Flutiform

• Inhaler (pressurised inhalation medicine)
• For breathing problems such as asthma
• Helps prevent shortness of breath
• Maintenance medicine (not a fast-acting reliever medicine)
• Also suitable for children from the age of 5 years

Flutiform is an inhaler (a pressurised inhalation, suspension): the active ingredients are inhaled so that the medicine is deposited in the lower airways. Flutiform contains two active ingredients:

• Fluticasone propionate, which protects the airways. This medicine helps to reduce swelling and inflammation in the lungs.
• Formoterol fumarate dihydrate, a long-acting bronchodilator. This medicine helps the airways in your lungs to stay open, making it easier for you to breathe.

This medicine helps to prevent breathing problems, such as with asthma and COPD, and helps to stop you becoming breathless and wheezy. Flutiform is not a quick-acting reliever inhaler. It is a maintenance inhaler and should be used regularly each day to keep the airways open and help prevent breathing difficulties.

This medicine should be used as directed by a doctor. The package leaflet contains step-by-step instructions on how to prepare the inhaler for first use and how to inhale the medicine correctly. Always rinse your mouth out after you have used your inhaler. This may help prevent you developing side effects, such as a sore mouth and throat or a hoarse voice.

Use in adults, adolescents and children aged 5 years and above

• 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, aerosol, suspension).
• Only adults and adolescents over 12 years of age should use the medium strength inhaler Flutiform inhaler 125 microgram /5 microgram, aerosol, suspension).

Flutiform inhaler should not be used in children under 5 years of age.

Alcohol/driving

Flutiform does not interact with alcohol and will normally not affect your ability to drive.

Taken too much/forgot to take/stop taking Flutiform

If you take more of your medicine than you should, contact your doctor or pharmacist for advice. You may suffer from certain symptoms (see the package leaflet).

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 use a double dose to make up for the forgotten one.

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.

Do not use Flutiform if you are allergic to any of the ingredients in this medicine (see section ‘What Flutiform contains').

When should this medicine be used with caution?

Talk to your doctor or pharmacist before using Flutiform if:

• You have or have had tuberculosis (TB). Symptoms include a persistent cough, often with blood-streaked phlegm, fever, tiredness, loss of appetite, loss of weight and night sweats.
• You have an untreated infection in your lungs or chest.
• You have 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).
• You have an abnormal bulging of a blood vessel wall (an aneurysm).
• You have diabetes.
• You have high blood pressure.
• You have an overactive thyroid gland (thyrotoxicosis) which can cause increased appetite, weight loss or sweating.
• You have low blood levels of potassium which can cause muscle weakness, twitching or abnormal heart rhythm (hypokalaemia).
• You have 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).
• You have 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.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using your inhaler. Your doctor or asthma nurse will advise you if you should take this medicine.

Other medicines and Flutiform

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that do not require a prescription. If you use this inhaler with some other medicines the effect of this inhaler or the other medicine may be altered. For a complete overview of medicines that may interfere with the way Flutiform works, please see the package leaflet.

Like all medicines, this medicine can cause side effects, although some people may not experience any. Side effects that are known to be associated with Flutiform include:

Uncommon (may affect up to 1 in 100 people)

• Worsening of asthma.
• Headache.
• Shaking.
• An irregular heartbeat or palpitations.
• Dizziness.
• Sleeping difficulties.
• Alteration in voice/hoarse voice.
• Dry mouth, sore or irritated throat.
• Skin 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).
• Palpitations (rapid heartbeat).
• Chest pain associated with heart disease.
• Muscle spasms.
• Coughing or shortness of breath.
• Diarrhoea.
• Stomach problems (indigestion).
• Changes in taste.
• A feeling of dizziness or ‘spinning’.
• Abnormal dreams.
• Agitation.
• Itchy skin.
• High blood pressure (hypertension).
• A feeling of unusual weakness.
• Swelling of hands, ankles or feet.

For a complete list of possible side effects, see the package leaflet. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. If you think you may have a severe allergic reaction, get medical help immediately.

The active substances are fluticasone propionate and formoterol fumarate dihydrate. There are three different strengths of inhaler available.

• 50 micrograms / 5 micrograms aerosol, suspension: each puff (actuation) contains 50 micrograms fluticasone propionate and 5 micrograms formoterol fumarate dihydrate.
• 125 micrograms / 5 micrograms aerosol, suspension: each puff (actuation) contains 125 micrograms fluticasone propionate and 5 micrograms formoterol fumarate dihydrate.
• 250 micrograms / 10 micrograms aerosol, suspension: each puff (actuation) contains 250 micrograms fluticasone propionate and 10 micrograms formoterol fumarate dihydrate.

The other ingredients are: sodium cromoglicate, ethanol, apaflurane HFA 227 (propellant).

Read the package leaflet before use.