Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - calquence

Document Subject

Generated Narrative: MedicinalProductDefinition mp515ad355eee6410eab8e10f3744bb3f9

identifier: http://ema.europa.eu/identifier/EU/1/20/1479/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Calquence 100 mg hard capsules

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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part: nan

type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-515ad355eee6410eab8e10f3744bb3f9

identifier: http://ema.europa.eu/identifier/EU/1/20/1479/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - calquence

Attesters

What is in this leaflet:

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

What Calquence is Calquence is a medicine used to treat cancer. 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). How Calquence 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 Calquence works or why this medicine has been prescribed for you, ask your doctor, pharmacist or nurse.

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 Calquence 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 Calquence 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)

medicine for migraines ergotamine

medicine for low blood sodium conivaptan

medicine for high blood sugars metformin

medicine to prevent organ rejection cyclosporine

medicines for fits (seizures) or epilepsy such as carbamazepine and phenytoin

pimozide a medicine used for Tourette (condition which causes uncontrolled movements and outbursts of words and sounds)

St. John s wort a herbal medicine for depression

theophylline medicine used for wheezing, shortness of breath, and chest tightness

medicines for reducing Stomach acid :* antacids such as calcium carbonate Take Calquence2 hours before or 2 hours after you take these medicines* histamine-2 receptor blockers such as ranitidine and famotidine Take Calquence 2 hours before or 10 hours after you take these medicines* proton pump inhibitors such as omeprazole Avoid taking these medicines while you are taking Calquence

methotrexate a medicine for diseases such as rheumatoid arthritis, psoriasis and ulcerative colitis, which are caused by the immune system working incorrectly.

This medicine should be taken at least 6 hours before or after Calquence. 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:

Antiplatelets (medicines that act against blot 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 Calquence, you must not drive or use machines. Calquence contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially sodium-free .

Calquence will only be prescribed to you by a doctor with experience in the use of medicines for cancer. Always take Calquence exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure. How much to take The usual dose is one capsule (100 mg) twice a day. Take doses about 12 hours apart. How to take Swallow the capsule whole with water at about the same time each day. Do not chew, dissolve or open the capsules as this may change how quickly the medicine gets into your body. You can take Calquence with food or between meals. You can check when you last took a capsule 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 Calquence than you should If you have taken more Calquence than you should, see a doctor or go to the nearest hospital straight away. Take the capsules 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.

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: Bleeding. 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 infections, 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). Uncommon serious side effects (may affect up to 1 in 100 people)

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), weakness or lack of energy

feeling sick to your stomach (nausea),vomiting, stomach pain, constipation (infrequent or hard to pass stool), 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 clot (platelets)

high blood pressure

dizziness

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

bronchitis (does not require immediate action)

herpes 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)

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.

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.

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 medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Calquence contains The active substance is acalabrutinib. Each hard capsule contains 100 mg of acalabrutinib. The other ingredients are:

Capsule content: microcrystalline cellulose, colloidal anhydrous silica, partially pregelatinised maize starch , magnesium stearate (E470b) and sodium starch glycollate (see section 2 Calquence contains sodium ).

Capsule shell: gelatine, titanium dioxide (E171), yellow iron oxide (E172) and indigo carmine (E132).

Printing ink: shellac, black iron oxide (E172), propylene glycol (E1520) and ammonium hydroxide. What Calquence looks like and contents of the pack Calquence is a hard gelatine capsule with a yellow body, blue cap, 20 mm hard capsule, marked with ACA 100 mg in black. Calquence is supplied in aluminium blisters containing either 6 or 8 hard capsules. Each carton contains
either 56 or 60 hard capsules. Not all pack sizes may be marketed. Marketing Authorisation Holder AstraZeneca AB SE-151 85 S dert lje Sweden Manufacturer AstraZeneca AB G rtunav gen SE-152 57 S dert lje Sweden For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien AstraZeneca S.A./N.V. Tel: +32 2 370 48 Lietuva UAB AstraZeneca Lietuva Tel: +370 5 2660

: +359 24455Luxembourg/Luxemburg AstraZeneca S.A./N.V. T l/Tel: +32 2 370 48 esk republika AstraZeneca Czech Republic s.r.o. Tel: +420 222 807 Magyarorsz g AstraZeneca Kft. Tel: +36 1 883 6Danmark AstraZeneca A/S Tlf: +45 43 66 64 Malta Associated Drug Co. Ltd Tel: +356 2277 8Deutschland AstraZeneca GmbH Tel: +49 40 809034Nederland AstraZeneca BV Tel: +31 85 808 9Eesti AstraZeneca Tel: +372 6549 Norge AstraZeneca AS Tlf: +47 21 00 64
AstraZeneca A.E. : +30 210 6871 sterreich AstraZeneca sterreich GmbH Tel: +43 1 711 31 0 Espa a AstraZeneca Farmac utica Spain, S.A. Polska AstraZeneca Pharma Poland Sp. z o.o. Tel: +34 91 301 91 Tel: +48 22 245 73 France AstraZeneca T l: +33 1 41 29 40 Portugal AstraZeneca Produtos Farmac uticos, Lda. Tel: +351 21 434 61 Hrvatska AstraZeneca d.o.o. Tel: +385 1 4628 Rom nia AstraZeneca Pharma SRL Tel: +40 21 317 60 Ireland AstraZeneca Pharmaceuticals (Ireland) DAC Tel: +353 1609 7Slovenija AstraZeneca UK Limited Tel: +386 1 51 35 sland Vistor hf. S mi: +354 535 7Slovensk republika AstraZeneca AB, o.z. Tel: +421 2 5737 7Italia AstraZeneca S.p.A. Tel: +39 02 00704Suomi/Finland AstraZeneca Oy Puh/Tel: +358 10 23

: +357 22490Sverige AstraZeneca AB Tel: +46 8 553 26 Latvija SIA AstraZeneca Latvija Tel: +371 67377United Kingdom (Northern Ireland) AstraZeneca UK Ltd Tel: +44 1582 836 This leaflet was last revised in Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: