Anastrozole Sandoz

Patient Information Leaflet

Please read 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 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 you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Anastrozole Sandoz is and what it is used for
2. What you need to know before taking Anastrozole Sandoz
3. How to take Anastrozole Sandoz
4. Possible side effects
5. How to store Anastrozole Sandoz
6. Package contents and other information

1. What Anastrozole Sandoz is and what it is used for

Anastrozole Sandoz contains a substance called anastrozole, which belongs to a group of medicines known as "aromatase inhibitors". Anastrozole Sandoz is used for the treatment of breast cancer in postmenopausal women.
Anastrozole Sandoz works by reducing the amount of hormones called oestrogens produced by the body.
This is achieved by blocking a natural substance (enzyme) in your body called "aromatase".

2. What you need to know before taking Anastrozole Sandoz

Do not take Anastrozole Sandoz:

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

• 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 Sandoz");
• 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 Sandoz.
If you are admitted to hospital, inform medical staff that you are taking Anastrozole Sandoz.
Other medicines and Anastrozole Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Anastrozole Sandoz may affect how some medicines work, and some medicines may affect Anastrozole Sandoz.
Do not take Anastrozole Sandoz 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 prevent Anastrozole Sandoz from working properly.
• Medicines containing estrogens, for example hormone replacement therapy (HRT). If this applies to you, consult your doctor or pharmacist.

Tell your doctor or pharmacist if you are taking any of the following:

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

Pregnancy and breastfeeding
Do not take Anastrozole Sandoz if you are pregnant or breastfeeding. Stop taking Anastrozole Sandoz 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 Sandoz will affect your ability to drive or use tools or machinery. However, some people may occasionally feel weak or drowsy while taking Anastrozole Sandoz. If this occurs, consult your doctor or pharmacist.
Anastrozole Sandoz contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially "sodium-free".
Anastrozole Sandoz contains lactose, a type of sugar
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 Sandoz

Always take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.

• The usual 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 Sandoz before, with, or after food.

Continue taking Anastrozole Sandoz 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 Sandoz must not be given to children and adolescents.
If you take more Anastrozole Sandoz than you should
If you take more Anastrozole Sandoz than you should, inform your doctor immediately.
If you forget to take Anastrozole Sandoz
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 a forgotten dose.
If you stop taking Anastrozole Sandoz
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 or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop taking Anastrozole Sandoz and seek urgent medical attention if any of the following very rare but serious side effects occur:

• Extremely severe skin reaction with the appearance of ulcers or blisters on the skin. Known as “Stevens-Johnson syndrome”.
• Allergic reaction (hypersensitivity) with swelling of the throat which may cause difficulty swallowing or breathing. Known as ‘angioedema’.

Other possible side effects:

Very common side effects (may affect more than 1 in 10 people)

• Headache.
• Hot flushes.
• Feeling unwell (nausea).
• Skin rash.
• Pain or stiffness in the joints.
• Inflammation of the joints (arthritis).
• Feeling weak.
• Loss of bone density (osteoporosis).

Common side effects (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).
• Itching, tingling or numbness of the skin, loss or absence of taste.
• Diarrhoea.
• Feeling unwell (vomiting).
• Changes in blood tests relating to liver function.
• Thinning of hair (hair loss).
• Allergic reactions (hypersensitivity) involving the face, lips and tongue.
• Bone pain.
• Vaginal dryness.
• Vaginal bleeding (usually during the first weeks of treatment – if bleeding continues, speak to your doctor).
• Muscle pain.

Uncommon side effects (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 one of your fingers or your thumb becomes locked in a bent position).
• Increased level of calcium in the blood. If you experience nausea, vomiting and thirst, consult your doctor, pharmacist or nurse, as you may need blood tests.

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

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

Effects on bones
Anastrozole Sandoz 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 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, pharmacist or nurse.
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 Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister/HDPE bottle and outer carton. The expiry date refers to the last day of that month.

ALU/PVC blister
This medicine does not require any special storage conditions.

HDPE bottle
Do not store above 30°C.

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 Anastrozole Sandoz Contains
The active substance is anastrozole.
Each film-coated tablet contains 1 mg of anastrozole.
The excipients are:
Tablet core:
monohydrate lactose, microcrystalline cellulose, sodium starch glycolate (type A), magnesium stearate, anhydrous colloidal silica, hydroxypropylcellulose
Tablet coating:
Opadry II White: monohydrate lactose, hypromellose, macrogol 4000, titanium dioxide (E171)

Description of the Appearance of Anastrozole Sandoz and Package Contents
Film-coated tablets, round and biconvex, white in colour, with "A1" engraved on one side.
The film-coated tablets are packaged in ALU/PVC blisters and placed in a box,
or packaged in an HDPE bottle with a PP screw cap.
Blister packs: 10, 20, 28, 30, 50, 56, 84, 90, 98, 100 film-coated tablets
Bottle: 10, 20, 28, 30, 50, 56, 84, 90, 98, 100 film-coated tablets
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Sandoz S.P.A.
Largo U. Boccioni, 1
21040 Origgio (Varese)
Italy

Manufacturers
Salutas Pharma GmbH – Otto Von Guericke Allee 1 – 39179 Barleben (Germany)
Lek Pharmaceuticals d.d. – Verovskova 57 – 1526 Ljubljana (Slovenia)

This medicinal product is authorized in the European Economic Area countries under the following names:
Belgium  Anastrozol Sandoz 1 mg filmomhulde tabletten
United Kingdom Anastrozole 1 mg Film-coated Tablets
Austria  Anastrozol Sandoz 1 mg – Filmtabletten
Denmark  Anastrozol Sandoz 1 mg filmomhulde tabletten
Finland  Anastrozol Sandoz 1 mg kalvopäällysteinen tabletti
Italy  Anastrozolo Sandoz
Slovenia  Anastrozol Sandoz 1 mg filmsko obložene tablete
Spain  Anastrozol Sandoz 1 mg comprimidos recubiertos con pelicula EFG
Sweden  Anastrozol Sandoz 1 mg filmdragerade tabletter
Romania  Anastraze 1 mg comprimate filmate