Spravato 28 mg nasal spray; solution

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

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.

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).

• 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.

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.

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.

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.

• 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.

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.

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.

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).

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.

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.

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.

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.

If you need steroid or decongestant medicines as a nasal spray, avoid using them during the hour before your Spravato treatment.

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”).

It is important to make sure you come in for your scheduled appointments, so that this medicine is effective for you.

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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

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

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.

Each nasal spray device is individually packaged in a sealed blister.

Not all pack sizes may be marketed.