Patient Information Leaflet: Information for the User

Blormat 2.5 mg film-coated tablets

letrozole
Equivalent medicine
Please read 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, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, 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, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Blormat is and what it is used for
What you need to know before taking Blormat
How to take Blormat
Possible side effects
How to store Blormat
Contents of the pack and other information

1. What Blormat is and what it is used for

What Blormat is and how it works
Blormat 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. Blormat reduces the amount of estrogen by blocking an enzyme ("aromatase") involved in estrogen production; therefore, it can inhibit the growth of estrogen-dependent breast cancer. As a result, the growth of cancer cells is slowed down or stopped, and/or their spread to other parts of the body is prevented.

What Blormat is used for
Blormat 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 cancer recurrence. 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. Blormat 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 Blormat works or why this medicine has been prescribed for you, please consult your doctor.

2. What you need to know before taking Blormat

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

if you are allergic to letrozole or to any of the other ingredients of this medicine (listed in section 6),
if you still have your menstrual cycle, 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 Blormat:

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

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 (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 Blormat
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 must take Blormat 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 Blormat.
You must not take Blormat 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 operate tools or machinery until you feel well again.
Blormat contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
Blormat contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.
Blormat contains tartrazine
It may cause allergic reactions.
For athletes: using this medicine without a therapeutic need constitutes doping and may lead to a positive anti-doping test.

3. How to take Blormat

Take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is one Blormat tablet to be taken once daily. Take Blormat
at the same time every day, as 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 another drink.

How long to take Blormat
Continue taking Blormat 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 regarding the duration of treatment with Blormat,
talk to your doctor.

Monitoring during treatment with Blormat
You must take this medicine only under close medical supervision. Your doctor will
regularly monitor your health status to ensure the treatment is having the intended effect.
Blormat 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 Blormat than you should
If you have taken too much Blormat, or if someone else has accidentally taken your tablets,
contact your doctor or hospital immediately for advice. Show them the tablet packaging.
Medical treatment may be necessary.

If you forget to take Blormat
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, and then take the next tablet as usual.
Do not take a double dose to make up for a forgotten dose.

If you stop taking Blormat
Do not stop taking Blormat unless instructed by your doctor. See also the section above
titled “How long to take Blormat”.

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 low oestrogen 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:

Uncommon (may affect up to 1 in 100 people):
Weakness, paralysis, or loss of sensation in any part of the body (particularly 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 painful to touch.
High fever, chills, or mouth ulcers due to infections (due to 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 colouration, 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 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 Blormat:
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 1 in 10 people):
Hot flushes
Increased cholesterol levels (hypercholesterolaemia)
Tiredness
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 (usually feeling 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 treatment with Blormat” 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, 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, somnolence, insomnia
Pain or burning sensation in the hands or wrist (carpal tunnel syndrome)
Reduced 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 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 the available data):
Trigger finger, a condition in which one of the fingers of the hand becomes 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 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 Blormat

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.

6. Package contents and other information

What Blormat contains

The active substance is letrozole. Each film-coated tablet contains 2.5 mg of letrozole.
The other ingredients are monohydrate lactose, sodium starch glycolate, microcrystalline cellulose, hypromellose, anhydrous colloidal silica, and magnesium stearate. The coating consists of hypromellose, titanium dioxide, macrogol 6000, yellow iron oxide (E172), red iron oxide (E172), and tartrazine (E102).

Description of the appearance of Blormat and contents of the pack
Blormat is supplied as film-coated tablets. The film-coated tablets are yellow, round, biconvex, smooth on both sides. The approximate length dimensions are: 6.0 ± 0.5 mm.
Each transparent PVC/PVDC/aluminum blister pack contains 30, 60, or 100 tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder
Farma Group S.r.l.
Via Farfisa, 18
60021 Camerano (AN)
Italy

Manufacturers
Galenicum Health S.L.U
Sant Gabriel, 50
Esplugues de Llobregat,
08950 Barcelona
Spain
SAG Manufacturing, S.L.U.
Ctra. N-I, Km 36
28750 San Agustin de Guadalix,
Madrid, Spain

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy: Blormat