Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - akynzeo

Document Subject

Generated Narrative: MedicinalProductDefinition mp7a98a4feed53c51bdbb3ffa9d578b887

identifier: http://ema.europa.eu/identifier/EU/1/15/1001/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Akynzeo 300 mg/0.5 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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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-7a98a4feed53c51bdbb3ffa9d578b887

identifier: http://ema.europa.eu/identifier/EU/1/15/1001/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - akynzeo

Attesters

What is in this leaflet

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

What Akynzeo is
Akynzeo contains two medicines ( active substances ) called:

• netupitant
• palonosetron.

What Akynzeo is used for Akynzeo is used to help prevent adults with cancer feeling sick (nausea) or being sick (vomiting) while having cancer treatment called chemotherapy .

How Akynzeo works Chemotherapy medicines can cause the body to release substances called serotonin and substance P. This stimulates the vomiting centre in the brain, making you feel or be sick. The medicines in Akynzeo attach to the receptors in the nervous system through which serotonin and substance P work: netupitant (an NK1 receptor antagonist) blocks the receptors for substance P, and palonosetron (a 5- HT3 receptor antagonist) blocks certain receptors for serotonin. By blocking the actions of substance P and serotonin in this way, the medicines help prevent the stimulation of the vomiting centre and the resulting sickness.

Do not take Akynzeo if:

• you are allergic to netupitant or palonosetron, 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 this medicine.
• you are pregnant.

Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Akynzeo if:

• you have liver problems
• you have a blockage in your gut, or you have had constipation in the past
• you or one of your close relatives has ever had a heart problem called QT interval prolongation
• you have any other heart problems
• you have been told you have an imbalance of minerals in your blood such as potassium and magnesium that has not been corrected.

If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking Akynzeo.

Children and adolescents Akynzeo should not be taken by children and adolescents under 18 years.

Other medicines and Akynzeo Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.

In particular tell your doctor, pharmacist or nurse if you are taking any of the following medicines:

• medicines for depression or anxiety called SSRIs (selective serotonin re-uptake inhibitors) - such as fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram or escitalopram
• medicines for depression or anxiety called SNRIs (serotonin noradrenaline re-uptake inhibitors)

• such as venlafaxine or duloxetine.

Also tell your doctor, pharmacist or nurse if you are taking any of the following medicines as your doctor may need to change the dose of these other medicines:

• medicines that might cause abnormal heartbeat such as amiodarone, nicardipine, quinidine, moxifloxacin, haloperidol, chlorpromazine, quetiapine, thioridazine or domperidone
• medicines with a narrow therapeutic range that are primarily metabolised by CYP3A4, such as cyclosporine, tacrolimus, sirolimus, everolimus, alfentanil, diergotamine, ergotamine, fentanyl, or quinidine
• some chemotherapy medicines - such as docetaxel or etoposide
• erythromycin - to treat bacterial infections
• midazolam - a sedative used to treat anxiety
• dexamethasone - can be used to treat feeling and being sick
• ketoconazole - to treat Cushing's syndrome
• rifampicin - to treat tuberculosis (TB) and other infections.

If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking Akynzeo.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Do not take Akynzeo if you are pregnant or if you are a woman of childbearing potential not using contraception.

Do not breast-feed if you are taking Akynzeo. This is because it is not known whether the medicine passes into breast milk.

Driving and using machines You may feel dizzy or tired after taking Akynzeo. If this happens, do not drive or use any tools or machines.

Akynzeo contains sucrose, sorbitol (E420), sodium and may contain traces of soya
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains 7 mg of sorbitol (E420) in each hard capsule.

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

It may contain traces of lecithin - which comes from soya. If you are allergic to peanut or soya, do not use this medicinal product.

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

How much to take

• The recommended dose is one capsule (each capsule contains 300 mg of netupitant and 0.5 mg of palonosetron).
• Take the capsule about 1 hour before you start your chemotherapy cycle.
• You can take Akynzeo with or without food.

Akynzeo is taken before the chemotherapy to prevent sickness and feelings of sickness from developing. Do not take Akynzeo in the days after you have chemotherapy - unless you are about to have another chemotherapy cycle.

If you take more Akynzeo than you should The usual dose is 1 capsule. If you think you may have taken more than you should, tell your doctor straight away. The symptoms of overdose may include headache, dizziness, constipation, anxiety, palpitations, euphoric mood and pain in the legs.

If you forget to take Akynzeo If you think you have forgotten to take your dose, tell your doctor straight away.

If you stop taking Akynzeo
Akynzeo is taken to help prevent you feeling and being sick when you are having chemotherapy. If you do not want to take Akynzeo, discuss this with your doctor. If you decide not to take Akynzeo (or another similar medicine), your chemotherapy is likely to make you feel sick and be sick.

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.

Serious side effects
Stop taking Akynzeo and tell your doctor straight away if you notice the following serious side effect - you may need urgent medical treatment:

Very rare: may affect up to 1 in 10,000 people

• severe allergic reaction signs include hives, skin rash, itching, difficulty breathing or swallowing, swollen mouth, face, lips, tongue or throat and sometimes a drop in blood pressure.

Other side effects Tell your doctor, pharmacist or nurse if you notice any of the following side effects:

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

• headache
• constipation
• feeling tired.

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

• hair loss
• lack of energy (feeling weak)
• decreased appetite
• high blood pressure
• raised, itchy rash on the skin (hives)
• problems with the muscles in your heart (cardiomyopathy)
• spinning sensation (vertigo), feeling dizzy or trouble sleeping (insomnia)
• stomach problems including stomach discomfort, feeling bloated, nausea, pain, indigestion, hiccups, wind or diarrhoea
• high levels of certain enzymes, including blood alkaline phosphatase and liver transaminases (shown in blood tests)
• high levels of creatinine - which measures kidney function (shown in blood tests)
• ECG (electrocardiogram) problems (called QT and PR interval prolongation , conduction disorder , tachycardia and atrioventricular block first degree )
• low levels of neutrophils - a kind of white blood cell which fight infections (shown in blood tests)
• high level of white blood cells (shown in blood tests).

Rare: (may affect up to 1 in 1 000 people)

• back pain, joint pain
• feeling hot, reddening of the face or other areas of the skin (feeling flushed)
• itchy skin rash
• feeling drowsy
• sleep problems
• ring in the ear
• vomiting
• low blood pressure
• chest pain (not related to the heart)
• numbness, blurred vision
• sudden nervous breakdown, change in mood
• infection and inflammation in the bladder (cystitis)
• haemorrhoids
• conjunctivitis (a type of eye inflammation)
• low level of potassium (shown in blood tests)
• modifications (or disturbances) in heart rhythm
• heart valve disorder (mitral valve incompetence)
• coating of the tongue, difficulty swallowing, dry mouth, belching, abnormal taste after medicine intake
• decreased blood flow to the heart muscle (myocardial ischemia)
• high levels of creatine phosphokinase/ creatine phosphokinase MB - which indicates sudden decreased blood flow to the heart muscle (shown in blood tests)
• high levels of troponin - which indicates heart muscle dysfunction (shown in blood tests)
• high levels of the pigment bilirubin - which indicates liver dysfunction (shown in blood tests)
• high levels of myoglobin which indicates muscle injury (shown in blood tests)
• high levels of blood urea which indicates kidney dysfunction (shown in blood tests)
• high level of lymphocytes type of white blood cell which help the body fight disease (shown in blood tests)
• low level of white blood cells (shown in blood tests)
• ECG (electrocardiogram) problems (called ST segment depression , ST-T segment abnormal
  bundle branch block right/left , and atrioventricular block second degree )

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 blister 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 Akynzeo contains

• The active substances are palonosetron and netupitant. Each hard capsule contains three tablets (300 mg of netupitant), and one soft capsule (palonosetron hydrochloride equivalent to 0.5 milligrams of palonosetron).
• The other ingredients are microcrystalline cellulose (E460), sucrose lauric acid esters, povidone K-30, croscarmellose sodium, colloidal hydrated silica, sodium stearyl fumarate, magnesium stearate, glycerol monocaprylocaproate (type I), glycerol, polyglyceryl oleate, purified water, butylhydroxyanisole (E320), gelatin, sorbitol (E420), 1,4 sorbitan, titanium dioxide (E171), shellac glaze (partially esterified), yellow, red and black iron oxide (E172), propylene glycol (E1520).

This medicine contains sucrose, sorbitol (E420), sodium and may contain soya - see section 2 for more information.

What Akynzeo looks like and contents of the pack The hard capsules are opaque with a white body and a caramel cap with HE1 printed on the body. Pack size containing 1 capsule in an aluminium blister or 4 x 1 hard capsules in aluminium perforated unit dose blisters. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer: Helsinn Birex Pharmaceuticals Ltd. Damastown Mulhuddart Dublin Ireland

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Immedica Pharma AB T l/Tel: + 46(0)8 533 39 Lietuva Farma Mondo Tel: + 370 689 36
Angelini Pharma Bulgaria EOOD Te .: +359 2 975 13 Luxembourg/Luxemburg Immedica Pharma AB T l/Tel: + 46(0)8 533 39 esk republika Angelini Pharma esk republika s.r.o. Tel: (+420) 546 123 Magyarorsz g Angelini Pharma Magyarorsz g Kft Tel.: + 36 1 336 1Danmark Swedish Orphan Biovitrum A/S Tlf: + 45 32 96 68 Malta Helsinn Birex Pharmaceuticals Ltd.
Tel.: + 353 1 822 5Deutschland Esteve Pharmaceuticals GmbH Tel: + 49 30 338427-0

Nederland Immedica Pharma AB Tel: + 46(0)8 533 39 Eesti Farma Mondo Tel: + 370 698 36Norge Swedish Orphan Biovitrum AS Tlf: +47 66 82 34
Galenica A.E. : +30 210 52 81 sterreich Angelini Pharma sterreich GmbH Tel: +43-5-9-606-0

Espa a Immedica Pharma AB Tel: +34(0)9 373 70 Polska Angelini Pharma Polska Sp. z o.o. Tel: +48 22 70 28 France Immedica Pharma France SARL T l: + 33(0)148 014 Portugal Immedica Pharma AB Tel: + 46(0)8 533 39 Hrvatska Bausch Health Poland sp. z.o.o. podru nica Zagreb
Tel: +385 1 670 0Rom nia Angelini Pharmaceuticals Romania Srl Tel: +40 21 331 67 Ireland Chugai Pharma France Tel: +33 1 79 36 36 Slovenija PharmaSwiss Tel: +386 1 2364 sland Swedish Orphan Biovitrum A/S Tlf: + 45 32 96 68 Slovensk republika Angelini Pharma Slovensk republika s.r.o. Tel: +421 2 5920 7Italia Italfarmaco Tel: + 39 02 64Suomi/Finland Oy Swedish Orphan Biovitrum Ab Puh./Tel: +358 201 558
Galenica A.E. : +30 210 52 81 Sverige Swedish Orphan Biovitrum AB (publ) Tel: +46 8 697 20 Latvija Farma Mondo Tel: + 370 698 36United Kingdom (Northern Ireland) Chugai Pharma France Tel: +33 1 79 36 36 This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency website http://www.ema.europa.eu.

Package Leaflet: Information for the patient

Akynzeo 235 mg/0.25 mg powder for concentrate for solution for infusion fosnetupitant/palonosetron

Read all of this leaflet carefully before you are given 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, ask your doctor, pharmacist or nurse.
• 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.