Package leaflet: Information for the user

Letrozolo pensa 2.5 mg film-coated tablets

Letrozole
Equivalent medicine
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, because it could be harmful.
If you experience any side effect, including any not listed in this leaflet, talk to your doctor or pharmacist. Contents of this leaflet
1. What Letrozolo pensa 2.5 mg is and what it is used for
2. What you need to know before taking Letrozolo pensa 2.5 mg
3. How to take Letrozolo pensa 2.5 mg
4. Possible side effects
5. How to store Letrozolo pensa 2.5 mg
6. Contents of the pack and other information

1. What is Letrozole pensa 2.5 mg and what is it used for

What is Letrozole pensa 2.5 mg and how does it work
Letrozole pensa 2.5 mg 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. Letrozole pensa reduces the amount of estrogen by blocking an enzyme ("aromatase") involved in estrogen production, and thus may block the growth of breast tumors that require estrogen to grow. As a result, the growth of tumor cells and/or their spread to other parts of the body is slowed down or stopped.

What Letrozole pensa 2.5 mg is used for
Letrozole pensa is used for the treatment of breast cancer in postmenopausal women, that is, 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 treatment with tamoxifen.
Letrozole pensa 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 Letrozole pensa works or why this medicine has been prescribed for you, consult your doctor.

2. What you need to know before taking Letrozolo pensa 2.5 mg

Follow your doctor's instructions carefully. They may differ from the general information
provided in this leaflet.
Do not take Letrozolo pensa 2.5 mg

if you are allergic to Letrozolo pensa or to any of the other ingredients of this medicine (listed in section 6),
if you still have your menstrual cycle, that is, 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 Letrozolo pensa 2.5 mg

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 Letrozolo pensa 2.5 mg” 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 Letrozolo pensa 2.5 mg. 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)
This medicine must not be used by children and adolescents.
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 Letrozolo pensa 2.5 mg
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 Letrozolo pensa only after you have entered menopause. However, your doctor will discuss with you the need to use an effective contraceptive method, as you could potentially become pregnant during treatment with letrozole.
You must not take Letrozolo pensa if you are pregnant or breastfeeding, as it may harm the unborn or breastfed baby.

If you are pregnant or breastfeeding, think you might be pregnant, or are planning a pregnancy, consult your doctor or pharmacist before taking this medicine.
Driving and use of machines
If you feel dizzy, tired, drowsy or generally unwell, do not drive or operate machinery until you feel normal again.
Letrozolo pensa 2.5 mg contains lactose
Letrozolo pensa 2.5 mg contains lactose (milk sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
For those engaged in sports activities: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

3. How to take Letrozole pensa 2.5 mg

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 tablet of Letrozole pensa 2.5 mg taken once daily.
Taking Letrozole pensa 2.5 mg at the same time every day will help you remember when to take your tablet.
The tablet can be taken with or without food and must be swallowed whole with a glass of water or another drink.

How long to take Letrozole pensa 2.5 mg
Continue taking letrozole every day for the duration 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 letrozole, speak with your doctor.

Monitoring during treatment with Letrozole pensa 2.5 mg
You must take this medicine under close supervision of your doctor. Your doctor will regularly monitor your health to ensure the treatment is having the desired effect.
Letrozole pensa 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 to monitor osteoporosis) before, during, and after treatment.

If you take more Letrozole pensa 2.5 mg than you should
If you have taken too much letrozole, 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 Letrozole pensa 2.5 mg

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 at the normal time.
Do not take a double dose to make up for the forgotten dose.

If you stop taking Letrozole pensa 2.5 mg
Do not stop taking Letrozole pensa unless instructed by your doctor.
See also the section above “How long to take Letrozole pensa 2.5 mg”.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences 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 estrogen levels 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:
Rare or uncommon side effects (i.e. may affect between 1 and 100 patients in 10,000):

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).
Difficulty breathing, chest pain, fainting, rapid heartbeat, bluish skin discoloration, or sudden pain in the arm, leg, or foot (symptoms of possible blood clot formation).
Swelling and redness along a vein that is extremely tender and painful to touch.
High fever, chills, or mouth ulcers due to infections (lack of white blood cells).
Severe and persistent blurred vision.
Inflammation of a tendon or tendinitis (connective tissues linking muscles to bones).
Tendon rupture (connective tissues linking muscles to bones).
If any of these effects occur, inform your doctor immediately. You must contact your doctor immediately if you experience any of the following symptoms during treatment with letrozole:
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 lips, eyes or mouth, skin peeling, fever (signs of skin disorders).

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

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

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

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 Letrozolo pensa 2.5 mg” 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 occur severely, inform your doctor.

Uncommon side effects (may affect up to 1 patient in 100):

Nervous system disorders such as anxiety, nervousness, irritability, drowsiness, memory problems, somnolence, insomnia
Impaired sensation, 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
If any of these effects occur severely, inform your doctor.

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 Letrozole Pensa 2.5 mg

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use Letrozole Pensa after the expiry date stated on the blister and carton after EXP. The first two digits indicate the month and the last four digits the year. The expiry date refers to the last day of the month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Letrozolo pensa 2.5 mg contains

The active substance is letrozole. Each film-coated tablet contains 2.5 mg of letrozole.
The other ingredients are monohydrate lactose, microcrystalline cellulose (E460), pregelatinized corn starch, sodium starch glycolate, magnesium stearate (E572), anhydrous colloidal silica (E551). The tablet coating ingredients are macrogol, talc (E553b), hypromellose (E464), titanium dioxide (E171), yellow iron oxide (E172).

Description of the appearance of Letrozolo pensa 2.5 mg and package contents
Letrozolo pensa is yellow, round, film-coated tablets, marked with "L900" on one side and "2.5" on the other.
NL/H/1688/001/DC
Letrozolo pensa is available in blister packs containing 28, 30 or 100 tablets per box.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:
Pensa Pharma S.p.A.
Via Ippolito Rosellini 12
20124 Milano, Italy

This medicinal product is authorized in the European Economic Area (EEA) Member States under the following names:
Netherlands: Letroveres 2.5 mg, filmomhulde tabletten RVG
Italy: Letrozolo pensa 2.5 mg film-coated tablets