InfoCons Consumer Protection informs you – Calquence – Package Leaflet

Before anything else

Read all of 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 further questions, please ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet (see section 4).

ℹ️ 1. What C alquence is and what it is used for

What C alquence is

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

What C alquence 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 affecting the lymph nodes.

How C alquence works

Calquence works by blocking BTK , a protein in the body that helps these cancer cells grow and survive .

By blocking BTK, Calquence helps to kill and can reduce the number of cancer cells which can slow down the worsening of the disease.

If you have any questions about how C alquence works or why this medicine has been prescribed for you, ask your doctor , pharmacist or nurse .

⚠️ 2. What you need to know before you take Calquence

Do not take Calquence if

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

If you are not sure, talk to your doctor, pharmacist or nurse before taking Calquence.

Warnings and precautions

Talk to your doctor , pharmacist or nurse before taking C alquence if you:

• have ever had unusual bruising or bleeding or are on any medicines that increase your risk of bleeding (see section 4 ‘Possible side effects’ ).
• have an infection (see section 4 ‘Possible side effects’)
• have recently had an operation or are about to have one . Your doctor may stop treatment with Calquence before and after a medical, surgical or dental procedure .
• have ever had hepatitis B (a liver infection) – this is because C alquence could cause hepatitis B to become active again and so that your doctor will look out for signs of this infection coming back (see section 4 ‘Possible side effects’) .
• have or ever had irregular heart beat (see section 4 ‘Possible side effects’).

Talk to your doctor if you develop a new lesion or any change in the appearance of an area on the skin as you are at a high risk of developing skin cancer, see section 4. Use sun protection and make regular skin examination.

Your doctor will check your blood cell counts as needed during treatment .

Children and adolescents

Do not give this medicine to children or adolescents aged less than 18 years. This is because it has not been studied in this age group.

Other medicines and Calquence

Tell your doctor, pharmacist or nurse if you are taking or have recently taken or might take any other medicines , especially if you take any of the following:

• antibiotics for bacterial infections – such as clarithromycin
• medicines for fungal infections – such as posaconazole, itraconazole, voriconazole
• ketoconazole – a medicine for Cushing’s syndrome (a condition in which the body produces too much of the hormone cortisol)
• medicines for HIV infections – 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 blood sodium
• metformin – a medicine for high blood sugars
• cyclosporine – a medicine to prevent organ rejection
• medicines for fits (seizures) or epilepsy – such as carbamazepine and phenytoin
• pimozide – a medicine used for Tourett e (condition which causes uncontrolled movements and outbursts of words and sounds)
• St. John’s wort – an herbal medicine for depression
• theophylline – a medicine used for wheezing, shortness of breath, and chest tightness
• methotrexate – a medicine for diseases such as rheumatoid arthritis, psoriasis and ulcerative colitis, which are caused by the immune system working incorrectly. o This medicine should be taken at least 6 hours before or after Calquence .

You can take stomach acid reducing medicines such as antacids (calcium carbonate), histamine -2 receptor blockers (ran itidine and famotidine) and proton pump inhibitors (omeprazole) with Calquence tablets.

Medicines that increase your risk of bleeding Calquence may make you bleed more easily . Tell your doctor, pharmacist, or nurse if you take other medicines that increase your risk of bleeding :

• Antiplatelet s (medicines that act against blo od clotting) such as acetylsalicylic acid and clopidogrel .
• Anticoagulants (blood thinners) such as warfarin or enoxaparin .

Pregnancy

Talk to your doctor before taking Calquence if you are pregnant, think you may be pregnant , or are planning on having a baby. This is because Calquence may harm your unborn baby.

Breast -feeding Do not breast -feed during treatment with Calquence and for 2 days after your last dose of Calquence. It is not known if Calquence passes into your breast milk.

Driving and using machines

Calquence is unlikely to affect the ability to drive and use machines. However, if you feel dizzy, weak or tired while taking C alquence , you must not drive or us e machines.

Calquence contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium -free’.

💊 3. How to take C alquence

Calquence will only be prescribed to you by a doctor with experience in the use of medicines for cancer.

Always take C alquence exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure.

Depending on your type of cancer, Calquence may be given in combination with other anticancer medicines.

How much to take

• The usual dose is one tablet (100 mg) twice a day. Take doses about 12 hours apart.

How to take

• Swallow the tablet whole with water at about the same time each day.
• Do not chew, crush , dissolve or divide the tablets .
• You can take C alquence with food or between meals .
• You can check when you last took a tablet of Calquence by looking on the blister. Pictures on the blister will help you to take your dose at the right time — the sun for the morning dose and the moon for the evening dose.

If you take more C alquence than you should

If you have taken more C alquence than you should, see a doctor or go to the nearest hospital straight away . Take the tablets and this leaflet with you.

If you forget to take a dose

• If less than 3 hours have passed after your usual time for taking a dose , take the missed dose right away. Take the next dose at your usual time.
• If more than 3 hours have passed after your usual time for taking a dose , skip the missed dose. Take the next dose at your usual time.
• Do not take a double dose of Calquence to make up for a forgotten dose.

If you have any further questions on 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 everybody gets them.

Stop taking Calquence and contact a doctor or go to your nearest emergency department immediately if you experience any of the following symptoms:

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

• Bleeding in different sites, including skin, gut and brain . Symptoms may be 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 [Pneumonia , a very common side effect (may affect more than 1 in 10 people) or Aspergillus infection s, an uncommon side effect (may affect up to 1 in 100 people) ].

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

• fast heart rate, missed heart beats, weak or uneven 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, dark or cloudy urine, unusual tiredness, or muscle or joint pain. This can be symptoms of tumor lysis syndrome (TLS) – a condition caused by the fast breakdown of cancer cells .

Other side effects

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

• muscle or joint pain
• headache
• rash
• feeling tired (fatigue), w eakness or lack of energy
• feeling sick to your stomach (nausea) ,vomiting, stomach pain, constipation (infrequent or hard to pass stool) , diarrhoea (frequent or loose stool s)
• decreased number of red blood cells , decreased number of neutrophils (a type of white blood cell s) or decreased number of cells that help blood clot (platelets)
• swelling especially of the ankles and feet
• dizziness
• high blood pressure
• headache, pressure in the eyes, nose or cheek area (sinusitis)
• sore throat and runny nose (nasopharyngitis)
• upper respiratory tract infection
• urinary tract infection (pain or burning feeling when passing urine)
• new cancers, including cancers of the skin, may happen during treatment with Calquence (see section 2 ‘What you need to know before you take Calquence’)
• herpes

Common (may affect up to 1 in 10 people)

• increased levels of the liver enzymes (aspartate aminotransferase and alanine aminotransferase) in blood tests [when used in combination with certain medicines to treat mantle cell lymphoma (MCL )].
• bronchitis
• fever, chills, weakness, confusion, being sick and yellowing of the skin or eyeballs (jaundice) – these may be signs of hepatitis B (a liver infection) becoming active again.
• inflammation of the lungs (pneumonitis)

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

• memory loss, trouble thinking, difficulty walking or sight loss – these may be signs 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 get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V . By reporting side effects you can help provide more information on the safety of this medicine.

🌡️ 5. How to store C alquence

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 blister foil and carton after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any m edicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

📦 6. Contents of the pack and other information

What C alquence 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 hydroxypropyl

cellulose (E463) and sodium stearyl fumarate (see section 2 ‘Calquence contains sodium’).

• Tablet coating : hypromellose (E464) , copovidone, titanium dioxide (E171) , macrogol, medium – chain triglycerides, iron oxide yellow (E172) and iron oxide red (E172) .

What C alquence looks like and contents of the pack

Calquence is an orange, 7.5 x 13 mm, oval, biconvex tablet, debossed with ‘ACA 100’ on one side and plain on the reverse.

Calquence is supplied in aluminium blisters containing either 8 or 10 film -coated tablets. On each blister there are sun/moon symbols to help you to take your dose at the right time — the sun for the morning dose and the moon for the evening dose. Both the sun and the moon blisters contain the same medicine. Each carton contains either 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 any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien AstraZeneca S.A./N.V.

Tel: +32 2 370 48 11 Lietuva UAB AstraZeneca Lietuva Tel: +370 5 2660550 България АстраЗенека България ЕООД Тел: +359 24455000 Luxembourg/Luxemburg AstraZeneca S.A./N.V.

Tél/Tel: +32 2 370 48 11 Česká republika AstraZeneca Czech Republic s.r.o.

Tel: +420 222 807 111 Magyarország AstraZeneca Kft.

Tel: +36 1 883 6500 Danmark AstraZeneca A/S Tlf.: +45 43 66 64 62 Malta Associated Drug Co. Ltd Tel: +356 2277 8000 Deutschland AstraZeneca GmbH Tel: +49 4 0 809034100 Nederland AstraZeneca BV Tel: +31 85 808 9900 Eesti AstraZeneca Tel: +372 6549 600 Norge AstraZeneca AS Tlf: +47 21 00 64 00 Ελλάδα AstraZeneca A.E.

Τηλ: +30 210 6871500 Österreich AstraZeneca Österreich GmbH Tel: +43 1 711 31 0 España AstraZeneca Farmacéutica Spain, S.A.

Tel: +34 91 301 91 00 Polska AstraZeneca Pharma Poland Sp. z o.o.

Tel: +48 22 245 73 00 France AstraZeneca Tél: +33 1 41 29 40 00 Portugal AstraZeneca Produtos Farmacêuticos, Lda.

Tel: +351 21 434 61 00 Hrvatska AstraZeneca d.o.o.

Tel: +385 1 4628 000 România AstraZeneca Pharma SRL Tel: +40 21 317 60 41 Ireland AstraZeneca Pharmaceuticals (Ireland) DAC Tel: +353 1609 7100 Slovenija AstraZeneca UK Limited Tel: +386 1 51 35 600 Ísland Vistor hf.

Sími: +354 535 7000 Slovenská republika AstraZeneca AB, o.z.

Tel: +421 2 5737 7777 Italia AstraZeneca S.p.A.

Tel: +39 02 00704500 Suomi/Finland AstraZeneca Oy Puh/Tel: +358 10 23 010 Κύπρος Αλέκτωρ Φαρµακευτική Λτδ Τηλ: +357 22490305 Sverige AstraZeneca AB Tel: +46 8 553 26 000 Latvija SIA AstraZeneca Latvija Tel: +371 67377100

This leaflet was last revised in

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Calquence (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/20/1479).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.