Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - spravato

Document Subject

Generated Narrative: MedicinalProductDefinition mp15885cc7c5a4f088fdfc128fa6bb5034

identifier: http://ema.europa.eu/identifier/EU/1/19/1410/001 (1 spray container)

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Spravato 28 mg nasal spray, solution

type: Full name

part

part: nan

type: Invented name part

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part: nan

type: Scientific name part

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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-15885cc7c5a4f088fdfc128fa6bb5034

identifier: http://ema.europa.eu/identifier/EU/1/19/1410/001 (1 spray container)

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - spravato

Attesters

What is in this leaflet

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

What Spravato is Spravato contains the active substance esketamine. This belongs to a group of medicines called anti-depressants and you have been given this medicine to treat your depression. What Spravato is used for Spravato is used in adults to reduce the symptoms of depression, such as, feeling sad, anxious, or worthless, sleeping difficulties, change in appetite, loss of interest in favourite activities, feeling of being slowed down. It is given, together with another antidepressant, if you have tried at least 2 other antidepressant medicines but they have not helped. Spravato is also used in adults to rapidly reduce symptoms of depression in a situation requiring immediate treatment (also known as a psychiatric emergency).

Do not use Spravato

if you are allergic to esketamine, a similar medicine called ketamine used for anaesthesia, or any of the other ingredients of this medicine (listed in section 6).

if you have ever had certain conditions such as:

an aneurysm (a weak spot in a blood vessel wall where it widens or bulges out)

bleeding in the brain

if you recently had a heart attack (within 6 weeks) This is because Spravato can cause a temporary increase in blood pressure that may lead to serious complications in these conditions. Do not use Spravato if any of the above apply to you. If you are not sure, talk to your doctor before using Spravato - your doctor will decide whether or not you can use this medicine. Warnings and precautions Talk to your doctor before using Spravato if you have:

a heart problem which is not well controlled such as: poor blood flow in the blood vessels of the heart frequently with chest pain (such as angina), high blood pressure, heart valve disease or heart failure

ever had problems with the blood supply to your brain (such as a stroke)

ever had problems with drug abuse prescribed medicines or illegal drugs

ever had a condition called psychosis - where you believe in things that are not true (delusions) or see, feel, or hear things that are not there (hallucinations)

ever had a condition called bipolar disorder, or symptoms of mania (where you become very over-active or over excited)

ever had an overactive thyroid that is not properly treated (hyperthyroidism)

ever had lung problems causing breathing difficulty (pulmonary insufficiency), including Chronic Obstructive Pulmonary Disease (COPD)

sleep apnoea and are extremely overweight

ever had slow or fast heartbeats causing shortness of breath, palpitations or chest discomfort, feeling light-headed or fainting

had a serious head injury or serious problems affecting the brain, particularly where there is increased pressure in the brain

severe liver problems. If any of the above apply to you (or you are not sure), talk to your doctor before using Spravato. Your doctor will decide whether you should use this medicine. Depression getting worse Tell your doctor or go to the nearest hospital straight away if you have thoughts of harming or killing yourself at any time. You may find it helpful to talk to a relative or a close friend if you are depressed and ask them if they think your depression is getting worse or if they are worried about your behaviour. You might ask them to read this leaflet. Blood pressure Spravato can increase your blood pressure for about 1 to 2 hours after you use it so your blood pressure will be measured before you start using Spravato and after using it. If your blood pressure is high before using this medicine, your doctor will decide whether to start the medicine or wait until your blood pressure is lower. If your blood pressure goes up after using this medicine and stays high for more than a few hours, you may need to have some more tests. This medicine may cause a temporary increase in your blood pressure after taking a dose. Your blood pressure will be checked before and after using this medicine. Tell the medical staff right away if you get chest pain, shortness of breath, sudden severe headache, change in vision, or seizures (fits) after using this medicine. Tell your doctor if you get any of the below while you are using Spravato

difficulty with your attention, judgment and thinking (see also Driving and using machines
and Possible side effects ). During and after each use of this medicine, your doctor will check your condition and decide how long to monitor you.

sleepiness (sedation), fainting, dizziness, spinning sensation, anxiety, or feeling disconnected from yourself, your thoughts, feelings, space and time (dissociation), difficulties in breathing (respiratory depression). Tell the medical staff right away if your feel like you cannot stay awake or if you feel like you are going to pass out.

pain when urinating or seeing blood in your urine these could be signs of bladder problems. These can occur with high doses of a similar medicine (called ketamine) used over a long period. Tell your doctor if you get any of the above while you are taking Spravato. Elderly (>65 years) If you are elderly (>65 years), you will be carefully monitored as you may be at increased risk of falling when you start moving around after treatment. Children and adolescents Do not give this medicine to children and adolescents younger than 18 years of age. This is because Spravato has not been studied for treatment-resistant depression in this age group. Other medicines and Spravato Tell your doctor if you are taking, have recently taken or might take any other medicines. Using Spravato with certain medicines may cause side effects. Especially tell your doctor if you take:

Medicines used to treat nervous disorders or severe pain (for example, benzodiazepines, opioids), or medicines or beverages containing alcohol

Stimulants such as those used for conditions such as narcolepsy or medicines for ADHD (for example, amphetamines, methylphenidate, modafinil, armodafinil)

Medicines that can increase your blood pressure, such as, thyroid hormones, asthma medications such as xanthine derivatives, medications for child birth bleeding (ergometrine) and heart medication such as vasopressin.

Medicines for depression or Parkinson s disease known as monoamine oxidase inhibitors (MAOIs) (for example, tranylcypromine, selegiline, phenelzine). 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 using this medicine. Contraception If you are able to become pregnant you must use contraception during treatment. Talk with your doctor about suitable methods of contraception. Pregnancy Do not use Spravato if you are pregnant. If you become pregnant while being treated with Spravato, talk to your doctor straight away to decide whether to stop treatment and to learn about other options for treatment. Breast-feeding Do not use Spravato if you are breast-feeding. Talk to your doctor before using Spravato if you are breast-feeding. Your doctor will discuss with you whether to stop breast-feeding or stop using this medicine. Your doctor will take into account the benefit of breast-feeding for you and your child, and the benefit of treatment for you. Driving and using machines Spravato can make you feel sleepy, dizzy, and have other side effects that can temporarily affect your ability to drive vehicles or use machines and do activities that need you to be completely alert. After being treated with this medicine, do not take part in these activities until the next day following a restful sleep.

Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. You will use the Spravato nasal spray yourself - under the supervision of your doctor or other healthcare professional in a healthcare setting, such as, the doctor s office or clinic. Your doctor or other healthcare professional will show you how to use the nasal spray device (see also Instructions for use). How much to use Your doctor will decide if you need 1, 2 or 3 nasal spray devices and how often you should go to the doctor s office or clinic for the medicine.

One nasal spray device delivers two sprays (one spray per nostril)

Spravato is used twice a week for the first 4 weeks If your treatment is continued:

Spravato is usually used once a week for the following 4 weeks

After this, Spravato is usually used either once a week or once every 2 weeks During and after each use of this medicine, your doctor will check you and decide how long to monitor you. Food and drink Some patients using Spravato may experience nausea or vomiting. You should avoid eating for 2 hours before treatment and not drinking liquids for 30 minutes before using this medicine. Nasal sprays If you need steroid or decongestant medicines as a nasal spray, avoid using them during the hour before your Spravato treatment. If you use more Spravato than you should You will use this medicine under the supervision of your doctor in the doctor s office or clinic. Therefore, it is unlikely that you will use too much. If you use too much Spravato, you are more likely to get side effects (see Possible side effects ). If you stop using Spravato It is important to make sure you come in for your scheduled appointments, so that this medicine is effective for you. If you have any further questions on the use of this medicine, ask your doctor.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor if you notice any of the following side effects. Very common (may affect more than 1 in 10 people)

feeling disconnected from yourself, your thoughts, feelings and things around you

feeling dizzy

headache

feeling sleepy

change in sense of taste

decreased feeling or sensitivity, including around the mouth area

spinning sensation ( vertigo )

vomiting

nausea

increased blood pressure Common (may affect up to 1 in 10 people)

feeling anxious

feeling extremely happy ( euphoria )

feeling confused

feeling detached from reality

feeling irritable

seeing, feeling, hearing or smelling things that are not there (hallucinations)

feeling agitated

eyes, ears, or sense of touch are deceived or tricked in some way (something is not what it seems to be)

panic attacks

change in perception of time

unusual feeling in the mouth (such as tingling or a crawling feeling)

muscle tremors

problems with thinking

feeling very sleepy with low energy

difficulty speaking

difficulty concentrating

blurred vision

persistent ringing in the ears (tinnitus)

increased sensitivity to noise or sounds

fast heartbeat

high blood pressure

nasal discomfort

irritated throat

sore throat

nasal dryness including dry crusts in the nose

itchy nose

decreased feeling or sensitivity in the mouth

dry mouth

excessive sweating

frequent need to pass urine

pain when passing urine

urgent need to pass urine

feeling abnormal

feeling drunk

feeling weak

crying

feeling of body temperature change Uncommon (may affect up to 1 in 100 people)

thoughts, speech and physical movements slow down

emotional distress

feeling uneasy or tense

fast eye movements that you cannot control

being hyperactive

increased saliva

cold sweats

problems walking Rare (may affect up to 1 in 1 000 people)

difficulties in breathing (respiratory depression) Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. 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 label. 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 to protect the environment.

What Spravato contains The active substance is esketamine. Each nasal spray device contains esketamine hydrochloride corresponding to 28 mg esketamine. The other ingredients are: Citric acid monohydrate Disodium edetate Sodium hydroxide (for pH adjustment) Water for injections What Spravato looks like and contents of the pack Spravato is a nasal spray solution. This medicine is a clear, colourless solution, provided in a single-use nasal spray device. Spravato is available in pack sizes containing 1, 2, 3, or 6 nasal spray devices and as multipacks containing 12 (4 packs of 3) or 24 (8 packs of 3) nasal spray devices. Each nasal spray device is individually packaged in a sealed blister. Not all pack sizes may be marketed. Marketing Authorisation Holder Janssen-Cilag International NV Turnhoutseweg B-2340 Beerse Belgium Manufacturer Janssen Pharmaceutica NV Turnhoutseweg B-2340 Beerse Belgium For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien Janssen-Cilag NV Tel/T l: +32 14 64 94 janssen@jacbe.jnj.com Lietuva UAB "JOHNSON & JOHNSON" Tel: +370 5 278 68 lt@its.jnj.com

&
.: +359 2 489 94 jjsafety@its.jnj.com Luxembourg/Luxemburg Janssen-Cilag NV T l/Tel: +32 14 64 94 janssen@jacbe.jnj.com esk republika Janssen-Cilag s.r.o. Tel: +420 227 012 Magyarorsz g Janssen-Cilag Kft. Tel.: +36 1 884 2janssenhu@its.jnj.com Danmark Janssen-Cilag A/S Tlf: +45 4594 8jacdk@its.jnj.com Malta AM MANGION LTD Tel: +356 2397 6Deutschland Janssen-Cilag GmbH Tel: +49 2137 955 jancil@its.jnj.com Nederland Janssen-Cilag B.V. Tel: +31 76 711 1janssen@jacnl.jnj.com Eesti UAB "JOHNSON & JOHNSON" Eesti filiaal Tel: +372 617 7ee@its.jnj.com Norge Janssen-Cilag AS Tlf: +47 24 12 65 jacno@its.jnj.com

Janssen-Cilag . . . . T : +30 210 80 90 sterreich Janssen-Cilag Pharma GmbH Tel: +43 1 610 Espa a Janssen-Cilag, S.A. Tel: +34 91 722 81 contacto@its.jnj.com Polska Janssen-Cilag Polska Sp. z o.o. Tel.: +48 22 237 60 France Janssen-Cilag T l: 0 800 25 50 75 / +33 1 55 00 40 medisource@its.jnj.com Portugal Janssen-Cilag Farmac utica, Lda. Tel: +351 214 368 Hrvatska Johnson & Johnson S.E. d.o.o. Tel: +385 1 6610 jjsafety@JNJCR.JNJ.com Rom nia Johnson & Johnson Rom nia SRL Tel: +40 21 207 1Ireland Janssen Sciences Ireland UC Tel: 1 800 709 medinfo@its.jnj.com Slovenija Johnson & Johnson d.o.o. Tel: +386 1 401 18 Janssen_safety_slo@its.jnj.com sland Janssen-Cilag AB c/o Vistor hf. S mi: +354 535 7janssen@vistor.is Slovensk republika Johnson & Johnson, s.r.o. Tel: +421 232 408 Italia Janssen-Cilag SpA Tel: 800.688.777 / +39 02 2510 1 janssenita@its.jnj.com Suomi/Finland Janssen-Cilag Oy Puh/Tel: +358 207 531 jacfi@its.jnj.com

: +357 22 207 Sverige Janssen-Cilag AB Tfn: +46 8 626 50 jacse@its.jnj.com Latvija UAB "JOHNSON & JOHNSON" fili le Latvij Tel: +371 678 93lv@its.jnj.com United Kingdom (Northern Ireland) Janssen Sciences Ireland UC Tel: +44 1 494 567 medinfo@its.jnj.com This leaflet was last revised in {MM/YYYY} OR {month YYYY}. Detailed information on this medicine is available on the European Medicines Agency web site: