Airflusal Forspiro 50 Microgram/500 Microgram Per Actuation Inhalation Powder Pre-Dispensed
PACKAGE LEAFLET: INFORMATION FOR THE USER SZ13502LT01A
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
• 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 on to 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 AirFluSal Forspiro is and what it is used for
2. What you need to know before you use AirFluSal Forspiro
3. How to use AirFluSal Forspiro
4. Possible side effects
5. How to store AirFluSal Forspiro
6. Contents of the pack and other information
What AirFluSal Forspiro is and what it is used for
2 What you need to know before you use AirFluSal Forspiro
Either side of the
Only use this lever when you are ready to take a dose.
The name of your medicine is AirFluSal Forspiro. AirFluSal Forspiro is an inhaler that contains two active ingredients, salmeterol and fluticasone propionate. Salmeterol is a long-acting bronchodilator. Bronchodilators help the airways in the lungs to stay open. This makes it easier for air to get in and out. The effects last for at least 12 hours. Fluticasone propionate is a corticosteroid which reduces swelling and irritation in the lungs.
The doctor has prescribed this medicine to help to prevent breathing problems associated with chronic obstructive pulmonary disease (COPD). AirFluSal Forspiro reduces the number of flare ups of symptoms related to COPD.
You must use AirFluSal Forspiro every day, as prescribed by your doctor. This will ensure that the medicine works properly in controlling these symptoms.
AirFluSal Forspiro helps to stop breathlessness and wheeziness coming on. However, AirFluSal Forspiro 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.
AirFluSal Forspiro is intended for use in adults with COPD 18 years of age and older only.
Not for use in asthma.
• if you are allergic (hypersensitive) to
salmeterol, fluticasone propionate or the other ingredient in this medicine (listed in section 6).
Warnings and precautions
Your doctor will supervise your treatment more closely if you have or ever had:
• heart disease, including irregular or fast heartbeat
• overactive thyroid gland
• high blood pressure
• diabetes mellitus (AirFluSal Forspiro may increase your blood sugar)
• low potassium in your blood
• tuberculosis (TB) now or in the past or other lung infections
Talk to your doctor before using AirFluSal Forspiro if any of the above applies to you.
Do not give this medicine to children and adolescents less than 18 years of age.
AirFluSal Forspiro is intended for use in adults 18 years of age and older only.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, before you start using AirFluSal Forspiro. This includes other medicines for COPD, other inhalers or any medicines obtained without a prescription. This is because AirFluSal Forspiro may not be suitable to be taken with some other medicines.
In particular tell your doctor if you are taking any of the following:
• Beta-blockers (such as atenolol, propranolol, sotalol). Beta blockers are mostly used for high blood pressure and heart conditions.
• Medicines to treat infections caused by viruses and fungi (such as ritonavir, ketoconazole, itraconazole and erythromycin). Some of these medicines may increase the amount of fluticasone propionate or salmeterol in your body, which can increase your risk of experiencing side effects, including irregular heartbeats, or may make side effects worse.
• Corticosteroids (taken by mouth or by injection). If you have used these medicines recently, this might increase the risk of AirFluSal Forspiro affecting the function of 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.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Your doctor will assess whether you can take this medicine or not.
AirFluSal Forspiro is unlikely to affect your ability to drive or use machines.
• Use AirFluSal Forspiro every day, until your doctor advises you to stop.
• Do not take more than the recommended dose.
• Do not stop taking AirFluSal Forspiro or reduce the dose of AirFluSal Forspiro without talking to your doctor first.
• AirFluSal Forspiro should be inhaled through the mouth into the lungs.
The recommended dose is:
One inhalation twice a day
It is very important to follow your doctor's instructions on how many inhalations to take and how often to take your medicine.
This medicine is not for use in children and adolescents less than 18 years of age.
If your breathing gets worse or is not well controlled even if AirFluSal Forspiro is used regularly as prescribed by your doctor, tell your doctor straight away. You may feel more wheezy, your chest feels tight more often or you may need more of your fast-acting ‘reliever' medicine.
If any of these happen, you should continue to take AirFluSal Forspiro but do not increase the number of inhalations you take. Your chest condition could be getting worse and you could become seriously ill. See your doctor straight away as you may need additional treatment.
Your doctor, nurse or pharmacist should show you how to use your inhaler. They should check on how you use it from time to time. If you do not use the inhaler properly or as prescribed, the medicine might not help your COPD and your symptoms as it should.
The inhaler contains 60 doses of powder medication in a coiled strip of foil. It has a dose counter which shows you how many doses you have remaining counting down from 60 to 0. When you have reached the last 10 doses the numbers will be on a red background.
The inhaler is not refillable - please dispose of the inhaler when it is empty and replace it with a new one.
The foil strip collects here for removal.
When you open the protective cap you can check how many doses are left.
• Open the transparent side chamber door.
• Remove the foil strip from the side chamber by carefully tearing away the full length of strip against the ‘teeth' of the side chamber as shown below. Do not pull or tug on the strip.
• Close the side chamber door and dispose of the used strip.
As you use the inhaler the side chamber will gradually fill up with used strip. The foil strips with black bars don’t contain medication. Eventually the numbered sections of the strip will appear in the side chamber.
Do not let more than 3 sections of foil strip build up in the side chamber as they may cause the inhaler to jam. Tear the strip away carefully as shown above, and dispose of it safely.
Hold the inhaler in your hands as seen in the pictures.
3 How to use AirFluSal Forspiro
AirFluSal Forspiro contains 11.95 mg lactose in each dose.
The amount of lactose in this medicine does not normally cause problems in people who are lactose intolerant.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Always use this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure.
• Open the protective cap downwards to
reveal the mouthpiece.
• Check the dose counter to see how many doses are left.
• Lift up the edge of the white lever. Make sure the side chamber is closed.
4 Possible side effects
5 How to store AirFluSal Forspiro
6 Contents of the pack and other information
Remember: Only operate the white lever when you are ready to inhale a dose of your medication. If you play with the white lever, you will waste doses.
as far as it will go and until it clicks. This action moves a new dose into position with the number at the top.
• Close: Afterwards close the white lever
fully so that it clicks back into its original position. The inhaler is now ready for immediate use.
• Away from the inhaler mouthpiece, breathe out as much as is comfortable. Never breathe directly into the inhaler as this could affect the dose.
• Hold the inhaler level with the protective cap pointing downwards.
• Close your lips firmly around the mouthpiece.
• Breathe in steadily and deeply through the inhaler, not through your nose.
• Remove the inhaler from your mouth and hold your breath for 5-10 seconds or as
long as you can without causing discomfort.
• Afterwards, breathe out slowly, but not into the inhaler.
• Close the protective cap over the mouthpiece.
• Rinse your mouth with water and spit it out. This may help to prevent you from getting fungal infections in the mouth and becoming hoarse.
• Wipe the outside of the mouthpiece with a clean, dry tissue if necessary.
• Do not attempt to take the inhaler apart to clean it or for any other purpose.
• Do not use water or wet wipes to clean the inhaler parts as dampness can affect the dose.
• Never insert a pin or other sharp objects into the mouthpiece, or any other part, as this could damage the inhaler.
It is important to use the inhaler as instructed.
If you accidentally take a larger dose than recommended, talk to your doctor, pharmacist or nurse. You may notice your heart beating faster than usual and you may 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, pharmacist or nurse for advice. This is because larger doses of this medicine may reduce the amount of steroid hormones produced by your adrenal gland.
If you forget to use AirFluSal Forspiro
If you forget to use your inhaler, take your next inhalation when it is due. Do not take a double inhalation to make up for a forgotten one.
If you stop using AirFluSal Forspiro
It is very important you use the inhaler every day, as the doctor recommended.
Keep taking your medicine until your doctor tells you to stop. Do not stop or suddenly reduce your dose of AirFluSal Forspiro.
This can make your breathing worse. Very rarely, if you suddenly stop using your inhaler or suddenly reduce the dose, this can cause you to have problems with your adrenal gland (adrenal insufficiency) and you may experience side effects. These 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. To prevent these symptoms occurring, your doctor may prescribe extra corticosteroids in tablet form (such as prednisolone).
If you do get any of the side effects listed above, or any other side effects, talk to your doctor or pharmacist straight away.
If you have any further questions on the use of this medicine or device, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions: you may notice your breathing suddenly gets worse immediately after using AirFluSal Forspiro. 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 your heart 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 AirFluSal Forspiro, stop using AirFluSal Forspiro and tell your doctor straight away. Allergic reactions to AirFluSal Forspiro are uncommon (they may affect up to 1 in 100 people).
Very Common, may affect more than 1 in 10 people • Headache
This usually gets better as treatment continues.
• Increased number of colds has been reported.
Common, may affect up to 1 in 10 people
• Thrush (sore, creamy-yellow, raised patches) in the mouth and throat. Also sore tongue, hoarse voice and throat irritation. Rinsing your mouth out with water and spitting it out immediately and/or brushing your teeth after taking each dose of your medicine may help. Your doctor may prescribe you an anti-fungal medication to treat the thrush.
• Aching, swollen joints and muscle pain
• Muscle cramps
• Pneumonia and bronchitis (lung infection)
Tell your doctor if you notice any of the following symptoms:
- increase in the liquid/phlegm which you cough up from your lungs (sputum)
- change in sputum colour
- increased cough
- increased breathing problems
• Bruising and fractures
• Inflammation of sinuses (a feeling of tension or fullness in the nose, cheeks and behind the eyes, sometimes with a throbbing ache).
• A reduction of the amount of potassium in the blood (you may get uneven heartbeats, muscle weakness, cramp).
Uncommon, may affect up to 1 in 100 people
• Increase in the amount of sugar (glucose) in your blood (hyperglycaemia).
If you have diabetes, more frequent blood sugar monitoring and possibly adjustment of your usual diabetic treatment may be required.
• Cloudy lens in the eye (cataract)
• Very fast heartbeat (tachycardia)
• Feeling shaky (tremor) with fast or uneven heartbeat (palpitation).
These are usually harmless and occur less as treatment continues.
• Chest pain
• Feeling worried
This effect mainly occurs in children.
• Disturbed sleep
• Allergic skin rash
Rare, may affect up to 1 in 1,000 people
• Breathing difficulties or wheezing which worsen immediately after using AirFluSal Forspiro.
If this happens stop using AirFluSal Forspiro. Use your fast-acting 'reliever' inhaler to help your breathing and tell your doctor immediately.
• AirFluSal Forspiro may affect the normal production of steroid hormones in the body, particularly if you have taken high doses for long periods of time.
The effects include:
- Slowing of growth in children and adolescents
- Thinning of the bones
- Increased eye pressure (glaucoma)
- Weight gain
- Rounded, moon shaped face (Cushing's Syndrome).
Your doctor will check you regularly for any of the above side effects and will make sure you are taking the lowest dose of salmeterol/ fluticasone propionate to control your disease.
• Behavioural changes, such as being unusually active and irritable
These effects mainly occur in children.
• Uneven heartbeats or heart gives an extra beat (arrhythmias).
Tell your doctor, but do not stop using AirFluSal Forspiro unless the doctor tells you to stop.
• Fungal infection in the oesophagus (gullet), which might cause difficulties in swallowing.
Frequency not known, but may also occur
• Depression or aggression
These effects mainly occur in children.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.
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.
AirFluSal® Forspiro® 50 microgram/500 microgram per actuation inhalation powder, pre-dispensed:
• The active substances are salmeterol and fluticasone. Each metered dose of AirFluSal Forspiro provides 50 micrograms of salmeterol (as salmeterol xinafoate) and 500 micrograms of fluticasone propionate. Corresponding with a delivered dose of:
• 45 micrograms of salmeterol (as salmeterol xinafoate) and 465 micrograms of fluticasone propionate
• The other ingredient is lactose monohydrate.
What AirFluSal Forspiro looks like and contents of the pack
• In the purple plastic dry-powder inhalation device, 60 doses of powder blend are contained in an aluminium blister.
• Each dose is pre-dispensed.
• Pack sizes:
1,2, 3, 4, 5, 6 or 10 devices containing 60 doses
Not all pack sizes may be marketed.
Marketing Authorisation Holder Sandoz Limited, Frimley Business Park,
Frimley, Camberley, Surrey, GU16 7SR, UK
Aeropharm GmbH, Francois-Mitterrand-Allee 1, 07407 Rudolstadt, Germany