-187 Dois Portos, Portugal

This medicinal product is authorized in the European Economic Area member states under the following names:
Italy: LETRIX 2.5 mg film-coated tablets

This leaflet was last updated on