Brestoral

PACKAGE LEAFLET: INFORMATION FOR THE USER

Brestoral 2.5 mg film-coated tablets

letrozole
Generic 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 others, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Brestoral is and what it is used for

What Brestoral is and how it works
Brestoral contains an active substance called letrozole, which belongs to a group of medicines known as aromatase inhibitors. It is a hormonal (or "endocrine") treatment for breast cancer.
The growth of breast tumours is often stimulated by oestrogens, which are female sex hormones. Brestoral reduces the amount of oestrogens by blocking an enzyme ("aromatase") involved in oestrogen production, and therefore can block the growth of breast tumours that require oestrogens 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 Brestoral is used for
Brestoral is used for the treatment of breast cancer in postmenopausal women, that is, women who have stopped having menstrual periods.
It is used to prevent cancer recurrence. 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. Brestoral is also used to prevent the spread of cancer to other parts of the body in patients with advanced-stage breast cancer.
If you have any questions about how Brestoral works or why this medicine has been prescribed for you, ask your doctor.

2. What you should know before taking Brestoral

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

• if you are allergic to letrozole or to any of the other ingredients of this medicine (listed in section 6),
• if you are still having menstrual periods, i.e. if you have not yet reached menopause,
• if you are pregnant,
• if you are breastfeeding. If you are in any of these conditions, do not take this medicine and speak with your doctor. Warnings and precautions Talk to your doctor or pharmacist before taking Brestoral:
• if you have severe kidney disease,
• if you have severe liver disease,
• if you have or have had osteoporosis or bone fractures (see also “Follow-up during treatment with Brestoral” in section 3). If you are in any of these conditions, inform your doctor. Your doctor must take this into account during treatment with Brestoral.

For those engaged in sports: using this medicine without a therapeutic need constitutes doping and
may lead to a positive result in anti-doping tests.
Children and adolescents (under 18 years of age)
Children and adolescents must not take this medicine.
Elderly people (over 65 years of age)
People over 65 years of age can use this medicine at the same dosage prescribed
for adults.
Other medicines and Brestoral
Tell 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 Brestoral only after you have entered menopause. However, your doctor should discuss with you the use of an effective contraceptive method, as you could potentially become pregnant during treatment with Brestoral.
• You must not take Brestoral if you are pregnant or breastfeeding, as it could harm your baby.

Driving and using machines
If you experience dizziness, fatigue, drowsiness or general malaise, do not drive or operate
machinery until you feel well again.
Brestoral contains lactose
Brestoral contains lactose (milk sugar). If your doctor has informed you that you have an
intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Brestoral

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 Brestoral tablet taken once daily. Taking Brestoral at the same time each day will help you remember when to take your tablets.
The tablet can be taken with or without food and must be swallowed whole with a glass of water or other liquid.

How long to take Brestoral
Continue taking Brestoral every day for as long as your doctor advises. You may need to take it for months or even years. If you have any doubts about how long to continue Brestoral treatment, speak with your doctor.

Monitoring during treatment with Brestoral
You must take this medicine under close medical supervision. Your doctor will regularly check your health to ensure the treatment is having the intended effect.
Brestoral 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 Brestoral than you should
If you have taken an excessive dose of Brestoral, or if someone else accidentally ingests your tablets, contact your doctor or go to the hospital immediately. Show them the tablet packaging. Medical treatment may be necessary.

If you forget to take Brestoral

• If it is almost time for your next dose (e.g., within the next 2 or 3 hours), skip the missed dose and take the next dose at your usual time.
• Otherwise, take the missed dose as soon as you remember, then take the next dose at the regular time.
• Do not take a double dose to make up for the missed one.

If you stop taking Brestoral
Do not stop treatment with Brestoral unless your doctor tells you to. See also the previous section “How long to take Brestoral”.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
Most side effects are mild or 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 due to reduced oestrogen levels in your body.
Do not be alarmed by this list of possible side effects. You may not experience any of them.

Some side effects could be serious:
Rare or uncommon side effects (i.e. may affect from 1 to 100 in every 10,000 patients):

• Weakness, paralysis or loss of sensation in any part of the body (particularly arms or legs), loss of coordination, nausea, or difficulty speaking or breathing (signs of a brain problem, for example due to a stroke)
• Sudden tightness in the chest (sign of a heart problem)
• Difficulty breathing, chest pain, loss of consciousness, rapid heartbeat, bluish skin colouration, or sudden pain in an arm, leg or foot (signs that a blood clot may have formed)
• Swelling and redness along a vein that has become extremely tender or painful to touch
• High fever, chills or mouth ulcers due to infections (white blood cell deficiency)
• Severe and persistent blurred vision

If any of these effects occur, inform your doctor immediately.
You must also inform your doctor immediately if any of the following symptoms occur during treatment with Brestoral:
Swelling, particularly of the face and throat (signs of an allergic reaction)
Yellowing of the skin and eyes, nausea, loss of appetite, dark-coloured urine (signs of hepatitis)
Erythema, red skin, blistering of the lips, eyes or mouth, skin peeling, fever (signs of a skin disorder)

Some side effects are very common. These side effects may affect more than 10 out of every 100 patients.

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

Some side effects are common. These side effects may affect from 1 to 10 out of every 100 patients.

• Skin rash
• Headache
• Dizziness
• Malaise (feeling unwell)
• Gastrointestinal problems such as nausea, vomiting, indigestion, constipation, diarrhoea
• Increased or decreased appetite
• Muscle pain
• Loss of bone thickness and mass (osteoporosis), which in some cases may lead to bone fractures (see also “Monitoring during treatment with Brestoral” in section 3)
• Swelling of the arms, hands, feet or ankles (oedema)
• Depression
• Weight gain
• Hair loss
• Increased blood pressure (hypertension)
• Abdominal pain
• Dry skin
• Vaginal bleeding
• Palpitations, rapid heartbeat (tachycardia)
• Joint stiffness (arthritis)
• Chest pain

If any of these side effects becomes severe, inform your doctor.
Other side effects are uncommon. These side effects may affect from 1 to 10 out of every 1,000 patients.

• Nervous disorders such as anxiety, nervousness, irritability, drowsiness, memory disturbances, insomnia
• Pain or burning sensation in the hands or wrist (carpal tunnel syndrome)
• Sensory disturbances, especially tactile
• Visual disturbances such as blurred vision, eye irritation
• Skin disorders such as itching (urticaria)
• Vaginal discharge or dryness
• Breast pain
• Fever
• Thirst, taste alterations, 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

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

If any of these side effects occurs 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.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 Brestoral

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 packaging after EXP. The
expiry date refers to the last day of that month.
Do not use the packs if they are damaged or show signs of tampering.
Do not dispose of any medicine 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 Brestoral contains
The active substance is letrozole. Each film-coated tablet contains 2.5 mg of letrozole.
The other components are monohydrate lactose, maize starch, microcrystalline cellulose, sodium starch glycolate (type A), silica, anhydrous colloidal magnesium stearate. The tablets are coated with macrogol, hypromellose, talc, titanium dioxide (E171), yellow iron oxide (E172), and red iron oxide (E172).

Description of the appearance of Brestoral and package contents
Brestoral is available as yellow, round, film-coated tablets, 6.1 mm in diameter (±0.2 mm), biconvex. The tablets are packaged in blisters of 30, 100 tablets.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
WAVE PHARMA S.R.L.
VIA TALAMONE 5, 00179 ROMA
Manufacturer
Bluefish Pharmaceuticals AB,
Gävlegatan 22, 113 30 Stockholm
Sweden
Genepharm S.A.
18th km Marathonos Avenue,
153 51 Pallini Attikis, Greece

This medicinal product is authorized in the Member States of the European Economic Area under the following names: