Document: Letrozole Bluefish 2.5 mg filmcoated tablets ENG PL change

• Letrozole Bluefish film-coated tablet PL
• Letrozole Bluefish 2.5 mg filmcoated tablets ENG PL

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PACKAGE LEAFLET

PACKAGE LEAFLET: INFORMATION FOR THE USER

Letrozole Bluefish 2.5 mg tablets

Letrozole

Read all of this leaflet carefully before you start taking this medicinebecause 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 or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you get any of the side effects, talk to your doctor or pharmacist. This include any possible side effects not listed in this leaflet.See section 4.

What is in this leaflet

1. What Letrozole Bluefish is and what it is used for

2. What you need to know before you take Letrozole Bluefish

3. How to take Letrozole Bluefish

4. Possible side effects

6. Contents of the pack and other information

What Letrozole Bluefish is and how it works

Letrozole Bluefish contains an active substance called letrozole. It belongs to a group of medicines called aromatase inhibitors. It is a hormonal (or “endocrine”) breast cancer treatment.Growth of breast cancer is frequently stimulated by oestrogens which are female sex hormones. Letrozole reduces the amount of oestrogen by blocking an enzyme (“aromatase”) involved in the production of oestrogens and therefore may block the growth of breast cancer that needs oestrogens to grow. As a consequence tumour cells slow or stop growing and/or spreading to other parts of the body.

What Letrozole Bluefish is used for

Letrozole Bluefish is used to treat breast cancer in women who have gone through menopause i.e cessation of periods.

. It is used to prevent cancer from happening again. It can be used as first treatment before breast cancer surgery in case immediate surgery is not suitable or it can be used as first treatment after breast cancer surgery or following five years of treatment with tamoxifen. Letrozole Bluefish is also used to prevent breast tumour spreading to other parts of the body in patients with advanced breast cancer.

If you have any question about how Letrozole Bluefish works or why this medicine has been prescribed for you, ask your doctor.

Follow all the doctor’s instructions carefully. They may differ from the general information in this leaflet.

Do not take Letrozole Bluefish

• if you are allergic to letrozole or to any of the other ingredients of this medicine (listed in section 6 ),.

• if you still have periods, i.e. if you have not yet gone through the menopause,

• if you are pregnant,

• if you are breast-feeding.

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

Warnings and precautions

• Talkto your doctor or pharmacist before taking Letrozole Bluefishif you have a severe kidney disease,

• if you have a severe liver disease,

• if you have a history of osteoporosis or bone fractures (see also “Follow-up during Letrozole Bluefish treatment” in section 3).

If any of these conditions apply to you, tell your doctor. Your doctor will take this into account during your treatment with Letrozole Bluefish.

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Children and adolescents (below 18 years)
Children or adoscelents should not use this medicine.

Older people (age 65 years and over)
People aged 65 years and over can use this medicine at the same dose as for other adults.

Other medicines and Letrozole Bluefish

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

Pregnancy, breast-feeding and fertility

- You must not take Letrozole Bluefish if you are pregnant or breast feeding as it may harm

your baby.

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- You should only take Letrozole Bluefish when you have gone through menopause.Howeveryour doctor should discuss with you the use of effective contraception, as you may still have the potential to become pregnant during treatment with Letrozole Bluefish.

Driving and using machines

If you feel dizzy, tired, drowsy or generally unwell, do not drive or operate any tools or machines until you feel normal again.

Letrozole Bluefish contains lactose

Letrozole Bluefish contains lactose (milk sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The usual dose is one tablet of Letrozole Bluefish to be taken once a day. Taking Letrozole at the same time each day will help you remember when to take your tablet.

The tablet can be taken with or without food and should be swallowed whole with a glass of water or another liquid.

How long to take Letrozole Bluefish
Continue taking Letrozole Bluefish 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 Letrozole Bluefish, talk to your doctor.

Follow-up during Letrozole Bluefish treatment

You should only take this medicine under strict medical supervision. Your doctor will regularly monitor your condition to check whether the treatment is having the right effect.

Letrozole Bluefish may cause thinning or wasting of your bones (osteoporosis) due to the reduction of oestrogens in your body. Your doctor may decide to measure your bone density (a way of monitoring for osteoporosis) before, during and after treatment.

If you take more Letrozole Bluefish than you should

If you have taken too much Letrozole Bluefish, or if someone else accidentally takes your tablets, contact adoctor or hospital for advice immediately. Show them the pack of tablets. Medical treatment may be necessary.

If you forget to take Letrozole Bluefish

• If it is almost time for your next dose (e.g. within 2 or 3 hours), skip the dose you missed and take your next dose when you are meant to.

• Otherwise, take the dose as soon as your remember, and then take the next tablet as you would normally.

• Do not take a double dose to make up for the one that you missed.

If you stop taking Letrozole Bluefish

Do not stop taking Letrozole Bluefish unless your doctor tells you. See also the section above “How long to take Letrozole Bluefish”.

Like all medicines, this medicine can cause side effects, although not everybody gets 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 flushes, hair loss or vaginal bleeding, may be due to the lack of oestrogens 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. they may affect between 1 to 100 in every 10,000 patients):

• Weakness, paralysis or loss of feeling in any part of the body(particularly arm or leg), loss of coordination, nausea, or difficulty speaking or breathing (sign of a brain disorder, e.g. 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 tender and possibly painful when touched.

• Severe fever, chills or mouth ulcers due to infections (lack of white blood cells)

• Severe persistent blurred vision

If any of the above occurs, tell your doctor straight away.

You should also inform the doctor straight away if you experience any of the following symptoms during treatment with Letrozole Bluefish:

• 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).

• Rash, red skin, blistering of the lips, eyes or mouth, skin peeling, fever (signs of skin disorder)

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

• Hot flushes

• Fatigue

• Increased sweating

• Pain in bones and joints (arthralgia)

• Increased level of cholesterol (hypercholesterolaemia).

If any of these affects you severely, tell your doctor.

Some side effects are common.These side effects may affect between 1 to 10 in every 100 patients.

• Skin rash

• Headache

• Dizziness

• Malaise (generally feeling unwell)

• Gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhoea

• Increase in or loss of appetite

• Pain in muscles

• Thinning or wasting of your bones (osteoporosis), leading to bone fractures in some cases (see also “Follow-up during Letrozole Bluefish treatment”in section 3)

• Swelling of arms, hands, feet, ankles (oedema)

• depression

• Weight increase

• Hair loss

• Raised blood pressure (hypertension)

• Abdominal pain

• Dry skin

• Vaginal bleeding

If any of these affects you severely, tell your doctor.

Other side effects are uncommon. These side effects may affect between 1 to 10 in every 1,000 patients.

• Nervous disorders such as anxiety, nervousness, irritability, drowsiness, memory problems, somnolence, insomnia

• Pain or burning sensation in the hands or wrist ( Carpal tunnel syndrome)

• Impairment of sensation, especially that of touch

• Eye disorders such as blurred vision, eye irritation

• Palpitations, rapid heart rate

• Skin disorders such as itching (urticaria)

• Vaginal discharge or dryness

• Joint stiffness (arthritis)

• Breast pain

• Fever

• Thirst, taste disorder, dry mouth

• Dryness of mucous membranes

• Weight decrease

• Urinary tract infection, increased frequency of urination

• Cough

• Increased level of enzymes.

Side effects with frequency not known

If any of these affects you severely, tell your doctor.

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist.This included any possible side effects not listed in this leaflet.You can also report side effects directly via the national reporting system in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Letrozole Bluefish

• Keep this medicine out of the sightand 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.

• Do not use any pack that is damaged or shows signs of tampering.

• Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longeruse. These measures will help to protect the environment.

6. Contents of the pack and other information

What Letrozole Bluefish contains

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

The other ingredients are Lactose monohydrate, Maize Starch, Microcrystalline Cellulose, Sodium Starch glycolate (type A), Silica, colloidal anhydrousMagnesium Stearate. The tablets are coated with Macrogol, Hypromellose, Talc, Titanium dioxide (E171), Yellow Iron Oxide (E172) and Red Iron Oxide (E172).

What Letrozole Bluefish looks like and contents of the pack

Letrozole Bluefish are yellow round, 6.1 mm (±0.2 mm) in diameter,biconvex film-coated tablets. The tablets are packed in blisters of 30, 100 tablets.

Marketing Authorisation Holder and manufacturer

Marketing Authorisation Holder

Bluefish Pharmaceuticals AB

P.O. Box 49013

100 28 Stockholm

Sweden

Manufacturer

Bluefish Pharmaceuticals AB

Torsgatan 11

111 23 Stockholm

Sweden

This medicinal product is authorised in the Member States of the EEA under the following names:

Name of MS	Name of medicinal product	MAH
AT	Letrozol Bluefish 2,5 mg filmtabletten	Bluefish Pharmaceuticals AB 11123 Stockholm, Sweden
DE	Letrozol Bluefish 2,5 mg filmtabletten
DK	Letrozol Bluefish
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
SE	Letrozole Bluefish 2,5 mg filmdragerade tabletter

This leaflet was last approved in 2016-06-22