Flixotide Evohaler 125 Micrograms
5. How to store Flixotide
6.
Practise in front of a mirror for the first few times. If you see a 'mist' coming from the top of your inhaler or the sides of your mouth you should start again.
Older children or 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. If this does not help, a special device called a HaleraidTM may make it easier. Your doctor, nurse or pharmacist will be able to advise you.
Cleaning your Evohaler
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.
Do not put the metal canister in water.
If you use more Flixotide than you should
If you use more than you should, 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 product, 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
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.
• Keep out of the sight and reach of children.
• Clean your inhaler on a weekly basis and if it becomes blocked as described under 'Cleaning',
• Do not use Flixotide Evohaler 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 store above 30°C. Do not refrigerate or freeze.
Protect from Frost and direct sunlight.
• If the inhaler gets very cold, take the metal canister out of the plastic case and warm it in your hands for a few minutes before use. Never use anything else to warm it up.
• The metal canister is pressurised. Do not puncture, break or burn it even when apparently empty.
• 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.
• If you are told to stop taking this medicine, return the inhaler to your pharmacist to be destroyed.
Contents of the pack and other information
What Flixotide contains
• Each actuation contains 125 micrograms of the active substance, fluticasone propionate.
• The aerosol also contains a CFC-free propellant, 1,1,1,2-tetrafluoroethane (HFA 134a).
What Flixotide Evohaler looks like and contents of the pack
Flixotide is a pressurised metered dose inhaler with an orange plastic body and a light orange plastic cap.
Each canister contains 120 metered actuations.
Manufacturer:
This product is manufactured by:
Glaxo Wellcome, SA Avda, Extremadura 3, Poligano Industrial Allenduero, 09400 Aranda de Duero. Spain.
It is procured from within the EU and repackaged by the Product Licence holder: G. Pharma Ltd, Dakota Avenue, Salford M50 2PU.
POM
08/05/2015
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 young people
• 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 (e.g. 400 micrograms daily in children). This can cause:
- 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.
PL 16369/0064
Flixotide® Evohaler ® 125 micrograms
Flixotide® and Evohaler® are registered trademarks of GlaxoSmithKline Group of Companies