Anastrozole Bluefish

Document: Anastrozole Bluefish film-coated tablet ENG PL change

PACKAGE LEAFLET: INFORMATION FOR THE USER

Anastrozole Bluefish 1 mg film-coated tablets

Anastrozole

Read all of this leaflet carefully before you start 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, 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 side effects,talk to your doctor or pharmacist.This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

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

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

3. How to take Anastrozole Bluefish

4. Possible side effects

How to store Anastrozole Bluefish

6. Contents of the pack and other information

WHAT ANASTROZOLE BLUEFISH IS AND WHAT IT IS USED FOR

Anastrozole Bluefish contains a substance called anastrozole. This belongs to a group of medicines called ‘aromatase inhibitors’. Anastrozole Bluefish is used to treat breast cancer in women who have gone through the menopause.

Anastrozole Bluefish works by cutting down the amount of the hormone called estrogen that your body makes. It does this by blocking a natural substance (an enzyme) in your body called ‘aromatase’.

WHAT YOU NEED TO KNOW BEFORE YOU TAKE ANASTROZOLE BLUEFISH

Do not take Anastrozole Bluefish

- if you are allergic (hypersensitivity) to anastrozole or any of the other ingredients of Anastrozole Bluefish (listed in section 6).

- if you are pregnant or breast-feeding (see the section called ‘Pregnancy and breast-feeding’).

Do not take Anastrozole Bluefish if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Anastrozole Bluefish.

Warnings and precautions

Talk to your doctor or pharmacist before takingAnastrozole Bluefish

- if you still have menstrual periods and have not yet gone through the menopause.

- if you are taking a medicine that contains tamoxifen or medicines that contain estrogen (see the section called ‘Other medicines and Anastrozole Bluefish).

- if you have ever had a condition that affects the strength of your bones (osteoporosis).

- if you have problems with your liver or kidneys.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Anastrozole Bluefish.

If you go into the hospital, let the medical staff know you are taking Anastrozole Bluefish.

Other medicines and Anastrozole Bluefish

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Anastrozole Bluefish can affect the way some medicines work and some medicines can have an effect on Anastrozole Bluefish.

Do not take Anastrozole Bluefish if you are already taking any of the following medicines:

- Certain medicines used to treat breast cancer (selective estrogen receptor modulators), e.g., medicines that contain tamoxifen. This is because these medicines may stop Anastrozole Bluefish from working properly.

- Medicines that contain estrogen, such as hormone replacement therapy (HRT).

If this applies to you, ask your doctor or pharmacist for advice.

Tell your doctor or pharmacist if you are taking the following:

- A medicine known as an ‘LHRH analogue’. This includes gonadorelin, buserelin, goserelin, leuprorelin and triptorelin. These medicines are used to treat breast cancer, certain female health (gynaecological) conditions, and infertility.

Pregnancy and breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Stop taking Anastrozole Bluefish if you become pregnant and talk to your doctor.

Driving and using machines

Anastrozole Bluefish is not likely to affect your ability to drive or use any tools or machines. However, some people may occasionally feel weak or sleepy while taking Anastrozole Bluefish. If this happens to you, ask your doctor or pharmacist for advice.

Anastrozole Bluefish contains lactose

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

HOW TO TAKE ANASTROZOLE BLUEFISH

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

- The recommendeddose is one tablet once a day.

- Try to take your tablet at the same time each day.

- Swallow the tablet whole with a drink of water.

- It does not matter if you take Anastrozole Bluefish before, with or after food.

Keep taking Anastrozole Bluefish for as long as your doctor tells you to. It is a long-term treatment and you may need to take it for several years. Check with your doctor or pharmacist if you are not sure.

Use in children and adolescents

Anastrozole Bluefish should not be given to children and adolescents.

If you take more Anastrozole Bluefish than you should

If you take more Anastrozole Bluefish than you should, talk to a doctor straight away.

If you forget to take Anastrozole Bluefish

If you forget to take a dose, just take your next dose as normal.

Do not take a double dose (two doses at the same time)to make up for a forgotten dose.

If you stop taking Anastrozole Bluefish

Do not stop taking your tablets unless your doctor tells you to.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicinescan cause side effects, although not everybody gets them.

Tell your doctor immediately:

If you experience any of the following very rare symptoms after taking this medicine, these symptoms can be serious:

swollen face, tongue or pharynx, difficulty to swallow, hives and difficulties to breath (angioedema).
Serious allergic reactions with blistering of the skin, mouth, eyes and genitals (Stevens-Johnsons syndrome).

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

Headache.
Hot flushes.
Feeling sick (nausea).
Skin rash.
Pain or stiffness in your joints.
Inflammation of the joints (arthritis).
Feeling weak.

Bone loss (osteoporosis).

Common side effects (may affect up to 1 in10 people)

Loss of appetite.
Raised or high levels of a fatty substance known as cholesterol in your blood. This would be seen in a blood test.
Feeling sleepy.
Carpal tunnel syndrome (tingling, pain, coldness, weakness in parts of the hand).
Diarrhoea.
Being sick (vomiting).
Changes in blood tests that show how well your liver is working.
Thinning of your hair (hair loss).
Allergic (hypersensitivity) reactions including face, lips, or tongue.
Bone pain.
Vaginal dryness.
Bleeding from the vagina (usually in the first few weeks of treatment – if the bleeding continues, talk to your doctor).
Muscle pain

Uncommon side effects (may affect up to 1 in 100 people)

Changes in special blood tests that show how your liver is working (gamma-GT and bilirubin).
Inflammation of the liver (hepatitis).
Hives or nettle rash.
Trigger finger (a condition in which your finger or thumb catches in a bent position).
Increased amounts of calcium in your blood. If you experience nausea, vomiting and thirst, you should tell your doctor, pharmacist or nurse as you may need to have blood tests.

Rare side effects (may affect up to 1 in 1000 people)

Rare inflammation of your skin that may include red patches or blisters.
Skin rash caused by hypersensitivity (this can be from allergic or anaphylactoid reaction).
Inflammation of the small blood vessels causing red or purple colouring of the skin. Very rarely symptoms of joint, stomach, and kidney pain may occur; this is known as ‘Henoch-Schönlein purpura’.

Effects on your bones

Anastrozole Bluefish lowers the amount of the hormone called estrogen that is in your body. This may lower the mineral content of your bones. Your bones may be less strong and may be more likely to fracture. Your doctor will manage these risks according to treatment guidelines for managing bone health in women who have gone through the menopause. You should talk to your doctor about the risksand treatment options.

Reporting of side effects

If you get any of the side effects, talk to your doctor or pharmacist.This includes any possible side effects not listed in this leaflet.You can also report side effects directlyvia the national reportingsystemlistedin Appendix V*. Byreportingside effects you can help provide more information on the safetyofthis medicine.

5. HOW TO STORE ANASTROZOLE BLUEFISH

Keep this medicine out of the sight and reach of children. Keep your tablets in a safe place where children cannot see or reach them. Your tablets could harm them.

Do not use Anastrozole Bluefishafter the expiry date which is stated on the carton and blister strip. The expiry date refers to the last day of that month.

This medicine does not required any special storage conditions.

Do not throw away 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 Anastrozole Bluefish contains

The active substance is Anastrozole. Each film-coated tablet contains 1mg Anastrozole.

The other ingredients are Lactose monohydrate 93 mg, Povidone (K30), Sodium starch glycolate, Magnesium stearate. The tablets are coated with Hypromellose, Macrogol 300, Titanium dioxide (E171).

What Anastrozole Bluefish looks like and contents of the pack

Anastrozole Bluefish are white and round film-coated tablets of diameter 6.0 - 6.2mm.Thetablets are packed in blister packs containing 28, 30, 98 & 100 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, Torsgatan 11, 111 23 Stockholm, Sweden

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

AT	Anastrozol Bluefish 1 mg Filmtabletten

DE	Anastrozol Bluefish 1 mg Filmtabletten
DK	Anastrozol Bluefish 1 mg filmdragerade tabletter
ES	Anastrozole Bluefish 1 mg comprimidos recubiertos con película
FR	Anastrozole Bluefish 1 mg comprimés peliculés
HU	Anastrozole Bluefish 1 mg filmtabletta
IE	Anastrozole Bluefish 1 mg film-coated tablets
IT	Adiunastrol 1 mg compresse rivestite con film
NL	Anastrozol Bluefish 1 mg filmomhulde tabletten
PL	Anastrozole Bluefish
SE	Anastrozole Bluefish 1 mg filmdragerade tabletter

IS Anastrozole Bluefish 1 mg filmuhúðaðar töflur

This leaflet was last revised in 2016-05-26