The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 27925/0094 .
Fusacomb Easyhaler 50/250 & 50/500 inhalation powder
Fusacomb Easyhaler 50 microgram/250 microgram/dose, inhalation powder
Fusacomb Easyhaler 50 microgram/500 microgram/dose, inhalation powder
1. What Fusacomb Easyhaler is and what it is used for
2. What you need to know before you use Fusacomb Easyhaler
3. How to use Fusacomb Easyhaler
4. Possible side effects
5. How to store Fusacomb Easyhaler
6. Contents of the pack and other information
Fusacomb Easyhaler contains two medicines, salmeterol and fluticasone propionate:
The doctor has prescribed this medicine to help prevent breathing problems such as:
You must use Fusacomb Easyhaler every day as directed by your doctor. This will make sure that it works properly in controlling your asthma or COPD.
Fusacomb Easyhaler helps to stop breathlessness and wheeziness coming on. However, Fusacomb Easyhaler should not be used to relieve a sudden attack of breathlessness or wheezing. If this happens you need to use a fast-acting ‘reliever’ (‘rescue’) inhaler, such as salbutamol. You should always have your fast-acting 'rescue' inhaler with you.
Talk to your doctor before using Fusacomb Easyhaler if you have:
Contact your doctor if you experience blurred vision or other visual disturbances.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines for asthma or any medicines obtained without a prescription. This is because Fusacomb Easyhaler may not be suitable to take with some other medicines.
Tell your doctor if you are taking the following medicines, before starting to use Fusacomb Easyhaler:
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Fusacomb Easyhaler is not likely to affect your ability to drive or use machines.
Fusacomb Easyhaler contains up to 17.1 milligrams of lactose in each dose. The amount of lactose in this medicine does not normally cause problems in people who are lactose intolerant. Lactose contains small amounts of milk proteins, which may cause allergic reactions.
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Adults and adolescents aged 12 years and over
Children below 12 years of age
Your symptoms may become well controlled using Fusacomb Easyhaler twice a day. If so, your doctor may decide to reduce your dose to once a day. The dose may change to:
It is very important to follow your doctor’s instructions on how many inhalations to take and how often to take your medicine.
If you are using Fusacomb Easyhaler for asthma, your doctor will want to regularly check your symptoms.
If your asthma or breathing gets worse tell your doctor straight away. You may find that you feel more wheezy, your chest feels tight more often or you may need to use more of your fast-acting ‘reliever’ medicine. If any of these happen, you should continue to take Fusacomb Easyhaler but do not increase the number of doses you take. Your chest condition may be getting worse and you could become seriously ill. See your doctor as you may need additional treatment.
It is important to use the inhaler as instructed. If you accidentally take a larger dose than recommended, talk to your doctor or pharmacist. You may notice your heart beating faster than usual and that you feel shaky. You may also have dizziness, a headache, muscle weakness and aching joints.
If you have used larger doses for a long period of time, you should talk to your doctor or pharmacist for advice. This is because larger doses of Fusacomb Easyhaler may reduce the amount of steroid hormones produced by the adrenal gland.
Do not take a double dose to make up for a forgotten dose. Just take your next dose at the usual time.
It is very important that you take your Fusacomb Easyhaler every day as directed. Keep taking it until your doctor tells you to stop. Do not stop or suddenly reduce your dose of Fusacomb Easyhaler. This could make your breathing worse.
In addition, if you suddenly stop taking Fusacomb Easyhaler or reduce your dose of Fusacomb Easyhaler this may (very rarely) cause you to have problems with your adrenal gland (adrenal insufficiency) which sometimes causes side effects.
These side effects may include any of the following:
When your body is under stress such as from fever, trauma (such as a car accident), infection, or surgery, adrenal insufficiency can get worse and you may have any of the side effects listed above.
If you get any side effects, talk to your doctor or pharmacist. To prevent these symptoms occurring, your doctor may prescribe extra corticosteroids in tablet form (such as prednisolone).
If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.
The instructions how to use the inhaler are at the end of the leaflet.
Like all medicines, this medicine can cause side effects, although not everybody gets them. To reduce the chance of side effects, your doctor will prescribe the lowest dose of Fusacomb Easyhaler to control your asthma or COPD.
Allergic reactions: you may notice your breathing suddenly gets worse immediately after using Fusacomb Easyhaler. You may be very wheezy and cough or be short of breath. You may also notice itching, a rash (hives) and swelling (usually of the face, lips, tongue or throat), or you may suddenly feel that your heart is beating very fast or you feel faint and light headed (which may lead to collapse or loss of consciousness). If you get any of these effects or if they happen suddenly after using Fusacomb Easyhaler, stop using Fusacomb Easyhaler and tell your doctor straight away. Allergic reactions to Fusacomb Easyhaler are uncommon (they affect less than 1 person in 100).
Tell your doctor if you have any of the following while taking Fusacomb Easyhaler, they could be symptoms of a lung infection:
Other side effects are listed below:
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
The following common side effects have also been reported in patients with Chronic Obstructive Pulmonary Disease (COPD):
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Frequency not known (cannot be estimated from the available data), but may also occur:
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Fusacomb Easyhaler is an inhaler containing your medicine. The inhalation powder is white. Each inhaler contains 60 doses and has a white body with purple upper part.
Fusacomb Easyhaler is available in packs of 1, 2 or 3 inhaler(s).
Not all pack sizes may be marketed.
Your pack may contain a protective cover. If you need a protective cover, please contact the Marketing Authorisation Holder (details given below).
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Detailed and updated information on this product is available by scanning this QR code (included also on outer carton and inhaler label) with a smartphone. The same information is also available on the following URL: www.oeh.fi/sfgb.
QR code to www.oeh.fi/sfgb
This leaflet was last revised in November 2021
Fusacomb Easyhaler may be different to inhalers you have used in the past. 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 and COPD 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 Fusacomb Easyhaler use correct inhalation technique, as described below. You can also use the instruction video at www.oeh.fi/sfgb.
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 1 month (50/250) or 2 months (50/500) of removing from the foil bag.
Step 1: SHAKE
Important points to remember
Step 2: CLICK
Important points to remember
Step 3: INHALE
Important points to remember
After you have used the inhaler:
This may help to stop you getting thrush and becoming hoarse.
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.
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.
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 dustcap 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 above, 1. Shake – 2. Click – 3. Inhale.
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.
If you have any further questions on the use of this product, ask your doctor or pharmacist.