Letrozole bluefish

Package leaflet: Information for the user

Letrozole Bluefish, 2.5 mg, coated tablets
( Letrozolum )
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 further questions, please 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

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
5. How to store Letrozole Bluefish
6. Contents of the pack and other information

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

What Letrozole Bluefish is and how it works
Letrozole Bluefish contains an active substance called letrozole. Letrozole belongs to a group of medicines known as aromatase inhibitors. It is used in hormone (endocrine) therapy for breast cancer. The growth of breast cancer is often stimulated by estrogens, which are female sex hormones. Letrozole reduces the amount of estrogen by inhibiting the activity of an enzyme (aromatase) involved in estrogen production. Therefore, it may slow down or stop the growth of breast cancer cells that depend on estrogen to grow. As a result of this action, cancer cells stop growing or grow more slowly and (or) stop spreading to other parts of the body.

What Letrozole Bluefish is used for
Letrozole Bluefish is used to treat breast cancer in postmenopausal women, that is, women who have stopped menstruating.
This medicine is used to prevent recurrence of breast cancer. It may be used as initial treatment before breast cancer surgery when immediate surgery is not recommended, or it may be used as initial treatment in patients after surgical removal of breast cancer or after 5 years of tamoxifen therapy. Letrozole Bluefish is also used to prevent the spread of advanced breast cancer in women.
If you have any doubts about how Letrozole Bluefish works or why it has been prescribed for you, please consult your doctor.

2. Important information before using Letrozole Bluefish

Always follow your doctor's instructions exactly. They may differ from the general information
provided in this leaflet.
When not to use Letrozole Bluefish

• if the patient is allergic to letrozole or to any of the other ingredients of this medicine (listed in section 6);
• in women of childbearing age, i.e. women who have not yet reached menopause;
• if the patient is pregnant;
• if the patient is breastfeeding.

If any of the above conditions apply to the patient, this medicine must not be used and the patient must inform
the doctor.
Warnings and precautions

• Before starting treatment with Letrozole Bluefish, consult your doctor or pharmacist if the patient has severe kidney disease;
• if the patient has severe liver disease;
• if the patient has a history of osteoporosis or bone fracture (see also section “Monitoring during treatment with Letrozole Bluefish” in section 3).

If any of the above conditions apply to the patient, the patient must inform the doctor.
The doctor will take this information into account when treating with Letrozole Bluefish.
Letrozole may cause inflammation or damage to tendons (see section 4). If the patient
experiences tendon pain or swelling, the affected area should be rested and the patient should contact the doctor.
Children and adolescents (under 18 years of age)
This medicine must not be used in children and adolescents.
Elderly patients (aged 65 years and older)
Letrozole Bluefish can be used in patients aged 65 years and older at the same dosage as in other adult patients.
Interactions of Letrozole Bluefish with other medicines
The patient must inform the doctor or pharmacist about all medicines currently used or recently used, as well as any medicines planned for use, including those available without a prescription.
Pregnancy, breastfeeding and effects on fertility

• Letrozole Bluefish should be used only in postmenopausal women. However, the doctor will discuss with the patient the need to use an effective method of contraception, because pregnancy may still occur during treatment with Letrozole Bluefish;
• Letrozole Bluefish must not be used during pregnancy or breastfeeding, as the medicine may harm the unborn or nursing child.

Driving and operating machinery
If dizziness, fatigue, drowsiness or general malaise occurs, the patient should not drive or operate tools or machinery until normal health status returns.
Letrozole Bluefish contains lactose
Letrozole Bluefish contains lactose (milk sugar). If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult the doctor before taking this medicine.

3. How to use Letrozole Bluefish

This medicine should always be taken as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
The usual dose of Letrozole Bluefish is one tablet daily. Taking Letrozole Bluefish at the same
time each day helps you remember when to take the next dose.
The tablet may be taken with or without food. Swallow the tablet whole with a glass of water or
another drink.

How long to take Letrozole Bluefish
Letrozole Bluefish should be taken daily for as long as your doctor recommends. You may need to
take the medicine for several months or even for several years. If you have any questions about
how long you should continue taking Letrozole Bluefish, speak to your doctor.

Monitoring during treatment with Letrozole Bluefish
This medicine should always be used under strict medical supervision. Your doctor will regularly
monitor your health to ensure the treatment is effective.
Letrozole Bluefish may cause thinning or loss of bone tissue (osteoporosis), due to reduced
estrogen levels in the body. Your doctor may order a measurement of your bone density (osteoporosis
monitoring test) before, during, and after treatment.

If you take more Letrozole Bluefish than you should
If you take too many Letrozole Bluefish tablets, or if someone accidentally takes them, contact your
doctor immediately or go to a hospital. Show the tablet packaging. Appropriate treatment may be
required.

If you miss a dose of Letrozole Bluefish

• If your next dose is due in 2 or 3 hours, do not take the missed dose. Take the next dose at the usual scheduled time.
• Otherwise, take the missed dose as soon as you remember, and then take the next tablet at the usual scheduled time.
• Do not take a double dose to make up for a missed dose.

Stopping Letrozole Bluefish
Do not stop taking Letrozole Bluefish unless your doctor tells you to. See also the section above
titled "Duration of treatment".

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Most side effects are mild to moderate in severity and usually resolve within a few days or weeks of treatment.
Some side effects, such as hot flushes, hair loss or vaginal bleeding, may be caused by low estrogen levels in the body.
Do not be alarmed by the list of possible side effects below. You may not experience any of them.

Some side effects may be serious:
Uncommon or rare side effects (i.e. may occur in 1 to 100 out of 10,000 patients)

• Weakness, paralysis or loss of sensation in any part of the body (especially in the arm or leg), loss of coordination, nausea or difficulty speaking or breathing (symptoms of brain dysfunction such as stroke);
• Sudden, crushing chest pain (symptom of heart dysfunction);
• Difficulty breathing, chest pain, fainting, rapid heartbeat, bluish skin colouration, sudden pain in arms, legs or feet (symptoms indicating possible blood clot formation in blood vessels);
• Swelling and redness along a vein, with marked tenderness and pain on touch;
• High fever, chills or mouth ulcers due to infections (due to reduced number of white blood cells);
• Severe, persistent blurred vision;
• Uncommonly - tendon inflammation (soft tissue connecting muscles and bones);
• Rarely - tendon rupture (soft tissue connecting muscles and bones).
  If any of the above symptoms occur, contact your doctor immediately.

You should also contact your doctor immediately if any of the following symptoms occur during treatment with Letrozole Bluefish:

• Swelling, mainly of the face and throat (symptoms of allergic reaction);
• Yellowing of the skin and eyes, nausea, loss of appetite, dark-coloured urine (symptoms of hepatitis);
• Skin rash, redness of the skin, blistering of lips, eyes or mouth, skin peeling, fever (symptoms of skin disorders).

Some side effects are very common. They may occur in more than 10 out of 100 patients.

• Hot flushes;
• Increased cholesterol levels (hypercholesterolemia);
• Fatigue;
• Excessive sweating;
• Bone and joint pain.

If any of the above side effects are severe, inform your doctor.

Some side effects are common. They may occur in 1 to 10 out of 100 patients.

• Skin rash;
• Headache;
• Dizziness;
• General malaise;
• Gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhoea;
• Increased or decreased appetite;
• Muscle pain;
• Thinning or weakening of bones (osteoporosis), sometimes leading to bone fractures (see also section 3 “Monitoring treatment with Letrozole Bluefish”);
• Swelling of hands, palms, feet or ankles;
• 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 the above side effects are severe, inform your doctor.

Some side effects are uncommon. They may occur in 1 to 10 out of 1,000 patients.

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

If any of the above side effects are severe, inform your doctor.

Side effects with unknown frequency

• Trigger finger, a condition in which a patient's finger or thumb remains in a bent position.

If any of the above side effects are severe, inform your doctor.

Reporting of side effects
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department for Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: [email protected]
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects helps to provide more information on the safety of the medicine.

5. How to store Letrozole Bluefish

• No special storage instructions are required for this medicine.
• Keep the medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton after "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
• Do not use if there are any signs of damage or opening of the packaging.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Letrozole Bluefish contains
The active substance is letrozole. Each coated tablet contains 2.5 mg of letrozole.
The other ingredients are: monohydrate lactose, maize starch, microcrystalline cellulose,
sodium carboxymethyl starch (type A), colloidal anhydrous silica, magnesium stearate.
The coating components in Opadry 02B38014 are: macrogol 4000, hypromellose 5 cP, talc, titanium dioxide
(E 171), yellow iron oxide (E 172), red iron oxide (E 172).
What Letrozole Bluefish looks like and contents of the pack
Letrozole Bluefish is yellow, round, biconvex coated tablets with a diameter of 6.1 mm (± 0.2 mm).
The medicine is available in blister packs, in pack sizes of 30 or 100 tablets.
Marketing Authorisation Holder
Bluefish Pharmaceuticals AB, P.O. Box 49013, 100 28 Stockholm, Sweden
Manufacturer:
Bluefish Pharmaceuticals AB, Gävlegatan 22, 113 30 Stockholm, Sweden.
Genepharm S.A., 18 km Marathonos Avenue, 153 51 Pallini Attikis, Greece
This medicinal product is authorised in the Member States of the European Economic Area under the following names: