Package leaflet: Information for the user

Griset 1 mg film-coated tablets

anastrozole
Generic medicine
Read this entire 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, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Griset is and what it is used for

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

Do not take Griset

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 Griset if any of the above apply to you. If in doubt, consult your doctor or pharmacist before taking Griset.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Griset

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 Griset").
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

Griset.
Griset.
For those engaged in sports activities
Using this medicine without a therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.
Other medicines and Griset
Tell 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. Griset may affect how some medicines work, and some medicines may affect Griset.
Do not take Griset 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 tamoxifene. This is because these medicines may interfere with the proper action of Griset.
Medicines If any of these apply to you, 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 gonadorelin, buserelin, goserelin, leuprorelin, and triptorelin. These medicines are used to treat breast cancer, certain gynecological conditions, and infertility.

Pregnancy and breastfeeding
Do not take Griset if you are pregnant or breastfeeding. Stop taking Griset if you become pregnant and speak to your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Griset However, some people may occasionally experience weakness or drowsiness while taking Griset. If this occurs, consult your doctor or pharmacist.
Griset contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Griset contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "sodium-free".

3. How to take Griset

Take Griset 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 each day.
Swallow the tablet whole with a glass of water.
It does not matter whether you take Griset before, with, or after food. Continue taking Griset for the entire period indicated by your doctor or pharmacist. This 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
Griset must not be given to children and adolescents.
If you take more Griset than you should
If you take more Griset than you should, inform your doctor immediately.
If you forget to take Griset
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 forgotten dose.
If you stop taking Griset
Do not stop taking the tablets unless instructed by your doctor.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop taking Griset and seek urgent medical treatment 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”.
Allergic reaction (hypersensitivity) with swelling of the throat, which may cause difficulty swallowing or breathing. This is known as “angioedema”.

Very common side effects (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 side effects (affect 1 to 10 in 100 people)

Loss of appetite
Increase or high levels in the blood of a fatty substance known as cholesterol, detectable by a blood test
Feeling drowsy
Carpal tunnel syndrome (tingling, pain, cold sensation, loss of strength in parts of the hand)
Itching, tingling or numbness of the skin, loss or absence of taste
Diarrhea
Feeling unwell (vomiting)
Changes in blood tests relating to liver function
Thinning of hair (hair loss)
Allergic reactions (hypersensitivity), including affecting 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 side effects (affect 1 to 10 in 1,000 people)

Changes in specific blood tests indicating liver function (gamma-GT and bilirubin)
Inflammation of the liver (hepatitis)
Hives (urticaria)
Trigger finger (a condition in which one of your fingers or your thumb becomes locked in a bent position)
Increased levels of calcium in your blood. If you experience nausea, vomiting, and thirst, inform your doctor, pharmacist, or nurse, as blood tests may be needed.

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

Unusual skin inflammation which may include red spots or blisters
Skin redness 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”.

Effects on bones
Griset reduces the amount of hormones called oestrogens in your body. This may reduce the mineral content of your bones; therefore, bones may become weaker and more prone to fractures. Your doctor will monitor these risks in accordance with treatment guidelines for managing bone health in postmenopausal women. Please consult your doctor regarding these risks and treatment options.
If any of the side effects worsen, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.
Reporting of side effects
If you get any side effect, 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 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 Griset

Do not store above 30 °C.
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 and on the blister after "Exp". The expiry date refers to the last day of the month.
Keep the tablets in the original packaging.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Griset 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 Griset and contents of the pack
Blister pack containing film-coated tablets.
Pack size: 28 tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Manufacturer
Genetic S.p.A., Contrada Canfora - 84084 Fisciano (SA)