Adasuve 9,1 mg polvo para inhalacion (unidosis)

Package Insert: Information for the User

ADASUVE 9.1 mg Powder for Inhalation (Single-Dose)

loxapine

Read this entire package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.

• If you have any questions, consult your doctor or nurse.

• If you experience any adverse effects, consult your doctor or nurse, even if they are not listed in this package insert. See section 4.

ADASUVE contains the active ingredient loxapine, which belongs to a group of medications called antipsychotics. ADASUVE acts by blocking certain brain chemicals (neurotransmitters), such as dopamine and serotonin, thereby producing calming effects and relief from aggressive behavior.

ADASUVE is used to treat the acute symptoms of mild to moderate agitation that may occur in adult patients with schizophrenia or bipolar disorder. These are conditions 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 condition may also feel depressed, guilty, anxious, or tense.

• (Bipolar Disorder) a feeling of "euphoria", with excessive energy, needing much less sleep than normal, speaking very quickly with many ideas, and sometimes great irritability.

Do not use ADASUVE

• if you are allergic to loxapine or amoxapine;
• if you have symptoms of bronchospasm or dyspnea;

• if you have respiratory 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 bronchospasm and sibilance, cough, chest tightness or shortness of breath. This usually occurs within 25 minutes of administration.
• The neuroleptic malignant syndrome (NMS) is a group of symptoms that can occur if you are taking antipsychotics, including ADASUVE. These symptoms can be high fever, muscle rigidity, irregular or rapid heart rate or pulse. NMS can cause death. Do not use ADASUVE again if you have had NMS.

• Antipsychotic medications like ADASUVE can cause movements that you may not be able to control, for example facial gestures, sticking out your tongue, hitting or biting your lips, rapid blinking or moving your legs, arms or fingers quickly. If this occurs, treatment with ADASUVE should be suspended.

• ADASUVE will be used with caution in intoxicated patients or those with delirium.

Before taking ADASUVE, notify 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 hypotension or hypertension
• if you have or have had seizures
• if you have or have had glaucoma (increased intraocular pressure)
• if you have or have had urinary retention (incomplete emptying of the bladder)
• if you have used ADASUVE before and have had symptoms of bronchospasm or dyspnea

• if you have had involuntary muscle movements or eye movements that you cannot control, 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 old.

Use of ADASUVE with other medications

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

• adrenaline
• medications to treat a respiratory problem

• medications that may cause seizures (e.g. clozapine, tricyclics or SSRIs, tramadol, mefloquine)
• medications to treat Parkinson's disease

• lorazepam or other central-acting medications (to treat anxiety, depression, pain or to sleep) or other medications that cause drowsiness
• drugs (illicit)

• medications such as fluvoxamine, propranolol and enoxacino, and other medications that inhibit a liver enzyme called “CYP450 1A2.”

• medications to treat schizophrenia, depression or pain, as it may increase the risk of seizures

The use of ADASUVE and adrenaline combined may cause hypotension.

Use of ADASUVE with alcohol

Since ADASUVE affects the nervous system, alcohol consumption should be avoided during treatment with ADASUVE.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor before using this medication. It is recommended that women do not breastfeed for a period of 48 hours after administration of ADASUVE and discard the milk produced during that periodand may produce the following symptoms in newborn babies, from mothers who have been treated with antipsychotic medications in the last trimester of pregnancy: tremors, rigidity and/or muscle weakness, drowsiness, agitation, breathing problems, and difficulty feeding. If your baby presents any of these symptoms, contact your doctor.

Driving and operating machinery

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

Use this medication exactly as instructed by your doctor or nurse for administration. If in doubt, consult 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 for treating 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 take the device in your hand, exhale, insert the mouthpiece into your mouth, inhale the medication 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 believe is necessary, inform your doctor or nurse. Patients who receive more ADASUVE than they should will experience any of the following symptoms: extreme fatigue or drowsiness, breathing difficulties, hypotension, throat irritation or bad taste in the mouth, uncontrollable muscle or eye movements.

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

Like all medications, it may cause adverse effects, although not everyone will experience them.

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

• respiratory symptoms, such as wheezing, coughing, shortness of breath, or chest tightness, as it could mean the medication is irritating the airways (rare unless you suffer from asthma or COPD);

• dizziness or fainting, as it could mean the medication is lowering your blood pressure (rare);

• worsening agitation or confusion, especially combined with fever or muscle rigidity (infrequent). These may be associated with a serious condition called malignant neuroleptic syndrome (MNS)

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

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 fatigue.

Uncommon (may affect up to 1 in 100 people): involuntary muscle or eye movements, lack of coordination, constant muscle contraction, or feeling restless or unable to stay still.

Other additional effects that may be related to the long-term use of loxapine by mouth and may be relevant to ADASUVE include fainting when standing up, increased heart rate, high blood pressure, blurred vision, dry eyes, and decreased urine output.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your nurse or doctor, even if it's a possible adverse effect that doesn't appear in this prospectus. You can also report them directly through the national notification system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use ADASUVE after the expiration date that appears on the label. The expiration date is the last day of the month indicated.

Store in the original packaging until it is to be used in order to protect it from light and moisture.

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

Medicines should not be thrown away. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

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

Appearance of ADASUVE and packaging contents

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

Marketing Authorization 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

For more information about this medication, please contact the local representative of the marketing authorization holder:

België/Belgique/BelgienLietuva

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

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

????????Luxembourg/Luxemburg

AOP Orphan Pharmaceuticals AG BGFerrer Internacional, S.A.

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

Ceská republikaMagyarország

AOP Orphan Pharmaceuticals AG CZAOP Orphan Pharmaceuticals AG HU

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

DanmarkMalta

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

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

DeutschlandNederland

Ferrer Deutschland GmbHFerrer Internacional, S.A.

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

EestiNorge

AOP Orphan Pharmaceuticals AG LTFerrer Internacional, S.A.

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

Ελλ?δαÖsterreich

Ferrer Galenica S.A.AOP Orphan Pharmaceuticals AG

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

EspañaPolska

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

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

FrancePortugal

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

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

HrvatskaRomânia

AOP Orphan Pharmaceuticals AGGalenica S.A.

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

IrelandSlovenija

Ferrer Internacional, S.A.AOP Orphan Pharmaceuticals AG

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

Last review date of this leaflet:

Other sources of information

The detailed information about this medication is available on the European Medicines Agency website: http://www.ema.europa.eu.

This information is intended solely for healthcare professionals:

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

Get familiar with ADASUVE:The following images show the important elements of ADASUVE.

Mouthpiece

Indicator light

Trigger

• 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 trigger is pulled. The inhaler is ready to use.

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

-{}-1. Open the bag

Do not open the bag until it is going to be used.Rip open the aluminum bag and remove the inhaler from its packaging.

2. Pull the trigger

Pull the plastic trigger hard 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 pulling the trigger (or until the green light goes out) to avoid automatic deactivation of the inhaler.

Give instructions to the patient to:

3. Exhale

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

4. Inhale

Inhale through the mouthpiece with a deep and continuous breath.

IMPORTANT: Check that the green light goes out after inhalation.

5. Hold your breath

Remove the mouthpiece from the 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.