Zolobrest

PACKAGE LEAFLET: INFORMATION FOR THE USER

ZOLOBREST 2.5 mg film-coated tablets

Generic 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 further 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 may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What ZOLOBREST is and what it is used for

What ZOLOBREST is and how it works
ZOLOBREST 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 tumours is often stimulated by oestrogens, which are female sex hormones.
ZOLOBREST reduces the amount of oestrogens by blocking an enzyme ("aromatase") involved in oestrogen production. Therefore, it can block the growth of breast tumours that require oestrogens to grow.
As a result, the growth of tumour cells and/or their spread to other parts of the body is slowed down or stopped.

What ZOLOBREST is used for
ZOLOBREST is used to treat 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. ZOLOBREST 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 doubts about how ZOLOBREST works or why this medicine has been prescribed for you, please consult your doctor.

2. What you need to know before taking ZOLOBREST

Carefully follow all instructions provided by your doctor, which may differ from the general information
contained in this patient leaflet.
Do not take ZOLOBREST

• if you are allergic (hypersensitive) 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. you have not yet reached menopause
• if you are pregnant
• if you are breastfeeding. If any of these conditions apply to you, do not take this medicine and consult your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking ZOLOBREST

• if you have severe kidney disease
• if you have severe liver disease
• if you have a history of osteoporosis or bone fractures (see also ‘Follow-up during treatment with ZOLOBREST’ in section 3).

If any of these conditions apply to you, inform your doctor. Your doctor will take this into account during
your treatment with ZOLOBREST.
For athletes: The use of this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
Children and adolescents (under 18 years)
Children and adolescents must not use this medicine.
Elderly (65 years or older)
People aged 65 years or older can use this medicine at the same dose as other adults.
Other medicines and ZOLOBREST
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
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

• You must take ZOLOBREST 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 ZOLOBREST.
• You must not take ZOLOBREST if you are pregnant or breastfeeding, as it may harm the baby.

Driving and using machines
If you experience dizziness, fatigue, drowsiness or general malaise, do not drive or operate any tools or
machinery until you return to normal.
ZOLOBREST contains lactose
ZOLOBREST contains lactose (milk sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take ZOLOBREST

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 ZOLOBREST tablet taken once daily. Taking
ZOLOBREST at the same time each day will help you remember when to take the tablet.
The tablet may be taken with or without food and must be swallowed whole with a glass
of water or another beverage.
How long you should take ZOLOBREST
Continue taking ZOLOBREST every day as directed by your doctor. You will likely
need to take it for months or even years. Consult your doctor if you have any questions about
the duration of treatment with ZOLOBREST.
Monitoring during treatment with ZOLOBREST
You must take this medicine under close medical supervision. Your doctor will regularly
monitor your health to ensure the treatment is having the intended effect.
ZOLOBREST may cause bone fragility or loss of bone mass (osteoporosis) due to reduced
estrogen levels in the body. Your doctor may decide to measure bone density (a way to
monitor osteoporosis) before, during, and after treatment.
If you take more ZOLOBREST than you should
If you have taken too much ZOLOBREST, or if someone else accidentally takes your tablets,
contact your doctor or hospital immediately for advice. Show them the tablet packaging.
Medical treatment will likely be necessary.
If you forget to take ZOLOBREST

• If it is almost 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, then continue taking your tablet at the normal time.
• Do not take a double dose to make up for a forgotten dose. If you stop taking ZOLOBREST Do not stop taking ZOLOBREST unless instructed by your doctor. See also the section above 'How long you should take ZOLOBREST'. If you have any doubts about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Most of the side effects are mild to moderate in severity 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 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 or rare side effects (may affect from 1 to 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 (signs of a brain disorder, e.g. stroke).
• Sudden chest pain with a feeling of tightness (signs of heart disease).
• Difficulty breathing, chest pain, fainting, rapid heartbeat, bluish skin colour, or sudden pain in the arm, leg or foot (signs indicating that a blood clot may have formed).
• Swelling and redness along a vein, which is extremely sensitive and possibly painful to touch.
• Severe fever, chills or mouth ulcers due to infections (due to low white blood cell count).
• Severe and persistent blurred vision.

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 ZOLOBREST:

• Swelling, mainly 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).
• 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 you are severely affected by any of these side effects, inform your doctor.
Some side effects are common (may affect up to 1 in 10 people)

• 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 fractures (see also 'Follow-up of treatment with ZOLOBREST' 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 heart rate
• Joint stiffness (arthritis)
• Chest pain

If you are severely affected by any of these side effects, inform your doctor.
Other side effects are uncommon. These side effects may affect between 1 and 10 out of 1,000 patients.

• Nervous system disorders such as anxiety, nervousness, irritability, drowsiness, memory problems, somnolence, insomnia, numbness, tingling or burning sensation in the fingers
• Pain or burning sensation in the hands and wrists (carpal tunnel syndrome)
• Impaired sensation, particularly touch
• Eye disorders such as blurred vision, eye irritation
• Skin disorders such as itching (urticaria)
• Vaginal discharge or dryness
• Breast pain
• Fever
• Thirst, altered taste, dry mouth
• Dryness of mucous membranes
• Weight loss
• Urinary tract infection, increased frequency of urination
• Cough
• Increased levels of liver enzymes
• Yellowing of the skin and eyes
• High levels of bilirubin in the blood (a breakdown product of red blood cells)

Side effects with unknown frequency
Trigger finger, a condition in which a finger or thumb remains bent in a fixed position.
If you are severely affected by any of these side effects, inform your doctor.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
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 ZOLOBREST

• 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 carton after 'Exp.'. The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
• Store in the original packaging to protect the medicine from moisture.
• Do not use packages that are damaged or show signs of tampering.

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 ZOLOBREST contains:
The active substance is letrozole. Each film-coated tablet contains 2.5 mg of letrozole.
The other components are:
Tablet core: monohydrate lactose, corn starch, hypromellose (E464), sodium starch glycolate, microcrystalline cellulose (E460), anhydrous colloidal silica (E551), magnesium stearate (E572).
Film coating: hypromellose (E464), titanium dioxide (E171), yellow iron oxide (E172), macrogol 400 and talc (E553b).
Description of the appearance of ZOLOBREST and the contents of the pack:
ZOLOBREST 2.5 mg are yellow, round, biconvex, film-coated tablets, smooth on both sides. ZOLOBREST is packaged in blisters containing 10 tablets, 14 tablets, 28 tablets, 30 tablets, 50 tablets, 60 tablets, 84 tablets, 90 tablets, 98 tablets and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder:
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain
Manufacturer:
Accord Healthcare Limited, Sage House, 319, Pinner Road, North Harrow, Middlesex HA1 4HF, United Kingdom
Wessling Hungary Limited, 1047 Budapest, Fóti út 56, Hungary
This medicinal product is authorized in the Member States of the European Economic Area under the
following names: