Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - daurismo

Document Subject

Generated Narrative: MedicinalProductDefinition mp80c767f44d11e1fb968f6d85169c54f0

identifier: http://ema.europa.eu/identifier/EU/1/20/1451/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Daurismo 25 mg film-coated tablets

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-80c767f44d11e1fb968f6d85169c54f0

identifier: http://ema.europa.eu/identifier/EU/1/20/1451/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - daurismo

Attesters

What is in this leaflet

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

Daurismo is a cancer medicine containing the active substance glasdegib. Daurismo is used with another cancer medicine, cytarabine, to treat adults newly diagnosed with a blood cancer called acute myeloid leukaemia (AML). How Daurismo works In AML, cancer cells called stem cells constantly make new leukaemic cancer cells. Daurismo works by blocking a key process in these stem cells, called the Hedgehog (Hh) pathway. This reduces their ability to make new cancer cells. By blocking the Hh pathway, Daurismo can also make cancer cells more sensitive to a cancer medicine, cytarabine, used to treat AML. Combining Daurismo with the medicine cytarabine may increase how long patients are likely to live by decreasing growth of the cancer and possibly by increasing cancer cell death. If you have any questions about how Daurismo works or why this medicine has been prescribed for you, ask your doctor.

Do not take Daurismo

if you are allergic to glasdegib or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Daurismo

if you or your partner are able to become pregnant (see section Pregnancy, breast-feeding and fertility).

if you have ever had QT interval prolongation (a change in electrical activity of the heart that can cause serious irregular heart rhythms) or know you are at danger of the condition.

if you take other medicines that you have been told can prolong QT interval.

if blood tests show you have abnormal levels of electrolytes (e.g. calcium, magnesium, potassium).

if you have kidney problems.

if you have a history of muscle cramps or weakness. Tell your doctor immediately while taking this medicine

if your muscles hurt or you have unexplained muscle cramps or weakness during treatment with Daurismo. Your doctor may need to change your dose, or stop your treatment temporarily or permanently. Children and adolescents Daurismo is not to be used in patients less than 18 years of age. Other medicines and Daurismo Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because Daurismo can affect the way some other medicines work. Some other medicines can affect the way Daurismo works. In particular, the following may increase the risk of side effects with Daurismo:

boceprevir a medicine used to treat hepatitis C.

cobicistat, ritonavir, telaprevir medicines used to treat HIV infection.

itraconazole, ketoconazole, voriconazole, posaconazole medicines used to treat fungal infections.

troleandomycin a medicine used to treat bacterial infections.

conivaptan a medicine used to regulate imbalance of water and salt.

amiodarone, disopyramide, dofetilide, ibutilide, sotalol, quinidine medicines used to treat heart problems.

droperidol, haloperidol, pimozide medicines used to treat psychotic diseases.

moxifloxacin a medicine used to treat a certain type of bacterial infections.

methadone a medicine used to treat pain and for the treatment of opioid addiction. The following medicines may reduce the effectiveness of Daurismo:

carbamazepine, phenytoin, anti-epileptics medicines used to treat seizures or fits.

rifampicin a medicine used to treat tuberculosis (TB).

St. John s wort (Hypericum perforatum) a herbal product used to treat mild depression and anxiety.

enzalutamide a medicine used to treat prostate cancer.

mitotane a medicine used to treat adrenal gland cancer.

bosentan a medicine used to treat high blood pressure.

efavirenz, etravirine medicines used to treat HIV infection.

modafinil a medicine used to treat sleep disorders.

nafcillin a medicine used to treat certain types of bacterial infections. Daurismo with food and drink Do not drink grapefruit juice or eat grapefruit while on treatment with Daurismo as it may change the amount of Daurismo in your body. Pregnancy, breast-feeding and fertility Pregnancy You must not become pregnant while taking Daurismo and you must not take it if you are pregnant. Daurismo can cause severe birth defects in babies or lead to the death of an unborn baby. Your doctor will give you more information about the effects of Daurismo on the unborn baby and will carry out a pregnancy test before you start taking the medicine. You must talk to your doctor immediately if you or your partner become pregnant or suspect you could be pregnant during treatment and for 30 days after your last dose of Daurismo. If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Contraception in women and men Women You should always use effective birth control (contraception) while taking Daurismo and for at least 30 days after the last dose of Daurismo. Talk to your doctor about birth control methods that are right for you and your partner. Men Men should always use effective contraception, including condoms (with spermicide, if available), even if you have had a vasectomy, while taking Daurismo and for at least 30 days after the last dose of Daurismo. You should not donate semen at any time while you are taking Daurismo and for at least 30 days after your last dose. Breast-feeding Do not breast-feed while taking Daurismo or during the one week after the last dose of Daurismo. It is not known if Daurismo passes into your breast milk and harms your baby. Fertility Daurismo may affect male and female fertility. Talk to your doctor about fertility preservation before taking Daurismo. Driving and using machines If you feel tired, or get muscle cramps, pain or nausea (feeling sick) while on treatment with Daurismo, take special care when driving and using machines. Daurismo contains sodium This medicine contains less than 1 mmol sodium (less than 23 mg) per tablet, that is to say Daurismo is essentially sodium -free . Daurismo contains lactose This medicine contains lactose (found in milk or dairy products). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Take Daurismo once a day at about the same time every day. Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is one tablet of 100 mg taken by mouth once a day with or without food. If you get certain side effects while you are taking Daurismo (see section 4 Possible side effects ), your doctor may lower your dose or stop treatment, either temporarily or permanently. If you vomit after taking Daurismo If you vomit after taking a dose of Daurismo, do not take an extra dose, just take your next dose at the usual time. If you take more Daurismo than you should If you accidentally take too many tablets, tell your doctor, pharmacist or nurse right away. You may require urgent medical attention. If you forget to take Daurismo If you forget to take a tablet, then take it as soon as you remember unless more than 10 hours have passed since the scheduled dose time, in which case, you should skip the dose. Do not take a double dose to make up for a forgotten dose. If you stop taking Daurismo Do not stop taking Daurismo unless your doctor tells you to. It is important to take Daurismo every day, as long as your doctor prescribes it to you. If you cannot take the medicine as your doctor has prescribed, or you feel you do not need it anymore, speak with your doctor right away. 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. Daurismo may cause severe birth defects. It may also lead to the death of a baby before it is born or shortly after being born. You must not become pregnant while taking this medicine (see section 2, What you need to know before you take Daurismo ). Other side effects with Daurismo, in combination with cytarabine, include: Very common: may affect more than 1 in 10 people

low haemoglobin

bleeding

fever

nausea

loss of appetite

muscle pain

feeling tired

decrease in the number of platelets in the blood

diarrhoea

pneumonia

changes in taste

swelling of arms and legs

constipation

abdominal (belly) pain

rash

shortness of breath

vomiting

weight loss

decrease in the number of white blood cells

decrease in the number of a type of white blood cells (neutrophils)

joint pain

hair loss Common: may affect up to 1 in 10 people

changes in the electrical activity of the heart

heart palpitations

blood infection

burning sensation during urination and frequent and urgent need to urinate (may be symptoms of urinary tract infection)

mouth irritation Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. 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 carton and the blister foil or bottle after EXP . The expiry date refers to the last day of that month. This medicine does not require any special storage conditions. Do not use this medicine if the pack is damaged or shows signs of tampering. 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 Daurismo contains

The active substance is glasdegib. Daurismo 25 mg film-coated tablets: each film-coated tablet contains glasdegib maleate equivalent to 25 mg of glasdegib. Daurismo 100 mg film-coated tablets: each film-coated tablet contains glasdegib maleate equivalent to 100 mg glasdegib.

The other ingredients are: Tablet core: sodium starch glycolate, microcrystalline cellulose, calcium hydrogen phosphate anhydrous, and magnesium stearate. See section 2 Daurismo contains sodium. Film-coating: lactose monohydrate, hypromellose, titanium dioxide, macrogol, triacetin, iron oxide yellow, and iron oxide red (100 mg tablets only). See section 2 Daurismo contains lactose. What Daurismo looks like and contents of the pack Daurismo 25 mg film-coated tablets

Round, yellow film-coated tablets, debossed with Pfizer on one side and GLS 25 on the other side.

Provided in blisters of 10 tablets. Each pack contains 60 tablets in either 6 blisters or in one plastic bottle. Daurismo 100 mg film-coated tablets

Round, pale orange film-coated tablets, debossed with Pfizer on one side and GLS 100 on the other side.

Provided in blisters of 10 tablets. Each pack contains 30 tablets in either 3 blisters or in one plastic bottle. Not all pack sizes may be marketed. Marketing Authorisation Holder Pfizer Europe MA EEIG Boulevard de la Plaine 1050 Bruxelles Belgium Manufacturer Pfizer Manufacturing Deutschland GmbH Betriebsst tte Freiburg Mooswaldallee 1 79090 Freiburg Germany For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien Luxembourg/Luxemburg Pfizer NV/SA T l/Tel: +32 (0)2 554 62 Lietuva Pfizer Luxembourg SARL filialas Lietuvoje Tel. + 370 52 51 4 ,
.: +359 2 970 4Magyarorsz g Pfizer Kft. Tel.: +36-1-488-37- esk republika Pfizer, spol. s r.o. Tel.: +420 283 004 Malta Vivian Corporation Ltd. Tel. +356 21344Danmark Pfizer ApS Tlf: +45 44 20 11 Nederland Pfizer bv Tel: +31 (0)800 63 34 Deutschland Pfizer Pharma GmbH Tel: +49 (0)30 550055 51Norge Pfizer AS Tlf: +47 67 52 61 Eesti Pfizer Luxembourg SARL Eesti filiaal Tel.: +372 666 7 sterreich Pfizer Corporation Austria Ges.m.b.H. Tel: +43 (0)1 521 15-0

Pfizer A.E. .: +30 210 6785 Polska Pfizer Polska Sp. z o.o. Tel.:+48 22 335 61 Espa a Pfizer, S.L. Tel: +34 91 490 99 Portugal Laborat rios Pfizer, Lda. Tel: +351 21 423 5France Pfizer T l: +33 (0)1 58 07 34 Rom nia Pfizer Romania S.R.L. Tel: +40 (0) 21 207 28 Hrvatska Pfizer Croatia d.o.o. Tel: +385 1 3908 Slovenija Pfizer Luxembourg SARL Pfizer, podru nica za svetovanje s podro ja farmacevtske dejavnosti, Ljubljana Tel.: + 386 (0)1 52 11 Ireland Pfizer Healthcare Ireland Tel: 1800 633 363 (toll free) +44 (0)1304 616Slovensk republika Pfizer Luxembourg SARL, organiza n zlo ka Tel.: + 421 2 3355 5 sland Icepharma hf. S mi: +354 540 8Suomi/Finland Pfizer Oy Puh./Tel: +358 (0)9 43 00 Italia Pfizer S.r.l. Tel: +39 06 33 18 Sverige Pfizer AB Tel: +46 (0)8 550 520 K Pfizer . . (Cyprus Branch) : +357 22 817United Kingdom (Northern Ireland) Pfizer Limited Tel: +44 (0) 1304 616Latvija Pfizer Luxembourg SARL fili le Latvij Tel.: + 371 670 35 This leaflet was last revised in MM/YYYY Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: