Aridol
Läkemedelsverket 2015-10-14
Package Leaflet: Information for the user
Aridol inhalation powder, hard capsule
Mannitol
Read all of this leaflet carefully before you are given this medicinebecause it contains important information for you.
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Keep this leaflet. You may need to read it again.
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If you have any further questions, ask your doctor or pharmacist.
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This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
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If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
What is in this leaflet:
1. What Aridol is and what it is used for
2. What you need to know before you take Aridol
3. How to take Aridol
4. Possible side effects
5. How to store Aridol
6. Contents of the pack and other information
1. What Aridol is and what it is used for
Aridol is a test to see if you have airways sensitivity or not.
Aridol contains the active substance mannitol.
Airways sensitivity may be caused by inflammation of the airways, making it difficult to breathe sometimes. People with airways sensitivity are often very susceptible to factors in the environment such as exercise, dust, smoke and other irritants.
Your doctor or another specifically trained healthcare professional will ask you to breathe in Aridol, using a small inhaler.
For people who do have airways sensitivity, their airways will become narrower and so they may find it harder to breathe.
People who do not have airways sensitivity will not experience their airways becoming narrower when breathing in Aridol. They will still be able to breathe normally.
As part of the test, you will be asked to blow into a tube that will measure the effect of Aridol on your lungs.
This medicine is only used to see whether you have airways sensitivity.
2. What you need to know before you take Aridol
Do not take Aridol:
if you are allergic (hypersensitive) to mannitol or any of the other ingredients;
if your lung capacity is severely reduced (this will be measured prior to the test);
if you now have or used to have a swollen or weakened blood vessel around the heart or brain (aneurysm);
if you have high blood pressure which is not controlled by medicine;
if you have had a heart attack in the last 6 months;
if you have had a stroke in the last 6 months.
Warnings and precautions
Talk to your doctor or pharmacist before taking Aridol:
if your lung capacity is reduced (this will be measured prior to the test);
if you have previously experienced difficulty in breathing, or have wheezed or coughed during a spirometry test (blowing into a measuring instrument);
if you are coughing up blood;
if you have air in the pleural space between the chest wall and the lungs, causing chest pain and shortness of breath (pneumothorax);
if you have recently had stomach, chest or eye surgery;
if you experience chest pain (angina pectoris);
if you have problems performing the spirometry test (the person doing the test will tell you);
if you have had an infection of the airways in the last 2 weeks.
If you experience breathlessness, wheezing and/or cough during the spirometry test, you may be given a medicine to keep your air passages open and the test will be stopped.
Do not take vigorous exercise on the day of the test, especially before the test is done as this may affect the test results.
Do not smoke for at least 6 hours before the test as this may affect the test results.
Do not take Aridol on your own. Aridol is only to be given in a suitable laboratory or clinic by trained professionals familiar with the use of similar tests and their possible effects, under the supervision of an experienced doctor.
Children and adolescents
Children under the age of 6 should not be given Aridol or perform the test.
Aridol is not recommended in patients 6‑18 years of age, due to limited information on the use of Aridol in this population.
Othermedicines and Aridol
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If you are taking medicines to treat asthma or allergies, you may need to stop taking these before the test. These medicines may affect your body’s response to Aridol. Your doctor will tell you which medicine(s) to stop and for how long (usually between 6 hours and 4 days before the test).
Aridol with food and drink
Do not drink coffee, tea or cola, eat chocolate or any other foods containing caffeine on the day of the test.
Fertility, pregnancy and breast-feeding
Do not take the Aridol test if you are pregnant.
You can take Aridol while 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 Aridol
Adults
You will be given Aridol via an inhaler by a doctor or another specially trained healthcare professional who will be with you throughout the test. You will not be left on your own.
You must not put Aridol capsules in your mouth or swallow them.
Performing the test
1. You will be asked to sit comfortably on a chair.
2. Initially you will be asked to blow forcefully into a tube (spirometry test).
3. A nose clip will then be put on your nose so you will only be able to breathe in and out of your mouth.
4. After breathing out fully, you will be asked to deeply breathe in the Aridol medicine using a special inhaler.
5. You will then hold your breath for five seconds before breathing out.
6. The nose clip will be removed and you will be asked to breathe normally.
7. Next you will be asked to blow forcefully into the tube again. This test measures the effect of Aridol on your lungs.
8. Steps 3-7 may be repeated up to 9 times with more and more Aridol depending on the effect on your lungs (as measured in step 7), until the test is finished.
9. Once the test has finished you may be given a medicine to help you breathe.
If you are unsure about any part of the test, or have questions about the medicine, please talk to the doctor or another specially trained healthcare professional performing the test.
If you have been given more Aridol than you should
If you think you may have been given too much medicine, tell the doctor or healthcare professional performing the test straight away. You may feel that you cannot breathe, become wheezy or cough if you have taken too much Aridol. The doctor may give you oxygen and medicines 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
Breathlessness
Chest tightness
Cough
Feeling sick
Headache
Sore nose and throat and discomfort when swallowing
Runny nose
Vomiting
Uncommon (may affect up to 1 in 100 people):
Cold hands and feet
Diarrhoea
Feeling dizzy
Feeling jittery
Feeling thirsty
Feeling tired
Flushing and sweating
Hoarseness
Itching and rash
Itchy eyes
Less oxygen in the blood
Mouth ulcers
Nosebleeds
Stomach pain
Sore muscles and joints
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
5. How to store Aridol
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.
6. Contents of the pack and other information
What Aridol contains
The active substance is mannitol.
The mannitol powder is contained within capsules which are utilised for inhalation. A capsule contains 0 mg, 5 mg, 10 mg, 20 mg or 40 mg mannitol.
What Aridol looks like and contents of the pack
The powder is white to off-white.
The empty capsule is clear, printed with two white bands.
The 5 mg capsule is half white, half clear, marked 5 mg.
The 10 mg capsule is half yellow, half clear, marked 10 mg.
The 20 mg capsule is half pink, half clear, marked 20 mg.
The 40 mg capsules are half red, half clear, marked 40 mg.
The capsules are supplied in blister packs. One diagnostic kit, packed in a box, consists of:
1 empty capsule
1 x 5 mg capsule
1 x 10 mg capsule
1 x 20 mg capsule
15 x 40 mg capsules
1 inhaler
Marketing Authorisation Holder
Pharmaxis Pharmaceuticals Limited
25 Moorgate
London
EC2R 6AY
United Kingdom
Manufacturer responsible for batch release
Mawdsleys Clinical Services
Quest 22
Silk Road
Off Wheatley Hall Road
Doncaster
DN2 4LT
United Kingdom
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
<See local PL>
This medicinal product is authorised in the Member States of the EEA under the following names:
Aridol: Belgium, France, Finland, Germany, Greece, Norway, Portugal, Sweden
Osmohale: Denmark, Ireland, Italy, Netherlands, Spain, UK
This leaflet was last revised in 2015-10-14
INFORMATION FOR HEALTHCARE PROFESSIONALS
The following information is intended for healthcare professionals only:
Contraindications
Known hypersensitivity to mannitol or to any of the capsule ingredients.
Aridol should not be given to patients with severe airflow limitation (FEV1 < 50% predicted or < 1.0 l) or conditions that may be compromised by induced bronchospasm or repeated blowing manoeuvres. These include: aortic or cerebral aneurysm, uncontrolled hypertension, myocardial infarction or a cerebral vascular accident in the previous six months.
Special warnings and precautions for use
Aridol is to be administered by inhalation only. Inhaled mannitol causes bronchoconstriction. The Aridol inhalation test should only be conducted in suitable laboratories/clinics under the supervision of an experienced physician and by a physician or another health professional appropriately trained to perform bronchial provocation tests and to manage acute bronchospasm. The responsible physician, appropriately trained to treat acute bronchospasm, including appropriate use of resuscitation equipment, must be close enough to respond quickly to an emergency. A stethoscope, sphygmomanometer, and pulse oximeter should be available. Patients should not be left unattended during the procedure once the administration of Aridol has begun.
Medications to treat severe bronchospasm must be present in the testing area. They include adrenaline for subcutaneous injection, and salbutamol or other beta agonists in metered-dose inhalers. Oxygen must be available. A small-volume nebuliser should be readily available for the administration of bronchodilators.
General precautions when conducting spirometry and bronchial provocation testing should be observed, and caution should be exercised in patients with the following: ventilatory impairment (baseline FEV1 of less than 70% of predicted normal values or an absolute value of 1.5 l or less in adults), spirometry induced bronchoconstriction, haemoptysis of unknown origin, pneumothorax, recent abdominal or thoracic surgery, recent intraocular surgery, unstable angina, inability to perform spirometry of acceptable quality or upper or lower respiratory tract infection in the previous 2 weeks.
If a patient has spirometry induced asthma or the FEV1 fall following the 0 mg capsule is greater than 10%, a standard dose of bronchodilator should be given and the Aridol challenge discontinued.
Exercise: Vigorous exercise should be fully avoided on the day of the test, as this may affect test results.
Smoking: Since smoking may affect test results it is recommended that patients refrain from smoking for at least 6 hours prior to testing.
The Aridol test should not be used in patients below 6 years of age due to their inability to provide reproducible spirometric measurements.
There is limited information on the use of Aridol in patients 6‑18 years of age therefore Aridol is not recommended in this population.
The effects of repeat Aridol testing within a short period of time have not been investigated therefore careful consideration should be given to repeat use of Aridol.
Inhaler instructions
These instructions show you how to use the inhaler device.
1. Remove Cap: Using both hands, hold the inhaler upright and remove the cap.
2. Open: Hold the base of the inhaler firmly with one hand and open the device by rotating the mouthpiece in the direction of the arrow as shown.
3. Load: Make sure your hands are dry, remove a capsule from the Aridol pack and place into the inhaler as illustrated.
It does not matter which way the capsule is placed in the chamber.
4. Close: Keeping the device in an upright position, twist the mouthpiece into the closed position until you hear it ‘click’.
5. Pierce Capsule: Hold the inhaler upright and fully depress both piercing buttons on the sides of the device at the same time. Do this once only, since piercing the capsule more than once may cause it to split/fragment. The piercing action makes holes in the capsule and allows the powder in the capsule to be released during inhalation.
6. Prepare for Inhalation: Tilt the inhaler so that the mouthpiece faces slightly downward at a 45 degree angle as shown on the picture below, until the capsule drops forward into the spinning chamber. Keep the device tilted in this way and instruct the patient to breathe out completely (away from the inhaler).
7. Inhale: The patient should tilt their head back slightly, and keeping the inhaler at a 45 degree angle, raise the device to their mouth and ensure they close their lips tightly around the mouthpiece. Encourage the patient to take a controlled rapid and deep inspiration to fill the lungs. The patient should then hold their breath for five seconds.
Note: During a successful inhalation you should hear a ‘rattling’ sound as the capsule spins in the inhaler.
8. Exhale: Remove the inhaler from the patient’s mouth, allow them to exhale and resume normal breathing.