PATIENT INFORMATION LEAFLET    2370

04.06.15[7]

Flixotide® 2 mg/2 ml Nebules®

(fluticasone propionate)

This medicine is available using the above name but will be referred to

as Flixotide throughout the following leaflet

Flixotide Nebules is also available in strength of 0.5 mg/2ml.

Read all of this leaflet carefully before you start taking 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, nurse 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, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Flixotide is and what it is used for

2.    What you need to know before you use Flixotide

3.    How to use Flixotide

4.    Possible side effects

5.    How to store Flixotide

6.    Contents of the pack and other information

1.    What Flixotide is and what it is used for

Flixotide contains a medicine called fluticasone propionate.

Fluticasone propionate belongs to a group of medicines called corticosteroids (often just called steroids). A very small dose of steroid is needed when it is inhaled. This is because it is inhaled straight to your lungs.

Flixotide works by reducing swelling and irritation in the lungs. It has what is called an ‘anti-inflammatory action'.

Flixotide helps to prevent asthma attacks in people who need regular treatment. This is why they are sometimes called ‘preventers'. They need to be used regularly, every day.

Flixotide will not help treat sudden asthma attacks where you feel breathless.

•    A different medicine is used for treating sudden attacks (called a ‘reliever').

•    If you have more than one medicine, be careful not to confuse them.

2.    What you need to know before you use Flixotide Do not use:

•    if you are allergic to fluticasone propionate or any of the other ingredients of this medicine (listed in Section 6).

Do not use Flixotide if any of the above apply to you. If you are not sure, talk to your doctor, nurse or pharmacist before using Flixotide.

Warnings and precautions

Talk to your doctor, nurse or pharmacist before taking Flixotide if:

•    you have ever been treated for tuberculosis (TB)

•    you are using Flixotide at the same time as taking steroid tablets.

Also if you have just finished taking steroid tablets. In both cases, you should carry a steroid warning card until your doctor tells you not to carry one.

If you are not sure if any of the above applies to you, talk to your doctor, nurse or pharmacist before using Flixotide.

Other medicines and Flixotide

Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. This includes herbal medicines.

Remember to take this medicine with you if you have to go into hospital. In particular tell your doctor or pharmacist if you are taking any of the following:

•    a type of antiviral medicine known as a ‘protease inhibitor' (such as ritonavir)

•    medicines used to treat fungal infections (such as ketoconazole)

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using Flixotide.

Using Flixotide with food and drink

You can use Flixotide at any time of day, with or without food.

Pregnancy and breast-feeding

If you are pregnant or are breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Driving and using machines

Flixotide is not likely to affect you being able to drive or use any tools or machines.

3. How to use Flixotide

Flixotide Nebules come in two different strengths. Your doctor will have decided which strength you need. Always use this medicine exactly as your doctor has told you. Check with your doctor, nurse or pharmacist if you are not sure.

Using this medicine

•    Do not inject or swallow the liquid. Flixotide Nebules should only be inhaled using your jet nebuliser. Using Flixotide Nebules with ultrasonic nebulisers is not generally recommended.

•    The jet nebuliser produces a fine mist which you breathe in through a mouthpiece or face mask.

•    Do not let the liquid, or the mist produced by the nebuliser get into your eyes. You can wear glasses or goggles to protect them.

•    Each small plastic container (Nebule®) contains some liquid.

•    The liquid is put into a nebuliser. This makes a fine mist for you to breathe in through a face mask or mouthpiece. Use of a mouthpiece prevents the medicine affecting the skin of your face, which may occur if you use a face mask over a long period of time. If you prefer to use a face mask, or you are using a face mask for your child, then you must protect the skin on your (or your child's) face with a barrier cream or wash your (or your child's) face thoroughly after treatment.

•    Use your nebuliser in a well-ventilated room as some of the mist will be released into the air and may be breathed in by others.

•    It takes a few days for this medicine to work and it is very important that you use it regularly.

Adults and Children over 16 years of age

•    The usual starting dose is 0.5 to 2.0 mg (500 to 2000 micrograms) twice a day.

•    Flixotide Nebules 0.5 mg/2 ml provides you with a dose of 500 micrograms.

•    Flixotide Nebules 2.0 mg/2 ml provides you with a dose of 2000 micrograms.

Flixotide Nebules 2 mg/2 ml are not for use in children under 16 years of age.

It is recommended that children being treated with steroids, including Flixotide Nebules have their height checked regularly by their doctor.

If you are using high doses of an inhaled steroid for a long time you may sometimes need extra steroids for example during stressful circumstances such as a road traffic accident or before an operation. Your doctor may decide to give you extra steroid medicines during this time.

Patients who have been on high doses of steroids, including Flixotide Nebules for a long time, must not stop taking their medicine suddenly without talking to their doctor. Suddenly stopping treatment can make you feel unwell and may cause symptoms such as vomiting, drowsiness, nausea, headache, tiredness, loss of appetite, low blood sugar level and fitting.

Using your Nebules

1    the Nebules are in a foil pack. Do not open the pack until you need to use them

2    hold the top of the Nebule you have just removed. Twist the body to open it

3 put the open end of the Nebule into the nebuliser bowl and squeeze slowly to empty the content

4    assemble the nebuliser and use it as directed

5    repeat steps 2 to 4 to make up the dose needed if necessary

Diluting your Nebules

Do not dilute the contents of a Nebule unless you are told to by your doctor

•    if your doctor has told you to dilute the solution, empty the contents of the Nebule into the nebuliser bowl

•    add the amount of sterile sodium chloride 0.9% solution your doctor has told you to use

•    put the top on the nebuliser bowl and shake gently to mix the contents. If dilution is necessary then only sterile sodium chloride 0.9% solution should be used.

After use

•    use a fresh Nebule for each dose. Only open a new one when you are ready to use it. If there is any liquid left over, throw it away. Do not save it to use again

•    throw away any solution remaining in the nebuliser bowl

•    clean your nebuliser in the recommended way.

If you use more Flixotide than you should

If you use more than you were told, talk to your doctor as soon as possible.

It is important that you take your dose as stated on the pharmacist's label or as advised by your doctor. You should not increase or decrease your dose without seeking medical advice.

If you forget to use Flixotide

•    Take the next dose when it is due.

•    Do not take a double dose to make up for the forgotten dose.

If you stop using Flixotide

•    Do not stop treatment even if you feel better unless told to do so by your doctor.

If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you notice any of the following serious side effects, stop using this medicine and talk to your doctor straight away. You may need urgent medical treatment.

•    allergic reactions (may affect up to 1 in 100 people) - the signs include skin rashes, redness, itching or weals like nettle rash or hives

•    severe allergic reactions (may affect up to 1 in 10,000 people) - the signs include swelling of your face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing, itchy rash, feeling faint and light headed and collapse

•    your breathing or wheezing gets worse straight after using your inhaler.

Other side effects include:

Very common (may affect more than 1 in 10 people)

•    thrush in the mouth and throat

Common (may affect up to 1 in 10 people)

•    sore tongue or throat

•    hoarseness of voice

Problems with your mouth and throat can be reduced by doing certain things straight after inhaling your dose. These are brushing your teeth, rinsing your mouth or gargling with water and spitting it out. Tell your doctor if you have these problems with your mouth or throat, but do not stop treatment unless you are told to.

The following side effects have also been reported in patients with Chronic Obstructive Pulmonary Disease (COPD):

•    Pneumonia and bronchitis (lung infection). Tell your doctor if you notice any of the following symptoms: increased sputum production, change in sputum colour, fever, chills, increased cough, increased breathing problems

•    Bruising.

Rare (may affect up to 1 in 1,000 people)

•    thrush (candidiasis) in the oesophagus

Very rare (may affect up to 1 in 10,000 people)

•    sleeping problems or feeling worried, over-excited and irritable. These effects are more likely to occur in children

•    joint pains

•    indigestion

•    level of sugar (glucose) in your blood may be increased

•    the way steroids are produced by your body may be affected when using Flixotide. This is more likely to happen if you use high doses for a long period of time. This can cause:

-    children and young people to grow more slowly

-    something called ‘Cushing's syndrome'. This happens when you have too much steroid in your body and it can cause thinning of your bones and eye problems (such as cataracts and glaucoma which is high pressure in the eye)

Your doctor will help stop this happening by making sure you use the lowest dose of steroid which controls your symptoms.

Although the frequency is not known, the following side effects may also occur:

•    depression, feeling restless or nervous. These effects are more likely to occur in children

•    nosebleeds

Talk to your doctor as soon as possible if:

•    after 7 days of using Flixotide your shortness of breath or wheezing does not get better, or gets worse

•    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. This can 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

Reporting of side effects

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 at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Flixotide

•    Keep out of the sight and reach of children.

•    Do not open the foil blisters until the nebules are required. Opened nebules should be stored in a refrigerator and used within 12 hours of opening. Shake before use. Do not store above 30°C. Protect from frost and do not freeze. Store in the outer carton and store in an upright positon.

•    Nebules removed from the foil pack should be protected from light and used within 28 days.

•    If the foil pack has not been opened, do not use Flixotide Nebules after the expiry date which is stated on the pack after ‘EXP'. The date refers to the last day of that month

•    If the suspension becomes discoloured or shows any other signs of deterioration, consult your doctor or pharmacist who will tell you what to do.

•    Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    Contents of the pack and other information What Flixotide contains

•    The active substance is fluticasone propionate

•    Each Nebule containing suspension for inhalation provides 2 mg of fluticasone propionate in 2 ml normal saline.

•    Other ingredients are polysorbate 20, sorbitan monolaurate, monosodium phosphate dihydrate, dibasic sodium phosphate anhydrous, sodium chloride and water for injection.

What Flixotide looks like and contents of the pack

Flixotide Nebules are available as opaque plastic ampoules with a twist off tab containing white, opaque, freely dispersed suspension sealed in foil blisters.

Each pack contains 10 Nebules individually packed in foil blisters

Product Licence Holder and Manufacturer

Flixotide Nebules are manufactured by Aspen Bad Oldesloe GmbH., Industriestrabe 32-36, 23843 Bad Oldesloe, Germany and procured from within the EU by Product Licence holder Star Pharmaceuticals Ltd., 5 Sandridge close, Harrow, Middlesex HA1 1XD. Repackaged by Servipharm Ltd.

| POM |    | PL 20636/2370

Leaflet revision and issue date (Ref.) 04.06.15[7]

Flixotide Nebules, Nebules and Nebule are trademarks of the GlaxoSmithKline group of companies.