Anastrozol Bluefish

Package Leaflet: Information for the User

Anastrozol Bluefish, 1 mg, coated tablets

Anastrozole

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package 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 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 those not listed in this package leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the package leaflet:

• 1. What is Anastrozol Bluefish and what is it used for
• 2. Important information 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 is Anastrozol Bluefish and what is it used for

Anastrozol Bluefish contains the active substance anastrozole, which belongs to a group of medicines called aromatase inhibitors.
Anastrozol Bluefish is used to treat breast cancer in post-menopausal women whose tumor has been shown to be estrogen receptor-positive.
Anastrozol Bluefish works by blocking the enzyme aromatase, which is involved in the production of female sex hormones, such as estrogen.

2. Important information before taking Anastrozol Bluefish

When not to take Anastrozol Bluefish

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

If any of the above applies to you, do not take Anastrozol Bluefish.
If you are in doubt, consult your doctor or pharmacist.

Warnings and precautions

Before starting treatment with Anastrozol Bluefish, discuss with your doctor, pharmacist, or nurse if:

• you are still having menstrual periods (have not yet reached menopause),
• you are taking tamoxifen or estrogen-containing medicines (see "Anastrozol Bluefish with other medicines"),
• you have any bone diseases (osteoporosis),
• you have kidney or liver disease.

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

Anastrozol Bluefish with other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, including those obtained without a prescription and herbal medicines, as Anastrozol Bluefish may affect the way they work, and some medicines may affect Anastrozol Bluefish.
Do not take Anastrozol Bluefish if you are already taking one of the following medicines:

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

If the above applies to you, contact your doctor or pharmacist.
Tell your doctor or pharmacist if:

• you are taking any luteinizing hormone-releasing hormone (LHRH) analogues, such as gonadorelin, buserelin, goserelin, leuprorelin, or triptorelin. These medicines are used to treat breast cancer, certain gynecological disorders, and infertility.

Pregnancy and breastfeeding

Do not take Anastrozol Bluefish if you are pregnant or breastfeeding.
Stop taking Anastrozol Bluefish and consult your doctor if you become pregnant.
Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines

Anastrozol Bluefish is unlikely to affect your ability to drive or use machines. However, some people taking Anastrozol Bluefish have experienced weakness and drowsiness. If this happens to you, consult your doctor or pharmacist.

Anastrozol Bluefish contains lactose

Anastrozol Bluefish contains lactose, a type of sugar. If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Anastrozol Bluefish contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially sodium-free.

3. How to take Anastrozol Bluefish

Always take this medicine exactly as your doctor or pharmacist has told you.
If you are in doubt, consult your doctor or pharmacist.

• The recommended dose is one coated tablet once a day.
• Take the medicine at the same time every day.
• Swallow the tablet whole with water.
• It does not matter whether you take the tablets before, during, or after a meal.

Take Anastrozol Bluefish for as long as your doctor has told you.
Treatment with Anastrozol Bluefish is long-term and may last for several years.
If you are in doubt, consult your doctor or pharmacist.

Children and adolescents

Anastrozol Bluefish should not be taken by children and adolescents.

Overdose

If you take more Anastrozol Bluefish than you should, contact your doctor immediately.

Missed dose

If you forget to take a dose, take the next dose at the usual time the next day.
Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

Stopping treatment

Do not stop taking Anastrozol Bluefish without consulting your doctor.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Anastrozol Bluefish can cause side effects, although not everybody gets them.
Tell your doctor immediately:
If you experience any of the following rare but serious side effects:

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

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

• Depression
• Headache
• Hot flashes
• Nausea
• Rash
• Pain and stiffness in the joints
• Arthritis
• Weakness
• Osteoporosis.

Common (may affect up to 1 in 10 people):

• Loss of appetite
• Increased cholesterol levels in the blood (shown by blood tests)
• Drowsiness
• Carpal tunnel syndrome (tingling, pain, coldness, weakness in the hand)
• Paresthesia (tingling, numbness, or prickling sensation on the skin), loss of taste
• Diarrhea
• Vomiting
• Increased liver enzyme activity shown by blood tests
• Thinning and hair loss
• Allergic reactions (hypersensitivity) on the face, lips, tongue
• Bone pain
• Vaginal dryness
• Vaginal bleeding (mainly in the first few weeks of treatment - if bleeding persists, consult your doctor)
• Muscle pain.

Uncommon (may affect up to 1 in 100 people):

• Changes in blood test results (increased gamma-GT and bilirubin levels in the blood)
• Hepatitis
• Hives or blistering rash on the skin
• Trigger finger (difficulty bending and straightening fingers)
• Increased calcium levels in the blood. If you experience nausea, vomiting, and thirst, tell your doctor, pharmacist, or nurse, as blood tests may be necessary.

Rare (may affect up to 1 in 1000 people):

• Inflammatory skin conditions, which may include red patches or scales
• Skin rashes caused by hypersensitivity (due to allergy or anaphylactoid reaction)
• Inflammation of small blood vessels, causing red or purple discoloration of the skin. Very rarely, this may be accompanied by joint pain, stomach pain, kidney pain, known as Henoch-Schönlein purpura.

Effect on bones

Anastrozol Bluefish reduces the levels of hormones in the body, such as estrogen, which may lead to a decrease in bone mineral density. This may weaken the bones and increase the risk of fractures. Your doctor will take steps to prevent this risk, following the treatment guidelines for maintaining bone health in post-menopausal women. Discuss this risk with your doctor and possible treatment.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Anastrozol Bluefish

Keep this medicine out of the sight and reach of children.
Store the tablets in a safe place, where children cannot see or reach them. The tablets can harm children.
Do not take this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the month.
There are no special precautions for storage of this medicinal product.
Medicines should 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 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: lactose monohydrate 93 mg, povidone (K30), sodium carboxymethylcellulose (type A), magnesium stearate. The coating contains hypromellose, macrogol 300, and titanium dioxide (E 171).

What Anastrozol Bluefish looks like and contents of the pack

Anastrozol Bluefish are white, round, coated tablets with a diameter of 6 - 6.2 mm. The tablets are packaged in blisters containing 28, 30, 98, or 100 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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 authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the package leaflet:06/2021