LETROZOLO 2.5 mg Фильм-coated таблетки

Содержание инструкции

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

Letrozolo Almus 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 their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What Letrozolo Almus is and what it is used for

What Letrozolo Almus is and how it works
Letrozolo Almus 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.
Letrozole 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 is slowed down or stopped and/or their spread
to other parts of the body.

What Letrozolo Almus is used for
Letrozolo Almus 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 if immediate surgery is not possible or
as a first treatment after breast surgery or after five years of tamoxifen treatment.
Letrozole 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 Almus works or why this medicine has been prescribed for you,
please ask your doctor.

2. What you need to know before taking Letrozolo Almus

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

• if you are allergic to letrozole or any of the other ingredients of this medicine (listed in section 6),
• if you still have your period, i.e. if you have not yet gone through 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 Almus

• 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 Almus” 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 Almus.

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 prescribed for
adult women.

Other medicines and Letrozolo Almus
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 Almus when you have entered menopause. However, your doctor will discuss with you the need to use an effective method of contraception as you may potentially be pregnant during treatment with Letrozolo Almus.
• You should not take Letrozolo Almus if you are pregnant or breastfeeding as it may be harmful to the baby. If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

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

Letrozolo Almus contains lactose
Letrozolo Almus contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact
them before taking this medicine.

For those who practice sports: the use of the drug without therapeutic necessity constitutes doping and may
still result in a positive anti-doping test.

3. How to take Letrozolo Almus

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have doubts
consult your doctor or pharmacist.
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The usual dose is one Letrozolo Almus tablet to be taken once a day. Take Letrozolo Almus
every day at the same time, this 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 of
another beverage.

For how long to take Letrozolo Almus
Continue to take Letrozolo Almus every day for as long as your doctor has told you. You may need to
take it for months or even for years. If you have questions about how long to take Letrozolo Almus, talk
to your doctor.

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

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

If you forget to take Letrozolo Almus

• If it is close to the time to take the 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 a missed dose.

If you stop taking Letrozolo Almus
Do not stop taking Letrozolo Almus unless you have been told to do so by your doctor. See also
above the paragraph “For how long to take Letrozolo Almus”.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

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 after a period of
treatment lasting from a few days to a few weeks.
Some of these side effects such as hot flushes, 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 can be serious:
Uncommon(may affect up to 1 in 100 people):
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• 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 (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(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 Almus:

• 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, peeling skin, fever (signs of skin conditions). Very common side effects(may affect more than 1 in 10):
• Hot flushes
• Increased cholesterol levels (hypercholesterolemia)
• Fatigue
• Increased sweating
• Bone and joint pain (arthralgia) If any of these effects occur severely, tell your doctor. Common side effects(may affect up to 1 in 10):
• Skin rash
• Headache
• Dizziness
• General 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 leads to bone fractures (see also “Monitoring during treatment with Letrozolo Almus” in section 3)
• Swelling of the arms, hands, feet, 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 occur severely, tell your doctor.

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Other side effects are uncommon(may affect up to 1 in 100):

• 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 the 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
• Dry mucous membranes
• Weight loss
• Urinary tract infections, increased frequency of urination
• Cough
• Increased levels of enzymes
• Yellowing of the skin and eyes
• Elevated blood levels of bilirubin (breakdown product of red blood cells)

Side effects with unknown frequency
Trigger finger, a condition in which one of the fingers of the hand remains locked in a bent position.
If any of these effects occur severely, tell your doctor.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-
reazione-avversa. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Letrozolo Almus

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and on the blister after Exp. The expiry
date refers to the last day of the month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater 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 Almus contains

• The active ingredient is letrozole. Each film-coated tablet contains 2.5 mg of letrozole.
• The other ingredients are Tablet core: lactose monohydrate, microcrystalline cellulose, corn starch, sodium starch glycolate (from potato), anhydrous colloidal silica, magnesium stearate Film coating: OPADRY II 85F32444 yellow (polyvinyl alcohol, talc, titanium dioxide (E171), macrogol/PEG 3350, quinoline yellow aluminium lake (E104), iron oxide red (E172), iron oxide black (E172)).

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Description of the appearance of Letrozolo Almus and contents of the pack
Letrozolo Almus is supplied as film-coated tablets. The film-coated tablets are
dark yellow in colour and round, convex in shape. Dimensions: 6.0 ± 0.2 mm.
Each blister contains 30 tablets.

Marketing Authorisation Holder
Almus S.r.l.
Via Cesarea 11/10
16121 Genova

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

This medicinal product is authorised in the Member States of the European Economic Area with the following
denominations:
Member State Name of the medicinal product
Spain Letrozol Almus Pharma 2.5 mg film-coated tablets EFG
France Létrozole Almus 2.5 mg, film-coated tablet
Italy Letrozolo Almus 2.5 mg film-coated tablets
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