Flutiform inhaler

Fluticasone is a synthetic corticosteroid and is used to decrease inflammation in the lungs. (NB. Corticosteroids are often simply called steroids, but it should be noted that they are very different from another group of steroids, called anabolic steroids, which have gained notoriety because of their abuse by some athletes and body builders.)

When fluticasone is inhaled into the lungs it is absorbed into the cells of the lungs and airways. Here it works by preventing the release of certain chemicals from the cells. These chemicals are important in the immune system and are normally involved in producing immune and allergic responses that result in inflammation. By decreasing the release of these chemicals in the lungs and airways, inflammation is reduced.

In asthma, the airways tighten due to inflammation and can also be blocked by mucus. This makes it difficult for air to get in and out of the lungs. Fluticasone is used in asthma to prevent the inflammation and excess mucus formation, and therefore help prevent asthma attacks and shortness of breath.

Formoterol is a type of medicine called a long-acting beta 2 agonist or bronchodilator. It works by acting on receptors in the lungs called beta 2 receptors. When formoterol stimulates these receptors it causes the muscles in the airways to relax. This allows the airways to open.

In asthma there is narrowing of the airways. By relaxing and opening the airways, formoterol makes it easier to breathe. Formoterol starts to work in one to three minutes and its effects last for about 12 hours.

Inhaling the medicines allows them to act directly in the lungs where they are needed. It also reduces the potential for side effects in other parts of the body, as the amount absorbed into the blood through the lungs is lower than if the medicines are taken by mouth.

How do I use it?

• Flutiform is a metered dose inhaler from which the medicine is inhaled into the lungs. Follow this link for instructions on how to use your metered dose inhaler. You should also make sure you read the information leaflet provided with your inhaler, as this will give detailed instructions on how to use and look after your inhaler.
• If you find it difficult to use the inhaler because you have problems pressing down the canister at the same time as breathing in, the AeroChamber Plus spacer device can be used with this inhaler to make it easier. Ask your pharmacist for more information and advice.
• The usual dose of this medicine is two puffs inhaled twice a day (morning and evening) every day, even when you don’t have asthma symptoms. However, it is important to follow the instructions given by your doctor. These will also be printed on the dispensing label that your pharmacist has put on this medicine.
• Don't exceed the dose of this medicine that your doctor has recommended you use.
• If you forget to take a dose, take it as soon as you remember. However, if it is nearly time for your next dose, leave out the missed dose. Do not take a double dose to make up for a forgotten dose.

Warning!

• This inhaler should not be used to relieve asthma attacks. You should keep your reliever inhaler (short-acting bronchodilator, eg salbutamol or terbutaline) with you at all times in case you need to relieve wheezing or shortness of breath.
• If this inhaler does not seem to prevent wheezing or chest tightness as well as usual, or for as long as usual, or if you find you need to use your reliever inhaler (eg salbutamol or terbutaline) more often than normal, you should consult your doctor as soon as possible. It may be that you are having a flare-up of your asthma and your doctor might need to give you another medicine.
• You should not suddenly stop using this medicine, even if you don't currently have any symptoms, unless your doctor tells you otherwise. This is because stopping treatment is likely to make your asthma symptoms return.
• Inhalers may cause an unexpected increase in wheezing and difficulty breathing (paradoxical bronchospasm) straight after using them. If this happens, don't use the inhaler again, use your reliever inhaler to open your airways and consult your doctor immediately.
• Inhaling corticosteroids can sometimes cause a fungal infection in the mouth called oral thrush. To minimise the risk of this, you should rinse your mouth with water after each time you use this inhaler. Consult your doctor if you develop white patches in your mouth or throat, as these are symptoms of thrush and it may need to be treated.
• Inhaled corticosteroids have considerably fewer side effects than steroids taken by mouth. However, when taken for long periods of time at high doses, inhaled steroids do have the potential to cause side effects such as glaucoma, cataracts, thinning of the bones (osteoporosis), slowed growth in children and adolescents, and to suppress the functioning of the adrenal glands (glands that produce natural steroid hormones). For this reason your doctor will prescribe the lowest effective dose to control your symptoms, and monitor for these side effects. Do not exceed the dose of this medicine that your doctor has prescribed for you.
• It is recommended that children and adolescents receiving long-term treatment with corticosteroids have their growth monitored. If a child's growth appears to be slowed your doctor may refer them to a specialist respiratory paediatrician. For further information talk to your doctor or pharmacist.
• People with severe asthma should have regular blood tests to monitor the amount of potassium in their blood. This is because low oxygen levels in the blood (hypoxia) and various asthma medicines, including this one, can potentially lower blood potassium levels.

Use with caution in

• Severe liver disease.
• People with an overactive thyroid gland (thyrotoxicosis).
• People with a tumour of the adrenal gland (phaeochromocytoma).
• Diabetes. It is recommended that people with diabetes should monitor their blood sugar more carefully when starting treatment with this medicine, as formoterol may increase blood sugar levels. If your diabetes treatment becomes less effective, ie your blood sugar levels are harder to control, you should consult your doctor.
• People with untreated low levels of potassium in the blood (hypokalaemia).
• Heart disease characterised by thickening of the internal heart muscle and a blockage inside the heart (hypertrophic obstructive cardiomyopathy).
• People with narrowing of the tract through which blood is pumped out of the heart (idiopathic subvalvular aortic stenosis).
• Very high blood pressure (hypertension).
• People with a weakening in the wall of an artery that causes it to bulge outwards (aneurysm).
• People with an irregular heartbeat (arrhythmia), or an abnormal heart rhythm seen as a 'prolonged QT interval' on a heart monitoring trace or ECG.
• People taking other medicines that can cause a 'prolonged QT interval' (see end of factsheet for examples).
• People with a serious defect in the heart's electrical message pathways resulting in decreased function of the heart (3rd degree heart block).
• Heart disease caused by inadequate blood flow to the heart (ischaemic heart disease, eg angina).
• Heart failure.
• People with fungal or viral infections in the airways.
• People with tuberculosis affecting the lungs.

Not to be used in

• Known sensitivity or allergy to any ingredient.
• The safety and effectiveness of this medicine in children and adolescents under 12 years of age has not been fully established. It is not currently recommended for this age group.
• The highest strength of Flutiform inhaler (250 microgram/10 microgram) should not be used in adolescents under 18 years of age.
• This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

• The safety of this medicine for use during pregnancy has not been established by the manufacturer and they do not recommend it for use in pregnancy, unless there is no alternative that is established as safer. However, it is important that asthma is well controlled in pregnant women. Wherever possible, asthma medications should be taken by inhaler, as this minimises the amount of medicine that enters the bloodstream and crosses the placenta. It is important to get medical advice from your doctor on how to control your asthma during pregnancy, but in general, inhaled medicines can be taken as normal during pregnancy.
• In general, asthma inhalers can be used as normal during breastfeeding, because the amount of medicine that passes into the breast milk after using an inhaler is negligible and unlikely to harm the baby. However, it is not known to what extent the medicines in this inhaler pass into breast milk and you should seek medical advice from your doctor before breastfeeding while using this medicine.

Label warnings

• Do not stop taking this medication except on your doctor's advice.
• Follow the printed instructions you have been given with this medication.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

Uncommon 

• Change in taste.
• Headache.
• Tremor.
• Dizziness.
• Awareness of your heartbeat (palpitations).
• Irregular heartbeat.
• Worsening of asthma.
• Changes in voice and hoarseness.
• Throat irritation.
• Dry mouth.
• Swelling of feet or ankles (peripheral oedema).
• Increased blood sugar levels (hyperglycaemia).

Rare 

• Thrush infection of the mouth or throat.
• Inflammation of the sinuses (sinusitis).
• Cough.
• Agitation.
• Disturbed sleep such as difficulty getting to sleep or abnormal dreams.
• Faster than normal heartbeat (tachycardia).
• Chest pain (angina).
• High blood pressure.
• Spinning sensations (vertigo).
• Rash or itching.
• Diarrhoea.
• Indigestion.
• Muscle pain or spasms.
• Weakness or loss of strength (asthenia).
• Low blood potassium level (hypokalaemia).

Very rare 

• Systemic effects (eg, Cushing's syndrome, adrenal suppression, slowed growth in children and adolescents, decreased bone mineral density, cataract and glaucoma) may occur after high doses for prolonged periods.
• Unexpected narrowing of the airways.

Frequency unknown

• Changes in behaviour (mainly in children).
• Anxiety.
• Depression.
• Aggression.

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while using this one, to make sure that the combination is safe.

The following medicines may increase the amount of fluticasone that is found in the bloodstream after inhaling the medicine and could therefore increase the risk of side effects on the rest of the body. These are called systemic side effects, for example, decreased production of natural steroid hormones by the adrenal glands (adrenal suppression) and Cushing's syndrome. These medicines should be used with caution in people using this inhaler:

the antifungals ketoconazole and itraconazole (long courses of treatment with these antifungals should be avoided where possible)
protease inhibitors for HIV infection, such as ritonavir (this inhaler is not recommended for people who are taking ritonavir)
telaprevir.
Fluticasone may be less effective at preventing asthma attacks for three to four days after taking the medicine mifepristone (used for termination of pregnancy or inducing labour if the baby has died in the womb).

Beta-blockers such as atenolol, propranolol or timolol should not generally be taken with this medicine. This is because beta-blockers have an opposite action to formoterol and can cause the airways to narrow, which can result in breathing difficulties for people with asthma. This problem has sometimes been seen with eye drops containing beta-blockers, eg used for glaucoma.

Formoterol can potentially cause a serious decrease in the levels of potassium in the blood (hypokalaemia), which may result in adverse effects. This effect can be increased by the following medicines, which can also lower potassium in the blood:

• acetazolamide
• xanthine derivates, such as theophylline or aminophylline
• corticosteroids, such as beclometasone and prednisolone
• other beta 2 agonists, such as salbutamol
• diuretics, such as bendroflumethiazide and furosemide.

This is why people with severe asthma, who may be taking several of these medicines, should have their blood potassium levels monitored regularly.

People taking digoxin may have an increased risk of abnormal heart rhythms if they experience abnormally low blood potassium levels while taking this medicine.

There may be an increased risk of abnormal heart rhythms (prolonged QT interval on the heart monitoring trace or ECG) if this medicine is taken in combination with other medicines that can have this effect, such as the following:

• atomoxetine
• certain antihistamines (terfenadine, astemizole, mizolastine)
• certain medicines for abnormal heartbeats (antiarrhythmics, eg quinidine, disopyramide, procainamide)
• certain antidepressants, eg amitriptyline, imipramine, maprotiline
• certain antipsychotics, eg thioridazine, chlorpromazine, sertindole, haloperidol
• certain antimalarials, eg halofantrine, chloroquine, quinine, artemether
• macrolide antibiotics, eg clarithromycin, erythromycin
• moxifloxacin.

References:

http://www.mims.co.uk/flutiform-novel-asthma-combination-inhaler/respiratory-system/article/1151489

http://www.netdoctor.co.uk/medicines/lungs/a8819/flutiform-fluticasone-and-formoterol/

http://www.medicines.ie/medicine/15620/SPC/Flutiform+50+microgram+5+microgram%2C+125+microgam+5+microgram+and+250+microgram+10+microgram++per+metered+dose+pressurised+inhalation%2C+suspensions/#MACHINEOPS

http://www.flutiform.com/healthcare/

http://www.mundipharma.ie/product/flutiform