Letrozole Doc Generici

PACKAGE LEAFLET: INFORMATION FOR THE USER

LETROZOLE DOC Generics 2.5 mg film-coated tablets

Equivalent medicine
Please read this entire leaflet carefully before taking this medicine, as 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, as it may be harmful
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What LETROZOLO DOC Generici is and what it is used for

What LETROZOLO DOC Generici is and how it works
LETROZOLO DOC Generici 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 DOC Generici 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 LETROZOLO DOC Generici is used for
LETROZOLO DOC Generici 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. LETROZOLO DOC Generici 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 DOC Generici works or why this medicine has been prescribed for you, please consult your doctor.

2. What you should know before taking LETROZOLO DOC Generici

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

• 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 postmenopausal,
• 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 LETROZOLO DOC Generici

• 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 DOC Generici” in section 3). If any of these conditions apply to you, inform your doctor. This will be taken into consideration by your doctor during treatment with LETROZOLO DOC Generici.

Letrozole may cause tendon inflammation 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)
This medicine must not be used in children and adolescents.
Elderly (65 years of age and older)
Women aged 65 years and older can take this medicine at the same dose as adult women.
If you participate in sports: using this medicine without a therapeutic need constitutes doping and
may result in a positive anti-doping test.
Other medicines and LETROZOLO DOC Generici
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
You should take LETROZOLO DOC Generici only after you have entered menopause. However, your doctor will discuss with you the need to use an effective contraceptive method, as you could potentially become pregnant during treatment with LETROZOLO DOC Generici.
You must not take LETROZOLO DOC Generici 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.
LETROZOLO DOC Generici contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
LETROZOLO DOC Generici contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.

3. How to take LETROZOLE DOC Generici

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 DOC Generici to be taken once daily.
Taking LETROZOLE DOC Generici at the same time every 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 DOC Generici
Continue taking LETROZOLE DOC Generici 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 DOC Generici, speak with your doctor.

Monitoring during treatment with LETROZOLE DOC Generici
You must take this medicine under close supervision by your doctor. Your doctor will regularly monitor your health to ensure the treatment is having the desired effect.
LETROZOLE DOC Generici 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 DOC Generici than you should
If you have taken too much LETROZOLE DOC Generici, or if someone else has accidentally taken your tablets, contact your doctor or hospital immediately for advice.
Show them the tablet packaging. Medical treatment may be necessary.

If you forget to take LETROZOLE DOC Generici

• 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 take the next tablet at your usual time;
• do not take a double dose to make up for a forgotten dose.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

If you stop taking LETROZOLE DOC Generici
Do not stop taking LETROZOLE DOC Generici unless instructed to do so by your doctor.
See also the section above titled “How long to take LETROZOLE DOC Generici”.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Most of the side effects are mild to moderate and usually disappear within a few days or 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:

Uncommon side effects (i.e. may affect up to 1 in 100 patients):

• 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, e.g. stroke).
• Sudden chest pain with a feeling of tightness (symptom of a heart condition).
• Swelling and redness of a vein which is extremely tender and painful to the touch.
• High fever, chills or mouth ulcers due to infections (caused by lack of white blood cells).
• Severe and persistent blurred vision.

Rare side effects (may affect up to 1 in 1,000 patients):

• Difficulty breathing, chest pain, fainting, rapid heartbeat, bluish skin colour, or sudden pain in the arm, leg or foot (symptoms of possible blood clot formation).

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 LETROZOLO DOC Generici:

• 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 patients.

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

Some side effects are common. These side effects may affect up to 1 in 10 patients.

• Skin rash
• Headache
• Dizziness
• Palpitations, tachycardia
• 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 DOC Generici” in section 3)
• Joint stiffness (arthritis)
• Swelling of the arms, hands, feet, ankles (oedema)
• Depression
• Chest pain
• Weight gain
• Hair loss
• Increased blood pressure (hypertension)
• Abdominal pain
• Dry skin
• Vaginal bleeding
  If any of these effects become severe, inform your doctor.

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

• Disorders of the nervous system 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 discharge or dryness
• 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)
• Inflammation of a tendon or tendinitis (connective tissues linking muscles to bones)

Other side effects are rare (may affect up to 1 in 1,000 patients)

• Rupture of a tendon (connective tissues linking muscles to bones)

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

• Trigger finger, a condition in which your finger or thumb remains bent.

If any of these effects become severe, inform your doctor.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine. Error. Bookmark not defined.

5. How to store LETROZOLE DOC Generics

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use LETROZOLE DOC Generics after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of the month indicated.
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 DOC Generici contains

• The active substance is letrozole. Each film-coated tablet contains 2.5 mg of letrozole.
• The other components are: Tablet core: monohydrate lactose, maize starch, sodium starch glycolate type A, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate. Coating: polyvinyl alcohol, talc, macrogol 3350, titanium dioxide (E171), and yellow iron oxide (E172).

Description of the appearance of LETROZOLO DOC Generici and package contents:
LETROZOLO DOC Generici 2.5 mg tablets are yellow, round, biconvex, film-coated.
Pack sizes:
Blister pack: 30 film-coated tablets
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
DOC Generici S.r.l. – Via Turati 40 – 20121 Milan, Italy

Responsible manufacturers for batch release
S.C. SINDAN-PHARMA S.R.L.
11th Ion Mihalache Blvd.
011171 - Bucharest 1
Romania

DOPPEL FARMACEUTICI S.r.l.
Via Martiri delle Foibe, 1
29016 Cortemaggiore (PC)
Italy

This leaflet was last updated on