Flixotide Nebules 0.5mg/2ml
4. Possible side effects
5. How to store Flixotide Nebules
6. Contents of the pack and other information
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 Nebules 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 Nebules
• 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 Nebules
• 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.
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
• Do not store above 30°C. Do not freeze. Store Upright.
• Store in the original container.
• Nebules removed from the foil wraps should be protected from light and used within 28 days.
• Do not leave suspension in your nebuliser once you have finished a treatment
• Opened nebules should be stored in a fridge and used within 12 hours of opening.
• Do not use the unopened pack after the date shown as 'EXP' on the carton and foil blisters.
• Keep out of the sight and reach of children.
• 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.
What Flixotide Nebules contains
• The liquid is a suspension of 0.5mg of the active ingredient fluticasone propionate in 2ml of normal saline.
• The other ingredients are polysorbate 20, sorbitan monolaurate, monosodium phosphate dihydrate, dibasic sodium phosphate, sodium chloride and water for injection.
What Flixotide Nebules looks like and contents of the pack
Each carton contains 10 Nebules (each of 2ml) packed in an aluminium foil overwrap containing a strip of five nebules. Your medicine is available in plastic ampoules containing white, opaque, freely dispersed suspension sealed in foil blisters.
Manufacturer
GlaxoSmithKline Australia Pty Ltd. 1061 Mountain Highway, Boronia, Victoria, AUSTRALIA
Procured from within the EU. Parallel Import Product Licence holder: G.Pharma Ltd. Dakota Ave. Salford M50 2PU
PL 16369/0800
Flixotide® Nebules® 0.5mg/2ml
11/05/2015
Flixotide® and Nebules® are registered trademarks of the GlaxoSmithKline group of companies
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 Nebules. 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 Nebules 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.