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Adasuve (loxapine) – Package leaflet - N05AH01

Updated on site: 05-Oct-2017

Package leaflet: Information for the user

ADASUVE 4.5 mg inhalation powder, pre-dispensed 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 get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.What ADASUVE is and what it is used for

2.What you need to know before you use ADASUVE

3.How to use ADASUVE

4.Possible side effects

5.How to store ADASUVE

6.Contents of the pack and other information

1.What ADASUVE is and what it is 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 thus causing calming effects and relieving aggressive behaviour.

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

(Schizophrenia) Hearing, seeing, or sensing things which are not there, suspiciousness, mistaken beliefs, incoherent speech and behaviour and emotional flatness. People with this condition may also feel depressed, guilty, anxious or tense.

(Bipolar disorder) Feeling “high”, having excessive amounts of energy, needing much less sleep than usual, talking very quickly with racing ideas, and sometimes severe 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 like asthma or chronic obstructive pulmonary disease (which your doctor may have called “COPD”).

Warnings and precautions

Your doctor or nurse will talk to you before you use ADASUVE and determine whether it is appropriate for you.

ADASUVE may cause narrowing of the airways (bronchospasm) and may cause you to wheeze, cough, feel chest tightness or have shortness of breath. Typically, this will occur within 25 minutes of use.

Neuroleptic Malignant Syndrome (NMS) is a set of symptoms that can occur if you are taking antipsychotic medicines, including ADASUVE. These symptoms can be high fever, rigid muscles, irregular or fast heart rate or pulse. NMS can cause death. Do not use ADASUVE again if NMS occurs.

Antipsychotic medicines like ADASUVE can cause movements that you may not be able to control including making faces, sticking out your tongue, smacking or puckering your lips, blinking rapidly, or moving your legs, arms or fingers rapidly. Treatment with ADASUVE may have to be stopped if this occurs.

ADASUVE should be used with caution in patients who are intoxicated or delirious.

Before treatment with ADASUVE, tell your doctor or nurse if you:

have or had breathing problems like asthma or other chronic lung diseases such as bronchitis or emphysema

have or had heart problems or stroke

have or had low or high blood pressure

have or had seizures (convulsions)

have or had glaucoma (increased pressure in the eye)

have or had urinary retention (incomplete emptying of the bladder)

already used ADASUVE and you developed symptoms of wheezing or shortness of breath

ever had muscle or eye movements you can’t control, lack of coordination, sustained muscle contraction, or feeling restless or unable to sit still

are an older person suffering from dementia (loss of memory and other mental abilities).

Tell your doctor if you develop any of these symptoms after using ADASUVE.

Children and adolescents

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

Other medicines and ADASUVE

Tell your doctor if you are using or have recently used or might use any other medicines, including:

adrenaline

medicines to treat a breathing problem

medicines that may put you at a risk for seizures (for example, clozapine, tricyclics or SSRIs, tramadol, mefloquine)

medicines to treat Parkinson’s disease

lorazepam or other centrally acting medicines (to treat anxiety, depression, pain, or to help you sleep) or any other medicines that cause sleepiness

recreational (illegal) drugs

medicines like fluvoxamine, propranolol, and enoxacin and other medicines that inhibit a certain liver enzyme called “CYP450 1A2.”

medicines to treat schizophrenia, depression, or pain since you may be more at risk for seizures

Using ADASUVE and adrenaline together may cause your blood pressure to drop.

ADASUVE with alcohol

Because ADASUVE affects the nervous system, alcohol should be avoided when using ADASUVE.

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. You should not breast-feed for a period of 48 hours after receiving ADASUVE and should discard the milk produced in the meantime.

The following symptoms may occur in newborn babies of mothers that have repeatedly used antipsychotic medicines in the last three months of their pregnancy: shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If your baby develops any of these symptoms you may need to contact your doctor.

Driving and using machines

Do not drive or use any tools or machines after using ADASUVE until you know how ADASUVE affects you since dizziness, sedation, and sleepiness have been reported as a potential side effect of ADASUVE.

3.How to use ADASUVE

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

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

You will use ADASUVE under the supervision of a doctor or nurse.

ADASUVE is for inhalation use. After the doctor or nurse has prepared ADASUVE for you to use, you will be asked to take the device in your hand, exhale and then put the mouthpiece in your mouth, inhale the medicine through the device and then hold your breath briefly.

If you use more ADASUVE than you should

If you are concerned that you are given more ADASUVE than you feel necessary, tell your doctor or nurse of your concern. Patients who have been given more ADASUVE than they should may experience any of the following symptoms: extreme tiredness or sleepiness, trouble breathing, low blood pressure, throat irritation or a bad taste in the mouth, muscle or eye movements you can’t control.

If you have any further questions on the use of this product, ask your doctor or nurse.

4.Possible side effects

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

Reporting of side effects

If you get any of the following side effects, talk to your doctor immediately and stop taking the medicine:

any breathing symptoms such as wheezing, cough, shortness of breath, or chest tightness, as these could mean that the medicine is irritating your airways (uncommon occurrence unless you have asthma or COPD);

light-headedness or fainting, as these could mean that the medicine is lowering your blood pressure (uncommon occurrence);

worsening agitation or confusion, especially combined with fever or muscle stiffness (rare occurrence). These can be associated with a severe condition called neuroleptic malignant syndrome (NMS)

Also talk to your doctor if you have any of the following side effects that could also happen with other forms of this medicine:

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

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): muscle or eye movements you can’t control, lack of coordination, sustained muscle contraction, or feeling restless or unable to sit still.

If you get any side effects, talk to your doctor 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.

Additional side effects which have been related to long term use of loxapine by mouth and which may be relevant for ADASUVE include faintness upon standing, increased heart rate, increased blood pressure, blurred vision, dry eyes, and decreased urination.

5.How to store 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 product label. The expiry date refers to the last day of that month.

Store in the original pouch until ready for use in order to protect from light and moisture.

Do not use ADASUVE if you notice an open or torn pouch or any signs of physical damage to the product.

Do not discard ADASUVE in the household waste. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.Contents of the pack and other information

What ADASUVE contains

The active substance is loxapine. Each single-dose inhaler contains 5 mg loxapine and delivers 4.5 mg of loxapine.

What ADASUVE looks like and contents of the pack

ADASUVE 4.5 mg inhalation powder, pre-dispensed consists of a single-dose, disposable white plastic inhaler that contains loxapine. ADASUVE is packaged in a sealed foil pouch that contains one single dose inhaler. ADASUVE 4.5 mg is supplied in a carton of 1 or 5 units.

Marketing Authorisation Holder and

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028- Barcelona

España

Manufacturer

Ferrer Internacional, S.A.

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

Barcelona, Spain

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

België/Belgique/Belgien

Lietuva

Ferrer Internacional, S.A.

AOP Orphan Pharmaceuticals AG LT

Tél/Tel: +34 93 600 37 00

Tel +370 672 12222

България

Luxembourg/Luxemburg

AOP Orphan Pharmaceuticals AG BG

Ferrer Internacional, S.A.

Teл.: +35 988 6666096

Tél/Tel: +34 93 600 37 00

Česká republika

Magyarország

AOP Orphan Pharmaceuticals AG CZ

AOP Orphan Pharmaceuticals AG HU

Tel: +420 251 512 947

Tel.: +36 1 3192633

Danmark

Malta

Ferrer Internacional, S.A.

Ferrer Internacional, S.A.

Tlf: +46 18 430 44 45

Tel.: +34 93 600 37 00

Deutschland

Nederland

Trommsdorff GmbH & Co. KG

Ferrer Internacional, S.A.

Tel: +49-(0) 2404/553-01

Tel.: +34 93 600 37 00

Eesti

Norge

AOP Orphan Pharmaceuticals AG LT

Ferrer Internacional, S.A.

Tel: +370 672 12222

Tlf: +46 18 430 44 45

Ελλάδα

Österreich

Ferrer Galenica S.A.

AOP Orphan Pharmaceuticals AG

Τηλ: +30 210 52 81 700

España

Polska

Ferrer Internacional, S.A.

AOP Orphan Pharmaceuticals S.A. PL

Tel.: +34 93 600 37 00

Tel: +48 22 5424068

France

Portugal

Ferrer Internacional, S.A.

Ferrer Portugal, S.A.

Tél: +34 93 600 37 00

Tel: +351 214449600

Hrvatska

România

AOP Orphan Pharmaceuticals AG

Galenica S.A.

Tel: +30 210 52 81 700

Ireland

Slovenija

Galen Limited

AOP Orphan Pharmaceuticals AG

Tel: +44 (0)28 38334974

Ísland

Slovenská republika

Ferrer Internacional, S.A.

AOP Orphan Pharmaceuticals AG SK

Sími: +46 18 430 44 45

Tel: +421 31 5502271

Italia

Suomi/Finland

Angelini S.p.A.

Ferrer Internacional, S.A.

Tel: +39 06 780531

Puh/Tel: +46 18 430 44 45

Κύπρος

Sverige

Τhespis Pharmaceutical Ltd Tηλ:

Ferrer Internacional, S.A.

++357 22 67 77 10

Tel: +46 18 430 44 45

Latvija

United Kingdom

AOP Orphan Pharmaceuticals AG LT

Galen Limited

Tel +370 672 12222

Tel: +44 (0)28 38334974

This leaflet was last revised in

Other sources of information

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

The following information is intended for healthcare professionals only:

For inhalation use only

Read all instructions before use. See the SmPC for more information.

Becoming familiar with ADASUVE: The pictures below show the important features of ADASUVE.

ADASUVE is provided in a sealed pouch.

When ADASUVE is removed from the pouch, the indicator light is off.

The indicator light turns on (green) when the tab is pulled out. The inhaler is then ready for use.

The indicator light automatically turns off again when the medicine is inhaled.

Read the following 5 steps before administering ADASUVE to a patient.

1. Open pouch

Do not open the pouch until ready to use. Tear open the foil pouch and remove the inhaler from the package.

2. Pull tab

Firmly pull the plastic tab from the rear of the inhaler. The green light turns on indicating that the inhaler is ready for use.

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

Instruct the patient to:

3. Exhale

Hold the inhaler away from the mouth and breathe out fully to empty lungs.

4. Inhale

Inhale through the mouthpiece with a steady deep breath.

IMPORTANT: Check that the green light turns off after the patient inhales.

5. Hold breath

Remove the mouthpiece from the mouth and hold breath briefly.

NOTE: If the green light stays on after the patient inhales, instruct the patient to repeat steps 3-5.

Package leaflet: Information for the user

ADASUVE 9.1 mg inhalation powder, pre-dispensed 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 get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.What ADASUVE is and what it is used for

2.What you need to know before you use ADASUVE

3.How to use ADASUVE

4.Possible side effects

5.How to store ADASUVE

6.Contents of the pack and other information

1. What ADASUVE is and what it is 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 thus causing calming effects and relieving aggressive behaviour.

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

(Schizophrenia) Hearing, seeing, or sensing things which are not there, suspiciousness, mistaken beliefs, incoherent speech and behaviour and emotional flatness. People with this condition may also feel depressed, guilty, anxious or tense.

(Bipolar disorder) Feeling “high”, having excessive amounts of energy, needing much less sleep than usual, talking very quickly with racing ideas, and sometimes severe 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 like asthma or chronic obstructive pulmonary disease (which your doctor may have called “COPD”).

Warnings and precautions

Your doctor or nurse will talk to you before you use ADASUVE and determine whether it is appropriate for you.

ADASUVE may cause narrowing of the airways (bronchospasm) and may cause you to wheeze, cough, feel chest tightness or have shortness of breath. Typically, this will occur within 25 minutes of use.

Neuroleptic Malignant Syndrome (NMS) is a set of symptoms that can occur if you are taking antipsychotic medicines, including ADASUVE. These symptoms can be high fever, rigid muscles, irregular or fast heart rate or pulse. NMS can cause death. Do not use ADASUVE again if NMS occurs.

Antipsychotic medicines like ADASUVE can cause movements that you may not be able to control including making faces, sticking out your tongue, smacking or puckering your lips, blinking rapidly, or

moving your legs, arms or fingers rapidly. Treatment with ADASUVE may have to be stopped if this occurs.

ADASUVE should be used with caution in patients who are intoxicated or delirious.

Before treatment with ADASUVE, tell your doctor or nurse if you:

have or had breathing problems like asthma or other chronic lung diseases such as bronchitis or emphysema

have or had heart problems or stroke

have or had low or high blood pressure

have or had seizures (convulsions)

have or had glaucoma (increased pressure in the eye)

have or had urinary retention (incomplete emptying of the bladder)

already used ADASUVE and you developed symptoms of wheezing or shortness of breath

ever had muscle or eye movements you can’t control, lack of coordination, sustained muscle contraction, or feeling restless or unable to sit still

are an older person suffering from dementia (loss of memory and other mental abilities).

Tell your doctor if you develop any of these symptoms after using ADASUVE.

Children and adolescents

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

Other medicines and ADASUVE

Tell your doctor if you are using or have recently used or might use any other medicines, including:

adrenaline

medicines to treat a breathing problem

medicines that may put you at a risk for seizures (for example, clozapine, tricyclics or SSRIs, tramadol, mefloquine)

medicines to treat Parkinson’s disease

lorazepam or other centrally acting medicines (to treat anxiety, depression, pain, or to help you sleep) or any other medicines that cause sleepiness

recreational (illegal) drugs

medicines like fluvoxamine, propranolol, and enoxacin and other medicines that inhibit a certain liver enzyme called “CYP450 1A2.”

medicines to treat schizophrenia, depression, or pain since you may be more at risk for seizures

Using ADASUVE and adrenaline together may cause your blood pressure to drop.

ADASUVE with alcohol

Because ADASUVE affects the nervous system, alcohol should be avoided when using ADASUVE.

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. You should not breast-feed for a period of 48 hours after receiving ADASUVE and should discard the milk produced in the meantime.

The following symptoms may occur in newborn babies of mothers that have repeatedly used antipsychotic medicines in the last three months of their pregnancy: shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If your baby develops any of these symptoms you may need to contact your doctor.

Driving and using machines

Do not drive or use any tools or machines after using ADASUVE until you know how ADASUVE affects you since dizziness, sedation, and sleepiness have been reported as a potential side effect of ADASUVE.

3. How to use ADASUVE

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

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

You will use ADASUVE under the supervision of a doctor or nurse.

ADASUVE is for inhalation use. After the doctor or nurse has prepared ADASUVE for you to use, you will be asked to take the device in your hand, exhale and then put the mouthpiece in your mouth, inhale the medicine through the device and then hold your breath briefly.

If you use more ADASUVE than you should

If you are concerned that you are given more ADASUVE than you feel necessary, tell your doctor or nurse of your concern. Patients who have been given more ADASUVE than they should may experience any of the following symptoms: extreme tiredness or sleepiness, trouble breathing, low blood pressure, throat irritation or a bad taste in the mouth, muscle or eye movements you can’t control.

If you have any further questions on the use of this product, ask your doctor or nurse.

4. Possible side effects

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

Reporting of side effects

If you get any of the following side effects, talk to your doctor immediately and stop taking the medicine:

any breathing symptoms such as wheezing, cough, shortness of breath, or chest tightness, as these could mean that the medicine is irritating your airways (uncommon occurrence unless you have asthma or COPD);

light-headedness or fainting, as these could mean that the medicine is lowering your blood pressure (uncommon occurrence);

worsening agitation or confusion, especially combined with fever or muscle stiffness (rare occurrence). These can be associated with a severe condition called neuroleptic malignant syndrome (NMS)

Also talk to your doctor if you have any of the following side effects that could also happen with other forms of this medicine:

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

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): muscle or eye movements you can’t control, lack of coordination, sustained muscle contraction, or feeling restless or unable to sit still.

If you get any side effects, talk to your doctor 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.

Additional side effects which have been related to long term use of loxapine by mouth and which may be relevant for ADASUVE include faintness upon standing, increased heart rate, increased blood pressure, blurred vision, dry eyes, and decreased urination.

5. How to store 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 product label. The expiry date refers to the last day of that month.

Store in the original pouch until ready for use in order to protect from light and moisture.

Do not use ADASUVE if you notice an open or torn pouch or any signs of physical damage to the product.

Do not discard ADASUVE in the household waste. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What ADASUVE contains

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

What ADASUVE looks like and contents of the pack

ADASUVE 9.1 mg inhalation powder, pre-dispensed consists of a single-dose, disposable white plastic inhaler that contains loxapine. ADASUVE is packaged in a sealed foil pouch that contains one single dose inhaler. ADASUVE 9.1 mg is supplied in a carton of 1 or 5 units.

Marketing Authorisation Holder and

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028- Barcelona

España

Manufacturer

Ferrer Internacional, S.A.

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

Barcelona, Spain

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

België/Belgique/Belgien

Lietuva

Ferrer Internacional, S.A.

AOP Orphan Pharmaceuticals AG LT

Tél/Tel: +34 93 600 37 00

Tel +370 672 12222

България

Luxembourg/Luxemburg

AOP Orphan Pharmaceuticals AG BG

Ferrer Internacional, S.A.

Teл.: +35 988 6666096

Tél/Tel: +34 93 600 37 00

Česká republika

Magyarország

AOP Orphan Pharmaceuticals AG CZ

AOP Orphan Pharmaceuticals AG HU

Tel: +420 251 512 947

Tel.: +36 1 3192633

Danmark

Malta

Ferrer Internacional, S.A.

Ferrer Internacional, S.A.

 

Tlf: +46 18 430 44 45

Tel.: +34 93 600 37 00

Deutschland

Nederland

Trommsdorff GmbH & Co. KG

Ferrer Internacional, S.A.

Tel: +49-(0) 2404/553-01

Tel.: +34 93 600 37 00

Eesti

Norge

AOP Orphan Pharmaceuticals AG LT

Ferrer Internacional, S.A.

Tel: +370 672 12222

Tlf: +46 18 430 44 45

Ελλάδα

Österreich

Ferrer Galenica S.A.

AOP Orphan Pharmaceuticals AG

Τηλ: +30 210 52 81 700

España

Polska

Ferrer Internacional, S.A.

AOP Orphan Pharmaceuticals S.A. PL

Tel.: +34 93 600 37 00

Tel: +48 22 5424068

France

Portugal

Ferrer Internacional, S.A.

Ferrer Portugal, S.A.

Tél: +34 93 600 37 00

Tel: +351 214449600

Hrvatska

România

AOP Orphan Pharmaceuticals AG

Galenica S.A.

Tel: +30 210 52 81 700

Ireland

Slovenija

Galen Limited

AOP Orphan Pharmaceuticals AG

Tel: +44 (0)28 38334974

Ísland

Slovenská republika

Ferrer Internacional, S.A.

AOP Orphan Pharmaceuticals AG SK

Sími: +46 18 430 44 45

Tel: +421 31 5502271

Italia

Suomi/Finland

Angelini S.p.A.

Ferrer Internacional, S.A.

Tel: +39 06 780531

Puh/Tel: +46 18 430 44 45

Κύπρος

Sverige

Τhespis Pharmaceutical Ltd

Ferrer Internacional, S.A.

Tηλ: ++357 22 67 77 10

Tel: +46 18 430 44 45

Latvija

United Kingdom

AOP Orphan Pharmaceuticals AG LT

Galen Limited

Tel +370 672 12222

Tel: +44 (0)28 38334974

This leaflet was last revised in

Other sources of information

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

The following information is intended for healthcare professionals only:

For inhalation use only

Read all instructions before use. See the SmPC for more information.

Becoming familiar with ADASUVE: The pictures below show the important features of ADASUVE.

ADASUVE is provided in a sealed pouch.

When ADASUVE is removed from the pouch, the indicator light is off.

The indicator light turns on (green) when the tab is pulled out. The inhaler is then ready for use.

The indicator light automatically turns off again when the medicine is inhaled.

Read the following 5 steps before administering ADASUVE to a patient.

1. Open pouch

Do not open the pouch until ready to use. Tear open the foil pouch and remove the inhaler from the package.

2. Pull tab

Firmly pull the plastic tab from the rear of the inhaler. The green light turns on indicating that the inhaler is ready for use.

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

Instruct the patient to:

3. Exhale

Hold the inhaler away from the mouth and breathe out fully to empty lungs.

4. Inhale

Inhale through the mouthpiece with a steady deep breath.

IMPORTANT: Check that the green light turns off after the patient inhales.

5. Hold breath

Remove the mouthpiece from the mouth and hold breath briefly.

NOTE: If the green light stays on after the patient inhales, instruct the patient to repeat steps 3-5.

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