How does it work?

Symbicort turbohaler contains two active ingredients, budesonideand formoterol fumarate (previously known as eformoterol fumarate in the UK).

Budesonide is a type of medicine known as a corticosteroid.Corticosteroids are hormones that are produced naturally by the adrenal glands.They have many important functions, including control of inflammatoryresponses. Budesonide is a synthetic corticosteroid and is used to decreaseinflammation in the lungs. (NB. Corticosteroids are often simply calledsteroids, but it should be noted that they are very different from anothergroup of steroids, called anabolic steroids, which have gained notorietybecause of their abuse by some athletes and body builders.)

When budesonide is inhaled into the lungs it is absorbed intothe cells of the lungs and airways. Here it works by preventing the release ofcertain chemicals from the cells. These chemicals are important in the immunesystem and are normally involved in producing immune and allergic responsesthat result in inflammation. By decreasing the release of these chemicals inthe lungs and airways, inflammation is reduced.

In asthma, and in chronic obstructive airways disease (COPD)such as chronic bronchitis, the airways tighten due to inflammation and canalso be blocked by mucus. This makes it difficult for air to get into and outof the lungs. Budesonide is used in asthma and COPD to prevent the inflammationand excess mucus formation, and therefore help prevent asthma attacks andshortness of breath.

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

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

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

Unlike metered dose inhalers, the Symbicort turbohaler does not require co-ordination of pressing acanister and breathing in at the same time.Instead, you simply breathe in through the mouthpiece of the turbohaler and themedicine will follow the inhaled air into the lungs. You may not taste or feelthe medicine as it is inhaled. It is important to breathe in forcefully anddeeply through the mouthpiece to ensure that an optimal dose is delivered tothe lungs. Never breathe out through the mouthpiece. You can get more advicefrom your doctor, asthma nurse or pharmacist on using theturbohaler.

What is it used for?

• Asthma.

Symbicort turbohaler is used to treat people whose asthma is notcontrolled with regular corticosteroids and as needed short-actingbronchodilators (relievers, eg salbutamol). As it is a single inhaler it canalso simplify treatment for people who are already using both a corticosteroidinhaler and a long-acting bronchodilator inhaler.

Symbicort can be used in one of two ways in the treatment ofasthma. It can be taken regularly to prevent asthma attacks (maintenancetherapy), with a separate reliever inhaler (eg salbutamol) used to relieveasthma attacks. Alternatively, it can be used regularly to prevent asthmaattacks AND used as a reliever when needed to relieve asthma attacks(maintenance and reliever therapy). The maintenance and reliever approach isonly suitable for adults aged 18 years and over using the Symbicort 100/6 orSymbicort 200/6 strengths.

• Chronic obstructive pulmonary disease (COPD).

Symbicort is used for people with severe COPD who have repeatedattacks of breathlessness, despite regular use of long-acting bronchodilatorssuch as formoterol or salmeterol.

Only the Symbicort 200/6 and 400/12 strengths are suitable fortreating COPD.

Warning!

• Follow the printed instructions you have been given with this medicine carefully. You should breath in forcefully and deeply through the mouthpiece of the turbohaler to ensure the correct dose reaches the lungs. You may not taste or feel any medication when using the turbohaler, as only a small amount of medicine is released. Never breath out through the mouthpiece.
• Inhaling corticosteroids can sometimes cause a fungal infection called 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.
• Don't exceed the dose of this medicine that your doctor has recommended you use.
• If you have been prescribed Symbicort turbohaler as maintenance and reliever therapy for asthma, you should make sure you carry it with you at all times so you can use it to relieve an asthma attack if needed. If you have been prescribed a separate reliever inhaler you should make sure you carry that with you at all times to relieve shortness of breath if needed.
• If you need to use your reliever medicine (either your separate reliever inhaler, eg salbutamol, or your Symbicort turbohaler) more frequently, or if it becomes less effective at treating attacks, you should consult your doctor because this may indicate that you are having a flare-up of your asthma or COPD, or it is getting worse.
• 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 maintenance treatment is likely to make your asthma/COPD 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 a separate reliever inhaler to open your airways and consult your doctor immediately.
• 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 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 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.
• Diabetes.
• Thyrotoxicosis.
• Tumour of the adrenal gland (phaeochromocytoma).
• Heart disease characterised by thickening of the internal heart muscle and a blockage inside the heart (hypertrophic obstructive cardiomyopathy).
• Narrowing of the main artery that leaves the heart to supply blood to the body (aortic stenosis).
• Fast, abnormal heart rhythms (tachyarrhythmias).
• Abnormal heart rhythm seen on a heart monitoring trace (ECG) as a 'prolonged QT interval'.
• Heart disease caused by inadequate blood flow to the heart (ischaemic heart disease).
• Severe cardiovascular disease.
• Severe heart failure.
• Very high blood pressure (severe hypertension).
• A weakening in the wall of an artery that causes it to bulge outwards (aneurysm).
• Untreated low potassium blood levels (hypokalaemia).
• Fungal or viral infections in the airways.
• Tuberculosis affecting the lungs.

Not to be used in

• Known sensitivity or allergy to any ingredient, including lactose.
• Symbicort 100/6 turbohaler is not recommended for children under six years of age. Symbicort 200/6 and 400/12 turbohalers are not recommended for children under 12 years of age.

This medicine should not be used if you are allergic to one orany of its ingredients. Please inform your doctor or pharmacist if you havepreviously experienced such anallergy. If you feel you haveexperienced an allergic reaction, stop using this medicine and inform yourdoctor or pharmacist immediately.

Pregnancy and breastfeeding

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

• 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 to the developing baby.
• Symbicort turbohaler should be used with caution during pregnancy and only if the benefits outweigh any possible risks to the developing baby. Seek further medical advice from your doctor.
• In general, asthma inhalers can be used as normal during breastfeeding, because the amount of medicine that passes into breast milk after using an inhaler is negligable and unlikely to harm the baby. The budesonide in this inhaler does pass into breast milk and is not expected to have any effects on a nursing child. However, it is not known if the formoterol in this inhaler passes into breast milk. You should seek medical advice from your doctor before breastfeeding while using this medicine.

Label warnings

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

Side effects

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

Common (affect between 1 in 10 and 1 in 100 people)

• Awareness of your heartbeat (palpitations).
• Shaking, usually of the hands (tremor).
• Headache.
• Yeast infection of the mouth or throat (oral thrush).
• Throat irritation.
• Cough and hoarseness.

Uncommon (affect between 1 in 100 and 1 in 1000 people)

• Increased heart rate (tachycardia).
• Dizziness.
• Feeling sick (nausea).
• Muscle cramps.
• Agitation or restlessness.
• Nervousness.
• Disturbed sleep.
• Bruises.

Rare (affect between 1 in 1000 and 1 in 10,000 people)

• Irregular heartbeats (arrhythmias).
• Decreased level of potassium in the blood (hypokalaemia).
• Wheezing and difficulty breathing (bronchospasm).
• Allergic reactions, such as rashes, itching, swelling of the tongue and throat (angioedema), or anaphylactic reactions.

Very rare (affect less than 1 in 10,000 people)

• Changes in blood pressure.
• Depression.
• Behavioural disturbances in children.
• High blood sugar level (hyperglycaemia).
• Taste disturbances.
• Chest pain (angina).
• Systemic effects (eg, Cushing's syndrome, suppression of the adrenal glands, slowed growth in children and adolescents, decreased bone mineral density, cataracts and glaucoma). These may occur after taking high doses for prolonged periods - see the warning section above.

The side effects listed above may not include all of the sideeffects reported by the medicine'smanufacturer. For moreinformation about any other possible risks associated with this medicine,please read the information provided with the medicine or consult your doctoror pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicinesyou are already taking, including those bought without a prescription andherbal medicines, before you start treatment with this medicine. Similarly,check with your doctor or pharmacist before taking any new medicines whileusing this one, to ensure that thecombination is safe.

Beta-blockers such as atenolol, propranolol or timolol shouldnot generally be taken with this medicine. This is because beta-blockers havean opposite action to formoterol and can cause the airways to narrow, which canresult in breathing difficulties for people with asthma or COPD. This problem hassometimes been seen with eye drops containing beta-blockers, eg used forglaucoma.

This medicine may potentially decrease the amount of potassiumin the blood. If it is taken in combination with any of the followingmedicines, which can also lower potassium in the blood, the risk of a low bloodpotassium level (hypokalaemia) is increased:

• other beta 2 agonists, such as salbutamol and salmeterol
• oral corticosteroids, such as prednisolone
• diuretics, eg bendroflumethiazide and furosemide
• xanthine derivates, eg theophylline.

A low blood potassium level can have serious effects, which iswhy people with severe asthma, who may be taking several of these medicines,should have their blood potassium level monitored regularly.

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

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

The following medicines may increase the amount of budesonidethat is found in the bloodstream after inhaling this medicine:

• the antibiotics clarithromycin and telithromycin
• the antifungals ketoconazole, itraconazole, posaconazole and voriconazole
• protease inhibitors for HIV infection, such as ritonavir.

These medicines can therefore increase your exposure tobudesonide and so increase the risk of side effects on the rest of the body(systemic side effects, for example, decreased production of natural steroidhormones by the adrenal glands (adrenal suppression) and Cushing's syndrome.)Due to this risk, these medicines should be avoided where possible in peopleusing Symbicort. Symbicort maintenance and reliever therapy is not recommendedfor people having long-term treatment with any of these medicines.

If this medicine is taken with the following medicines there maybe a risk of a rise in blood pressure:

• furazolidone
• monoamine oxidase inhibitor antidepressants (MAOIs), eg phenelzine
• procarbazine.

Other medicines containing the same active ingredients

There are currently no other medicines available in the UK thatcontain both budesonide and formoterol. Both these medicines are available asseparate inhalers.