LETROZOLO 2.5 mg Film-coated tablets

Зміст інструкції

1. LETROZOLO DOC Generici 2,5 mg film-coated tablets
   1. What LETROZOLO DOC Generici is and what it is used for
   2. What you need to know before taking LETROZOLO DOC Generici
   3. How to take LETROZOLO DOC Generici
   4. Possible side effects
   5. How to store LETROZOLO DOC Generici
   6. Contents of the pack and other information

LETROZOLO DOC Generici 2,5 mg film-coated tablets

Generic medicine

Read this leaflet carefully before you start 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What LETROZOLO DOC Generici is and what it is used for
• 2. What you need to know before you take LETROZOLO DOC Generici
• 3. How to take LETROZOLO DOC Generici
• 4. Possible side effects
• 5. How to store LETROZOLO DOC Generici
• 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 called aromatase inhibitors. It is a hormonal (or “endocrine”)
treatment for breast cancer. The growth of breast cancer is frequently stimulated
by estrogens, which are female sex hormones. LETROZOLO DOC Generici reduces the amount
of estrogens by blocking an enzyme (“aromatase”) that is involved in the production of
estrogens and therefore can block the growth of breast tumors that need estrogens to
grow. As a consequence, the growth of tumor 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 women in
menopause, i.e., who no longer have menstrual cycles.
It is used to prevent the recurrence of breast cancer. It can be used as a
first-line treatment before breast surgery in cases where immediate surgery
is not possible or as a first-line treatment after breast surgery or after five years of tamoxifen treatment. LETROZOLO DOC Generici is also used to prevent the
spread of breast cancer to other parts of the body in patients with advanced breast
cancer.
If you have any questions about how LETROZOLO DOC Generici works or why this medicine has been
prescribed to you, please ask your doctor.

2. What you need to know before taking LETROZOLO DOC Generici

Follow the 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 any of the other ingredients of this medicine (listed in section 6),
• if you still have your menstrual cycle, i.e. 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 tell your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking LETROZOLO DOC Generici

• if you have a severe kidney disease
• if you have a severe liver disease
• if you have a history of osteoporosis or bone fractures (see also “Monitoring treatment with LETROZOLO DOC Generici“ in section 3) If any of these conditions apply to you, tell your doctor. This will be taken into consideration by the doctor during treatment with LETROZOLO DOC Generici.

Letrozole may cause inflammation of the tendons or tendon injury (see section 4). At the
first sign of tendon pain or swelling, rest the painful area and contact your doctor.

Children and adolescents (under 18 years of age)
Children and adolescents should not use this medicine.

Elderly (65 years of age or older)
Women aged 65 years or older can use this medicine at the same dose as
for adult women.

If you participate in sports: the use of the medicine without a therapeutic need constitutes doping and

may still result in a positive doping test.

Other medicines and LETROZOLO DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those available without a prescription.

Pregnancy, breastfeeding and fertility
You should only take LETROZOLO DOC Generici when you have entered menopause. However, the
doctor will discuss with you the need to use an effective method of contraception as you could
potentially be pregnant during treatment with LETROZOLO DOC Generici.
You must not take LETROZOLO DOC Generici if you are pregnant or breastfeeding because
it may be harmful to the baby.

Driving and using machines
If you feel dizzy, tired, sleepy or unwell, do not drive or
operate machinery until you feel normal again.

LETROZOLO DOC Generici contains lactose
If your doctor has told you that you have an intolerance to some sugars, contact them 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 LETROZOLO DOC Generici

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have doubts, consult your doctor or pharmacist.
The recommended dose is one LETROZOLO DOC Generici tablet to be taken once a
day. Taking LETROZOLO DOC Generici every day at the same time will help you remember
when to take the tablet.
The tablet should be taken with or without food and should be swallowed whole with a glass
of water or another beverage.

How long to take LETROZOLO DOC Generici
Continue to take LETROZOLO DOC Generici every day for the duration that your doctor has
told you. You may need to take it for months or even years. If you have questions about how long
to take LETROZOLO DOC Generici, talk to your doctor.

Monitoring during treatment with LETROZOLO DOC Generici
You must take this medicine under close medical supervision. The doctor will check
your health status regularly to verify that the treatment has the desired effect.
LETROZOLO DOC Generici may cause fragility or loss of bone mass (osteoporosis) due to the
decrease of estrogens in the body. The doctor may decide to perform a bone density measurement (a way to check for osteoporosis) before, during and after treatment.

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

If you forget to take LETROZOLO DOC Generici

• if it is close to the time to take your next dose (for example within 2 or 3 hours), skip the dose you forgot and take your next dose when it is scheduled
• otherwise, take the dose as soon as you remember and then take your next tablet as you would normally
• do not take a double dose to make up for a missed dose.

If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

If you stop taking LETROZOLO DOC Generici
Do not stop taking LETROZOLO DOC Generici unless you are told to do so by
your doctor.
See also above the paragraph “How long to take LETROZOLO DOC Generici“.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Most side effects are mild to moderate and usually disappear within a treatment period of a few days to a few weeks.
Some of these side effects, such as hot flashes, hair loss, or vaginal bleeding, may be caused by a lack of estrogen in the body.
Do not be concerned by this list of possible side effects. You may not experience any of them.

Some side effects may be serious:
Uncommon effects(i.e. may affect up to 1 in 100 people):

• Weakness, paralysis, or loss of sensation in any other part of the body (especially arm or leg), loss of coordination, nausea, or difficulty speaking or breathing (symptom of a brain condition, such as stroke).
• Sudden chest pain with a feeling of tightness (symptom of a heart condition).
• Swelling and redness along a vein that is extremely sensitive and also painful to the touch.
• High fever, chills, or mouth ulcers caused by infections (lack of white blood cells).
• Severe and persistent blurred vision.

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

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

If any of these effects occur, tell your doctor immediately.
You should tell 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, reddened skin, blisters on the lips, eyes, or mouth, skin peeling, fever (signs of skin conditions).

Some side effects are very common.These side effects may affect more than 1 in 10 patients.

• Hot flashes
• Increased cholesterol levels (hypercholesterolemia)
• Fatigue
• Increased sweating
• Bone and joint pain (arthralgia) If any of these effects occur severely, tell your doctor.

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

• Skin rash
• Headache
• Dizziness
• Palpitations, tachycardia
• General feeling of discomfort (usually feeling unwell)
• 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 leads 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 (edema)
• Depression
• Chest pain
• Weight gain
• Hair loss
• Increased blood pressure (hypertension)
• Abdominal pain
• Dry skin
• Vaginal bleeding If any of these effects occur severely, tell your doctor.

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

• Nervous system disorders such as anxiety, nervousness, irritability, drowsiness, memory problems, insomnia
• Pain or burning sensation in the hands or wrist (carpal tunnel syndrome)
• Impaired sensitivity, 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 the mucous membranes
• Weight loss
• Urinary tract infections, increased frequency of urination
• Cough
• Increased levels of liver enzymes
• Jaundice (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 that connect muscles to bones).

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

• Rupture of a tendon (connective tissues that connect muscles to bones).

Side effects with unknown frequency(frequency cannot be estimated on the basis of available data)

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

If any of these effects occur severely, tell your doctor.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please tell your doctor. You can also report side effects directly through 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. The bookmark is not defined.

5. How to store LETROZOLO DOC Generici

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use LETROZOLO DOC Generici after the expiry date which is stated on the pack after
“EXP”. The expiry date refers to the last day of the month indicated.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What LETROZOLO DOC Generici contains

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

Description of the appearance of LETROZOLO DOC Generici and contents of the pack:
LETROZOLO DOC Generici 2.5 mg tablets are yellow, round, lenticular, film-coated.
film.

Packs:
Blisters: 30 film-coated tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
DOC Generici S.r.l. – Via Turati 40 – 20121 Milan
Manufacturers responsible 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

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