RAOLOZ 1 mg Coated Tablet

Зміст інструкції

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

RAOLOZ 1 mg film-coated tablets

anastrozole

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 they have the same symptoms as you, as it may 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 RAOLOZ is and what it is used for
• 2. What you need to know before you take RAOLOZ
• 3. How to take RAOLOZ
• 4. Possible side effects
• 5. How to store RAOLOZ
• 6. Contents of the pack and other information

1. What is RAOLOZ and what is it used for

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

2. What you need to know before you take RAOLOZ

Do not take RAOLOZ:
if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in
section 6);
if you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”).
Do not take RAOLOZ if you fall into one of the above cases. If in doubt, consult your doctor or
pharmacist before taking RAOLOZ.

Warnings and precautions
Talk to your doctor or pharmacist before taking RAOLOZ. Consult your doctor or pharmacist if:
you still have your period and are not yet menopausal,
you are taking a medicine that contains tamoxifen or medicines containing estrogens (see section
"Other medicines and RAOLOZ”),
you have or have ever had a condition that alters bone strength (osteoporosis),
you have problems with the liver or kidneys.
If you are not sure if you fall into one of the above cases, consult your doctor or pharmacist before taking
RAOLOZ.
If you are hospitalized, inform the medical staff that you are taking RAOLOZ.

Children and adolescents
RAOLOZ is not recommended in children and adolescents.

For athletes

If you participate in sports: the use of the medicine without therapeutic necessity constitutes doping and may

still result in a positive doping test.

Other medicines and RAOLOZ
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
These include medicines that you can buy without a prescription and herbal remedies. In fact,
RAOLOZ can affect the way some medicines work and some medicines can have an
effect on RAOLOZ.
Do not take RAOLOZ 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 can
prevent the correct action of RAOLOZ. Medicines containing estrogens, for example hormone
replacement therapy (HRT).
If you fall into one of these cases, ask your doctor or pharmacist for advice.
Tell your doctor or pharmacist if you are taking medicines known as “gonadotropin-releasing hormone
(LHRH) analogues”. This includes gonadorelina, buserelina, goserelina,
leuprorelina and triptorelina. These medicines are used to treat breast cancer, for the
treatment of certain female (gynecological) diseases and infertility.

Fertility, pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy and breastfeeding
Do not take RAOLOZ if you are pregnant or if you are breastfeeding.
Stop taking Raoloz if you become pregnant and talk to your doctor.
Fertility
There are no data available on the effect of Raoloz on fertility. Animal studies have shown
negative effects on reproduction.

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

RAOLOZ contains lactose and sodium
This medicine contains lactose. If your doctor has diagnosed you with intolerance to certain sugars, contact
them before taking the medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take RAOLOZ

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask 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 RAOLOZ before, during or after meals.
Continue to take RAOLOZ for the entire period indicated by your doctor. It is a long-term treatment and
you may need to follow it for several years.
If you have any doubts, ask your doctor or pharmacist.

If you take more RAOLOZ than you should
In case of accidental ingestion/intake of an excessive dose of RAOLOZ, immediately notify your
doctor or go to the nearest hospital.

If you forget to take RAOLOZ
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 forgotten
dose.

If you stop taking RAOLOZ
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.

Stop taking RAOLOZ and seek urgent medical attention if you experience any of the following serious but very rare side effects:

• Extremely severe skin reaction, with the appearance of ulcers or blisters on the skin. This is known as “Stevens-Johnson syndrome”.
• Allergic reaction (hypersensitivity) with swelling of the throat, which can cause difficulty swallowing or breathing, known as “angioedema”.

Other side effects include:

Very common side effects (may affect more than 1 in 10 people):
hot flushes;
feeling of weakness;
joint pain or stiffness;
joint inflammation (arthritis);
skin rash;
feeling unwell (nausea);
headache;
depression;
loss of bone density (osteoporosis).

Common side effects (may affect up to 1 in 10 people):
vaginal dryness;
vaginal bleeding (usually in the first few weeks of treatment). If the bleeding continues, consult your doctor;
thinning hair (hair loss);
diarrhoea;
loss of appetite;
increased or high levels in the blood of a fatty substance known as cholesterol. This can be seen with a blood test;
feeling unwell (vomiting);
feeling sleepy;
carpal tunnel syndrome (tingling, pain, cold sensation, loss of strength in some parts of the hand);
changes in blood tests showing how well your liver is working;
bone pain;
muscle pain;
itching, tingling or numbness of the skin, loss/lack of taste;
allergic reactions (hypersensitivity) including to the face, lips, tongue.

Uncommon side effects (may affect up to 1 in 1,000 people):
trigger finger (a condition in which your finger or thumb assumes a bent position);
changes in some specific blood tests that highlight the functionality of your liver (gamma-GT and bilirubin);
liver inflammation (hepatitis);
urticaria;
increased amounts of calcium in your blood. If you experience nausea, vomiting and thirst, inform your doctor or pharmacist as it may be necessary to perform blood tests.

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 can 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
RAOLOZ reduces the amount of hormones called estrogens present in your body. This may reduce the mineral content of your bones; therefore, they may become less strong and fracture more easily.
Your doctor will monitor these risks in accordance with the treatment guidelines for the management of bone health in postmenopausal women. You should talk to 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 https://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 RAOLOZ

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 pack after “Exp.”. The expiry date
refers to the last day of that month.
Store in the original packaging
Do not store at a temperature above 30°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What RAOLOZ contains

• The active ingredient is: anastrozole. Each film-coated tablet contains 1 mg of anastrozole.
• The other ingredients are: lactose monohydrate, povidone K30, sodium starch glycolate, magnesium stearate, hypromellose 5cp, macrogol 300, titanium dioxide (E171).

Description of the appearance of RAOLOZ and contents of the pack
Raoloz film-coated tablets are white, round and biconvex.
Raoloz is available in packs of 28 tablets.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Istituto Gentili S.r.l., Via San Giuseppe Cottolengo, 15 - 20143 Milano
Manufacturer
Genetic S.p.A., Contrada Canfora - 84084 Fisciano (SA)