RAZIOLET 2.5 mg Tabletki powlekane

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1. RAZIOLET 2.5 mg film-coated tablets
   1. WHAT IS RAZIOLET AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE TAKING RAZIOLET
   3. HOW TO TAKE RAZIOLET
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE RAZIOLET
   6. Contents of the pack and other information

RAZIOLET 2.5 mg film-coated tablets

Letrozole
Read this leaflet carefully before you start to use the 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 their symptoms are the same as yours because it could 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 RAZIOLETis and what it is used for
• 2. What you need to know before you use RAZIOLET
• 3. How to take RAZIOLET
• 4. Possible side effects
• 5. How to store RAZIOLET
• 6. Contents of the pack and other information

1. WHAT IS RAZIOLET AND WHAT IT IS USED FOR

What is RAZIOLET and how does it work
RAZIOLET contains an active substance called letrozole, which 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 generally stimulated by estrogens, which are female sex hormones. RAZIOLET
reduces the amount of estrogens by blocking the enzyme (“aromatase”) involved in the production of estrogens and therefore
can block the growth of breast tumors that need estrogens to grow. As a consequence, it is
slowed down or blocked the growth of tumor cells and/or their migration to other parts of the body.

What is RAZIOLET used for
RAZIOLET is used for the treatment of breast cancer in postmenopausal women, i.e., those who no longer
have menstrual periods.
It is used to prevent the recurrence of breast cancer. It can be used as a first
treatment before breast surgery in cases where immediate surgery is not possible or as a
first treatment after breast surgery or after five years of tamoxifen treatment.
RAZIOLET is also used to prevent the migration of breast cancer to other parts of the body in
patients with advanced stage breast cancer..
If you have any questions about how RAZIOLET works or why this medicine has been prescribed for you, please ask your
doctor.

2. WHAT YOU NEED TO KNOW BEFORE TAKING RAZIOLET

Follow the doctor's instructions carefully. They may differ from the general information contained in
this leaflet.

Do not take RAZIOLET:

• if you are allergic to letrozole or any of its excipients. (see section 6),
• if you still have your menstrual cycle, i.e. if you have not yet entered 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 RAZIOLET

• 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 RAZIOLET” in section 3).

If any of these conditions apply to you, inform your doctor.This will be taken into consideration by the doctor during
treatment with RAZIOLET.
For athletes: the use of the drug without a therapeutic need constitutes doping and may still result in positive anti-doping tests.
Letrozole can cause tendon inflammation 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 take this medicine.

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

Other medicines and RAZIOLET
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 must only take RAZIOLET when you have entered menopause. However, your doctor will discuss with you the need to use an effective contraceptive method as you may still potentially initiate a pregnancy during treatment with RAZIOLET.
• you must not take RAZIOLET if you are pregnant or breastfeeding as it may be harmful to your baby.

Driving and operating machinery
If you experience dizziness, fatigue, drowsiness or general malaise, do not drive or operate machinery
until you feel normal again.

RAZIOLET contains lactose
RAZIOLET contains lactose (sugar contained in milk). If your doctor has diagnosed you with an intolerance to
certain sugars, contact them before taking this medicine.

3. HOW TO TAKE RAZIOLET

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your
doctor or pharmacist.
The usual dose is one RAZIOLET tablet to be taken once a day. Taking RAZIOLET every day at the same time will
help you remember when to take the tablet.
The tablet can be taken with or without food and must be swallowed whole with a glass of water or other
liquid.

How long to take RAZIOLET
Continue to take RAZIOLET 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 RAZIOLET, talk to your doctor.

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

If you take more RAZIOLET than you should
If you have taken too much RAZIOLET, or if someone takes your tablets by mistake, contact your
doctor or hospital immediately for advice. Show them the tablet pack. Medical treatment may be necessary.

If you forget to take RAZIOLET

• 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 the next dose when you are supposed to take it.
• otherwise take the dose as soon as you remember and then take the next tablet as you would normally.
• Do not take a double dose to make up for forgotten doses.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most side effects are mild to moderate and will usually disappear after a few days
or a few weeks of treatment.
Some side effects, such as hot flushes, hair loss or vaginal bleeding, may
be related to the lack of estrogen in your body.
Do not be worried by this list of possible side effects. You may not experience any of them.

Some side effects can be serious:
Rare or uncommon side effects(i.e. they may affect between 1 and 100 patients in 10,000):

• 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 (signs of brain disorders, e.g. stroke)
• sudden chest pain with a feeling of oppression (signs of heart disorders)
• difficulty breathing, chest pain, fainting, rapid heartbeat, bluish discoloration of the skin, or sudden pain in the arm, leg or foot (signs of a possible blood clot)
• swelling and redness along a vein that is very sensitive and in some cases painful to the touch
• high fever, chills or mouth ulcers due to infections (lack of white blood cells)
• severe and persistent blurred vision If any of these effects occur, see your doctor immediately.You should immediately inform your doctor if you experience any of the following symptoms during treatment with RAZIOLET :
• swelling mainly of the face and throat (signs of allergic reactions).
• 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, peeling skin, fever (signs of skin conditions).

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

• 100.
• hot flushes
• increased cholesterol levels (hypercholesterolemia)
• fatigue
• increased sweating
• bone and joint pain (arthralgia) If any of these effects occur severely, see your doctor

Some side effects are common.These side effects may affect between 1 and 10 patients in every 100

• skin rash
• headache
• dizziness
• general feeling of unwellness (usually feeling unwell)
• gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhea
• increase or loss of appetite
• muscle pain
• fragility or loss of bone mass (osteoporosis), which in some cases leads to bone fractures (see also “Monitoring during treatment with RAZIOLET ” in paragraph 3)
• swelling of the arms, hands, feet, ankles (edema) depression
• weight gain
• hair loss
• increased blood pressure (hypertension)
• abdominal pain
• dry skin
• vaginal bleeding

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

Other side effects are uncommon.These side effects may affect between 1 and 10 patients in every 1000

• 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 sensation, especially to touch
• eye disorders such as blurred vision, eye irritation
• palpitations, fast heartbeat
• skin disorders such as itching (urticaria)
• vaginal discharge or dryness
• joint stiffness (arthritis)
• breast pain
• fever
• thirst, taste disturbances, dry mouth
• dry mucous membranes
• weight loss
• urinary tract infections, increased frequency of urination
• cough
• increased levels of liver enzymes
• inflammation of a tendon or tendinitis (connective tissues that connect muscles to bones) If any of these effects occur severely, inform your doctor.

Other rare side effects

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

Side effects with frequency not known

• Trigger finger, a condition in which one of the fingers of the hand remains locked in a bent position. Reporting of side effectsIf you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. 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.

5. HOW TO STORE RAZIOLET

Keep this medicine out of the reach and sight of children.
Do not use RAZIOLETafter the expiry date stated on the packaging after EXP. The expiry date refers to the last day of that month.

• do not store at a temperature above 30°C.
• store in the original packaging to protect the medicine from moisture.
• do not use a package that is damaged or shows signs of tampering.

6. Contents of the pack and other information

What RAZIOLET contains

• The active ingredient is letrozole. Each film-coated tablet contains 2.5 mg of letrozole
• The excipientsare: Core:lactose monohydrate, microcrystalline cellulose (E460), pregelatinized starch, sodium glycolate starch, magnesium stearate (E572), colloidal silicon dioxide (E551)

Film Coating: macrogol (PEG 8000), hypromellose (E464), talc (E553b), titanium dioxide (E171), yellow iron oxide (E172).

Description of the appearance of RAZIOLET and contents of the pack
RAZIOLET is a film-coated tablet of yellow color.
RAZIOLET is available in blisters of: 10, 28, 30, 50, 60, 84, 90, 98 or 100 tablets per box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Elleva Pharma S.r.l., Via San Francesco n. 5/7, 80034 Marigliano (NA)

Manufacturer
Genetic S.p.A. – Contrada Canfora – 84084 Fisciano (SA) - Italy

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