Combisal 25 microgram /125 microgram per metered dose pressurised inhalation, suspension

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it onto others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

• If you are allergic (hypersensitive) to salmeterol, fluticasone propionate or to the other ingredient norflurane (HFA 134a).

Talk to your doctor or pharmacist before taking Combisal if you have:

• Heart disease, including an irregular or fast heartbeat.
• Overactive thyroid gland.
• High blood pressure.
• Diabetes mellitus (Combisal may increase your blood sugar).
• Low potassium in your blood.
• Tuberculosis (TB) now, or in the past, or other lung infections.

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:

• ß blockers (such as atenolol, propranolol and sotalol). ß blockers are mostly used for high blood pressure or other heart conditions.
• Medicines to treat infections (such as ketoconazole, itraconazole and erythromycin) including some medicines for HIV treatment (such as ritonavir, cobicistat-containing products). Some of these medicines may increase the amount of fluticasone propionate or salmeterol in your body. This can increase your risk of experiencing side effects with Combisal, including irregular heartbeats, or may make side effects worse. Your doctor may wish to monitor you carefully if you are taking these medicines.
• Corticosteroids (by mouth or by injection). If you have had these medicines recently, this might increase the risk of this medicine affecting your adrenal gland.
• Diuretics, also known as ‘water tablets’ used to treat high blood pressure.
• Other bronchodilators (such as salbutamol).
• Xanthine medicines. These are often used to treat asthma.

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.

• Combisal 25/50 - 2 puffs twice a day
• Combisal 25/125 - 2 puffs twice a day
• Combisal 25/250 - 2 puffs twice a day

• Combisal 25/50 - 2 puffs twice a day
• Combisal is not recommended for use in children below 4 years of age.

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:

• once at night - if you have night-time symptoms
• once in the morning - if you have daytime symptoms

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.

• Your doctor, nurse or pharmacist should show you how to use your inhaler. They should check how you use it from time to time. Not using the Combisal properly or as prescribed may mean that it will not help your asthma as it should.
• The medicine is contained in a pressurised canister in a plastic casing with a mouthpiece.
• A new full inhaler has enough medicine for a minimum of 120 actuations of medication. After 120 puffs the inhaler may no longer have enough medicine to give a full dose of medication.

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:

• Remove the mouthpiece cover.
• Do not remove the metal canister from the plastic casing at any time.
• Wipe the inside and outside of the mouthpiece and the plastic casing with a dry cloth or tissue.
• Replace the mouthpiece cover. It will ‘click’ into place when fitted correctly.
• Do not use too much force.
• Do not wash or put any parts of your inhaler in water.

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:

• Stomach pain.
• Tiredness and loss of appetite, feeling sick.
• Sickness and diarrhoea.
• Weight loss.
• Headache or drowsiness.
• Low levels of sugar in your blood.
• Low blood pressure and seizures (fits).

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 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.

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).

• Combisal is supplied to you in a metered dose inhaler which delivers your medicine in a pressurised suspension for you to inhale through your mouth into your lungs.
• The pressurised canister contains a homogenous suspension for inhalation.
• The canister is fitted into a plastic casing incorporating a mouthpiece and fitted with a purple dust cap.
• Each pack contains 1 inhaler. Each inhaler contains 120 actuations.

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