Femelix

Package leaflet: Information for the user

FEMELIX 2.5 mg film-coated tablets

letrozole
Equivalent medicine
Please read all of this leaflet carefully before 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 could be harmful.
• If you experience any side effects, including 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 taking 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 FEMELIX is and what it is used for

What FEMELIX is and how it works
FEMELIX 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 often stimulated by estrogens, which are female sex hormones.
FEMELIX reduces the amount of estrogen by blocking an enzyme ("aromatase") involved in estrogen production, and thus can inhibit the growth of estrogen-dependent breast cancer.
As a result, tumor cells slow down their growth or stop growing and/or spreading to other parts of the body.

What FEMELIX is used for
FEMELIX 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 cancer. It may be used as initial treatment before surgery for breast cancer when immediate surgery is not possible, or as initial 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, please consult your doctor.

2. What you need to know before taking FEMELIX

Follow your 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 to any of the other ingredients of this medicine (listed in section 6),
• if you still have menstrual periods, i.e. if you are not yet postmenopausal,
• 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 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 FEMELIX" in section 3).

If any of these conditions apply to you, inform your doctor. Your doctor will take them into account during treatment
with FEMELIX.
Letrozole may cause tendon inflammation or tendon injury (see section 4). If you experience any signs of tendon pain or swelling, rest the affected area and contact your doctor.
Children and adolescents (under 18 years of age)
Children and adolescents must not use this medicine.
Elderly (aged 65 years and over)
Patients aged 65 years and over can use this medicine at the same dose as other adults.
Other medicines and FEMELIX
Inform 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 FEMELIX only after you have entered menopause. However, your doctor should discuss with you the use of an effective contraceptive method, as you may still have the possibility of becoming pregnant during treatment with FEMELIX.
• You must not take FEMELIX during pregnancy or breastfeeding, as it may harm your baby.

Driving and using machines
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 diagnosed you with an intolerance to
certain 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 engaged in sports activities: using the drug without therapeutic need constitutes doping and may
lead to a positive result in anti-doping tests.

3. How to take FEMELIX

Take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The usual dose is one FEMELIX tablet taken once daily. Taking FEMELIX at the same time every day will help you remember when to take the tablet.
The tablet can be taken with or without food and should be swallowed whole with a glass of water or another liquid.

How long to take FEMELIX
Continue taking FEMELIX every day for as long as your doctor has instructed. You may need to take it for months or even years. If you have any questions about how long you should continue taking FEMELIX, speak with 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 whether the treatment is having the desired effect.
FEMELIX may cause thinning or loss of bone mass (osteoporosis) due to reduced estrogen levels in the body. Your doctor may decide to measure your 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 tablet pack.
Medical treatment may be necessary.

If you forget to take FEMELIX

• If it is nearly time for your next dose (e.g., within 2 or 3 hours), skip the missed dose and take the next dose at the usual time.
• Otherwise, take the missed dose as soon as you remember, and then take the next tablet as you normally would.
• Do not take a double dose to make up for a forgotten 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 experiences them.
Most side effects are mild to moderate and usually 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 oestrogen in the 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 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 (symptoms of a brain disorder, e.g. stroke).
• Sudden chest pain with a feeling of tightness (symptom of a heart condition).
• Swelling and redness along a vein that is extremely tender and possibly painful to touch.
• Severe fever, chills, or mouth ulcers due to infections (caused by lack of white blood cells).
• Severe and persistent blurred vision.
• Inflammation of a tendon or tendinitis (connective tissues linking muscles to bones).

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

• Difficulty breathing, chest pain, fainting, rapid heartbeat, bluish skin colour, or sudden pain in the arm, leg, or foot (symptoms of possible blood clot formation).
• Rupture of a tendon (connective tissues linking muscles to bones).

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

• Swelling mainly affecting 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, red skin, blisters on the lips, eyes or in the mouth, skin peeling, fever (signs of skin disorders).

Some side effects are very common (may affect more than 1 in 10 people):

• Hot flushes
• Increased cholesterol levels (hypercholesterolaemia)
• Fatigue
• Increased sweating
• Bone and joint pain (arthralgia). If any of these effects become severe, inform your doctor.

Some side effects are common (may affect up to 1 in 10 people):

• Skin rash
• Headache
• Dizziness
• Malaise (general feeling of being unwell)
• Gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhoea
• Increased or decreased appetite
• Muscle pain
• Thinning or loss of bone mass (osteoporosis), which in some cases may lead to bone fractures (see also "Monitoring during FEMELIX treatment" 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
• Palpitations, rapid heartbeat
• Joint stiffness (arthritis)
• Chest pain

If any of these effects become severe, inform 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, drowsiness, insomnia
• Pain or burning sensation in the hands or wrists (carpal tunnel syndrome)
• Impaired sensation, particularly 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
• Dryness of 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 from available data):

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

If any of these effects become severe, inform your doctor.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.

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 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 stated on the container after "Exp.". The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
If your doctor tells you to stop taking FEMELIX, return any unused tablets to the pharmacist for disposal. Keep the tablets only if your doctor instructs you to do so. Do not dispose of them via wastewater or household waste. This will help protect the environment.

6. Package contents 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): monohydrate lactose, microcrystalline cellulose, maize starch, anhydrous colloidal silica, sodium carboxymethyl starch type A, magnesium stearate; and (tablet coating): polyvinyl alcohol, talc, titanium dioxide (E171), macrogol 3350, quinoline yellow aluminium lake (E104), red iron oxide (E172) and black iron oxide (E172).

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

Marketing Authorization Holder
Elleva Pharma S.r.l., Via S. Francesco 5-7, 80034 Marigliano (Naples), Italy

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