Raoloz

Package leaflet: Information for the user

RAOLOZ 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 effects, including 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 taking 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 RAOLOZ is and what it is used for

RAOLOZ contains an active substance called anastrozole, which belongs to a group of medicines known as "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 is achieved by blocking a natural substance (enzyme) in your body called "aromatase".

2. What you should know before taking RAOLOZ

Do not take RAOLOZ:
if you are allergic to the active substance 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 any of the above apply to you. 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 are still having menstrual periods and have not yet reached menopause,
you are taking a medicine containing tamoxifen or medicines containing estrogens (see section
"Other medicines and RAOLOZ"),
you have or have ever had a condition affecting bone strength (osteoporosis),
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
RAOLOZ.
If you are admitted to hospital, inform medical staff that you are taking RAOLOZ.
Children and adolescents
RAOLOZ is not recommended for children and adolescents.
For those engaged in sports activities
If you participate in sports: using this medicine without therapeutic need constitutes doping and may
lead to a positive anti-doping test.
Other medicines and RAOLOZ
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicines.
This includes medicines you can buy without a prescription and herbal remedies. RAOLOZ may affect how some medicines work, and some medicines may affect 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 may prevent RAOLOZ from working properly. Medicines containing estrogens, for example hormone replacement therapy (HRT).
If any of these apply to you, consult your doctor or pharmacist.
Inform your doctor or pharmacist if you are taking medicines known as “gonadotropin-releasing hormone analogues (LHRH analogues)”. These include gonadorelin, buserelin, goserelin,
leuprorelin and triptorelin. These medicines are used to treat breast cancer, certain gynecological conditions and infertility.
Fertility, pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy and breastfeeding
Do not take RAOLOZ if you are pregnant or breastfeeding.
Stop taking Raoloz if you become pregnant and speak to your doctor.
Fertility
There are no data available on the effect of Raoloz on fertility. Animal data have shown adverse effects on reproduction.
Driving and using machines
It is unlikely that RAOLOZ will affect your ability to drive or operate tools or
machinery.
However, some people may occasionally experience weakness or drowsiness while
taking RAOLOZ.
If this occurs, consult your doctor or pharmacist.
RAOLOZ contains lactose and sodium
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this 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 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 RAOLOZ before, during, or after meals.
Continue taking RAOLOZ for the entire duration indicated by your doctor. This is a long-term treatment and
you may need to continue it for several years.
If you have any doubts, consult your doctor or pharmacist.
If you take more RAOLOZ than you should
In case of accidental ingestion or overdose of RAOLOZ, inform your doctor immediately or go to the nearest
hospital.
If you forget to take RAOLOZ
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 forgotten
dose.
If you stop taking RAOLOZ
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 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:

• A very severe skin reaction, with ulcers or blisters appearing on the skin. This is known as “Stevens-Johnson syndrome”.
• An allergic reaction (hypersensitivity) with swelling of the throat, which may 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 weak;
joint pain or stiffness;
inflammation of the joints (arthritis);
rash;
feeling unwell (nausea);
headache;
depression;
loss of bone density (osteoporosis).
Common side effects (may affect from 1 to 10 in 100 people):
vaginal dryness;
vaginal bleeding (usually during the first weeks of treatment). If bleeding continues, consult your doctor;
hair thinning (hair loss);
diarrhoea;
loss of appetite;
increase or high levels in the blood of a fatty substance known as cholesterol. This can be detected with a blood test;
feeling unwell (vomiting);
drowsiness;
carpal tunnel syndrome (tingling, pain, cold sensation, loss of strength in parts of the hand);
changes in blood tests indicating how well your liver is functioning;
bone pain;
muscle pain;
tingling, prickling or numbness of the skin, loss or absence of taste;
allergic reactions (hypersensitivity), including of the face, lips, and tongue.
Uncommon side effects (may affect from 1 to 10 in 1,000 people):
trigger finger (a condition in which your finger or thumb becomes bent);
changes in certain specific blood tests indicating liver function (gamma-GT and bilirubin);
inflammation of the liver (hepatitis);
urticaria;
increased levels of calcium in your blood. If you experience nausea, vomiting, and thirst, inform your doctor or pharmacist, as blood tests may be needed.
Rare side effects (may affect from 1 to 10 in 10,000 people):

• unusual skin inflammation which may include red spots or blisters;
• skin erythema caused by hypersensitivity (this may be due to an allergic or anaphylactic reaction);
• inflammation of the capillaries causing red or purple skin discolouration. Very rarely, joint, stomach, and kidney pain may occur; this is known as “Henoch-Schönlein purpura”.

Effects on bones
RAOLOZ reduces the amount of hormones called oestrogens in your body. This may reduce the mineral content of your bones; therefore, your bones may become weaker and more likely to fracture.
Your doctor will monitor these risks in accordance with treatment guidelines for managing bone health in postmenopausal women. You should discuss these risks and treatment options with your doctor.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects 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.
Store 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 stated on the carton after "Exp.". The expiry date refers to the last day of that month.
Store in the original packaging.
Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What RAOLZ contains

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

Description of the appearance of RAOLZ and contents of the pack
Raoloz film-coated tablets are white, round and biconvex.
Raoloz is available in packs of 28 tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Istituto Gentili S.r.l., Via San Giuseppe Cottolengo, 15 - 20143 Milan
Manufacturer
Genetic S.p.A., Contrada Canfora - 84084 Fisciano (SA)