FEMELIX 2.5 mg Tabletki powlekane

Treść ulotki

1. FEMELIX 2.5 mg film-coated tablets
   1. What is FEMELIX and what is it for
   2. What you need to know before taking FEMELIX
   3. How to take FEMELIX
   4. Possible side effects
   5. How to store FEMELIX
   6. Contents of the pack and other information

FEMELIX 2.5 mg film-coated tablets

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

1. What is FEMELIX and what is it for

What is FEMELIX and how does it work
FEMELIX contains an active ingredient 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 often stimulated by estrogens, which are female sex hormones. FEMELIX reduces the amount of estrogens by blocking an enzyme
("aromatase") involved in the production of estrogens and can therefore block the growth of breast cancer that needs estrogens to grow. As a result, cancer cells slow down their
growth or stop growing and/or spreading to other parts of the body.

What is FEMELIX used for
FEMELIX 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 cancer from recurring. It can be used as a first-line treatment
before surgery for breast cancer in cases where immediate surgery is not possible, or it can be used as a first-line treatment after surgery
for breast cancer or after five years of treatment with tamoxifen. FEMELIX
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 FEMELIX works or why this medicine has been prescribed for you,
consult your doctor.

2. What you need to know before taking FEMELIX

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

Do not take FEMELIX

• 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 reached 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 FEMELIX

• 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 FEMELIX" in section 3).

If any of these conditions apply to you, tell your doctor. The doctor will take this into account during treatment
with FEMELIX.
Letrozole may cause inflammation of the tendons or tendon injury (see section 4). If you experience
any signs 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 and over)
People aged 65 years and over can use this medicine at the same dose as
other adults.

Other medicines and FEMELIX
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 FEMELIX when you have entered menopause. However, your doctor should discuss the use of effective contraception with you, as you may still have the possibility of becoming pregnant while taking FEMELIX.
• You should not take FEMELIX 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 tools or
machinery until you feel normal again.

FEMELIX contains lactose
FEMELIX contains lactose (a milk sugar). If your doctor has told you that you have an intolerance to
some sugars, contact them before taking this medicine.

FEMELIX contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially "sodium-free".

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

3. How to take FEMELIX

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 FEMELIX tablet to be taken once a day. Taking FEMELIX
at the same time each day 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 another liquid.

How long to take FEMELIX
Continue to take FEMELIX every day for as long as your doctor has told you. It may be
necessary to take it for months or even years. If you have questions about how long to continue to
take FEMELIX, talk to your doctor.

Monitoring during FEMELIX treatment
You must take this medicine only under strict medical supervision. Your doctor will regularly
monitor your condition to check if the treatment is having the desired effect.
FEMELIX may cause thinning or loss of bone mass (osteoporosis) due to the
reduction of estrogen in the body. Your doctor may decide to measure bone density (a way to
monitor osteoporosis) before, during and after treatment.

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

If you forget to take FEMELIX

• If it is close to the time of your next dose (for example within 2 or 3 hours), skip the dose you forgot and take your next dose when it is due.
• 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 stop taking FEMELIX
Do not stop taking FEMELIX unless your doctor tells you to. See also the
previous section "How long to take FEMELIX".

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 generally disappear after
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 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 side effects(may affect up to 1 in 100 people):

• 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 possibly painful when touched.
• Severe fever, chills or mouth ulcers due to infections (lack of white blood cells).
• Blurred vision that is severe and persistent.
• Inflammation of a tendon or tendinitis (connective tissues that connect muscles to bones)

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

• Difficulty breathing, chest pain, dizziness, rapid heart rate, bluish discoloration of the skin or sudden pain in the arm, leg or foot (symptoms of a possible blood clot formation).
• Rupture of a tendon (connective tissues that connect muscles to bones)

If any of the above conditions occur, tell your doctor immediately.
You should also tell your doctor immediately if you experience any of the following symptoms
during treatment with FEMELIX:

• 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 diseases).

Very common side effects(may affect more than 1 in 10 people):

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

Common side effects(may affect up to 1 in 10 people):

• Skin rash
• Headache
• Dizziness
• General feeling of discomfort
• Gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhea
• Increased or decreased appetite
• Muscle pain
• Thinning or loss of bone mass (osteoporosis), which in some cases leads to bone fractures (see also "Monitoring during FEMELIX treatment" in paragraph 3)
• Swelling of arms, hands, feet, ankles (edema)
• Depression
• Weight gain
• Hair loss
• Increased blood pressure (hypertension)
• Abdominal pain
• Dry skin
• Vaginal bleeding
• Palpitations, rapid heart rate
• Joint stiffness (arthritis)
• Chest pain

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

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

• Nervous system disorders such as anxiety, nervousness, irritability, drowsiness, memory problems, sleepiness, 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 discharge or dryness
• Breast pain
• Fever
• Thirst, taste disturbances, dry mouth
• Dry mucous membranes
• Weight loss
• Urinary tract infection, increased frequency of urination
• Cough
• Increased enzyme levels
• Yellowing of the skin and eyes
• Elevated levels of bilirubin in the blood (a breakdown product of red blood cells)

Side effects with unknown frequency(frequency cannot be estimated based on available data)

• Trigger finger, a condition in which a finger or thumb locks in a bent position.

If any of these effects occurs severely, tell your doctor.
If you experience any side effect, including those not listed in this leaflet, tell your
doctor or pharmacist

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at https://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 FEMELIX

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 pack after "Exp.". The expiry
date refers to the last day of that month.
This medicine does not require any special storage conditions.
If your doctor tells you to stop taking FEMELIX, return any unused tablets to the
pharmacist for destruction. Keep the tablets only if your doctor tells you to do so. Do not dispose of
them in wastewater or household waste. This will help protect the environment.

6. Contents of the pack and other information

What FEMELIX contains

• The active substance of FEMELIX is letrozole. Each film-coated tablet contains 2.5 mg of letrozole.
• The excipients are (tablet core): lactose monohydrate, microcrystalline cellulose, corn starch, anhydrous colloidal silica, type A carboxymethyl starch, magnesium stearate and (tablet coating): polyvinyl alcohol, talc, titanium dioxide (E171), macrogol 3350, aluminium quinoline yellow lacquer (E104), iron oxide red (E172) and iron oxide black (E172).

Descriptionof the appearance of FEMELIXand contents of the pack
FEMELIX is available in the form of film-coated tablets. The tablets are round with
a white core and a dark yellow coating with a diameter of 6.0 mm ± 0.2 mm. The packs
contain 30 tablets.
The tablets are packaged in hard aluminium blisters 20 μm + PVDC 20 g/m2 (covering foil) with transparent PVC 200 + PE 25 + PVDC 60 g/m2 (forming foil).

Marketing authorisation holder
Elleva Pharma S.r.l., Via S. Francesco 5-7, 80034 Marigliano (Napoli), Italy

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