The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: PL16950/0169, PL16950/0167, PL16950/0168.
flutiform 50 microgram/5 microgram, 125 microgram/5 microgram and 250 microgram/10 microgram per actuation pressurised inhalation, suspensions
Flutiform® 50 microgram /5 microgram, 125 microgram /5 microgram and 250 microgram /10 microgram per actuation pressurised inhalation, suspension
fluticasone propionate/formoterol fumarate dihydrate
1. What Flutiform inhaler is and what it is used for
2. What you need to know before you use Flutiform inhaler
3. How to use Flutiform inhaler
4. Possible side effects
5. How to store Flutiform inhaler
6. Contents of the pack and other information
Please note:- Flutiform pressurised inhalation, suspension is the product name, however throughout this leaflet it is shortened to Flutiform inhaler. Sometimes this may refer to a specific strength.
Flutiform 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.
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.
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.
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.
If you are pregnant or breastfeeding, think you may 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.
This medicine is unlikely to affect your ability to drive or use machines.
This medicine contains 2 mg of alcohol in each dose (2 inhalations). The amount in each dose is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not have any noticeable effects. 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.
Always use this inhaler exactly as your doctor, pharmacist or asthma nurse has told you. Check with your doctor, pharmacist 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.
The usual dose is two inhalations twice a day, that is two puffs (actuations) in the morning and two in the evening. Your doctor will prescribe the dose required to treat your asthma. Only adults should use the highest strength inhaler (Flutiform 250 microgram /10 microgram).
Only adults and adolescents over 12 years of age should use the medium strength inhaler Flutiform inhaler 125 microgram /5 microgram).
Flutiform inhaler should not be used in children under 5 years of age.
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 medicine is contained in an aerosol can (see Diagram 1) which sits inside a plastic dispenser (also known as an actuator). The actuator also has a counter to tell you how many puffs (actuations) are left after it has been primed. The counter is also coloured coded. It starts off green then, when there are less than 50 puffs (actuations) left it changes to yellow and when there are less than 30 puffs (actuations) left it changes to red. When this is getting near to zero, you should contact your doctor or asthma nurse for a replacement inhaler. Do not use your inhaler when the counter reads zero.
Before you use your inhaler for the first time or if it hasn’t been used for more than 3 days or if it has been exposed to freezing conditions
If your inhaler is new or it hasn’t been used for more than 3 days then it must be ‘primed’ to ensure it works properly and gives you the correct dose.
If your inhaler has been exposed to freezing temperatures it must be allowed to warm at room temperature for 30 minutes then it must be ‘primed’ to ensure it works properly and gives you the correct dose.
Your inhaler should always be shaken immediately before use.
If you feel you are getting breathless or wheezy while using Flutiform inhaler, you should continue to use Flutiform inhaler 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 gradually reduce the dose of Flutiform inhaler.
Perform steps 2 to 5 below, slowly.
1. Remove the mouthpiece cover (see Diagram 2) and check that your inhaler is clean and free from any dust.
2. The inhaler should be shaken immediately before releasing each puff (actuation) to ensure the contents of your inhaler are evenly mixed.
3. Sit upright or stand. Breathe out as far as is comfortable and as slowly and as deeply as possible.
4. Hold your inhaler upright (as shown in Diagram 3) and put the mouthpiece in your mouth with your lips around it. Hold the inhaler with your thumb(s) on the base of the mouthpiece and forefinger/index finger(s) on the top of the inhaler. Do not bite the mouthpiece.
5. Breathe in slowly and deeply through your mouth and, at the same time, press down on the aerosol can to release one puff (actuation). Continue to breathe in steadily and deeply (ideally for about 2-3 seconds in children or 4-5 seconds in adults).
6. While holding your breath, remove the inhaler from your mouth. Continue to hold your breath for as long as is comfortable. Do not breathe out into the inhaler.
7. For the second puff (actuation), keep the inhaler in a vertical position then repeat steps 2 to 6.
8. Replace the mouthpiece cover.
You can practise in front of a mirror. If you see a ‘mist’ from the top of the inhaler or around your mouth when you use your inhaler then you may not have inhaled your medicine properly. Take another dose by repeating from Step 2 above.
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 have weak hands it may be easier to hold the inhaler in both hands placing both index fingers on the aerosol can and both thumbs on the base of the inhaler.
If you have difficulty using your inhaler your doctor or asthma nurse may give you a device called an AeroChamber Plus®Flow-Vu® spacer device, to help you to breathe your medicine into your lungs properly. Your doctor, pharmacist or asthma nurse will advise you how to use the AeroChamber Plus®Flow-Vu® spacer device with your inhaler. The AeroChamber Plus® Flow-Vu® spacer device will come with instructions for use and with care and cleaning instructions which you must read carefully.
It is important that you follow these instructions carefully and clean your inhaler weekly. To clean your inhaler:
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 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.
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.
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 inhaler 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 1000 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.
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 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 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.
The active substances are fluticasone propionate and formoterol fumarate dihydrate. There are three different strengths of inhaler available. Each puff (actuation) contains either 50 micrograms fluticasone propionate and 5 micrograms formoterol fumarate dihydrate, 125 micrograms fluticasone propionate and 5 micrograms formoterol fumarate dihydrate or 250 micrograms fluticasone propionate and 10 micrograms formoterol fumarate dihydrate.
The other ingredients are:
These inhalers are small aerosol cans containing a white to off white liquid suspension fitted with a metering valve. The aerosol cans are inserted into grey and white plastic dispensers (actuators) with a light grey mouthpiece cover. Each inhaler contains 120 puffs (actuations). There is one inhaler in a pack.
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 inhaler
Reference number: 16950/0167
This leaflet was last revised in February 2021
Distributed by Napp Pharmaceuticals Ltd. under licence from Jagotec AG.
® FLUTIFORM is a registered trade mark of Jagotec AG and is used under licence.
AEROCHAMBER, AEROCHAMBER PLUS and AEROCHAMBER PLUS FLOW-VU are registered trade marks of Trudell Medical International.
NAPP and the ‘NAPP’ logo are registered trade marks of the Napp Pharmaceutical Group.
© 2012 – 2021 Napp Pharmaceuticals Limited.