FOGLIO ILLUSTRATIVO: INFORMAZIONI PER L’UTILIZZATORE

Brestoral 2,5 mg compresse rivestite con film

Medicinale equivalente

 

Read this leaflet carefully before taking this drug.

  • Keep this You may need to read it again.
  • If you have any further questions or doubts, contact your doctor or
  • This medicine has been prescribed for you only. Do not pass it on to others. It may cause them harm even if their symptoms are the same as
  • If any of the side effects worsens, or if you notice any side effect that is not listed in this leaflet, contact your doctor or

 

Contents of this leaflet:

1.What Brestoral is and what it is for 2.Before taking Brestoral

3.How to take Brestoral 4.Possible side effects 5.How to store Brestoral 6.Other information

 

1.    WHAT BRESTORAL IS AND  WHAT IT  IS  FOR

What Brestoral is

Brestoral contains an  active  ingredient called letrozole which  belongs  to  a  group  of  drugs called  "aromatase inhibitors".   It is a hormonal (or “endocrine”) breast cancer treatment.

 

What Brestoral is for

It is used to prevent cancer from recurring. It can be used as first treatment after breast cancer surgery or after five years of treatment with tamixofen. Brestoral is also used to prevent the spreading of breast tumours to other parts of the body in patients with advanced breast cancer. Brestoral must  only be used:

  • for estrogen-receptor-positive breast cancers; and
  • by women  in  menopause,  after  menstrual

cycles have ceased.

 

How Brestoral works

The growth of breast cancer is often stimulated by estrogens which are female sex hormones. Brestoral reduces the amount of estrogens by blocking an enzyme (“aromatase”) involved in the production of estrogens. As a result, the growth of tumor cells and/or their spreading to other parts of the body is slowed down or interrupted.

 

Monitoring therapy with Brestoral

This medicine must be taken under strict medical supervision only. Your doctor will regularly monitor your condition to check whether the treatment is producing the  desired effects.

Brestoral may cause the  thinning  or  wasting of your bones (osteoporosis) due to the reduction of estrogens in your body. Your doctor may decide to measure your bone density (a way of monitoring osteoporosis) before,     during     and      after      treatment.   If you have any question as to how Brestoral works or why it has been prescribed to you, ask your doctor.

 

2.  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 (hypersensitive) to letrozole or any of the other ingredients of Brestoral listed in section 6 of this leaflet;
  • still have menstrual cycles, i.e. if you are not

yet in menopause;

  • are pregnant;
  • are breastfeeding.

If any of these conditions apply to you, do not take this medicine and talk to your doctor.

Be especially careful with Brestoral if:

  • you have a severe kidney disease;
  • you have a severe liver disease;
  • you have a history of osteoporosis or bone fractures (see also "Monitoring therapy with Brestoral” in Section  1).

If any of these conditions apply to you, talk to your doctor. The doctor will have to consider this during therapy with Brestoral.

For those who practice sports: use of this drug without a therapeutic need is doping and can produce a positive result in anti- doping tests.

Taking Brestoral with other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without  a prescription.

 

Children and teenagers (below 18 years of age) Children and teenagers must not take  this drug.

Elderly (beyond 65 years of age) People   aged

65 or older can use this drug at the same dosage prescribed for adults.

 

Pregnancy and breastfeeding

  • Do not take Brestoral if you are pregnant or breastfeeding as it may harm your
  • Because Brestoral is only recommended for women who are in menopause, the restrictions regarding pregnancy and breastfeeding will probably not apply to
  • However, if you have only recently entered menopause or if you  are  in  a  peri-  menopausal   state,   your   doctor   must  discuss with you the  need  for  a  pregnancy  test before taking Brestoral and the use of contraceptives  as  there  is  a  possibility  for you   to   get pregnant.

 

Driving and using machines

If you feel dizzy, tired, drowsy or a general malaise, do not drive or operate any tools or machines until you feel normal again.

 

Important information on some components  of Brestoral

Brestoral contains lactose (milk sugar). If you have been told by your doctor that you are intolerant to some sugars, contact your doctor before taking this medicine.

 

3.   HOW TO TAKE BRESTORAL

Always take this medicine exactly as your doctor or pharmacist has instructed you. Check with your doctor or pharmacist if you are not sure or  if you have any doubts.

 

How much Brestoral to take

The recommended dose is one tablet of Brestoral to be taken once a day. Taking Brestoral at the same time every day will help you remember when to take your tablet.

 

How to take Brestoral

The tablet must be swallowed whole with a  glass of water or other beverage.

 

How  long  to  take  Brestoral   for   Continue taking Brestoral every day for as long as your doctor tells you. You may need to take  it for months or even years. If you have any questions about how long to keep taking Brestoral tablets, talk to your doctor.

If you take more Brestoral than you should If you have taken too much Brestoral, or if someone else accidentally takes your tablets, contact a doctor or hospital for advice immediately. Show them the package of tablets. Medical treatment may be necessary.

 

If you forget to take Bretoral

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

If you stop taking Brestoral

Do not stop taking Brestoral unless  your doctor tells you to. See also the Section above “How long to take Bestoral for”.

 

 

4.    POSSIBILE SIDE EFFECTS

Like all medicines, Brestoral can cause side effects although not everyone experiences them. Most of the side effects are mild to moderate  and  will  generally  disappear  after  a few  days to  a  few  weeks  of treatment.

Some of these side effects, such as hot flashes, hair loss or vaginal bleeding may be due to the lack of estrogens in your 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. they may affect  between  1   to   100  in   10,000   patients)

  • Weakness, paralysis or loss  of sensitivity  in the  arm  or  in  the  leg or in any other part of  the body, loss of coordination, nausea or difficulty speaking or breathing (sign or a brain disorder, for example a stroke).
  • Sudden oppressive   chest   pain   (sign   of   a   heart   disorder).
  • Difficulty breathing, chest pain, fainting, rapid heart rate, bluish skin discoloration, or sudden arm, leg or foot pain (signs that  a blood  clot  may  have formed).
  • Swelling and redness along a vein which is extremely sensitive or painful when  
  • Severe fever, chills or mouth ulcers due to infections (lack        of             white        blood        cells).
  • Severe persistent  blurred

Some patients have experienced other side effects during treatment with Brestoral:

  • Swelling mainly of the face and throat (signs of allergic reaction).
  • Yellow skin and eyes, nausea, loss of appetite, dark-coloured urine (signs of hepatitis).
  • Skin rash, red skin, blistering of the lips, eyes or mouth, skin peeling, fever (signs of skin disorder).

 

If any of the aboveside effects occur, contact your doctor immediately.

Some   side   effects   are   very  common

(they may affect more than 10 in 100 people).

- Hot flashes

  • Fatigue
  • Increased perspiration
  • Pain in bones and joints (arthralgia)

 

If any of the above side effects affect you severely, inform your doctor.

Some side effects are common (they may affect 1 to 10 people in 100).

  • Skin rash
  • Headache
  • Dizziness
  • General malaise or discomfort
  • Gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhea
  • Increase or loss of appetite
  • Muscle pain
  • Thinning or wasting of your bones (osteoporosis), sometimes leading to bone fractures (see also “Monitoring therapy with Brestoral” in section 1)
  • Swelling of arms, hands, feet, ankles (oedema)
  • Depression
  • Weight increase
  • Hair loss

If any of the above side effects affect you severely, inform your doctor.

 

Other side effects are uncommon (may affect 1 to 10 people in 1,000)

  • Nervous disorders such as anxiety, nervousness, irritability, drowsiness, memory problems, insomnia
  • Sensitivity impairment, especially of touch
  • Eye disorders such as blurred vision, eye irritation
  • Palpitations, rapid       heart     rate, high blood pressure (hypertension)
  • Skin disorders such as itching (urticaria), dry skin
  • Vaginal disorders such as bleeding, discharging or dryness
  • Abdominal pain
  • Joint stiffness (arthritis)
  • Breast pain
  • Fever
  • Thirst, altered taste sensation, dry  mouth
  • Dryness of mucous membranes
  • Weight loss
  • Urinary tract infection, increased frequency of urination
  • Cough

If any of the above affects you severely, inform your doctor.

You may also experience abnormal blood values during treatment with Brestoral, for example high levels of cholesterol (hypercholesterolaemia) or high blood levels of liver enzymes.

If any side effect worsens or if you experience any side effect not listed in this leaflet, inform your doctor or pharmacist.

 

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 package. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help protect the environment.

 

6.    OTHER INFORMATION What Brestoral contains

The active ingredient is letrozole. Each film- coated tablet contains 2.5mg of   letrozole.

The other ingredients are: lactose monohydrate, corn starch, microcrystalline cellulose, sodium starch glycolate (type A), silica, magnesium stearate, colloidal anhydrous.

Tablet coating: macrogol, hypromellose, talc, titanium dioxide (E171), yellow iron oxide (E172) and red iron oxide (E172).

 

What Brestoral looks like and package contents

Brestoral tablets are film coated, yellow, round and biconvex in shape.

Tablets are packed in blisters of 30 or 100 tablets.

 

Marketing Authorization Holder and manufacturer:

Bluefish Pharmaceuticals AB Torsgatan 11

111 23 Stockholm, Sweden

 

 

This medicinal product is authorized for sale in the following Member States of the European Union with the following  names:

 

Member State

Product name

MA Holder

AT

Letrozol Bluefish 2,5 mg filmtabletten

 

 

 

 

 

 

 

Bluefish Pharmaceuticals AB 11123

Stockholm, Sweden

DE

Letrozol Bluefish 2,5 mg filmtabletten

DK

Letrozol Bluefish 2,5 mg

ES

Letrozole Bluefish 2,5 mg comprimidos recubiertos con película

FI

Letrozole Bluefish 2,5 mg tabletti, kalvopäällysteinen Letrozole Bluefish 2,5 mg filmdragerade tabletter

FR

Letrozole Bluefish 2,5 mg comprimés peliculés

HU

Letrozole Bluefish 2,5 mg filmtabletta

IE

Letrozole Bluefish 2.5 mg film-coated tablets

IT

Brestoral 2,5 mg compresse rivestite con film

NL

Letrozol Bluefish 2,5 mg filmomhulde tabletten

PL

Letrozole Bluefish 2,5 mg

SE

Letrozole Bluefish 2,5 mg filmdragerade tabletter

 

This leaflet was last approved in February 2015

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