Active ingredient
- fluticasone propionate
- formoterol fumarate dihydrate
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.
The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet are: PL 16950/0338, PL 16950/0339.
Flutiform K-haler 50 microgram /5 microgram, 125 microgram /5 microgram per actuation pressurised inhalation, suspension.
Package leaflet: Information for the user
Flutiform® K-haler® 50 microgram /5 microgram, and Flutiform® K-haler® 125 microgram /5 microgram per actuation pressurised inhalation, suspension
fluticasone propionate/formoterol fumarate dihydrate
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in this leaflet:
1. What Flutiform K-haler is and what it is used for
2. What you need to know before you use Flutiform K-haler
3. How to use Flutiform K-haler
4. Possible side effects
5. How to store Flutiform K-haler
6. Contents of the pack and other information
1. What Flutiform K-haler is and what it is used for
Please note:-
Flutiform K-haler pressurised inhalation, suspension is the full name of the product, however throughout this leaflet it is referred to as Flutiform K-haler or simply as an inhaler, sometimes together with a reference to a specific strength.
Flutiform K-haler is an inhaler (a pressurised inhalation suspension) which contains two active ingredients:
Together these two active ingredients help to improve your breathing. It is advised that you should use this medicine every day as directed by your doctor or asthma nurse. The inhaler is breath-triggered (or breath-actuated) which means that it will release these two active ingredients when you breath in through the mouthpiece.
This medicine helps to prevent breathing problems such as asthma and helps to stop you becoming breathless and wheezy. However, it does not work if you are already having an asthma attack i.e. you are already breathless and wheezing. You will need to use a fast- acting ‘reliever’ medicine such as salbutamol if this happens.
2. What you need to know before you use Flutiform K-haler
Do not use Flutiform K-haler if you:
Warnings and precautions
Talk to your doctor, pharmacist or asthma nurse before using this inhaler
Before treatment with this inhaler tell your doctor, pharmacist or asthma nurse if you have:
Contact your doctor if you experience blurred vision or other visual disturbances.
If you are going to have an operation or are extremely stressed, please tell your doctor as you may need additional steroid treatment to control your asthma.
Other medicines and Flutiform K-haler
Tell your doctor, pharmacist or asthma nurse if you are taking, have recently taken or might take any other medicines including medicines obtained without a prescription. If you use this inhaler with some other medicines the effect of this inhaler or the other medicine may be altered.
Tell your doctor, pharmacist or asthma nurse if you are taking:
If you are going to have an operation under a general anaesthetic, please tell the doctor at the hospital that you are using this inhaler.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you might be pregnant or are planning to have a baby ask your doctor or asthma nurse for advice about using your inhaler. Your doctor or asthma nurse will advise you if you should take this medicine.
Driving and using machines
This medicine is unlikely to affect your ability to drive or use machines.
Flutiform K-haler contains ethanol (alcohol) and sodium cromoglicate
This medicine contains very small amounts of ethanol (alcohol) i.e. 1.00 mg per actuation (puff). It also contains a very small amount of sodium cromoglicate however patients who are currently taking cromoglicate (used to treat asthma, allergic rhinitis and allergic conjunctivitis) should continue as normal.
3. How to use Flutiform K-haler
Always use this inhaler exactly as your doctor, pharmacist or asthma nurse has told you. Check with your doctor, or asthma nurse if you are not sure. You should use your inhaler regularly i.e. two actuations (puffs) in the morning and two actuations (puffs) in the evening every day to get the most benefit from your inhaler, unless your doctor tells you otherwise or advises you to stop. Do not take more than the prescribed dose. Your doctor may have prescribed your inhaler for a different indication other than asthma/or at a different dose from that normally prescribed and as described in this leaflet. You should always use your inhaler exactly as your doctor or asthma nurse has advised. If you are not sure about how much to take or how often to use your inhaler please check with your doctor, pharmacist or asthma nurse.
Adults and adolescents over 12 years of age
The usual dose is two inhalations twice a day, that is two puffs (actuations) in the morning and two in the evening. Your doctor or asthma nurse will prescribe the dose required to treat your asthma.
Flutiform K-haler should not be used in children under 12 years of age.
Instructions for use
Read this leaflet very carefully prior to use and follow the instructions for use in the text and diagrams below. Your doctor, pharmacist or asthma nurse will show you how to use your inhaler properly. The inhaler is breath-triggered (or breath-actuated) which means that it will automatically release the two active ingredients when you breath in through the mouthpiece. The medicine is contained in an aerosol can which is hidden inside a plastic casing. The plastic casing also has a counter to tell you how many puffs (actuations) are left . This counter is colour coded. When there are less than 28 puffs (actuations) left it starts changing to red and you should contact your doctor or asthma nurse for a replacement inhaler. You should not use your inhaler when the counter reads “0” or has turned completely red.
Before you use your inhaler for the first time or if it hasn’t been used for more than 3 days
If your inhaler is new or it hasn’t been used for more than 3 days then it must be ‘set up’ (primed) to ensure it works properly and gives you the correct dose.
Setting up your inhaler
You must set up your inhaler before using it for the first time, or if it hasn't been for more than 8 days.
This ensures it works properly and gives younthe correct dose.
1 Always shake well before opening the orange cover.
2 Always keep the inhaler upright, open the orange cover as fas as possible and then close it fully.
3 Step 1 and 2 should be performed a total of four times
If you drop your inhaler or leave the mouthpiece cover open for more than 10 minutes, then your inhaler needs to be triggered once before use as in steps 1 and 2 above.
If you expose your inhaler to freezing conditions you should leave it to warm at room temperature for 30 minutes then trigger once before use as in steps 1 and 2 above.
Your inhaler should always be shaken immediately before use.
Daily use
1 Shake well.
Keep the inhaler upright and open the orange cover fully
Breathe out as slowly and deeply as possible
2 To release the medication, hold your inhaler upright, put the mouthpiece in your mouth and breathe in slowly an deeply
Hold your breathe as long as is comfortable
3 Keep upright and close the orange cover fully after each puff
Using your inhaler
If you feel you are getting breathless or wheezy while using Flutiform K-haler, you should continue to use Flutiform K-haler but go to see your doctor or asthma nurse as soon as possible, as you may need additional treatment. Once your asthma is well controlled your doctor or asthma nurse may consider it appropriate to reduce the dose of Flutiform K-haler.
Always rinse your mouth out, gargle with water or brush your teeth after you have taken your inhaler and spit out the residue. This may help prevent you developing a sore mouth and throat or a hoarse voice.
If you use more Flutiform K-haler than you should
It is important that you take your dose as stated on the pharmacist’s label or as advised by your doctor or asthma nurse. You should not increase or decrease your dose without seeking medical advice.
If you take more of your medicine than you should, contact your doctor, pharmacist or asthma nurse for advice. You may suffer from severe chest pain (angina), high or low blood pressure, a headache, muscle cramps, difficulty in sleeping, nervousness, a dry mouth, a loss of appetite, seizures, fits or convulsions. You may feel shaky, light headed, faint, tired, sick or generally unwell. You may also notice changes in the rate of your heart beat and your blood may have low levels of potassium or an increase in the amount of sugar in your blood. You may also suffer from symptoms such as abdominal pain, being sick, weight loss, decreased level of consciousness (which could make you feel drowsy or confused) or a low blood sugar level.
If you have taken more than the prescribed dose for a long period of time, you should talk to your doctor, pharmacist or asthma nurse for advice. This is because large doses may reduce the amount of steroid hormones produced normally by your adrenal glands (see section 4).
If you forget to use Flutiform K-haler
If you forget to take a dose, take it as soon as you remember. However, if it is nearly time for your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.
If you stop using Flutiform K-haler
It is very important that you take this inhaler every day as directed by your doctor even if you feel well as it will help to control your asthma. If you want to stop using your inhaler talk to your doctor first. Your doctor will tell you how to do this, usually by decreasing the dose gradually so that you do not trigger an asthma attack.
4. Possible side effects
Like all medicines, this inhaler can cause side effects, although not everybody gets them. Your doctor or asthma nurse will prescribe the lowest dose necessary to control your asthma which may reduce the possibility of side effects occurring.
All medicines can cause allergic reactions, although serious allergic reactions are reported rarely. Tell your doctor immediately if you get any sudden swelling of the eyelids, face, throat, tongue or lips, rash or itching especially those covering your whole body, symptoms such as dizziness, light-headedness or fainting or any sudden changes in your breathing pattern such as increased wheezing or shortness of breath.
As with other inhalers, your breathing may worsen immediately after using your inhaler. You may notice an increase in wheezing and shortness of breath. If this happens stop using your Flutiform K-haler and use your quick acting ‘reliever’ inhaler. Contact your doctor or asthma nurse straight away. Your doctor or asthma nurse will assess you and may start you on a different course of treatment. You should carry your ‘reliever’ inhaler with you at all times.
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Not known: frequency cannot be estimated from the available data
The following side effects are associated with formoterol fumarate but they have not been reported during clinical trials with this inhaler:
Inhaled steroids can affect the normal production of steroid hormones in your body, particularly if you use high doses for a long time. The effects include:
These effects are much less likely to happen with inhaled steroids than with steroid tablets.
Reporting of side effects
If you get any side effects, talk to your doctor,or pharmacist or asthma 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 Flutiform K-haler
Keep this medicine out of the sight and reach of children.
Do not use this inhaler after the expiry date which is stated on the label, foil pouch and carton after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C. Do not refrigerate or freeze. If the inhaler is exposed to freezing conditions it must be allowed to warm at room temperature for 30 minutes then primed once before use (see section 3 “How to use…”). Do not use the inhaler if it has been removed from the foil pouch for more than 3 months, or if the dose indicator reads ‘0’.
Do not expose to temperatures higher than 50°C. The aerosol can contains a pressurised liquid so do not puncture, break or burn the can even when apparently empty. 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.
6. Contents of the pack and other information
What Flutiform K-haler contains
The active substances are fluticasone propionate and formoterol fumarate dihydrate. There are two different strengths of inhaler available.
Each puff (actuation) contains 50 micrograms fluticasone propionate and 5 micrograms formoterol fumarate dihydrate or 125 micrograms fluticasone propionate and 5 micrograms formoterol fumarate dihydrate.
The other ingredients are:
What Flutiform K-haler looks like and the contents of the pack
These inhalers are small aerosol cans sealed inside pale grey plastic casings with orange mouthpiece covers. You cannot see the aerosol can inside the plastic casing. The aerosol cans contain a white to off-white liquid suspension and are fitted with a metering valve. Each inhaler contains 120 puffs (actuations). There is one inhaler in a pack. Multiple pack size is 3 x 1 inhaler (120 actuations).
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
This leaflet is also available in large print, Braille or as an audio CD. To request a copy, please call the RNIB Medicine Information line (free of charge) on:
0800 198 5000
You will need to give details of the product name and reference number.
These are as follows:
Product name: Flutiform K-haler
Reference number: 16950/0338
This leaflet was last revised in September 2017
Other sources of information
To view the interactive training tool visit www.flutiformkhaler.co.uk
Distributed by Napp Pharmaceuticals Ltd. under licence from Jagotec AG.
® FLUTIFORM is a registered trade mark of Jagotec AG and is used under licence.
K-HALER is a registered trade mark of Mundipharma AG.
NAPP and the ‘NAPP’ logo are registered trade marks of the Napp Pharmaceutical Group.
© 2012-2018 Mundipharma independent associated companies
P1268-A R0V22 UK AW 29-09-2017
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