ADASUVE 9.1 mg INHALATION POWDER (SINGLE-DOSE)

Introduction

Package Leaflet: Information for the User

ADASUVE 9.1 mg powder for inhalation (single dose)

loxapine

Read all of this leaflet carefully before you start using 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 or nurse.

• If you experience side effects, consult your doctor or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is ADASUVE and what is it used for

ADASUVE contains the active substance loxapine, which belongs to a group of medicines called antipsychotics. ADASUVE works by blocking certain chemicals in the brain (neurotransmitters), such as dopamine and serotonin, which produces calming effects and relief from aggressive behavior.

ADASUVE is used to treat acute symptoms of mild to moderate agitation that may occur in adult patients with schizophrenia or bipolar disorder. These are diseases characterized by symptoms such as:

• (Schizophrenia) seeing, hearing, or feeling things that do not exist, distrust, false beliefs, incoherent speech and behavior, and emotional indifference. People with this disease may also feel depressed, guilty, anxious, or tense.

• (Bipolar Disorder) feeling "high", with excessive energy, needing much less sleep than usual, talking very quickly with many ideas, and sometimes great irritability.

2. What you need to know before you use ADASUVE

Do not use ADASUVE

• if you are allergic to loxapine or amoxapine;
• if you have symptoms of wheezing or shortness of breath;

• if you have lung problems such as asthma or chronic obstructive pulmonary disease (which your doctor may call "COPD").

Warnings and precautions

Consult your doctor or nurse before starting to use ADASUVE to determine if it is suitable for you.

• ADASUVE may cause narrowing of the airways (bronchospasm) and wheezing, coughing, chest tightness, or shortness of breath. This usually occurs within 25 minutes of administration.
• Neuroleptic Malignant Syndrome (NMS) is a set of symptoms that can occur if you are taking antipsychotics, including ADASUVE. These symptoms can be high fever, muscle stiffness, irregular or rapid heartbeat. NMS can be fatal. Do not use ADASUVE again if you have had NMS.

• Antipsychotic medicines like ADASUVE may cause movements that you cannot control, such as facial gestures, sticking out your tongue, hitting or biting your lips, blinking rapidly, or moving your legs, arms, or fingers quickly. If this happens, treatment with ADASUVE should be stopped.

• ADASUVE will be used with caution in patients who are intoxicated or have delirium.

Before taking ADASUVE, inform your doctor or nurse:

• if you have or have had respiratory problems such as asthma and other chronic lung diseases, such as bronchitis or emphysema.
• if you have or have had heart problems or stroke
• if you have or have had low blood pressure or high blood pressure
• if you have or have had seizures (convulsions)
• if you have or have had glaucoma (increased eye pressure)
• if you have or have had urinary retention (incomplete emptying of the urinary bladder)
• if you have already used ADASUVE and have presented symptoms of wheezing or shortness of breath

• if you have suffered from uncontrolled muscle or eye movements, lack of coordination, constant muscle contraction, or feeling of restlessness or if you cannot stay still

• if you are an elderly person with dementia (loss of memory and other mental abilities)

Children and adolescents

ADASUVE is not recommended for use in children and adolescents under 18 years of age.

Using ADASUVE with other medicines

Tell your doctor if you are taking or have recently taken or may need to take any other medicines, including:

• adrenaline
• medicines to treat a respiratory problem

• medicines that may cause you to have seizures (e.g., clozapine, tricyclics, or ISRS, tramadol, mefloquine)
• medicines to treat Parkinson's disease

• lorazepam or other central-acting medicines (for anxiety, depression, pain, or to help you sleep) or other medicines that cause drowsiness
• illicit drugs

• medicines such as fluvoxamine, propranolol, and enoxacin, and other medicines that inhibit a liver enzyme called "CYP450 1A2."

• medicines to treat schizophrenia, depression, or pain, because you may have a higher risk of having seizures

The use of ADASUVE and adrenaline combined may cause low blood pressure.

Using ADASUVE with alcohol

Since ADASUVE affects the nervous system, you should avoid consuming alcohol during treatment with ADASUVE.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. It is recommended that women do not breastfeed for 48 hours after administration of ADASUVE and discard the milk produced during this period. ADASUVE may cause the following symptoms in newborn babies, in mothers who have been treated with antipsychotic medicines in the last trimester of pregnancy: trembling, stiffness, and/or muscle weakness, drowsiness, agitation, breathing problems, and difficulty feeding. If your baby has any of these symptoms, you should contact your doctor.

Driving and using machines

Do not drive or use tools or machines after taking ADASUVE until you know how it affects you, as the possible side effects of ADASUVE are dizziness, sedation, and drowsiness.

3. How to use ADASUVE

Always use this medicine exactly as your doctor or nurse has told you. If you are not sure, ask your doctor or nurse again.

The recommended initial dose is 9.1 mg. After 2 hours, your doctor may prescribe a second dose after carefully considering your condition and may reduce the dose to 4.5 mg if your doctor believes this is a more suitable dose to treat your condition.

ADASUVE must be used under the supervision of a doctor or nurse.

ADASUVE is indicated for inhalation use. After the doctor or nurse has prepared ADASUVE, you will be asked to hold the device with your hand, exhale, insert the mouthpiece into your mouth, inhale the medicine through the device, and hold your breath for a few seconds.

If you take more ADASUVE than you should

If you think you have taken more ADASUVE than you should, inform your doctor or nurse. Patients who receive more ADASUVE than they should may experience any of the following symptoms: extreme tiredness or drowsiness, breathing problems, low blood pressure, throat irritation, or bad taste in the mouth, uncontrolled muscle or eye movements.

If you have any other questions about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, ADASUVE can cause side effects, although not everybody gets them.

If you experience any of the following side effects, consult your doctor immediately and stop taking the medicine:

• respiratory symptoms, such as wheezing, coughing, shortness of breath, or chest tightness, as this may mean that the medicine is irritating the airways (uncommon unless you have asthma or COPD);

• dizziness or fainting, as this may mean that the medicine is lowering your blood pressure (uncommon);

• worsening of agitation or confusion, especially combined with fever or muscle stiffness (rare). These can be associated with a serious condition called Neuroleptic Malignant Syndrome (NMS)

Also, consult your doctor if you experience any of the following side effects that can also occur with other forms of this medicine:

Very common(may affect more than 1 in 10 people): bad taste in the mouth or drowsiness.

Common(may affect up to 1 in 10 people): dizziness, throat irritation, dry mouth, or tiredness

Uncommon(may affect up to 1 in 100 people): uncontrolled muscle or eye movements, lack of coordination, constant muscle contraction, or feeling of restlessness or if you cannot stay still.

Other additional effects that have been associated with long-term use of loxapine by mouth and that may be relevant for ADASUVE include fainting when standing up, increased heart rate, high blood pressure, blurred vision, dry eyes, and decreased urine production.

Reporting of side effects

If you experience any side effects, consult your doctor or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of ADASUVE

Keep this medicine out of the sight and reach of children.

Do not use ADASUVE after the expiry date which is stated on the label. The expiry date is the last day of the month shown.

Store in the original package to protect from light and moisture.

Do not use ADASUVE if the bag is open or torn or if there are signs of physical damage to the medicine.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

The active substance is loxapine. Each single-dose inhaler contains 10 mg of loxapine and delivers 9.1 mg of loxapine.

Appearance of ADASUVE and pack contents

ADASUVE 9.1 mg powder for inhalation (single dose), consists of a white plastic, disposable, single-use inhaler containing loxapine. Each inhaler is packaged in a sealed aluminum bag. ADASUVE 9.1 mg is available in a box of 1 or 5 single-dose inhalers.

Marketing Authorisation Holder

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028- Barcelona

Spain

Manufacturer

Ferrer Internacional, S.A.

Joan Buscalla, 1-9, 08173 Sant Cugat del Vallès

Barcelona, Spain

You can request more information about this medicine by contacting the local representative of the Marketing Authorisation Holder:

België/Belgique/BelgienLietuva

Ferrer Internacional, S.A. AOP Orphan Pharmaceuticals AG LT

Tél/Tel: +34 93 600 37 00 Tel +370 672 12222

????????Luxembourg/Luxemburg

AOP Orphan Pharmaceuticals AG BG Ferrer Internacional, S.A.

Te?.: +35 988 6666096 Tél/Tel: +34 93 600 37 00

Ceská republikaMagyarország

AOP Orphan Pharmaceuticals AG CZ AOP Orphan Pharmaceuticals AG HU

Tel: +420 251 512 947 Tel.: +36 1 3192633

DanmarkMalta

Ferrer Internacional, S.A. Ferrer Internacional, S.A.

Tlf: +34 93 600 37 00 Tel.: +34 93 600 37 00

DeutschlandNederland

Ferrer Deutschland GmbH Ferrer Internacional, S.A.

Tel: +49 (0) 2407 502311 0 Tel.: +34 93 600 37 00

EestiNorge

AOP Orphan Pharmaceuticals AG LT Ferrer Internacional, S.A.

Tel: +370 672 12222 Tlf: +34 93 600 37 00

Ελλ?δαÖsterreich

Ferrer Galenica S.A. AOP Orphan Pharmaceuticals AG

Τηλ: +30 210 52 81 700 Tel: +43 1 5037244-0

EspañaPolska

Ferrer Farma, S.A. AOP Orphan Pharmaceuticals S.A. PL

Tel.: +34 93 600 37 00 Tel: +48 22 5424068

FrancePortugal

Ferrer Internacional, S.A. Ferrer Portugal, S.A.

Tél: +34 93 600 37 00 Tel: +351 214449600

HrvatskaRomânia

AOP Orphan Pharmaceuticals AG Galenica S.A.

Tel: +43 1 5037244-0 Tel: +30 210 52 81 700

IrelandSlovenija

Ferrer Internacional, S.A. AOP Orphan Pharmaceuticals AG

Tel.: +34 93 600 37 00 Tel: +43 1 5037244-0

ÍslandSlovenská republika

Ferrer Internacional, S.A. AOP Orphan Pharmaceuticals AG SK

Sími: +34 93 600 37 00

Tel: +421 31 5502271

Date of last revision of this leaflet:

Other sources of information

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

This information is intended only for healthcare professionals:

Read all the instructions before using this medicine. See the SPC for more information.

Familiarize yourself with ADASUVE:The following images show the important elements of ADASUVE.

mouthpiece

indicator light

tab

• ADASUVE is packaged in a sealed bag.
• When ADASUVE is removed from the bag, the indicator light is off.
• The indicator light turns on (green) when the tab is removed. The inhaler is ready to use.

• The indicator light turns off automatically again when the medicine has been inhaled. Read the following 5 steps before administering ADASUVE to a patient.

-{}- 1. Open the bag

Do not open the bag until you are ready to use it.Tear the aluminum bag and remove the inhaler from its packaging.

1. Pull the tab.

Pull the plastic tab from the back of the inhaler. The green light will turn on, indicating that the inhaler is ready to use.

Use it within the first 15 minutes after removing the tab (or until the green light turns off) to avoid automatic deactivation of the inhaler.

Give the patient the following instructions:

1. Exhale

Hold the inhaler away from your mouth and exhale completely to empty your lungs.

1. Inhale

Inhale through the mouthpiece with a deep and continuous inspiration.

IMPORTANT: Check that the green light turns off after inhalation.

1. Hold your breath

Remove the mouthpiece from your mouth and hold your breath for a few seconds.

NOTE: If the green light remains on after the patient has inhaled, instruct the patient to repeat steps 3 to 5.