ANASTROZOLE BLUEFISH

Package leaflet: Information for the user

Anastrozol Bluefish, 1 mg, film-coated tablets
Anastrozolum
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet as 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 personally. 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, pharmacist or nurse. See section 4.

Leaflet contents:

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

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

Anastrozol Bluefish contains a substance called anastrozole, which belongs to a group of medicines known as aromatase inhibitors.
Anastrozol Bluefish is used to treat postmenopausal women with breast cancer in whom the tumour has been shown to be estrogen receptor-positive.
Anastrozol Bluefish inhibits the action of aromatase – an enzyme involved in the production of female sex hormones such as estrogens. This occurs through inhibition of a substance (enzyme) called aromatase.

2. Important information before using Anastrozol Bluefish

When not to use Anastrozol Bluefish

• if the patient is allergic to anastrozole or any of the other ingredients of this medicine (listed in section 6),
• if the patient is pregnant or breastfeeding (see section "Pregnancy and breastfeeding").

If any of the situations listed above apply to the patient, Anastrozol Bluefish must not be used.
If in doubt, consult a doctor or pharmacist.

Warnings and precautions
Before starting treatment with Anastrozol Bluefish, discuss with a doctor, pharmacist, or nurse if:

• the patient is still menstruating (menopause has not yet occurred),
• the patient is taking a medicine containing tamoxifen or medicines containing estrogens (see "Anastrozol Bluefish and other medicines"),
• the patient has any bone disorders (osteoporosis),
• the patient has kidney or liver problems.

If in doubt whether any of these conditions apply, consult a doctor or pharmacist before using Anastrozol Bluefish.
If admitted to hospital, inform medical staff that you are taking Anastrozol Bluefish.

Anastrozol Bluefish and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. This includes medicines obtained without a prescription and herbal medicines, because Anastrozol Bluefish may affect how some medicines work, and some medicines may affect Anastrozol Bluefish.

Do not use Anastrozol Bluefish if the patient is already taking any of the following medicines:

• certain medicines used to treat breast cancer (selective estrogen receptor modulators), e.g. medicines containing tamoxifen, because Anastrozol Bluefish may stop working properly,
• medicines containing estrogen, such as hormone replacement therapy (HRT).

If any of the above situations apply, contact your doctor or pharmacist.

Tell your doctor or pharmacist if:

• the patient is taking any medicine from the group of LHRH analogues, such as: gonadorelin, buserelin, goserelin, leuprorelin, triptorelin. These medicines are used in the treatment of breast cancer, certain gynecological conditions, and infertility.

Pregnancy and breastfeeding
Anastrozol Bluefish must not be used during pregnancy or while breastfeeding.
Treatment with Anastrozol Bluefish must be discontinued and a doctor consulted if pregnancy occurs.
Before taking any medicine, consult a doctor or pharmacist.

Driving and operating machinery
It is unlikely that Anastrozol Bluefish impairs the ability to drive or operate machinery. However, weakness and drowsiness have been observed in some patients taking Anastrozol Bluefish. If this applies to the patient, contact a doctor or pharmacist.

Anastrozol Bluefish contains lactose
Anastrozol Bluefish contains lactose, a type of sugar. If the patient has previously been diagnosed with intolerance to certain sugars, consult a doctor before taking this medicine.

Anastrozol Bluefish contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet; this means the medicine is considered "sodium-free".

3. How to use Anastrozol Bluefish

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.

• The recommended dose is 1 coated tablet once daily.
• The medicine should be taken regularly at the same time each day.
• The tablet should be swallowed whole with water.
• It does not matter whether the patient takes the tablet before, during, or after a meal.

Anastrozol Bluefish should be taken for as long as directed by the doctor. Treatment with this medicine
is long-term and may last for several years. If in doubt, consult a doctor or pharmacist.
Children and adolescents
Anastrozol Bluefish must not be used in children and adolescents.
Taking more Anastrozol Bluefish than recommended
If more than the recommended dose is taken, consult a doctor immediately.
Missed dose of Anastrozol Bluefish
If a dose is missed, the next dose should be taken the following day at the usual time.
Do not take a double dose (two doses at the same time) to make up for a missed dose.
Stopping Anastrozol Bluefish treatment
Do not stop taking Anastrozol Bluefish without consulting a doctor.
If you have any further questions about the use of this medicine, consult your
doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
You must immediately inform your doctor if any of the following rare side effects occur after using this medicine. These side effects may be serious:

• Swelling of the face, tongue or throat, difficulty swallowing, hives and breathing difficulties (angioedema).
• Severe allergic reactions with blisters on the skin, mouth, eyes and genital organs (Stevens-Johnson syndrome).

Very common (may affect more than 1 in 10 people):

• Depression
• Headache
• Hot flushes
• Nausea
• Rash
• Joint pain and stiffness
• Arthritis (osteoarthritis)
• Weakness
• Bone demineralisation (osteopor游戏副本

5. How to store Anastrozol Bluefish

Keep this medicine out of sight and reach of children.
Tablets should be stored in a safe place where children cannot see or access them. Tablets may harm a child.
Do not use this medicine after the expiry date stated on the outer carton and blister after "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
No special precautions for storage are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Anastrozol Bluefish contains
The active substance is anastrozole. Each coated tablet contains 1 mg of anastrozole.
The other ingredients are: monohydrate lactose 93 mg, povidone (K30), sodium carboxymethyl starch (type A), magnesium stearate. The coated tablets are covered with a film coating containing hypromellose, polyethylene glycol 300 and titanium dioxide (E 171).
What Anastrozol Bluefish looks like and contents of the pack
Anastrozol Bluefish are white, round, film-coated tablets with a diameter of 6 – 6.2 mm. The tablets are packed in blisters containing 28, 30, 98 or 100 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
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 European Economic Area countries under the following names: