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Patient Information: A Guide to Using your Inhaher: Giona Easyhaler 100 mcg/dose Inhalation Powder, 200 mcg/dose Inhalation Powder.
Read this whole section carefully before you start using this inhaler: You may need to read it again.
This medicine has been prescribed by your doctor for you personally and you should not pass it on to other people. It may harm them, even if their symptoms are the same as yours.
If you have further questions, ask your doctor or your pharmacist.
In this section: 1. What's in GIONA EASYHALER.
2. Before you use GIONA EASYHALER.
3. Using GIONA EASYHALER.
4. Possible side effects.
5. Storing GIONA EASYHALER safe.
GIONA EASYHALER 100 MCG/DOSE INHALATION POWDER, GIONA EASYHALER 200 MCG/DOSE INHALATION POWDER: The active substance in GIONA EASYHALER is budesonide.
GIONA EASYHALER 100 mcg/dose also contains a small amount of lactose (4 mg/dose). GIONA EASYHALER 200 mcg/dose also contains a small amount of lactose (8 mg/dose).
GIONA EASYHALER comes in packs containing one inhalers with or without a protective cover.
1. WHAT'S IN GIONA EASYHALER and what it does: Your medicine - GIONA - comes in an inhaler - the EASYHALER. The medicine comes as a dry powder for you to breathe in. There is enough powder in the EASYHALER for 200 puffs (or inhalations). For GIONA EASYHALER 100 mcg/dose, each puff contains 100 micrograms of budesonide. For GIONA EASYHALER 200 mcg/dose, each puff contains 200 micrograms of budesonide.
Treating asthma: Budesonide is one of a family of medicines called corticosteroids, which are used to treat asthma and other breathing problems. Corticosteroids are versions of natural chemicals produced by the body. They work by gradually reducing the swelling and irritation in the lungs which are often the cause of asthma attacks.
Use it regularly: This type of inhaler is a "preventer" and you need to use it regularly for it to work properly - even when your asthma is not giving you problems. If you stop using the inhaler altogether, it may make your asthma worse.
GIONA EASYHALER is not the same as a "reliever" inhaler: it won't stop an asthma attack that has already started. Make sure you have a reliever inhaler (usually blue) always handy.
2. BEFORE YOU USE GIONA EASYHALER points to check: People who shouldn't take GIONA EASYHALER: There are some people who shouldn't take this medicine. Don't use GIONA EASYHALER: If you are allergic to budesonide (the main ingredient) or to lactose. If you are, or think you may be, talk to your doctor before you use the inhaler.
People who should take special care with GIONA EASYHALER: Some people need to take special care when taking GIONA EASYHALER. You may be asked to keep a regular check on your asthma using something called a peak flow meter. If your asthma, wheezing or tightness in the chest get worse, tell your doctor. Like other corticosteroids at high doses budesonide may have an effect on the adrenal gland. Your doctor may ask for a blood sample from time to time.
Take special care: If you have ever had a reaction to budesonide or lactose; If you have tuberculosis, or have ever been treated for it; If you have liver disease; If you have anything else wrong with your eyes, nose, throat or lung.
If any of these applies to you, and you haven't already talked it over with your doctor, talk to your doctor before you use GIONA EASYHALER. She/he may need to prescribe a different medicine.
Women who are pregnant or breast-feeding: Talk to your doctor before you use GIONA EASYHALER. Ask your doctor or pharmacist for advice before taking any medicine.
You can drive or use machines: GIONA EASYHALER won't make you drowsy.
Important information about the excipient: The small amount of lactose in GIONA EASYHALER is unlikely to cause problems in patients with lactose intolerance. If you have been told by your doctor that you have an intolerance to some other sugars, contact your doctor before taking this medicinal product.
Using other medicines and GIONA EASYHALER: GIONA EASYHALER usually causes no problems with other medicines. But you do need to take care: If you take an antifungal medicine containing ketoconazole; If you use a nose spray with corticosteroid in it; If you take steroid tablets (pills containing corticosteroids).
If so, tell your doctor. Your dose may need to be altered to take this into account.
Tell your doctor also about all other medicines you are using. This may also include medicines you can buy without a doctor's prescription and medicinal products used some time ago.
Make sure your doctor knows what other illnesses or allergies you have.
If you have to consult a doctor because of any other medical problem in the future, let your doctor know that you have been given GIONA EASYHALER treatment.
3. USING GIONA EASYHALER the usual dose and instructions: How much to take: Your doctor has worked out the correct dose for you. From time to time, your doctor may adjust the dose to find the lowest dose needed to control your asthma. Follow your doctor's advice and the pharmacist's label on the package.
The usual dose is one to two inhalations twice a day, once in the morning and once in the evening. You may only need to take GIONA EASYHALER once a day in the evening but you must only do this if your doctor has specifically told you to. It is important that you take it at the same time each evening.
If GIONA EASYHALER is to be used by your child, make sure that it is used correctly, as your doctor has told you.
GIONA EASYHALER is intended for oral inhalation.
You should notice that your breathing gets easier over time, although GIONA EASYHALER will usually take a few weeks to have its full effect. You must use it regularly. If you find that your asthma is getting worse, or not getting any better, talk to your doctor.
If you have been taking steroid tablets for your asthma, your doctor may have told you to reduce the number of tablets gradually once you start to use GIONA EASYHALER. As a result of this, you may have symptoms like stuffy or runny nose, rash (eczema), muscle and joint pain, or you may feel generally unwell, if so, continue using GIONA EASYHALER and tell your doctor.
If your wheezing or chest tightness is worse than usual, or come back more quickly than usual, tell your doctor as soon as possible; your asthma may be getting worse and you may need extra treatment.
If you have taken too much: If you take too much GIONA EASYHALER talk to your doctor. Always use your inhaler as your doctor has told you.
If you forget to use GIONA EASYHALER: If you miss a puff, don't worry just take one as soon as you remember. If it is already time for your next puff; take the next one as usual. Do not take double dose to make up.
The instructions how to use the inhaler are at the end of this section.
4. POSSIBLE SIDE EFFECTS what to look for, what to do: Budesonide can cause side effects in some people.
Common side effects (more than 1 out of 100): Sometimes inhaled budesonide causes a sore throat, hoarse voice or a cough. It can also cause thrush (a candida infection) in the mouth. Rinsing out your mouth with water or brushing your teeth after a puff can help to prevent these effects, which are not serious, if you get any of these, don't stop taking GIONA EASYHALER. Talk to a doctor as soon as possible.
Rare side effects (less than 1 out of 1000): Depression, irritability, anxiety, growth and behaviour problems in children, easy bruising, thinning of the skin, rash and other skin symptoms.
Very rare side effects (less than 1 out of 10 000): Nervousness, suppression of the adrenal gland, cataract (which can interfere with your sight), glaucoma (high pressure in the eye), decrease in bone mineral density.
If you think you might have any of these rare or very rare side effects, or if you're worried about any of them, talk to your doctor as soon as possible.
Very rarely, some people get an allergic reaction to inhaled budesonide. In the most serious cases it cause reactions called anaphylaxis or angioedema. These are the signs, which come on soon after using the drug: sudden large drop in blood pressure, itching, rash, reddened skin, swelling of the eyes, lips, face or throat. If you get any of these, don't take any more GIONA EASYHALER. Talk to a doctor straight away.
Very rarely, inhaled drugs can cause increase in wheezing and shortness of breath immediately after dosing. If this occurs, stop taking GIONA EASYHALER and use your reliever inhaler (usually blue). Talk to a doctor straight away.
If you notice any effects not mentioned in this monograph, whether or not you think they're linked with GIONA EASYHALER, tell your doctor or pharmacist.
5. STORING GIONA EASYHALER: Do not store above 30°C. GIONA EASYHALER is affected by damp and moisture.
Therefore, it is recommended to keep the EASYHALER in its protective cover.
If your GIONA EASYHALER gets damp, you need to replace it with a new one.
Replace GIONA EASYHALER 6 months after you opened the laminate pouch. Write down the date you opened the pouch to help you remember.
How to use the EASYHALER inhaler: GIONA EASYHALER may be different to inhalers you have used in the past. Therefore it is very important that you use it properly as using incorrectly can lead to you not receiving the right amount of medicine. This could make you very unwell or could lead to your asthma not being treated as it should.
Your doctor, nurse or pharmacist will show you how to use your inhaler properly. Make sure you understand the correct way to use the inhaler. If you are unsure contact your doctor, nurse or pharmacist. As with all inhalers, caregivers should ensure that children prescribed GIONA EASYHALER use correct inhalation technique, as described as follows.
When you first get your EASYHALER: The EASYHALER comes in a foil bag. Do not open the foil bag until you are ready to start using the medicine as it helps to keep the powder dry in the inhaler.
When you are ready to start treatment open the bag and record the date e.g., in your calendar.
Use the inhaler within 6 months of removing from the foil bag.
HOW TO USE CORRECTLY: Step 1: SHAKE Remove the dustcap.
Shake the inhaler 3 to 5 times holding it in the upright position.
Important points to remember: It is important to keep the inhaler in the upright position.
If you accidentally click while you shake the inhaler, empty the powder from the mouthpiece.
Step 2: CLICK: Keep holding the inhaler upright between your forefinger and thumb.
Press down until you hear a click, and let the inhaler click back again. This releases a dose.
Only click down once.
Important points to remember: The inhaler will not click if the dustcap is still on.
Only click down once.
If you accidentally click more than once, empty the powder from the mouthpiece.
Click to release dose before you inhale, not at the same time.
Keep the inhaler upright when you click it and when you inhale the dose. If you tip it, the powder could fall out before you are able to inhale it.
Step 3: INHALE: Keep holding the inhaler upright.
Breathe out normally.
Place the mouthpiece in your mouth between your teeth and close your lips tightly around the mouthpiece.
Take a strong and deep breath in.
Take the inhaler out of your mouth, hold breath for at least 5 seconds, then breathe out normally.
Important points to remember: Make sure the whole mouthpiece is well inside your mouth, so that the medication gets into your lungs.
Make sure your lips make a good seal around the mouthpiece.
Do not breathe out into the inhaler. This is important: it could clog up the inhaler. If you breathed out into the inhaler, empty the powder from mouthpiece.
If you need to take another inhalation, please repeat the steps 1-3 Shake-Click-Inhale.
After you have used the inhaler: Put the dust cap back on the mouthpiece. It stops the inhaler going off by accident.
After you have taken the dose, rinse your mouth with water, and spit it out and/or brush your teeth.
This may help to stop you getting thrush and becoming hoarse.
How to empty the powder from the mouthpiece: If you click the inhaler by accident, or if you might have clicked it more than once, or if you breathe out into it, empty the mouthpiece.
Tap the mouthpiece to empty the powder onto a table top, or the palm of your hand.
Then start again with steps Shake-Click-Inhale.
Cleaning the EASYHALER: Keep your inhaler dry and clean. If necessary you may wipe the mouthpiece of your inhaler with a dry cloth or tissue. Do not use water: the powder in the EASYHALER is sensitive to moisture.
Using the EASYHALER with a protective cover: You may use a protective cover with your inhaler. This helps to improve durability of the product. When you first insert your inhaler in the protective cover make sure the dust cap is on the inhaler as this stops it going off by accident. You can use the inhaler without removing it from the protective cover.
Follow the same instructions as previously mentioned, 1. Shake, 2. Click, 3. Inhale.
Remember to: Keep the inhaler in the upright position when clicking it.
Replace the dustcap after taking the dose as this stops the inhaler going off by accident.
When to switch to a new EASYHALER: The dose counter shows the number of remaining doses. The counter turns after every 5th click. When the dose counter starts turning red, there are 20 doses left.
If you do not already have a new EASYHALER, contact your doctor for a new prescription. When the counter reaches 0 (zero), you need to replace the EASYHALER.
If you use the protective cover, you can keep it and insert your new inhaler into it.
Remember: 1. Shake, 2. Click, 3. Inhale.
After you have taken the dose, rinse your mouth with water and spit it out and/or brush your teeth.
Do not get your inhaler wet, protect it from moisture.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
