Adasuve (loxapine) – Labelling - N05AH01

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

POUCH

1. NAME OF THE MEDICINAL PRODUCT

ADASUVE 4.5 mg inhalation powder loxapine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each inhaler delivers 4.5 mg loxapine.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Inhalation powder

One single-dose inhaler

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Directions for use inside

Read the package leaflet before use

Do not open pouch until ready to use

Inhalation use

Directions for use

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

1. Open pouch. Do not open 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 to 5.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children

7. OTHER SPECIAL WARNING(S), IF NECESSARY

Do not use in patients with asthma or COPD or acute respiratory symptoms

A short-acting beta-agonist bronchodilator should be available for treatment of possible bronchospasm. Patients should be observed during the first hour after each dose for signs and symptoms of bronchospasm.

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

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

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028- Barcelona

España

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/13/823/001 (5 single-dose inhalers)

EU/1/13/823/003 (1 single-dose inhaler)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

DEVICE HOUSING

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

ADASUVE 4.5 mg inhalation powder loxapine

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

4.5 mg

6.OTHER

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

POUCH

1. NAME OF THE MEDICINAL PRODUCT

ADASUVE 9.1 mg inhalation powder loxapine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each inhaler delivers 9.1 mg loxapine.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Inhalation powder

One single-dose inhaler

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Directions for use inside

Read the package leaflet before use

Do not open pouch until ready to use

Inhalation use

Directions for use

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

1. Open pouch. Do not open 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 to 5.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children

7. OTHER SPECIAL WARNING(S), IF NECESSARY

Do not use in patients with asthma or COPD or acute respiratory symptoms

A short-acting beta-agonist bronchodilator should be available for treatment of possible bronchospasm. Patients should be observed during the first hour after each dose for signs and symptoms of bronchospasm.

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

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

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028- Barcelona

España

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/13/823/002 (5 single-dose inhalers)

EU/1/13/823/004 (1 single-dose inhaler)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

DEVICE HOUSING

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

ADASUVE 9.1 mg inhalation powder loxapine

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

9.1 mg

6. OTHER