Package leaflet: Information for the user

Anastrozole SUN 1 mg film-coated tablets

Generic medicine
Please read all of 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 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:

What Anastrozole SUN is and what it is used for
What you need to know before taking Anastrozole SUN
How to take Anastrozole SUN
Possible side effects
How to store Anastrozole SUN
Contents of the pack and other information

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

Anastrozolo SUN contains a substance called anastrozole, which belongs to a group of medicines known as "aromatase inhibitors". Anastrozolo SUN is used for the treatment of breast cancer in postmenopausal women.
Anastrozolo SUN 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 taking Anastrozole SUN

Do not take Anastrozole SUN

if you are allergic to anastrozole 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 Anastrozole SUN if any of the above apply to you. If in doubt, consult your doctor or pharmacist before taking Anastrozole SUN.
Warnings and precautions
Talk to your doctor or pharmacist before taking Anastrozole SUN

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 section “Other medicines and Anastrozole SUN”)
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 Anastrozole SUN.
If you are admitted to hospital, inform medical staff that you are taking Anastrozole SUN.
For those engaged in sports: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

Other medicines and Anastrozole SUN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Anastrozole SUN may affect how some medicines work, and some medicines may affect Anastrozole SUN.
Do not take Anastrozole SUN 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 tamoxifen. This is because these medicines may prevent Anastrozole SUN 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 the following:

a medicine known as an “LHRH analogue”. This includes gonadorelin, buserelin, goserelin, leuprorelin and triptorelin. These medicines are used to treat breast cancer, certain gynaecological conditions and infertility.

Pregnancy, breastfeeding and fertility
Do not take Anastrozole SUN if you are pregnant or breastfeeding. Discontinue Anastrozole SUN if you become pregnant and speak to your doctor.
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
It is unlikely that Anastrozole SUN will affect your ability to drive or use tools or machines.
However, some people may occasionally experience weakness or drowsiness while taking Anastrozole SUN. If this occurs, consult your doctor or pharmacist.

Anastrozole SUN contains lactose monohydrate
Anastrozole SUN 1 mg film-coated tablets contain 68.75 mg of lactose monohydrate per tablet. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Anastrozole SUN

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or
pharmacist.

The recommended dose is one tablet once daily.
Try to take the tablet at the same time each day.
Swallow the tablet whole with a glass of water.
It does not matter whether you take Anastrozole SUN before, with or after food.

Continue taking Anastrozole SUN for the entire duration indicated by your doctor. This is a long-term treatment and
you may need to take it for several years.
Use in children and adolescents
Anastrozole SUN must not be given to children and adolescents.
If you take more Anastrozole SUN than you should
If you take more Anastrozole SUN than you should, inform your doctor immediately.
If you forget to take Anastrozole SUN
If you forget to take a dose, take the next dose at the usual time.
Do not take a double dose to make up for the forgotten dose.
If you stop taking Anastrozole SUN
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.
If you experience any of the following serious but very rare side effects, stop treatment with
Anastrozole SUN and seek immediate medical attention:

extremely severe skin reaction, with ulcers or blisters appearing on the skin. This is known as “Stevens-Johnson syndrome”.
allergic reaction (hypersensitivity) with swelling of the throat, which may cause difficulty in swallowing or breathing. This is known as “angioedema”.

Very common (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 weak
loss of bone density (osteoporosis)
depression.

Common (may affect up to 1 in 10 people)

loss of appetite
increase or elevated levels in the blood of a fatty substance known as cholesterol, detectable by a blood test
drowsiness
carpal tunnel syndrome (tingling, pain, cold sensation in parts of the hand)
tingling, prickling, or numbness of the skin, loss or absence of taste
diarrhoea
feeling unwell (vomiting)
changes in blood tests related to liver function
hair thinning (hair loss)
allergic reactions (hypersensitivity), including of the face, lips, and tongue
bone pain
vaginal dryness
vaginal bleeding (usually during the first weeks of treatment – if bleeding continues, discuss this with your doctor)
muscle pain.

Uncommon (may affect up to 1 in 100 people)

changes in certain specific blood tests indicating liver function (gamma-GT and bilirubin)
inflammation of the liver (hepatitis)
hives (urticaria)
trigger finger (a condition in which a finger or thumb becomes locked in a bent position)
high levels of calcium in the blood. If you currently have severe nausea, vomiting, and thirst, consult your doctor, pharmacist, or nurse. Blood tests may be needed.

Rare (may affect up to 1 in 1,000 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 small blood vessels causing red or purple skin discolouration. Very rarely, joint, stomach, and kidney pain may occur; this is known as “Henoch-Schönlein purpura”.

If you experience any of these effects, call an ambulance or consult a doctor immediately – urgent medical treatment may be required.

Effects on bones
Anastrozole SUN reduces the amount of hormones called oestrogens in the body. This may reduce the mineral content of bones; therefore, 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. Please consult your doctor about these risks and treatment options.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Anastrozole SUN

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 harmful to 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.
This medicine does not require any special storage conditions. Store in the outer packaging.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Anastrozolo SUN contains

The active substance is anastrozole. One film-coated tablet contains 1 mg of anastrozole.
The other components of the tablet core are monohydrate lactose, povidone K30 (E1201), sodium starch glycolate (type A), magnesium stearate (E572). The tablet core is coated with Opadry white film-coating agent containing hypromellose 6CP (E464), titanium dioxide (E171), macrogol 400.

Description of the appearance of Anastrozolo SUN 1 mg film-coated tablets and package contents
White to off-white, round, biconvex, film-coated tablets, with "A1" engraved on one side.
The film-coated tablets are available in PVC/Al blisters containing 10 or 14 tablets, packed in cartons containing
28, 30, 60, 84 or 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Sun Pharma France
31 Rue des Poissonniers
92 200 Neuilly-sur-Seine
France
Local representative:
Sun Pharma Italia Srl
Viale Giulio Richard, 3
20143 Milano
Italy
This medicinal product is authorised in the European Economic Area countries under the following
names:
Germany: Anastrozol SUN 1 mg Filmtabletten
Italy: Anastrozolo SUN 1 mg compresse rivestite con film
Netherlands: Anastrozol SUN 1 mg, filmomhulde tabletten
United Kingdom: Anastrozole 1 mg Film-coated Tablets