Calquence

Package leaflet: Information for the patient

Calquence 100 mg hard capsules

acalabrutinib
Please read 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, pharmacist or nurse.
• 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 to them.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What Calquence is and what it is used for

What Calquence is

• Calquence contains the active substance acalabrutinib.
• It belongs to a group of medicines called Bruton tyrosine kinase (BTK) inhibitors.

What Calquence is used for
Calquence is used to treat adults with chronic lymphocytic leukaemia (CLL).
CLL is a cancer of white blood cells called B-lymphocytes (or B-cells). These cells are part of the
immune system (the body's defences).
Calquence is used to treat adults with mantle cell lymphoma (MCL).
MCL is a type of blood cancer that affects the lymph nodes.

How Calquence works
Calquence works by blocking BTK, a protein in the body that helps cancer cells grow and survive. By inhibiting BTK, Calquence helps kill cancer cells and may reduce their number, thereby slowing disease progression.
If you have any questions about how Calquence works or why this medicine has been prescribed for you, please consult your doctor, pharmacist, or nurse.

2. What you need to know before taking Calquence

Do not take Calquence

• if you are allergic to acalabrutinib or to any of the other ingredients of this medicine (listed in section 6).

If you are unsure, consult your doctor, pharmacist, or nurse before taking Calquence.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Calquence if:

• you have ever had unusual bruising or bleeding, or if you are taking any medicine that increases the risk of bleeding (see section 4 “Possible side effects”)
• you have an infection (see section 4 “Possible side effects”)
• you have recently undergone or are about to undergo surgery. Your doctor may interrupt treatment with Calquence before and after any medical, surgical, or dental procedure
• you have had hepatitis B (a liver infection), as Calquence could cause reactivation of hepatitis B; your doctor will monitor for signs of recurrence of this infection (see section 4 “Possible side effects”)
• you have or have ever had an irregular heartbeat (see section 4 “Possible side effects”).

Contact your doctor if you develop a new skin lesion or any change in the appearance of an area of skin, as you are at increased risk of developing skin cancer (see section 4). Use sunscreen and have regular skin examinations.
Your doctor will check your blood counts during treatment, if necessary.
Children and adolescents
This medicine must not be given to children and adolescents under 18 years of age, as it has not been studied in this age group.
Other medicines and Calquence
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines, especially if you are taking:

• antibiotics for bacterial infections – such as clarithromycin
• medicines for fungal infections – such as posaconazole, itraconazole, or voriconazole
• ketoconazole – a medicine for Cushing's syndrome (a condition in which the body produces too much cortisol)
• medicines for HIV infection – such as indinavir and ritonavir
• medicines for hepatitis C – such as telaprevir
• rifampicin – an antibiotic for bacterial infections (tuberculosis)
• ergotamine – a medicine for migraines
• conivaptan – a medicine for low sodium levels in the blood
• metformin – a medicine for high blood sugar levels
• cyclosporine – a medicine to prevent organ rejection
• medicines for seizures (fits) or epilepsy – such as carbamazepine and phenytoin
• pimozide – a medicine used for Tourette's syndrome (a disorder causing uncontrollable movements and excessive words and sounds)
• St. John’s wort (hypericum, Hypericum perforatum L.) – a herbal medicine for depression
• theophylline – a medicine used for wheezing, shortness of breath, and chest tightness
• medicines to reduce stomach acid: or antacids – such as calcium carbonate. Take Calquence 2 hours before or 2 hours after taking these medicines.
• histamine-2 receptor blockers – such as ranitidine and famotidine. Take Calquence 2 hours before or 10 hours after taking these medicines.
• proton pump inhibitors – such as omeprazole. Avoid taking these medicines while taking Calquence.
• methotrexate – a medicine for conditions such as rheumatoid arthritis, psoriasis, and ulcerative colitis, which are caused by improper functioning of the immune system.
• This medicine should be taken at least 6 hours before or after Calquence.

Medicines that increase the risk of bleeding
Calquence may increase the risk of bleeding. Inform your doctor, pharmacist, or nurse if you are taking other medicines that increase the risk of bleeding:

• antiplatelet agents (medicines that prevent blood clotting) such as acetylsalicylic acid and clopidogrel
• anticoagulants (blood thinners) such as warfarin or enoxaparin.

Pregnancy
If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor for advice before taking Calquence. This is because Calquence may harm your unborn baby.
Breast-feeding
Do not breast-feed during treatment with Calquence and for 2 days after the last dose of Calquence. It is not known whether Calquence passes into breast milk.
Driving and using machines
It is unlikely that Calquence will affect your ability to drive or use machines. However, if you experience dizziness, weakness, or fatigue while taking Calquence, do not drive or operate machinery.
Calquence contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.

3. How to take Calquence

Calquence will only be prescribed by a doctor experienced in the use of anticancer medicines. Always take Calquence exactly as your doctor has told you. If you are unsure, consult your doctor, pharmacist, or nurse.
Depending on the type of cancer, Calquence may be administered in combination with other anticancer medicines.

How much to take

• The usual dose is one capsule (100 mg) twice daily. Take the doses approximately 12 hours apart.

How to take it

• Swallow the capsule whole with water at approximately the same time each day.
• Do not chew, crush, or open the capsules, as this may alter the rate at which the medicine is absorbed by the body.
• You may take Calquence with food or between meals.
• You can keep track of when you took your last Calquence capsule by looking at the blister pack. The pictures on the blister will help you take your dose at the right time: the sun for the morning dose and the moon for the evening dose.

If you take more Calquence than you should
If you have taken more Calquence than you should have, consult a doctor or go immediately to the nearest hospital. Take the capsules and this patient information leaflet with you.

If you forget to take a dose

• If less than 3 hours have passed since you were supposed to take the missed dose, take it as soon as possible and then take the next dose at your regular time.
• If more than 3 hours have passed since the scheduled time for the missed dose, skip the missed dose. Take the next dose at your regular time.
• Do not take a double dose to make up for the forgotten dose.

If you have any doubts about how to use this medicine, speak to your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Calquence and contact your doctor or go immediately to the nearest emergency room if
you experience any of the following symptoms:

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

• Bleeding at various sites, including skin, intestines, and brain. Symptoms may include black stools or stools with blood, pink or brown urine, nosebleeds, bruising, unexpected bleeding, vomiting or coughing up blood, dizziness, weakness, confusion.
• Infections. Signs may include fever, chills, feeling weak or confused, cough, shortness of breath [lung infection, a very common adverse reaction (may affect more than 1 in 10 people) or aspergillosis, an uncommon adverse reaction (may affect up to 1 in 100 people)].

Common severe side effects (may affect up to 1 in 10 people)

• Rapid heartbeat, skipped heartbeats, weak or irregular pulse, dizziness, feeling faint, chest discomfort or shortness of breath (signs of heart rhythm problems known as atrial fibrillation and atrial flutter).
• Fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, cloudy or dark-coloured urine, unusual tiredness, or muscle or joint pain. These may be symptoms of tumour lysis syndrome (TLS), a condition caused by the rapid breakdown of tumour cells.

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

• Muscle or joint pain
• Headache
• Rash
• Tiredness, weakness or lack of energy
• Stomach discomfort (nausea), vomiting, stomach ache, constipation (rare or hard stools), diarrhoea (frequent or loose stools)
• Decrease in the number of red blood cells, decrease in the number of neutrophils (a type of white blood cells), or decrease in the number of blood cells that help blood clot (platelets)
• High blood pressure
• Dizziness
• Headache, pressure between the eyes, nose or cheeks (sinusitis)
• Sore throat and runny nose (nasopharyngitis)
• Upper respiratory tract infection
• Urinary tract infection (pain or burning during urination)
• New cancers, including skin cancers, may develop during treatment with Calquence (see section 2 “What you need to know before taking Calquence”)
• Herpes

Common (may affect up to 1 in 10 people):

• Increased levels of liver enzymes (aspartate aminotransferase and alanine aminotransferase) in blood tests [when used in combination with certain medicines for the treatment of mantle cell lymphoma (MCL)].
• Bronchitis
• Fever, chills, weakness, confusion, malaise, and yellowing of the skin or eyes (jaundice), which may be signs of reactivated hepatitis B (a liver infection).
• Inflammation of the lungs (pneumonia)

Uncommon side effects (may affect up to 1 in 100 people):

• Memory loss, difficulty thinking, difficulty walking, or loss of vision – these may be symptoms of a serious brain infection (progressive multifocal leukoencephalopathy or PML).
• Lymphocytosis (a higher than normal amount of lymphocytes, a type of white blood cells, in the blood).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor. You can also report side effects directly via the national reporting system listed in Annex V. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Calquence

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after
Exp./EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 Calquence contains
The active substance is acalabrutinib. Each hard capsule contains 100 mg of acalabrutinib.
The other components are:

• capsule contents: microcrystalline cellulose, anhydrous colloidal silica, partially pregelatinized maize starch, magnesium stearate (E470b) and sodium starch glycolate (see section 2 “Calquence contains sodium”)
• capsule shell: gelatin, titanium dioxide (E171), iron oxide yellow (E172) and indigotine (E132)
• printing ink: shellac, iron oxide black (E172), propylene glycol (E1520) and ammonium hydroxide.

Description of the appearance of Calquence and pack sizes
Calquence is a 20 mm hard gelatin capsule with a yellow body and blue cap, printed in black with “ACA 100 mg”.
Calquence is supplied in aluminium blisters containing 6 or 8 hard capsules. Each pack contains 56 or 60 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
AstraZeneca AB
SE-151 85 Södertälje
Sweden

Manufacturer
AstraZeneca AB
Gärtunavägen
SE-152 57 Södertälje
Sweden

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
AstraZeneca S.A./N.V. UAB AstraZeneca Lietuva
Tel: +32 2 370 48 11 Tel: +370 5 2660550

България Luxembourg/Luxemburg
АстраЗенека България ЕООД AstraZeneca S.A./N.V.
Тел: +359 24455000 Tél/Tel: +32 2 370 48 11

Česká republika Magyarország
AstraZeneca Czech Republic s.r.o. AstraZeneca Kft.
Tel: +420 222 807 111 Tel: +36 1 883 6500

Danmark Malta
AstraZeneca A/S Associated Drug Co. Ltd
Tlf: +45 43 66 64 62 Tel: +356 2277 8000

Deutschland Nederland
AstraZeneca GmbH AstraZeneca BV
Tel: +49 40 809034100 Tel: +31 85 808 9900

Eesti Norge
AstraZeneca AstraZeneca AS
Tel: +372 6549 600 Tlf: +47 21 00 64 00

Ελλάδα Österreich
AstraZeneca A.E. AstraZeneca Österreich GmbH
Τηλ: +30 210 6871500 Tel: +43 1 711 31 0

España Polska
AstraZeneca Farmacéutica Spain, S.A. AstraZeneca Pharma Poland Sp. z o.o.
Tel: +34 91 301 91 00 Tel: +48 22 245 73 00

France Portugal
AstraZeneca AstraZeneca Produtos Farmacêuticos, Lda.
Tél: +33 1 41 29 40 00 Tel: +351 21 434 61 00

Hrvatska România
AstraZeneca d.o.o. AstraZeneca Pharma SRL
Tel: +385 1 4628 000 Tel: +40 21 317 60 41

Ireland Slovenija
AstraZeneca Pharmaceuticals (Ireland) DAC AstraZeneca UK Limited
Tel: +353 1609 7100 Tel: +386 1 51 35 600

Ísland Slovenská republika
Vistor hf. AstraZeneca AB, o.z.
Sími: +354 535 7000 Tel: +421 2 5737 7777

Italia Suomi/Finland
AstraZeneca S.p.A. AstraZeneca Oy
Tel: +39 02 00704500 Puh/Tel: +358 10 23 010

Κύπρος Sverige
Αλέκτωρ Φαρµακευτική Λτδ AstraZeneca AB
Τηλ: +357 22490305 Tel: +46 8 553 26 000

Latvija
SIA AstraZeneca Latvija
Tel: +371 67377100

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/

Patient information leaflet

Calquence 100 mg film-coated tablets

acalabrutinib
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 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, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Calquence is and what it is used for

What Calquence is

• Calquence contains the active substance acalabrutinib.
• It belongs to a group of medicines called Bruton’s tyrosine kinase (BTK) inhibitors.

What Calquence is used for
Calquence is used to treat adults with chronic lymphocytic leukaemia (CLL).
CLL is a cancer of white blood cells called B-lymphocytes (or B-cells). These cells are part of the
immune system (the body's defences).
Calquence is used to treat adults with mantle cell lymphoma (MCL).
MCL is a type of blood cancer that affects the lymph nodes.
How Calquence works
Calquence works by blocking BTK, a protein in the body that helps cancer cells grow and survive. By inhibiting BTK, Calquence helps kill cancer cells and may reduce their number, thereby slowing disease progression.
If you have any questions about how Calquence works or why this medicine has been prescribed for you, please consult your doctor, pharmacist, or nurse.

2. What you need to know before taking Calquence

Do not take Calquence

• if you are allergic to acalabrutinib or to any of the other ingredients of this medicine (listed in section 6).

If you are unsure, consult your doctor, pharmacist, or nurse before taking Calquence.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Calquence if:

• you have ever had unusual bruising or bleeding, or if you are taking any medicine that increases the risk of bleeding (see section 4 “Possible side effects”)
• you have an infection (see section 4 “Possible side effects”)
• you have recently undergone or are about to undergo surgery. Your doctor may stop treatment with Calquence before and after any medical, surgical, or dental procedure
• you have had or have hepatitis B (a liver infection), as Calquence could cause reactivation of hepatitis B; your doctor will monitor you for signs of this infection returning (see section 4 “Possible side effects”)
• you have or have ever had an irregular heartbeat (see section 4 “Possible side effects”).

Talk to your doctor if you develop a new skin lesion or any changes in the appearance of an area of skin, as you are at increased risk of developing skin cancer (see section 4). Use sunscreen and have regular skin examinations.
Your doctor will monitor your blood counts during treatment, if necessary.
Children and adolescents
This medicine must not be given to children and adolescents under 18 years of age, as it has not been studied in this age group.
Other medicines and Calquence
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines, especially if you are taking:

• antibiotics for bacterial infections – such as clarithromycin
• medicines for fungal infections – such as posaconazole, itraconazole, or voriconazole
• ketoconazole – a medicine for Cushing’s syndrome (a condition in which the body produces too much cortisol)
• medicines for HIV infection – such as indinavir and ritonavir
• medicines for hepatitis C – such as telaprevir
• rifampicin – an antibiotic for bacterial infections (tuberculosis)
• ergotamine – a medicine for migraines
• conivaptan – a medicine for low sodium levels in the blood
• metformin – a medicine for high blood sugar levels
• cyclosporine – a medicine to prevent organ rejection
• medicines for seizures (fits) or epilepsy – such as carbamazepine and phenytoin
• pimozide – a medicine used for Tourette’s syndrome (a disorder causing uncontrollable movements and excessive sounds and words)
• St. John’s wort (Hypericum perforatum L.) – a herbal medicine for depression
• theophylline – a medicine used for wheezing, shortness of breath, and chest tightness
• methotrexate – a medicine for conditions such as rheumatoid arthritis, psoriasis, and ulcerative colitis, which are caused by improper functioning of the immune system.
• this medicine must be taken at least 6 hours before or after Calquence.

You may take medicines that reduce stomach acid, such as antacids (calcium carbonate), histamine-2 receptor blockers (ranitidine and famotidine), and proton pump inhibitors (omeprazole) with Calquence tablets.
Medicines that increase the risk of bleeding
Calquence may increase the risk of bleeding. Inform your doctor, pharmacist, or nurse if you are taking other medicines that increase the risk of bleeding:

• antiplatelet agents (medicines that prevent blood clotting) such as acetylsalicylic acid and clopidogrel
• anticoagulants (blood thinners) such as warfarin or enoxaparin.

Pregnancy
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, ask your doctor for advice before taking Calquence. This is because Calquence may harm the unborn baby.
Breast-feeding
Do not breast-feed during treatment with Calquence and for 2 days after the last dose of Calquence. It is not known whether Calquence passes into breast milk.
Driving and using machines
It is unlikely that Calquence will affect your ability to drive or operate machinery. However, if you experience dizziness, weakness, or fatigue while taking Calquence, you should not drive or operate machinery.
Calquence contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially ‘sodium-free’.

3. How to take Calquence

Calquence will only be prescribed by a doctor experienced in the use of anticancer medicines. Take Calquence exactly as instructed by your doctor. If you have any doubts, consult your doctor, pharmacist, or nurse.
Depending on the type of cancer, Calquence may be administered in combination with other anticancer medicines.

How much to take

• The usual dose is one tablet (100 mg) twice daily. Take the doses approximately 12 hours apart.

How to take it

• Swallow the tablet whole with water at approximately the same time each day.
• Do not chew, crush, dissolve, or split the tablets.
• You may take Calquence with food or between meals.
• You can keep track of when you took your last dose of Calquence by looking at the blister pack. The images on the blister will help you take the dose at the right time: the sun for the morning dose and the moon for the evening dose.

If you take more Calquence than you should
If you have taken more Calquence than you should have, consult a doctor or go immediately to the nearest hospital. Take the tablets and this patient information leaflet with you.

If you forget to take a dose

• If less than 3 hours have passed since the time you were supposed to take the missed dose, take it as soon as possible and then take the next dose at your usual time.
• If more than 3 hours have passed since the scheduled time for the dose, skip the missed dose. Take the next dose at your usual time.
• Do not take a double dose to make up for a forgotten dose.

If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Calquence and contact your doctor or go immediately to the nearest emergency room
if you experience any of the following symptoms:

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

• Bleeding at various sites, including skin, intestine, and brain. Symptoms may include black stools or blood in stools, pink or brown urine, nosebleeds, bruising, unexpected bleeding, vomiting or coughing up blood, dizziness, weakness, confusion
• Infections. Signs may include fever, chills, feeling weak or confused, cough, shortness of breath [lung infection, a very common adverse reaction (may affect more than 1 in 10 people) or aspergillosis, an uncommon adverse reaction (may affect up to 1 in 100 people)].

Common severe side effects (may affect up to 1 in 10 people):

• Fast heartbeat, skipped heartbeats, weak or irregular pulse, dizziness, feeling faint, chest discomfort, or shortness of breath (signs of heart rhythm problems known as atrial fibrillation and atrial flutter).
• Fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, cloudy or dark-coloured urine, unusual tiredness, or muscle or joint pain. These may be symptoms of tumour lysis syndrome (TLS), a condition caused by the rapid breakdown of tumour cells.

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

• Muscle or joint pain
• Headache
• Rash
• Tiredness, weakness, or lack of energy
• Stomach discomfort (nausea), vomiting, stomach ache, constipation (rare or hard stools), diarrhoea (frequent or loose stools)
• Decreased number of red blood cells, decreased number of neutrophils (a type of white blood cells), or decreased number of cells that help blood to clot (platelets)
• High blood pressure
• Dizziness
• Headache, pressure between the eyes, nose, or cheeks (sinusitis)
• Sore throat and runny nose (nasopharyngitis)
• Upper respiratory tract infection
• Urinary tract infection (pain or burning during urination)
• New tumours, including skin tumours, may develop during treatment with Calquence (see section 2 “What you need to know before taking Calquence”)
• Herpes

Common (may affect up to 1 in 10 people):

• Increased levels of liver enzymes (aspartate aminotransferase and alanine aminotransferase) in blood tests [when used in combination with certain medicines for the treatment of mantle cell lymphoma (MCL)].
• Bronchitis
• Fever, chills, weakness, confusion, discomfort, and yellowing of the skin or eyes (jaundice) – these may be signs of reactivated hepatitis B (a liver infection)
• Inflammation of the lungs (pneumonia)

Uncommon side effects (may affect up to 1 in 100 people):

• Memory loss, difficulty thinking, difficulty walking, or loss of vision – these may be symptoms of a serious brain infection (progressive multifocal leukoencephalopathy or PML)
• Lymphocytosis (a higher than normal number of lymphocytes, a type of white blood cells, in the blood).

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Calquence

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after
Exp./EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 Calquence contains
The active substance is acalabrutinib. Each film-coated tablet contains 100 mg of acalabrutinib
(as acalabrutinib maleate).
The other ingredients are:

• Tablet core: mannitol (E421), microcrystalline cellulose (E460), low-substituted hydroxypropylcellulose (E463) and sodium stearyl fumarate (see section 2 “Calquence contains sodium”).
• Tablet coating: hypromellose (E464), copovidone, titanium dioxide (E171), macrogol, medium-chain triglycerides, yellow iron oxide (E172) and red iron oxide (E172).

Description of the appearance of Calquence and pack contents
Calquence is an orange-coloured tablet, 7.5 x 13 mm, oval, biconvex, with "ACA 100" engraved on one side and smooth on the other side.
Calquence is supplied in aluminium blisters containing 8 or 10 film-coated tablets. Each blister has sun/moon symbols to help you take the dose at the correct time: the sun for the morning dose and the moon for the evening dose. Both the sun and moon blisters contain the same medicine.
Each pack contains 56 or 60 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
AstraZeneca AB
SE-151 85 Södertälje
Sweden

Manufacturer
AstraZeneca AB
Gärtunavägen
SE-152 57 Södertälje
Sweden

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
AstraZeneca S.A./N.V. UAB AstraZeneca Lietuva
Tel: +32 2 370 48 11 Tel: +370 5 2660550

България Luxembourg/Luxemburg
АстраЗенека България ЕООД AstraZeneca S.A./N.V.
Тел: +359 24455000 Tél/Tel: +32 2 370 48 11

Česká republika Magyarország
AstraZeneca Czech Republic s.r.o. AstraZeneca Kft.
Tel: +420 222 807 111 Tel: +36 1 883 6500

Danmark Malta
AstraZeneca A/S Associated Drug Co. Ltd
Tlf: +45 43 66 64 62 Tel: +356 2277 8000

Deutschland Nederland
AstraZeneca GmbH AstraZeneca BV
Tel: +49 40 809034100 Tel: +31 85 808 9900

Eesti Norge
AstraZeneca AstraZeneca AS
Tel: +372 6549 600 Tlf: +47 21 00 64 00

Ελλάδα Österreich
AstraZeneca A.E. AstraZeneca Österreich GmbH
Τηλ: +30 210 6871500 Tel: +43 1 711 31 0

España Polska
AstraZeneca Farmacéutica Spain, S.A. AstraZeneca Pharma Poland Sp. z o.o.
Tel: +34 91 301 91 00 Tel: +48 22 245 73 00

France Portugal
AstraZeneca AstraZeneca Produtos Farmacêuticos, Lda.
Tél: +33 1 41 29 40 00 Tel: +351 21 434 61 00

Hrvatska România
AstraZeneca d.o.o. AstraZeneca Pharma SRL
Tel: +385 1 4628 000 Tel: +40 21 317 60 41

Ireland Slovenija
AstraZeneca Pharmaceuticals (Ireland) DAC AstraZeneca UK Limited
Tel: +353 1609 7100 Tel: +386 1 51 35 600

Ísland Slovenská republika
Vistor hf. AstraZeneca AB, o.z.
Sími: +354 535 7000 Tel: +421 2 5737 7777

Italia Suomi/Finland
AstraZeneca S.p.A. AstraZeneca Oy
Tel: +39 02 00704500 Puh/Tel: +358 10 23 010

Κύπρος Sverige
Αλέκτωρ Φαρµακευτική Λτδ AstraZeneca AB
Τηλ: +357 22490305 Tel: +46 8 553 26 000

Latvija
SIA AstraZeneca Latvija
Tel: +371 67377100

Other sources of information
More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu/