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COMBISAL 25 microgram/50 microgram, 25 microgram/125 microgram, 25 microgram/250 microgram per metered dose pressurised inhalation, suspension
COMBISAL 25 microgram/50 microgram per metered dose pressurised inhalation, suspension
COMBISAL 25 microgram/125 microgram per metered dose pressurised inhalation, suspension
COMBISAL 25 microgram/250 microgram per metered dose pressurised inhalation, suspension
Salmeterol (as xinafoate)/Fluticasone Propionate
1. What Combisal is and what it is used for
2. What you need to know before you use Combisal
3. How to use Combisal
4. Possible side effects
5. How to store Combisal
6. Contents of the pack and other information
Combisal contains two active substances: salmeterol (as xinafoate) and fluticasone propionate.
The doctor has prescribed this medicine to help prevent breathing problems such as asthma.
You must use Combisal every day as directed by your doctor. This will make sure that it works properly in controlling your asthma.
Combisal helps to stop breathlessness and wheeziness coming on. However Combisal 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 ‘reliever’ inhaler with you.
Talk to your doctor or pharmacist before taking Combisal if you have:
Contact your doctor if you experience blurred vision or other visual disturbances.
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.
This includes medicines for asthma or any medicines obtained without a prescription. This is because Combisal may not be suitable to be taken with some other medicines.
Tell your doctor if you are taking the following medicines, before starting to use Combisal:
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.
Combisal is not likely to affect your ability to drive or use machines.
The use of the drug without therapeutic necessity constitutes doping and may still determine positivity to anti-doping tests.
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The inhaler has been designed to deliver 120 actuations. However it is not possible to tell when the inhaler is empty and when the 120 puffs have been released.
There may still be a small amount of fluid left over in the container.
Please make sure that your inhaler is replaced after you have released 120 puffs so that you can be certain that you are getting the right amount of your medicine in each puff.
Your symptoms may become well controlled using Combisal 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 puffs to take and how often to take your medicine.
When you are using Combisal for asthma, your doctor will want to regularly check your symptoms.
However, 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 Combisal but do not increase the number of puffs you take. Your chest condition may be getting worse and you could become seriously ill. See your doctor as you may need additional treatment.
1. Before using the inhaler for the first time, test that it is working. To test the inhaler remove the mouthpiece cover by gently squeezing the sides with your thumb and forefinger and pull apart.
2. To make sure the inhaler works, give it a good shake, then point the mouthpiece away from you and press the canister firmly to release a puff into the air. Repeat these steps, shaking the inhaler before releasing a second puff into the air. The total puffs released into the air, before using the inhaler, should be two.
3. After these first two test puffs, you can start using your inhaler.
4. If you have not used your inhaler for a week or more then test the inhaler. To test the inhaler give it a good shake, then point the mouthpiece away from you and press the canister firmly to release two puffs into the air.
Never detach the metal canister from the inhaler at any time.
If the inhaler gets very cold (below 0°C), take the metal canister out of the plastic case and warm it in your hands for few minutes before use. Never use anything else to warm it up. After warming and before using, press the canister firmly to release two puffs into the air.
Before your inhaler runs out of medicine you must re-order a new inhaler, so that you are not left without medication.
It is important to start to breathe as slowly as possible just before using your inhaler.
1. Stand or sit upright when using your inhaler.
2. Remove the mouthpiece cover (Figure A).
3. Check inside and outside to make sure that the mouthpiece is clean and free of dust or other loose particles.
4. Shake the inhaler 4 or 5 times to ensure that the contents of the inhaler are evenly mixed (Figure B).
5. Hold the inhaler upright with your thumb on the base, below the mouthpiece. Breathe out as far as is comfortable (Figure C).
6. Place the mouthpiece in your mouth between your teeth. Close your lips around it. Do not bite.
7. Breathe in through your mouth slowly and deeply.
Just after starting to breathe in, press firmly down on the top of the canister to release a puff of medicine.
Do this while still breathing in steadily and deeply (Figure D).
8. Hold your breath, take the inhaler from your mouth and your finger from the top of the inhaler. Continue holding your breath for a few seconds, or as long as is comfortable.
9. Wait about half a minute between taking each puff of medicine and then repeat steps 4 to 8.
10. Afterwards, 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.
11. After use always replace the mouthpiece cover straight away to keep out dust. (Figure E). When the mouthpiece cover is fitted correctly it will ‘click’ into position. Do not use too much force.
Do not rush steps 5, 6, 7 and 8. It is important that you breathe in as slowly as possible just before using your inhaler. You should use your inhaler whilst standing in front of a mirror for the first few times. If you see “mist” coming from the top of your inhaler or the sides of your mouth, you should start again from step 4.
As with all inhalers, caregivers should ensure that children prescribed Combisal use the correct inhalation technique, as described above.
If you or your child find it difficult to use the inhaler, either your doctor or other healthcare provider may recommend using an AeroChamber Plus® spacer device with your inhaler. Your doctor, nurse, pharmacist or other healthcare provider should show you how to use the spacer with your inhaler and how to care for your spacer and will answer any questions you may have. It is important that if you are using a spacer device with your inhaler that you do not stop using the spacer without talking to your doctor or nurse first. Other spacer devices are not recommended for use with Combisal and you should not switch from the AeroChamber Plus® device to another. It is also important that you do not change or stop using the spacer without talking to your doctor, they will know how to modify the therapy. Always talk to your doctor before making any changes to your asthma treatment.
Older children and people with weak hands may find it easier to hold the inhaler with both hands. Put the two forefingers on top of the inhaler and both thumbs on the bottom below the mouthpiece.
To stop your inhaler blocking, it is important to clean it at least once a week. To clean your inhaler:
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 Combisal 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 Combisal every day as directed. Keep taking it until your doctor tells you to stop. Do not stop or suddenly reduce your dose of Combisal. This could make your breathing worse.
In addition, if you suddenly stop taking Combisal or reduce your dose of Combisal 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.
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 Combisal to control your asthma.
Allergic reactions: you may notice your breathing suddenly gets worse immediately after using Combisal. 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 Combisal, stop using Combisal and tell your doctor straight away.
Allergic reactions to Combisal are uncommon (they affect less than 1 person in 100).
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 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 1000 people)
Your doctor will check you regularly for any of these side effects and make sure you are taking the lowest dose of Combisal to control your asthma.
Not known, (frequency cannot be estimated from the available data)
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (website: 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.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Each metered dose (ex valve) contains 25 micrograms of salmeterol (as salmeterol xinafoate) and 50, 125 or 250 micrograms of fluticasone propionate. The other ingredient is propellant: norflurane (HFA 134a).
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This leaflet was last revised in May 2023