Raziolet

Patient Information Leaflet

RAZIOLET 2.5 mg film-coated tablets

Letrozole
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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, 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, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What RAZIOLET is 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

1. WHAT RAZIOLET IS AND WHAT IT IS USED FOR

What RAZIOLET is and how it works
RAZIOLET contains an active substance called letrozole, which 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 generally stimulated by estrogens, which are female sex hormones. RAZIOLET
reduces the amount of estrogen by blocking the enzyme ("aromatase") involved in estrogen production; therefore,
it can inhibit the growth of breast tumors that require 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 blocked.

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

2. WHAT YOU SHOULD KNOW BEFORE TAKING RAZIOLET

Follow your 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 to any of the other ingredients of this medicine (see 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 or pharmacist before taking RAZIOLET:

• 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 RAZIOLET” 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 RAZIOLET.
For those engaged in sports: using this medicine without a therapeutic need constitutes doping and may lead to a positive anti-doping test.
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)
RAZIOLET must not be used in children and adolescents.
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 RAZIOLET
Tell 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 RAZIOLET 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 RAZIOLET.
• you must not take RAZIOLET if you are pregnant or breastfeeding, as it may be harmful to your 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.
RAZIOLET contains lactose
RAZIOLET contains lactose (a sugar found in milk). If your doctor has diagnosed you with an intolerance to certain sugars, consult him or her before taking this medicine.

3. HOW TO TAKE RAZIOLET

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

The usual dose is one RAZIOLET tablet taken once daily. Taking RAZIOLET at the same time each day will help you remember when to take it.
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 taking RAZIOLET every day for the duration prescribed by your doctor. You may need to take it for months or even years. If you have questions about how long you should take RAZIOLET, speak with your doctor.

Monitoring during treatment with RAZIOLET
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.
RAZIOLET may cause bone fragility or loss of bone mass (osteoporosis) due to reduced estrogen levels in your body. Your doctor may decide to measure your bone density (a way to monitor osteoporosis) before, during, and after treatment.

If you take more RAZIOLET than you should
If you have taken too much RAZIOLET, or if someone accidentally takes 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 RAZIOLET

• If it is almost time for your next dose (for example, within 2 or 3 hours), skip the missed dose and take the next dose at the scheduled 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 stop taking RAZIOLET
Do not stop taking RAZIOLET unless your doctor tells you to. See also the section above “How long to take RAZIOLET”.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most of the side effects are mild to moderate and usually go away after a few days or a few weeks of treatment.
Some of the side effects, such as hot flushes, hair loss or vaginal bleeding, may be related to the lack of oestrogens in your 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 or rare side effects (i.e. may affect between 1 and 100 in 10,000 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 (signs of brain disorders, e.g. stroke)
• sudden chest pain with a feeling of pressure (signs of heart disorders)
• difficulty breathing, chest pain, fainting, rapid heartbeat, bluish skin colouration, or sudden pain in the arm, leg or foot (signs of possible blood clot formation)
• swelling and redness along a vein that is very tender and in some cases painful to the touch
• high fever, chills or mouth ulcers due to infections (due to lack of white blood cells)
• severely and persistently blurred vision

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

• swelling, mainly of the face and throat (signs of allergic reaction)
• yellowing of the skin and eyes, nausea, loss of appetite, dark-coloured 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 10 out of 100 patients.

• hot flushes
• increased cholesterol levels (hypercholesterolaemia)
• fatigue
• increased sweating
• bone and joint pain (arthralgia)

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

Some side effects are common. These side effects may affect between 1 and 10 out of 100 patients.

• 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
• fragility or loss of bone mass (osteoporosis), which in some cases leads to bone fractures (see also “Monitoring during treatment with RAZIOLET” 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

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

Other side effects are uncommon. These side effects may affect between 1 and 10 out of 1,000 patients.

• 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)
• impaired sensitivity, especially to touch
• eye disorders such as blurred vision, eye irritation
• palpitations, rapid heartbeat
• skin disorders such as itching (urticaria)
• vaginal discharge or dryness
• joint stiffness (arthritis)
• 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
• tendon inflammation or tendinitis (connective tissues linking muscles to bones)

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

Other rare side effects

• tendon rupture (connective tissues linking muscles to bones)

Side effects with unknown frequency

• Trigger finger, a condition in which one of the fingers of the hand becomes locked in a bent position.

Reporting of side effects

If you experience any side effect, 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 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 RAZIOLET 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.
• store in the original packaging to protect the medicine from moisture.
• do not use if the packaging is damaged or shows signs of tampering.

6. Package contents and other information

What RAZIOLET contains

• The active substance is letrozole. Each film-coated tablet contains 2.5 mg of letrozole.

• The excipients are:
  Core: monohydrate lactose, microcrystalline cellulose (E460), pregelatinized corn starch, sodium starch glycolate, magnesium stearate (E572), colloidal silicon dioxide (E551)

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

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

Marketing Authorization 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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