What is a Patient Information Leaflet and why is it useful?

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.

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Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

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: 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.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist or asthma nurse.
  • 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, pharmacist or asthma nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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:

  • Fluticasone propionate which belongs to a group of medicines called steroids. Steroids help to reduce swelling and inflammation in the lungs.
  • Formoterol fumarate dihydrate which belongs to a group of medicines called long-acting beta2 agonists. Long-acting beta2 agonists are long-acting bronchodilators which help the airways in your lungs to stay open, making it easier for you to breathe.

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:

  • are allergic to fluticasone propionate, formoterol fumarate or any of the other ingredients of this medicine (listed in section 6).

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:

  • tuberculosis (TB) now or in the past. Symptoms include a persistent cough often with blood streaked phlegm, fever, tiredness, loss of appetite, loss of weight and night sweats;
  • an infection of the lungs or chest;
  • heart problems such as problems with the blood flow to your heart or narrowing of one of your heart valves (the aortic valve), heart failure which can cause shortness of breath or ankle swelling, a condition where the heart muscle is enlarged (hypertrophic obstructive cardiomyopathy), an irregular heart beat (cardiac arrhythmias) or if you have been told that your heart trace is abnormal (prolongation of the QTc interval);
  • an abnormal bulging of a blood vessel wall (an aneurysm);
  • diabetes;
  • high blood pressure;
  • an overactive thyroid gland which can cause increased appetite, weight loss or sweating (thyrotoxicosis);
  • low blood levels of potassium which can cause muscle weakness, twitching or abnormal heart rhythm (hypokalaemia);
  • poor adrenal gland function (if your adrenal gland is not working properly you may have symptoms such as headaches, weakness, tiredness, abdominal pain, loss of appetite, weight loss, dizziness, very low blood pressure, diarrhoea, feeling or being sick, or fits) or a tumour of the adrenal gland (phaeochromocytoma);
  • liver problems.

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:

  • medicines known as beta blockers (such as atenolol to treat high blood pressure, sotalol to treat an irregular heart beat, metoprolol to treat a fast heart beat or timolol eye drops to treat glaucoma);
  • certain other medicines used to treat asthma or breathing conditions (such as theophylline or aminophylline);
  • medicines containing adrenaline or related substances (including other beta agonists like salbutamol or beta antagonists including atenolol, metoprolol, propranolol, timolol). Additional long-acting beta2 agonists should not be used together with this inhaler. If your asthma becomes worse between doses of Flutiform K-haler then you should use your quick acting ‘reliever’ inhaler for immediate relief;
  • medicines to treat allergic reactions (antihistamines);
  • medicines to treat high blood pressure or fluid build up by increasing the amount of urine produced (diuretics);
  • medicines used to treat heart failure (such as digoxin);
  • medicines to treat abnormal heart rhythms (such as quinidine, disopyramide, procainamide);
  • medicines to treat symptoms of depression or mental disorders such as monoamine oxidase inhibitors (for example phenelzine and isocarboxazid), tricyclic antidepressants (for example amitriptyline and imipramine), or you have taken any of these types of medicine in the last two weeks;
  • medicines used to treat psychiatric or mental disorders (phenothiazines or antipsychotics);
  • other medicines containing steroids;
  • antifungal medicines (such as ketaconazole or itraconazole);
  • some medicines may increase the effects of Flutiform K-haler and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, atazanavir, indinavir, nelfinavir, saquinavir or cobicistat);
  • antibiotics (such as clarithromycin, telithromycin or furazolidone);
  • medicine to treat Parkinson’s disease (levodopa);
  • medicine to treat an underactive thyroid gland (levothyroxine);
  • medicine to treat Hodgkin’s disease (procarbazine);
  • medicine to induce labour (oxytocin).

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

  • Always point the mouthpiece away from you when setting up (priming).
  • Follow the instructions to set up your inhaler.
  • As the mouthpiece is closed it will release one puff (actuation).

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.

  • The inhaler should be shaken immediately before each puff (actuation) to ensure the contents of your inhaler are evenly mixed.
  • Sit upright or stand. Breathe out as slowly and deeply as possible. See diagram 1.
  • Hold your inhaler upright, open the orange mouthpiece cover and put the mouthpiece in your mouth with your lips around it. Do not bite the mouthpiece.
  • Breathe in slowly and deeply through the mouthpiece, which will automatically trigger the release of a puff (actuation). While holding your breath, remove the inhaler from your mouth and close the mouthpiece cover. Continue to hold your breath for as long as is comfortable. Do not breathe out into the inhaler. See diagrams 2 and 3. If you see a ‘mist’ as you close the mouthpiece cover then you have not taken your inhaler properly and will need to repeat the steps above.
  • For the second puff (actuation), hold the inhaler upright and repeat the steps 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 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

  • Worsening of asthma.
  • Headache.
  • Shaking.
  • An irregular heartbeat or palpitations.
  • Dizziness.
  • Difficulty in sleeping.
  • Alteration in voice/hoarse voice.
  • Dry mouth, sore or irritated throat.
  • Rash.

Rare: may affect up to 1 in 1,000 people

  • An increase in the amount of sugar in your blood. If you are diabetic you may need to check your blood sugar more often and adjust your usual diabetic treatment. Your doctor may need to monitor you more closely.
  • Thrush or other fungal infections in the mouth and throat.
  • Inflammation of the sinuses (sinusitis).
  • Fast heartbeat.
  • Chest pain associated with heart disease.
  • Muscle spasms.
  • Coughing or shortness of breath.
  • Diarrhoea.
  • Indigestion.
  • Changes in taste.
  • A feeling of dizziness or ‘spinning’.
  • Abnormal dreams.
  • Agitation.
  • Itchy skin.
  • High blood pressure.
  • A feeling of unusual weakness.
  • Swelling of hands, ankles or feet.

Not known: frequency cannot be estimated from the available data

  • Blurred vision.
  • Sleeping problems, depression or feeling worried, aggression, anxiety, restlessness, nervousness, over-excitment or irritability. These effects are more likely to occur in children.

The following side effects are associated with formoterol fumarate but they have not been reported during clinical trials with this inhaler:

  • Low blood levels of potassium which can cause muscle weakness, twitching or abnormal heart rhythm.
  • An abnormal heart trace potentially leading to an abnormal heart rhythm (QTc interval prolongation).
  • High levels of lactic acid in the blood.
  • Feeling sick.
  • Muscle pain.

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:

  • changes in bone mineral density (thinning of the bones);
  • cataracts (clouding of the lens in the eye);
  • glaucoma (increased pressure in the eye);
  • bruising or thinning of the skin;
  • an increased chance of catching an infection;
  • slowing of the rate of growth of children and adolescents;
  • a round (moon shaped) face;
  • an effect on the adrenal gland (a small gland next to the kidney) which means you may have symptoms such such as weakness, tiredness, difficulty in coping with stress, abdominal pain, loss of appetite, weight loss, headache, dizziness, very low blood pressure, diarrhoea, feeling or being sick or fits.

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:

  • Sodium cromoglicate
  • Ethanol
  • Apaflurane HFA 227 (propellant)

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

Napp Pharmaceuticals Limited
Cambridge Science Park
Milton Road
Cambridge
CB4 0GW
UK

Manufacturer

Bard Pharmaceuticals Limited
Cambridge Science Park
Milton Road
Cambridge
CB4 0GW
UK

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