ADIUNASTROL

PACKAGE LEAFLET: INFORMATION FOR THE USER

Adiunastrol 1 mg film-coated tablets

Anastrozole
Generic medicine
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT ADIUNASTROL IS AND WHAT IT IS USED FOR

Adiunastrol contains a substance called anastrozole. This belongs to a group of medicines known as 'aromatase inhibitors'.
Adiunastrol is used for the treatment of breast cancer in postmenopausal women.
Adiunastrol works by reducing the amount of hormones called oestrogens produced by the body. This occurs by blocking a natural substance (an enzyme) in the body called 'aromatase'.

2. WHAT YOU SHOULD KNOW BEFORE TAKING ADIUNASTROL

Do not take Adiunastrol

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

Do not take Adiunastrol if you are in any of the above conditions. If you are unsure, consult your doctor or pharmacist before taking Adiunastrol.

Warnings and precautions
Talk to your doctor or pharmacist before taking Adiunastrol:

• if you are still having menstrual periods and have not yet reached menopause.
• if you are taking a medicine containing tamoxifen or medicines containing estrogens (see the section entitled "Other medicines and Anastrozole Bluefish").
• if you have or have ever had a condition affecting bone strength (osteoporosis).
• if you have liver or kidney problems.

If you are unsure whether any of the above apply to you, consult your doctor or pharmacist before taking Adiunastrol.
If you are admitted to hospital, inform medical staff that you are taking Adiunastrol.
For individuals engaged in sports: using this medicine without a therapeutic need constitutes doping and may lead to a positive anti-doping test.

Other medicines and Adiunastrol
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines purchased without a prescription and herbal medicines.
Adiunastrol may affect how some medicines work, and some medicines may affect Adiunastrol.
Do not take Adiunastrol if you are already taking any of the following medicines:

• Certain medicines used to treat breast cancer (selective estrogen receptor modulators), for example medicines containing tamoxifene. This is because these medicines may interfere with the proper action of Adiunastrol.
• Medicines containing estrogens, for example hormone replacement therapy (HRT). If you are in any of these situations, ask your doctor or pharmacist for advice.

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

• A medicine known as an ‘LHRH analogue’, including gonadorelin, buserelin, goserelin, leuprorelin, and triptorelin. These medicines are used to treat breast cancer, certain gynecological conditions, and infertility.

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Stop taking Adiunastrol if you become pregnant and speak to your doctor.

Driving and using machines
It is unlikely that Adiunastrol will affect your ability to drive or operate tools or machinery. However, some people may occasionally feel weak or experience drowsiness while taking Adiunastrol. If this occurs, consult your doctor or pharmacist.

Adiunastrol contains lactose.
Adiunastrol contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. HOW TO TAKE ADIUNASTROL

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

• The recommended dose is one tablet once daily.
• Try to take the tablet at the same time every day.
• Swallow the tablet whole with a glass of water.
• It does not matter whether you take Adiunastrol before, with, or after food. Continue taking Adiunastrol for the entire duration prescribed by your doctor. This is a long-term treatment and you may need to take it for several years. If you have any doubts, consult your doctor or pharmacist.

Use in children and adolescents
Adiunastrol must not be given to children and adolescents.
If you take more Adiunastrol than you should
If you take more Adiunastrol than prescribed, contact your doctor immediately.
If you forget to take Adiunastrol
If you forget to take a dose, take the next dose at the usual time.
Do not take a double dose (two doses at the same time) to make up for the missed dose.
If you stop taking Adiunastrol
Do not stop taking the tablets unless instructed by your doctor.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Inform your doctor immediately if you experience any of the following very rare symptoms after taking this medicine, as these symptoms may be serious:

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

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

• Headache
• Hot flushes
• Feeling unwell (nausea)
• Skin rash
• Joint pain or stiffness
• Inflammation of the joints (arthritis)
• Feeling of weakness
• Bone loss (osteoporosis)

Common adverse reactions (may affect up to 1 in 10 people)

• Loss of appetite
• Increase or elevated blood levels of a fatty substance known as cholesterol, detectable by a blood test
• Drowsiness
• Carpal tunnel syndrome (tingling, pain, cold sensation, weakness in parts of the hand)
• Diarrhea
• Feeling unwell (vomiting)
• Changes in blood tests related to liver function
• Hair thinning (hair loss)
• Allergic reactions (hypersensitivity), including affecting the face, lips and tongue
• Bone pain
• Vaginal dryness
• Vaginal bleeding (usually during the first weeks of treatment – if bleeding continues, discuss with your doctor)
  • Muscle pain

Uncommon adverse reactions (may affect up to 1 in 100 people)

• Changes in specific blood tests indicating liver function (gamma-GT and bilirubin)
• Inflammation of the liver (hepatitis)
• Urticaria
  • Trigger finger (a condition in which a finger or thumb assumes a bent position)
  • Increased levels of calcium in the blood. If you experience nausea, vomiting and thirst, inform your doctor, pharmacist or nurse, as blood tests may be required.

Rare adverse reactions (may affect up to 1 in 1,000 people)

• Rare skin inflammation which may include red spots or blisters
• Skin rash due to hypersensitivity (this may be caused by an allergic or anaphylactoid reaction)
• Inflammation of small blood vessels causing red or purple skin discolouration. Very rarely, symptoms such as joint, stomach and kidney pain may occur; this is known as “Henoch-Schönlein purpura”.

Effects on bones
Adiunastrol reduces the amount of a hormone called estrogen in the body. This may reduce bone mineral content. Bones may become weaker and more prone to fractures. Your doctor will monitor these risks according to treatment guidelines for managing bone health in postmenopausal women. You should discuss risks and treatment options with your doctor.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE ADIUNASTROL

Keep this medicine out of sight and reach of children.
Store the tablets in a safe place where children cannot see or access them. The tablets may be dangerous for them.
Do not use this medicine after the expiry date stated on the carton and on the blister strip. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. PACKAGING CONTENTS AND OTHER INFORMATION

What Adiunastrol contains
The active substance is Anastrozole. Each film-coated tablet contains 1 mg of Anastrozole.
The other components are Lactose monohydrate 93 mg, Povidone (K30), Sodium starch glycolate, Magnesium stearate. The tablets are coated with Hypromellose, Macrogol 300, Titanium dioxide (E171).

Description of the appearance of Adiunastrol and packaging contents
Adiunastrol are white, round, film-coated tablets with a diameter of 6.0–6.2 mm.
The tablets are contained in blister packs of 28, 30, 98, and 100 tablets.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
WAVE PHARMA S.R.L.
VIA TALAMONE 5, 00179 ROMA

Manufacturer
Bluefish Pharmaceuticals AB, Gävlegatan 22, 113 30 Stockholm, Sweden.
Genepharm S.A., 18th 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:
AT 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 Patient Information Leaflet was last revised on