ANASTROZOLE MYLAN GENERICS

PACKAGE LEAFLET: INFORMATION FOR THE USER

Anastrozole Mylan Generics 1 mg film-coated tablets

Read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further 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 seem identical to yours, as it may be harmful to them.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Anastrozole Mylan Generics is and what it is used for
2. What you need to know before taking Anastrozole Mylan Generics
3. How to take Anastrozole Mylan Generics
4. Possible side effects
5. How to store Anastrozole Mylan Generics
6. Contents of the pack and other information

1. What Anastrozolo Mylan Generics is and what it is used for

Anastrozolo Mylan Generics tablets contain a substance called anastrozole. This
belongs to a group of medicines called "aromatase inhibitors". Anastrozole is
used to treat breast cancer in women who have been through menopause.
Anastrozole works by lowering the amount of a hormone called estrogen produced by
your body. It does this by blocking a natural substance (an enzyme) in your body called
"aromatase".

2. What you should know before taking Anastrozole Mylan Generics

Do not take Anastrozole Mylan Generics:

• 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 the section entitled “Pregnancy and breastfeeding”)
  Do not take Anastrozole in any of the cases listed above. If you are unsure, speak with your doctor or pharmacist before taking Anastrozole Mylan Generics.

Warnings and precautions
Talk to your doctor or pharmacist before taking Anastrozole Mylan Generics if:

• You still have menstrual cycles and have not yet reached menopause.
• You are taking a medicine containing tamoxifen or medicines containing estrogens (see the section entitled “Other medicines and Anastrozole Mylan Generics”).
• You have ever had conditions affecting bone strength (osteoporosis).
• You have liver or kidney problems.

If you are unsure whether any of the above situations apply to you, talk to your doctor or pharmacist before taking Anastrozole Mylan Generics.
If you are admitted to hospital, you must inform the medical staff that you are taking Anastrozole Mylan Generics.
For athletes: The use of this medicine without a therapeutic need constitutes doping and may lead to a positive anti-doping test.

Other medicines and Anastrozole Mylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines you buy without a prescription and herbal medicines. This is because Anastrozole Mylan Generics may affect how some medicines work, and some medicines may affect Anastrozole Mylan Generics.

Do not take Anastrozole Mylan Generics if you are already taking the following medicines:

• Certain medicines used to treat breast cancer (selective estrogen receptor modulators), for example medicines containing tamoxifene. This is because such medicines may prevent Anastrozole Mylan Generics from working properly.
• Medicines containing estrogens, such as those used for hormone replacement therapy (HRT). If this applies to you, consult your doctor or pharmacist.

Tell your doctor or pharmacist if you are taking:

• A medicine known as an “LHRH analogue”, such as gonadorelin, buserelin, goserelin, leuprorelin, or triptorelin. These medicines are used to treat breast cancer, certain gynecological conditions, and infertility.

Pregnancy and breastfeeding
Do not take Anastrozole Mylan Generics if you are pregnant or breastfeeding. Stop taking Anastrozole Mylan Generics if you become pregnant and speak to your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
It is unlikely that Anastrozole Mylan Generics will affect your ability to drive or operate tools or machinery. However, some people may occasionally experience weakness and drowsiness while taking Anastrozole Mylan Generics. If this happens to you, consult your doctor or pharmacist.

Anastrozole Mylan Generics contains lactose and sodium
Anastrozole Mylan Generics contains lactose, a milk sugar. If your doctor has diagnosed you with an intolerance to certain sugars, such as lactose, 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 Anastrozole Mylan Generics

Take Anastrozole Mylan Generics exactly as your doctor or pharmacist has told you. If you have any doubts, consult your doctor or pharmacist.

• The recommended dose is one tablet (1 mg of anastrozole) to be taken once daily.
• Try to take your tablet at the same time every day.
• Swallow your tablet whole with a glass of water.
• It does not matter whether you take Anastrozole Mylan Generics before, during or after meals.

Continue taking Anastrozole Mylan Generics for as long as your doctor tells you to.
This is a long-term treatment and you may need to continue taking it for several years. If you have any doubts, consult your doctor or pharmacist.
Use in children and adolescents
Anastrozole Mylan Generics must not be given to children and adolescents.
If you take more Anastrozole Mylan Generics than you should
If you have taken more Anastrozole Mylan Generics than you should, contact your doctor immediately.
If you forget to take Anastrozole Mylan Generics
If you forget to take a dose, simply take your 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 Anastrozole Mylan Generics
Do not stop taking the tablets unless your doctor tells you to.
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 everyone experiences them.
If you experience any of the following side effects, stop taking Anastrozole Mylan Generics immediately.
Contact your doctor immediately or go to the nearest hospital emergency department:

Uncommon (may affect up to 1 in 100 people)

• Inflammation of the liver (hepatitis) with nausea, vomiting, loss of appetite, fever, itching, yellowing of the skin and eyes, pale stools or dark urine.

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

• Skin rash due to hypersensitivity (this may result from a severe allergic reaction)
• Inflammation of small blood vessels causing red or purple skin discolouration. Very rarely, symptoms such as joint pain, stomach pain, and kidney pain may occur; this is known as “Henoch-Schönlein purpura”.

Very rare (affects less than 1 in 10,000 patients)

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

Other side effects include:
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
• Bone loss (osteoporosis)
• Depression

Common (may affect up to 1 in 10 people)

• Loss of appetite
• Increase or high levels in the blood of a fatty substance known as cholesterol. This may be detected during blood tests
• Feeling sleepy
• Carpal tunnel syndrome (tingling, pain, cold sensation, weakness in parts of the hand)
• Itching, tingling or numbness of the skin, loss or absence of taste
• Diarrhoea
• Malaise (vomiting)
• Changes in blood tests showing liver function levels
• Thinning of hair (hair loss)
• Allergic reactions (hypersensitivity), including of the face, lips or tongue
• Bone pain
• Vaginal dryness
• Vaginal bleeding (usually during the first weeks of treatment – if bleeding persists, discuss this with your doctor)
• Muscle pain

Uncommon (may affect up to 1 in 100 people)

• Changes in specific blood tests showing how your liver is working (gamma-GT and bilirubin)
• Hives or skin rash
• Increased or high levels of calcium in the blood. If you experience nausea, vomiting and thirst, inform your doctor or pharmacist, as you may need blood tests.
• Trigger finger (a condition in which your fingers or thumb become locked in a bent position)

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

• Rare skin inflammations which may include red spots or blisters, known as erythema multiforme

Not known (frequency cannot be estimated from the available data)

• Dry eyes
• Lichenoid eruption (small itchy red or purple bumps on the skin)
• Inflammation of a tendon or tendinitis (connective tissue that joins muscles to bones)
• Tendon rupture (connective tissue that joins muscles to bones)
• Memory impairment

Effects on bones
Anastrozole lowers the levels of a hormone called oestrogen in your body.
This may cause a reduction in the mineral content of your bones. Your bones may become less strong and fractures may occur more easily. Your doctor will manage these risks in accordance with treatment guidelines for bone health management in postmenopausal women. You should discuss the risks and treatment options with your doctor.

Reporting of side effects
If you experience 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
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 Anastrozole Mylan Generics

Keep Anastrozole Mylan Generics out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the pack after the word “Exp.”. The expiry date refers to the last day of that month.
Do not dispose of medicines 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 Anastrozolo Mylan Generics contains

• The active substance is anastrozole. One tablet contains 1 mg of anastrozole.
• The excipients in the tablet core are: monohydrate lactose (see section 2 “Anastrozolo Mylan Generics contains lactose and sodium”), sodium starch glycolate, povidone (E1201), magnesium stearate (E572). The excipients in the film coating are: macrogol, hypromellose (E464), titanium dioxide (E171).

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

Marketing Authorisation Holder:
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan, Italy

Responsible manufacturer for batch release:
McDermott Laboratories t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13,
Ireland
Synthon BV
Microweg 22, 6545 CM Nijmegen
The Netherlands
Synthon Hispania, S.L.
C/Castello, 1 Poligono Las Salinas,
08830 Sant Boi de Llobregat, Barcelona
Spain
Generics [UK] Ltd
Station Close, Potters Bar, Hertfordshire, EN6 1TL
United Kingdom
Mylan Hungary Kft.
H-2900, Komárom
Mylan utca 1
Hungary
Viatris UK Healthcare Limited
Building 20, Station Close, Potters Bar, EN6 1TL,
United Kingdom

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Netherlands: Anastrozol Viatris 1 mg, filmomhulde tabletten
Austria: Anastrozol Viatris 1 mg Filmtabletten
Czech Republic: Anastrozol Viatris
Spain: Anastrozol Viatris 1 mg comprimidos recubiertos con película EFG
France: Anastrozole Viatris 1 mg, comprimé peliculé
Ireland: Agerdex 1 mg film-coated tablets
Italy: Anastrozolo Mylan Generics
Portugal: Anastrozol Mylan
United Kingdom (Northern Ireland): Anastrozole 1 mg Film-coated Tablet