OSMOHALE POWDER FOR INHALATION (HARD CAPSULES)

2. What you need to know before you take Osmohale

Do not take Osmohale

• if you are allergic(hypersensitive) to mannitol or any of the other ingredients;
• if your lung capacityis severely reduced(this will be measured before the test);
• if you currently have or have had a dilated or weakened blood vessel around the heart or brain (aneurysm);
• if you have uncontrolled high blood pressure;
• if you have had a heart attackin the last 6 months;
• if you have had a strokein the last 6 months.

Warnings and Precautions

Consult your doctor or pharmacist before taking Osmohale.

• if your lung capacityis reduced(this will be measured before the test);
• if you have previously experienced difficulty breathing, or have had wheezingor coughingduring a spirometry test (a study where you blow into a measuring instrument);
• if you cough up blood;
• if you have air in the pleural space between the chest wall and the lungs, which causes chest pain and shortness of breath (pneumothorax);
• if you have recently undergone eye, stomach, or chestsurgery;
• if you experience chest pain(angina pectoris);
• if you have problems performing spirometry(the person performing it will inform you);
• if you have had a respiratory tract infectionin the last 2 weeks.

If you experience shortness of breath, wheezing, and/or coughing during the spirometry test, you may be given a medicine to keep your airways open, and the test will be stopped.

Do not engage in strenuous exerciseon the day of the test, especially before taking it, as it may affect the results.

Do not smokefor at least 6 hours before the test, as it may affect the results.

Do not take Osmohale on your own. Osmohale should only be administered in a clinic or laboratory, by trained professionals familiar with the use of similar tests and their possible effects, under the supervision of an experienced doctor.

Children and Adolescents

Osmohale should not be administered to children under 6 years of age.

Osmohale is not recommended in patients from 6 to 18 years of age due to limited information available on the use of the medicine in this population.

Other Medicines and Osmohale

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

If you are using other medicines for the treatment of asthma or allergies, you may need to stop them before the test. These medicines may affect your body's reaction to Osmohale. Your doctor will tell you which medicine(s) to stop and for how long (usually between 6 hours and 4 days before the test).

Using Osmohale with Food and Drinks

On the day of the test, do not drink coffee, tea, or cola, or eat chocolate or other foods that contain caffeine.

Pregnancy, Breast-feeding, and Fertility

Do not undergo the test with Osmohale if you are pregnant.

You can use Osmohale during breast-feeding.

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and Using Machines

No effects have been observed.

3. How to Take Osmohale

Follow the instructions for administration of this medicine exactly as told by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist again.

Adults

A doctor or another healthcare professional specifically trained will administer Osmohale using an inhaler and will accompany you during the test. You will not be left alone.

Do not put the Osmohale capsules in your mouth or swallow them.

Conducting the Test

1. You will be asked to sit comfortably in a chair.
2. Initially, you will be asked to blow forcefully into a tube (spirometry).
3. A nasal clip will be placed on you so that you can only inhale and exhale through your mouth.
4. After exhaling all the air, you will be asked to inhale the Osmohale medicine deeply using a special inhaler.
5. You will then be asked to hold your breath for five seconds before exhaling.
6. The nasal clip will be removed, and you will be asked to breathe normally.
7. Then, you will be asked to blow forcefully into the tube again. This test measures the effect of Osmohale on your lungs.
8. Steps 3 to 7 may be repeated up to 9 times, with more Osmohale depending on the effect on your lungs (as measured in step 7), until the test is completed.
9. Once the study is finished, you may be given a medicine to help you breathe.

If you are unsure about any part of the test or have any questions about the medicine, talk to the doctor or healthcare professional specifically trained who is conducting the test.

If you take more Osmohale than you should

If you think you may have been given too much of the medicine, tell the doctor or healthcare professional conducting the test immediately. If you have taken too much Osmohale, you may feel that you cannot breathe, experience wheezing, or cough. The doctor may give you oxygen or medicine to help you breathe.

4. Possible Side Effects

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

List of Side Effects

Common(may affect up to 1 in 10 people):

• Asthma
• Shortness of breath
• Chest tightness
• Cough
• Feeling sick
• Headache
• Nose and throat pain, discomfort when swallowing
• Runny nose
• Vomiting

Uncommon(may affect up to 1 in 100 people):

• Cold extremities
• Diarrhea
• Dizziness
• Nervousness
• Thirst
• Tiredness
• Redness and sweating
• Hoarseness
• Itching and skin rash
• Itching in the eyes
• Reduced oxygen in the blood
• Mouth ulcers
• Nosebleeds (epistaxis)
• Stomach pain
• Muscle and joint pain

Reporting of Side Effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package 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.

5. Storage of Osmohale

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C.

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

6. Container Contents and Additional Information

Osmohale Composition

The active ingredient is mannitol.

The inhalation capsules contain mannitol powder. One capsule contains 0 mg, 5 mg, 10 mg, 20 mg, or 40 mg of mannitol.

Product Appearance and Container Contents

The powder is white or almost white.

The empty capsule is transparent with two white printed bands

The 5 mg capsule is half white and half transparent, with the inscription 5 mg.

The 10 mg capsule is half yellow and half transparent, with the inscription 10 mg.

The 20 mg capsule is half pink and half transparent, with the inscription 20 mg.

The 40 mg capsules are half red and half transparent, with the inscription 40 mg.

The capsules are presented in blisters. A diagnostic kit, packaged in a box, consists of:

• 1 empty capsule
• 1 capsule of 5 mg
• 1 capsule of 10 mg
• 1 capsule of 20 mg
• 15 capsules of 40 mg
• 1 inhaler

Marketing Authorization Holder

Pharmaxis Europe Limited

108 Q House Furze Road,

Sandyford, Dublin 18,

D18AY29, Ireland

Manufacturer

MIAS Pharma Limited

Suite 1 Stafford House

Strand Road, Portmarnock

Co. Dublin, D13 WC83

Ireland

Arvato Supply Chain Solutions SE

Gottlieb-Daimler Straße 1

33428 Harsewinkel

North Rhine-Westphalia

Germany

If you have any questions about this medication, please contact the local representative of the marketing authorization holder:

Laboratorio Aldo-Unión, S.L.

Baronesa de Maldá, 73

08950 Esplugues de LL.

Barcelona

Spain

Tel: +34 93 372 71 11

Fax: +34 93 371 61 98

This medication is authorized in the Member States of the European Economic Area under the following names:

Aridol: Finland, Germany, Norway, Sweden

Osmohale: Denmark, Ireland, Netherlands, Spain, United Kingdom (Northern Ireland)

Date of the last revision of this leaflet:06/2022

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

INFORMATION FOR HEALTHCARE PROFESSIONALS

This information is intended solely for healthcare professionals:

Contraindications

Known hypersensitivity to mannitol or any of the capsule components.

Osmohale should not be administered to patients with severe respiratory limitation (expected FEV1 <50% or <1.0 l), or conditions that may be compromised by the induction of bronchospasms or the repetition of blowing maneuvers. These include: cerebral or aortic aneurysm, uncontrolled hypertension, myocardial infarction or a cerebrovascular accident in the previous six months.

Special Warnings and Precautions for Use

Osmohale should be administered exclusively by inhalation. Mannitol inhalation causes bronchoconstriction. The Osmohale inhalation test should only be performed in clinics or laboratories, by a doctor or other healthcare professional properly trained to perform bronchial provocation tests and to manage acute bronchospasms, and under the supervision of an experienced doctor. The responsible doctor, with the proper training to treat acute bronchospasms, including the proper use of resuscitation equipment, should be close enough to respond quickly in case of an emergency. A stethoscope, sphygmomanometer, and pulse oximeter should be available. Once Osmohale administration has begun, the patient should not be left unattended during the procedure.

In the test area, there should be medications for the treatment of severe bronchospasms, including adrenaline for subcutaneous injection, and salbutamol or other beta agonists in graduated dose inhalers. Oxygen should be available. A small volume nebulizer should be available for the administration of bronchodilators.

General precautions for spirometry and bronchial provocation tests should be observed, including additional precautions in patients with the following conditions: respiratory failure (basal FEV1 less than 70% of expected normal values or an absolute value of 1.5 l or less in adults), bronchoconstriction induced by spirometry, hemoptysis of unknown origin, pneumothorax, recent abdominal or thoracic surgery, recent intraocular surgery, unstable angina, inability to perform acceptable quality spirometry, or lower or upper respiratory tract infection in the previous 2 weeks.

If the patient presents with spirometry-induced asthma, or the FEV1 drop is greater than 10% after continuous administration after the 0 mg capsule, a standard dose of bronchodilator should be applied and the Osmohale provocation should be suspended.

Exercises: Vigorous physical exercise should be completely avoided on the day of the test, as it may affect the results.

Smoking: As smoking may affect the test results, it is recommended that patients abstain from smoking for at least 6 hours prior to the study.

The Osmohale test should not be used in patients under 6 years of age, due to their inability to provide reproducible spirometric measurements.

Information on the use of Osmohale in patients from 6 to 18 years of age is limited; consequently, the use of Osmohale is not recommended in this population.

The effects of repeated tests with Osmohale over a short period have not been investigated; consequently, special consideration should be given to the repeated use of Osmohale.

Instructions for the Inhaler Device

These instructions show how to use the inhaler

1. Removing the cap: With both hands, hold the inhaler in a vertical position and remove the cap.

1. Opening: Hold the base of the inhaler firmly with one hand, and open the device by turning the mouthpiece in the direction of the arrow, as shown in the image.

1. Loading: Make sure your hands are dry; remove a capsule from the inhaler box and place it in the inhaler as shown in the illustration.

It does not matter which side the capsule is inserted into the chamber.

1. Closing: While holding the device in a vertical position, turn the mouthpiece to the closed position, until you hear a "click".

1. Piercing the capsule: Hold the inhaler in a vertical position and press the two piercing buttons located on the sides of the device simultaneously.

Do this only once, as piercing the capsule more than once could cause it to break or fragment. Piercing opens holes in the capsule, allowing the powder to come out during inhalation.

1. Preparing for inhalation: Tilt the inhaler so that the mouthpiece is slightly downward at a 45-degree angle, as shown in the following figure, until the capsule falls into the rotating chamber. Keep the device tilted in this way and instruct the patient to exhale completely (outside the inhaler).

1. Inhalation: The patient should tilt their head slightly back, and holding the inhaler at 45 degrees, bring it to their mouth and adjust their lips to the mouthpiece. Instruct the patient to inspire rapidly and deeply to fill their lungs. Then the patient should hold their breath for five seconds.

Note: During a correct inhalation, a "rattle" sound should be heard as the capsule rotates inside the inhaler.

1. Exhalation: Remove the inhaler from the patient's mouth, and let them exhale and resume normal breathing.

1. Verification: To empty, the Osmohale capsule must rotate inside the inhaler. If after inhalation the capsule has not emptied, a second inhalation may be required (with the same capsule). Check the capsule after each inhalation.

Note:

The inhaler is designed for SINGLE USE (one device per provocation test), and should not be cleaned during the test.

Discard the inhaler after each Osmohale provocation. The inhaler should not be sterilized or reused, as this could compromise the integrity of the following test results.

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READ THE COMPLETE PRODUCT CHARACTERISTICS SUMMARY BEFORE PERFORMING THIS PROVOCATION TEST.