ADIUNASTROL 1 mg Фильм-Coated Таблетка

Содержание инструкции

1. Adiunastrol 1 mg film-coated tablets
   1. WHAT IS ADIUNASTROL AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ADIUNASTROL
   3. HOW TO TAKE ADIUNASTROL
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE ADIUNASTROL
   6. PACKAGE CONTENTS AND OTHER INFORMATION

Adiunastrol 1 mg film-coated tablets

Anastrozole
Generic medicine

Read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even 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 you take 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 IS ADIUNASTROL AND WHAT IT IS USED FOR

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

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE 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 if you are breastfeeding (see the section called “Pregnancy and breastfeeding”). Do not take Adiunastrol if you are in any of the conditions listed above. If you are unsure, ask your doctor or pharmacist before taking Adiunastrol.

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

• If you still have menstrual periods and are not yet in menopause.
• If you are taking a medicine that contains tamoxifen or medicines containing estrogens (see the section called "Other medicines and Adiunastrol Bluefish”).
• If you have or have ever had a condition that alters bone strength (osteoporosis).
• If you have problems with your liver or kidneys.

If you are unsure if you fall into any of the above cases, ask your doctor or pharmacist before taking
Adiunastrol.
If you are hospitalized, inform the medical staff that you are taking Adiunastrol.
For those who engage in sports: the use of the drug without therapeutic necessity constitutes doping and may
still result in a positive doping test.

Other medicines and Adiunastrol
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines. This includes medicines you buy without a prescription and herbal medicines.
Indeed, Adiunastrol can affect the way some medicines work and some medicines can
have an effect on Adiunastrol.
Do not take Adiunastrol if you are already taking any of the following medicines:

• Some medicines used to treat breast cancer (selective estrogen receptor modulators), for example medicines containing tamoxifen. This is because these medicines may prevent Adiunastrol from working properly.
• Medicines containing estrogens, for example hormone replacement therapy (HRT). If you are in any of these cases, 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 gonadorelina, buserelin, goserelin, leuprorelina and triptorelina. These medicines are used to treat breast cancer, some female (gynaecological) diseases and infertility.

Pregnancy and breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Stop taking Adiunastrol if you become pregnant and talk to your doctor.

Driving and using machines
It is unlikely that Adiunastrol will affect your ability to drive vehicles or use tools or
machinery. However, some people may occasionally feel weak and sleepy during
taking Adiunastrol. If this happens to you, ask your doctor or pharmacist.

Adiunastrol contains lactose.
Adiunastrol contains lactose, a type of sugar. If your doctor has diagnosed you with intolerance to some
sugars, contact them before taking this medicine.

3. HOW TO TAKE ADIUNASTROL

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts,
consult your doctor or pharmacist.

• The recommended dose is one tablet once a day.
• Try to take the tablet at the same time each day.
• Swallow the tablet whole with a glass of water.
• It does not matter if you take Adiunastrol before, with, or after meals. Continue to take Adiunastrol for the entire period indicated by your doctor. It 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 should not be administered 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 as usual.
Do not take a double dose (two doses at the same time) to make up for a missed dose.

If you stop taking Adiunastrol
Do not stop taking the tablets unless instructed by your doctor.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can 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:

• swelling of the face, 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 side effects(may affect more than 1 in 10 people)

• Headache
• Hot flushes
• Feeling unwell (nausea)
• Skin rash
• Pain or stiffness in the joints
• Joint inflammation (arthritis)
• Feeling of weakness.
• Bone loss (osteoporosis)

Common side effects (may affect up to 1 in 10 people)

• Loss of appetite
• Increased or high levels in the blood of a fatty substance known as cholesterol, which can be checked with a blood test
• Feeling sleepy
• Carpal tunnel syndrome (numbness, pain, cold sensation, weakness in parts of the hand)
• Diarrhea
• state of m alaise (vomiting)
• Changes in blood tests relating to your liver function
• Thinning hair (hair loss)
• Allergic reactions (hypersensitivity) including on the face, lips and tongue
• Bone pain
• Vaginal dryness
• Vaginal bleeding (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 specific blood tests that highlight liver function (gamma-GT and bilirubin)
• Inflammation of the liver (hepatitis)
• Hives
• Trigger finger (a condition in which a finger or thumb assumes a curved position).
• Increased amount of calcium in the blood. If you experience nausea, vomiting and thirst, you should inform your doctor, pharmacist or nurse as blood tests may be necessary.

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

• Rare skin inflammation that may include red spots or blisters.
• Skin rash caused by hypersensitivity (this may be caused by an allergic or anaphylactoid reaction).
• Inflammation of small blood vessels that causes a red or purple discoloration of the skin. Very rarely, symptoms of pain in the joints, stomach and kidneys may occur; this is known as “Henoch-Schönlein purpura”.

Effects on bones
Adiunastrol reduces the amount of a hormone called estrogen, present in the body. This may reduce
the mineral content of the bones. Bones may be less strong and more prone to fractures. Your doctor
will check these risks in accordance with treatment guidelines for managing bone health in
menopausal women. You should talk to your doctor about the risks and treatment options.

Reporting of side effects
If you get any side effects, talk to your
doctor or pharmacist. You can also report side effects directly through the national reporting system at
www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide
more information on the safety of this
medicine.

5. HOW TO STORE ADIUNASTROL

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

6. PACKAGE CONTENTS AND OTHER INFORMATION

What Adiunastrol contains
The active ingredient is Anastrozole. Each film-coated tablet contains 1mg of 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).

Description of the appearance of Adiunastrol and package contents
Adiunastrol are white and 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.
Not all pack sizes may be marketed.

Marketing Authorisation 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 authorised in the Member States of the European Economic Area with the following
denominations:
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 Anastrozol Bluefish 1 mg filmdragerade tabletter
IS Anastrozole Bluefish1 mg filmuhúðaðar töflur