ANASTROZOLO 1 мг Фильм-coated таблетки

Содержание инструкции

1. Anastrozolo Aurobindo 1 mg film-coated tablets
   1. What is Anastrozolo Aurobindo and what is it used for
   2. What you need to know before you take Anastrozolo Aurobindo
   3. How to take Anastrozolo Aurobindo
   4. Possible side effects
   5. How to store Anastrozolo Aurobindo
   6. Contents of the pack and other information

Anastrozolo Aurobindo 1 mg film-coated tablets

Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 Anastrozolo Aurobindo is and what it is used for
• 2. What you need to know before you take Anastrozolo Aurobindo
• 3. How to take Anastrozolo Aurobindo
• 4. Possible side effects
• 5. How to store Anastrozolo Aurobindo
• 6. Contents of the pack and other information

1. What is Anastrozolo Aurobindo and what is it used for

Anastrozolo Aurobindo contains a substance called anastrozole, which belongs to a group
of medicines called “aromatase inhibitors”. Anastrozolo Aurobindo is used for the treatment
of breast cancer in postmenopausal women.
Anastrozolo Aurobindo works by reducing the amount of hormones called estrogens produced
by the body. This happens by blocking a natural substance (enzyme) in your body,
called “aromatase”.

2. What you need to know before you take Anastrozolo Aurobindo

Do not take Anastrozolo Aurobindo

• 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”).

Do not take Anastrozolo Aurobindo if you fall into any of the above cases. If in doubt,
consult your doctor or pharmacist before taking Anastrozolo Aurobindo.

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

• if you still have menstrual periods and are not yet postmenopausal.
• if you are taking a medicine that contains tamoxifen or medicines containing estrogens (see “Other medicines and Anastrozolo Aurobindo”).
• 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 not sure if you fall into any of the above cases, consult your doctor or pharmacist before
taking Anastrozolo Aurobindo.
If you are admitted to hospital, tell the medical staff that you are taking Anastrozolo
Aurobindo.

Other medicines and Anastrozolo Aurobindo
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 remedies. Indeed, Anastrozolo Aurobindo can affect the way some medicines
work and some medicines can have an effect on Anastrozolo Aurobindo.
Do not take Anastrozolo Aurobindo 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 Anastrozolo Aurobindo from working correctly.
• Medicines containing estrogens, for example hormone replacement therapy (HRT). If you fall into 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, buserelina, goserelina, leuprorelina and triptorelina. These medicines are used to treat breast cancer, some female (gynaecological) conditions and infertility.

Pregnancy and breastfeeding
Do not take Anastrozolo Aurobindo if you are pregnant or if you are breastfeeding.
Stop taking Anastrozolo Aurobindo if you become pregnant and talk to your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
It is unlikely that Anastrozolo Aurobindo will affect your ability to drive or operate
tools or machinery. However, some people may occasionally feel weak or
drowsy while taking Anastrozolo Aurobindo. If this happens, ask your doctor or
pharmacist for advice.

Anastrozolo Aurobindo contains lactose
If your doctor has told you that you have an intolerance to some sugars, consult your doctor before
taking this medicine.

3. How to take Anastrozolo Aurobindo

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

• The recommended dose is one tablet once a day.
• Try to take the tablet every day at the same time.
• Swallow the tablet whole with a sip of water.
• It does not matter if you take Anastrozolo Aurobindo before, with or after meals.

Continue to take Anastrozolo Aurobindo for the entire period indicated by your doctor. It is a
long-term treatment and you may need to take it for several years.

Use in children and adolescents
Anastrozolo Aurobindo must not be administered to children and adolescents.

If you take more Anastrozolo Aurobindo than you should
If you take more Anastrozolo Aurobindo than you should, inform your doctor immediately.

If you forget to take Anastrozolo Aurobindo
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 the missed
dose.

If you stop taking Anastrozolo Aurobindo
Do not stop taking the tablets unless instructed by your doctor.
If you have any further 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.

Serious side effects:
If you experience any of the following serious side effects, call an ambulance or see a doctor immediately – you may urgently need medical treatment:

• A very severe skin reaction with the appearance of ulcers or blisters on the skin. This is known as ‘Stevens-Johnson syndrome’. Very rare (may affect less than 1 in
• 10,000);
• Allergic reaction (hypersensitivity) with swelling of the throat that can cause difficulty swallowing or breathing. This is known as ‘angioedema’. Very rare (may affect less than 1 in 10,000);

Other side effects:

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 in some parts of the hand).
• Diarrhoea.
• Feeling sick (vomiting).
• Changes in blood tests relating to the function of your liver.
• Thinning of the hair (hair loss).
• Allergic reactions (hypersensitivity) including to 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).

Uncommon side effects (may affect up to 1 in 1,000 people)

• Changes in some specific blood tests that show the function of your liver (gamma-GT and bilirubin).
• Inflammation of the liver (hepatitis).
• Hives.
• Trigger finger (a condition in which one of your fingers or thumb becomes bent and stuck in a curved position).

Rare side effects (may affect up to 1 in 10,000 people)

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

Effects on bones
Anastrozole reduces the amount of hormones called estrogens in the body. This may
reduce the mineral content of the bones; therefore, the bones may be less strong and more prone to
fractures. Your doctor will check these risks in accordance with treatment guidelines for the
management of bone health in postmenopausal women. Consult your doctor about these
risks and treatment options.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at
http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Anastrozolo Aurobindo

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 may be
dangerous for them.
This medicine does not require any particular storage conditions.
Do not take Anastrozolo Aurobindo after the expiry date which is stated on the pack and blister
after “EXP”. The first two numbers indicate the month and the last four numbers indicate the year. The
expiry date refers to the last day of that month.
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 to protect the environment.

6. Contents of the pack and other information

What Anastrozolo Aurobindo contains

• The active ingredient is anastrozole. Each film-coated tablet contains 1 mg of anastrozole.
• The other excipients in the tablet core are lactose monohydrate, sodium starch glycolate, povidone (E1201) and magnesium stearate (E572). The excipients in the tablet coating are macrogol, hypromellose (E464) and titanium dioxide (E171).

Description of the appearance of Anastrozolo Aurobindo 1 and contents of the pack
Anastrozolo Aurobindo 1 mg is a white, film-coated, round tablet, with the inscriptions
“ANA” and “1” on one side.
Anastrozolo Aurobindo is available in blisters of 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100, 120
or 300 tablets and in hospital blisters of 28, 50, 84, 98, 300 or 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
AUROBINDO PHARMA (ITALIA) – Via San Giuseppe 102 – 21047 Saronno (Varese)

Manufacturer:
Synthon BV
Microweg 22
6545 CM Nijmegen (Netherlands)
Synthon Hispania, S.L.
C/Castelló, 1
Polígono Las Salinas
08830 Sant Boi de Llobregat
Barcelona (Spain)

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Austria Anastrozol Aurobindo 1 mg Filmtabletten
Belgium Anastrozol Aurobindo 1 mg tablets
Czech Republic Anastrozol Aurobindo 1 mg
Denmark Anastrozol Aurobindo
Estonia Anastrozole Aurobindo
Finland Anastrozol Aurobindo 1 mg
Germany Anastrozol-Aurobindo 1 mg Filmtabletten
Greece Ansyn
Hungary Anaromat
Iceland Anastrozol Aurobindo
Ireland Anastrozole 1mg Film-coated Tablets
Italy Anastrozolo Aurobindo
Lithuania Anastrozole Aurobindo 1 mg plėvele dengtos tabletės
Luxembourg Anastrozol Aurobindo
Latvia Anastrozole Aurobindo 1 mg apvalkotās tabletes
Netherlands Anastrozol Aurobindo 1 mg
Poland Ansyn
Portugal Anastrozol Aurobindo 1 mg comprimidos revestidos por película
Romania Anaromat
Slovenia Ansyn 1 mg filmsko obložene tablete
Slovakia Ansyn 1 mg
Spain Anastrozol Aurobindo 1 mg comprimidos recubiertos con pelicula EFG
Sweden Anastrozol Aurobindo
United Kingdom Anastrozole 1mg Tablets