Patient Information Leaflet for Flixotide Accuhaler (fluticasone propionate as powder for inhalation in a multidose system) 50 micrograms, 100 micrograms, 250 micrograms and 500 micrograms

Your doctor has decided to prescribe Flixotide Accuhaler as part of your treatment. Flixotide Accuhaler is available in several strengths. Your doctor will have decided which strength you need. Flixotide Accuhaler 250 micrograms and Flixotide Accuhaler 500 micrograms are only indicated for adults and children over 16 years.

This leaflet tells you about Flixotide Accuhaler and how to use it. Please read it carefully before using your Accuhaler and keep it until you have finished the medicine.

WHAT IS A FLIXOTIDE ACCUHALER INHALER?

Flixotide Accuhaler is a plastic inhaler device containing a foil strip with 60 blisters. Each blister contains 50, 100, 250 or 500 micrograms of the active ingredient fluticasone propionate and lactose which acts as the ‘carrier’. The blisters protect the powder for inhalation from the effects of the atmosphere. The device has a counter which tells you the number of blisters remaining. It counts down from 60 to 0. To show when the last five blisters have been reached, the numbers appear in red. When the counter shows 0, your inhaler is empty and should be disposed of.

HOW YOUR MEDICINE WORKS

Fluticasone propionate is one of a group of medicines called corticosteroids which are often referred to simply as ‘steroids’. Corticosteroids are used to treat asthma because they have an anti-inflammatory action. They reduce the swelling and irritation in the walls of the small air passages in the lungs, and so ease breathing problems. Corticosteroids also help to prevent attacks of asthma. This is why they are called ‘preventers’. Fluticasone propionate should be taken regularly every day.

Fluticasone propionate should not be confused with other steroids such as anabolic steroids misused by some athletes and taken as tablets or injection.

USES

Flixotide Accuhaler is used to treat asthma in people who need regular treatment.

MAKE SURE THAT THIS MEDICINE IS SUITABLE FOR YOU

TELL YOUR DOCTOR BEFORE STARTING TO TAKE THIS MEDICINE

• if you have ever had to stop taking this or another medicine for this illness because you were allergic to Flixotide or fluticasone propionate,
• if you have been told that you are allergic to lactose or milk protein,
• if you are pregnant (or intending to become pregnant),
• if you are breast-feeding a baby,
• if you are being, or have ever been, treated for tuberculosis (TB).

Sometimes this medicine may not be suitable and your doctor may want to give you something different. In some cases, Flixotide Accuhaler may not be suitable to use with other medicines so be sure you tell your doctor:

• if you are taking a type of antiviral medicine known as a protease inhibitor (e.g. ritonavir),
• if you are taking certain medicines used to treat fungal infections (e.g. ketoconazole).

Check with your pharmacist or doctor if you are not sure.

Make sure that your doctor knows what other medicines you are taking, including any you have bought from the chemist. Remember to take these medicines with you if you have to go into hospital.

If you have just started to use a Flixotide Accuhaler instead of, or as well as, taking steroid tablets, you should continue to carry a ‘steroid warning card’ (if you have one) until your doctor tells you that you don’t need to any longer.

TAKING YOUR MEDICINE

REMEMBER the medicine in the Flixotide Accuhaler should be inhaled into your lungs. You should be able to taste the powder on your tongue if you have used the inhaler correctly. The instructions for using the inhaler are given later on in this leaflet. If you have any difficulties or do not understand the instructions, ask your doctor, nurse or pharmacist.

MAKE SURE YOU KNOW HOW AND WHEN TO USE YOUR ACCUHALER AND HOW MANY BLISTERS TO TAKE. Your doctor should have told you and the instructions should be on the pharmacist’s label. If they are not, or you are not sure, ask your doctor or pharmacist.

SIDE EFFECTS

Most people do not have any problems when taking this medicine.

• Some people occasionally develop thrush in their mouth and find that their tongue becomes sore, or that their voice becomes hoarse, or their throat becomes irritated, after inhaling this medicine. Brushing your teeth, or rinsing your mouth or gargling with water and spitting it out immediately after each dose may help. Tell your doctor but do not stop treatment unless you are told to.
• Some people may be allergic to this medicine. If you develop a skin rash or swelling (e.g. of the hands, feet, face or throat) stop using your Flixotide Accuhaler and tell your doctor straight away.
• Very occasionally some people have noticed joint pains or indigestion.
• In rare instances, treatment with Flixotide Accuhaler may affect the normal production of steroids in the body. This is more likely to happen if high doses (for example doses higher than 400 micrograms daily in children) are being used over a long period of time. One of the rare effects is that children and adolescents may grow more slowly than others. Children and adolescents who are receiving treatment over a long period of time will have their height checked regularly by their doctor. Other effects can include symptoms caused by an excess of steroid in the body (known as Cushing’s syndrome), thinning of the bones and certain eye disorders (known as cataract and glaucoma).
• Very rarely this medicine may cause anxiety, sleep disorders and behavioural changes, including hyperactivity and irritability (predominantly in children).
• In very rare instances, the level of sugar (glucose) in your blood may be increased.

It is important that if you or your child is on high doses of inhaled steroid and become unwell with vague symptoms such as tummy ache, sickness, diarrhoea, headache or drowsiness you see a doctor immediately. This is more likely to happen during an infection such as a viral infection or stomach upset. It is important that your steroid is not stopped suddenly as this could make your asthma worse and could also cause problems with the body’s hormones. If you or your child develops an illness like this, you should make sure that the doctor knows that you/your child is on inhaled steroids and the daily dose. Check with your doctor if you are uncertain.

Your doctor will help prevent these possible side effects by prescribing the lowest dose of Flixotide at which your asthma is well controlled.

If you feel unwell or notice anything unusual which you don’t understand, tell your doctor as soon as possible.

STORING YOUR MEDICINE

• Keep your Flixotide Accuhaler in a safe place where children cannot see and reach it.
• As the product is sensitive to moisture, store the Flixotide Accuhaler in the original package. Protect from direct heat or sunlight and do not store above 30°C.
• Do not use after the date shown as ‘EXP’ on the carton and device.
• If you are told to stop taking this medicine, RETURN ANY FLIXOTIDE ACCUHALERS TO YOUR PHARMACIST to be destroyed.

HOW TO USE YOUR ACCUHALER INHALER

When you take your Accuhaler out of its box, it will be in the closed position.

A new Accuhaler contains 60 individual blisters containing your medicine in powder form. The contents of each blister are accurately measured and hygienically protected.

The Accuhaler requires no maintenance and no refilling.

The counter on top of your Accuhaler tells you how many blisters are left. Numbers 5 to 0 will appear in RED, to warn you when there are only a few blisters left.

FURTHER INFORMATION

REMEMBER: This medicine is for YOU. Only a doctor can prescribe it for you. Never give it to someone else. It may harm them even if their symptoms are similar.

This leaflet does not tell you everything about your medicine. If you have any questions or are not sure about anything, ask your doctor, nurse or pharmacist.

You will be able to find more information about prescribed medicines from books in public libraries.

The information in this leaflet only applies to Flixotide Accuhaler.