Femara

Package leaflet: Information for the user

Femara 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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

1. What Femara is and what it is used for

What Femara is and how it works
Femara contains an active substance called letrozole. It 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 often stimulated by estrogens, which are female sex hormones. Femara reduces the amount of estrogen by blocking an enzyme ("aromatase") involved in estrogen production, and therefore can block the growth of breast tumors that require estrogen to grow. As a result, the growth of cancer cells and/or their spread to other parts of the body is slowed down or stopped.

What Femara is used for
Femara is used to treat 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 may 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 tamoxifen therapy. Femara 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 Femara works or why this medicine has been prescribed for you, please consult your doctor.

2. What you need to know before taking Femara

Follow your doctor's instructions carefully. They may differ from the general information
provided in this leaflet.
Do not take Femara

• 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 Femara

• 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 Femara” in section 3). If any of these conditions apply to you, inform your doctor. This will be taken into consideration by your doctor during treatment with Femara.

Children and adolescents (under 18 years of age)
Children and adolescents must not use this medicine.
Elderly (65 years of age and over)
Women aged 65 years and over can take this medicine at the same dose as adult women.
Other medicines and Femara
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 only take Femara 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 Femara.
• You must not take Femara if you are pregnant or breastfeeding, as it may harm the baby.

Driving and using machines
If you feel dizzy, tired, drowsy, or generally unwell, do not drive or
use machinery until you feel normal again.
Femara contains lactose
Femara contains lactose (milk sugar). If your doctor has diagnosed you with an intolerance to certain
sugars, contact him before taking this medicine.
For those engaged in sports: using this medicine without a therapeutic need constitutes doping and may
lead to a positive anti-doping test.

3. How to take Femara

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The usual dose is one Femara tablet to be taken once daily. Taking Femara at the same time each day will help you remember when to take it.
The tablet should be taken with or without food and must be swallowed whole with a glass of water or another drink.

How long to take Femara
Continue taking Femara every day for the length of time prescribed by your doctor. You may need to take it for months or even years. If you have any questions about how long you should take Femara, speak with your doctor.

Monitoring during treatment with Femara
This medicine must be taken under close medical supervision. Your doctor will regularly monitor your health to ensure the treatment is having the desired effect.
Femara may cause bone fragility 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 of monitoring osteoporosis) before, during, and after treatment.

If you take more Femara than you should
If you have taken too much Femara, or if someone else has accidentally taken 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 Femara

• 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 usual time.
• Otherwise, take the missed dose as soon as you remember, then continue taking your tablets as normal.
• Do not take a double dose to make up for a forgotten tablet.

If you stop taking Femara
Do not stop taking Femara unless your doctor tells you to. See also the section above, “How long to take Femara”.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
Most of the side effects are mild to moderate and usually disappear after a period of treatment ranging 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 low levels 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 (may affect up to 1 in 100 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 (symptoms of a brain disorder, for example 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 (due to lack of white blood cells).
• Severe and persistent blurred vision.

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

• Difficulty breathing, chest pain, fainting, rapid heartbeat, bluish skin colouration, or sudden pain in the arm, leg or foot (symptoms of possible blood clot formation).

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

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

Some side effects are very common (may affect more than 10 in 100 patients):

• 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 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 may lead to bone fractures (see also “Monitoring during treatment with Femara” in section 3)
• Swelling of the arms, hands, feet, ankles (oedema)
• 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 become severe, inform your doctor.

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

• Nervous system disorders such as anxiety, nervousness, irritability, drowsiness, memory problems, somnolence, insomnia
• Pain or burning sensation in the hands or wrists (carpal tunnel syndrome)
• Impaired sensation, especially to 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
• Dryness of mucous membranes
• Weight loss
• Urinary tract infections, increased frequency of urination
• Cough
• Increased levels of liver enzymes
• Yellowing of the skin and eyes
• Elevated blood levels of bilirubin (a breakdown product of red blood cells)

Side effects with unknown frequency (frequency cannot be estimated from the available data):
Trigger finger, a condition in which one of the fingers of the hand remains locked in a bent position.
If any of these effects become severe, inform your doctor.

Reporting of side effects
If you experience any side effects, 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.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 Femara

• Keep out of the reach and sight of children.
• Do not use Femara after the expiry date stated on the carton after "Exp". The expiry date refers to the last day of the month.
• Do not store 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. Package contents and other information

What Femara contains

• The active substance is letrozole. Each film-coated tablet contains 2.5 mg of letrozole.
• The other components are monohydrate lactose, microcrystalline cellulose, maize starch, sodium carboxymethylstarch, magnesium stearate and anhydrous colloidal silica. The coating consists of hypromellose, talc, macrogol 8000, titanium dioxide (E 171) and yellow iron oxide (E 172).

Description of the appearance of Femara and package contents

• Femara is supplied as film-coated tablets. The film-coated tablets are dark yellow in colour and round in shape. They are marked on one side with "FV" and with "CG" on the other side.
• Each blister contains 10, 14, 28, 30 or 100 tablets. Not all pack sizes may be available in your country.

Marketing Authorization Holder and Manufacturer
NOVARTIS FARMA S.P.A
LARGO UMBERTO BOCCIONI, 1
ORIGGIO (VARESE)
Local representative
Novartis Farma S.p.A.
Origgio (VA)
Manufacturer
Novartis Farma S.p.A. – Origgio – VA
This medicinal product is authorized in the European Economic Area Member States under the following names: