Symbicort Rapihaler

Budesonide, formoterol fumarate dihydrate.

Each single actuation (delivered dose, the amount of drug that leaves the mouthpiece) contains budesonide 160 micrograms and formoterol fumarate dihydrate 4.5 micrograms. Each dose is administered as 2 actuations.
Formoterol fumarate dihydrate is hereafter referred to as "formoterol".
Excipients/Inactive Ingredients: Apaflurane (HFA 227), Povidone K25, Macrogol (polyethylene glycol) 1000.

Pharmacotherapeutic group: Adrenergics and other drugs for obstructive airway diseases. ATC code: R03AK07.
Pharmacology: Pharmacodynamics: Mechanism of action and pharmacodynamic effects: Symbicort contains formoterol and budesonide, which have different modes of action and show additive effects in terms of reduction of asthma and COPD exacerbations. The specific properties of budesonide and formoterol allow the combination to be used as maintenance treatment of asthma.
The mechanisms of action of the two substances, respectively are discussed as follows.
Budesonide: Budesonide is a glucocorticosteroid which when inhaled has a rapid (within hours) and dose-dependent anti-inflammatory action in the airways, resulting in reduced symptoms and fewer asthma exacerbations. Inhaled budesonide has less severe adverse effects than systemic corticosteroids. The exact mechanism responsible for the anti-inflammatory effect of glucocorticosteroids is unknown.
Formoterol: Formoterol is a selective β₂ adrenoceptor agonist that when inhaled results in rapid and long acting relaxation of bronchial smooth muscle in patients with reversible airways obstruction. The bronchodilating effect is dose dependent, with an onset of effect within 1-3 minutes after inhalation. The duration of effect is at least 12 hours after a single dose.
Symbicort Rapihaler: Clinical efficacy in Asthma: Therapeutic equivalence between Symbicort Rapihaler and Symbicort Turbuhaler was demonstrated in three clinical efficacy and safety studies, including asthmatic patients from 6 to 79 years of age and one long-term safety study in adolescents and adults with asthma. The safety profile of Symbicort Rapihaler has been shown to be as safe and well tolerated as Symbicort Turbuhaler. As a result of demonstrating therapeutic equivalence, the clinical efficacy for Symbicort Rapihaler in asthma described as follows is based on studies conducted with Symbicort Turbuhaler.
It has been shown in a separate study that Symbicort Rapihaler can be used safely with a named spacer device in children.
Symbicort Turbuhaler: Clinical Efficacy for Regular maintenance therapy: Clinical studies have shown that the addition of formoterol to budesonide improved asthma symptoms and lung function, and reduced exacerbations. The effect on lung function of Symbicort Turbuhaler, given as a maintenance dose only, was equal to that of budesonide and formoterol administered in separate inhalers in adults and exceeded that of budesonide alone in adults and children. All treatment arms used a short acting β₂ adrenoceptor agonist as needed. There was no sign of attenuation of the anti-asthmatic effect over time.
In a 12-week paediatric study, 85 children aged 6-11 years were treated with Symbicort (2 inhalations of 80/4.5 micrograms/inhalation twice daily), and a short-acting β₂ adrenoceptor agonist as needed. Lung function was improved and the treatment was well tolerated compared to the corresponding dose of budesonide Turbuhaler.
Clinical efficacy in COPD: Symbicort Rapihaler: In one 12-month study and one 6-month study in patients with COPD, Symbicort Rapihaler 160/4.5 was superior to placebo, budesonide and formoterol for post-dose FEV₁ and predose FEV₁. In the 12-month study, Symbicort Rapihaler was also superior to placebo and formoterol for both the number of, and the time to first severe COPD exacerbation (a worsening of COPD requiring oral steroid use of hospitalization.) Thus, the contribution of both budesonide and formoterol to the effect of Symbicort Rapihaler was demonstrated. Symbicort Rapihaler 160/4.5 also significantly reduced breathlessness, daily rescue medication use, night-time awakenings and improved health-related quality of life compared with placebo in both studies. Serial FEV₁ measures over 12 hours were obtained in subsets of patients in both studies. The median time to onset of bronchodilation (>15% improvement in FEV₁) was seen within 5 minutes at the end of treatment in patients receiving Symbicort Rapihaler 160/4.5. Maximal improvement in FEV₁ occurred at approximately 2 hours post-dose and post-dose bronchodilator effect was generally maintained over 12 hours. The treatment was well tolerated.
Pharmacokinetics: Absorption: Symbicort Rapihaler: There was no evidence of pharmacokinetic interactions between budesonide and formoterol when given together.
In studies where Symbicort Rapihaler was administered to healthy subjects and patients with moderate asthma, peak plasma concentrations for budesonide occurred approximately 30 minutes and for formoterol 10 minutes after dosing. Peak plasma concentrations were 30-40% higher in healthy subjects compared to asthma patients. However, the total systemic exposure was comparable to that in asthma patients.
In repeat dose studies plasma concentrations of budesonide and formoterol generally increased in proportion to dose.
Collectively, in pharmacokinetic studies conducted in adults with asthma, systemic exposure to budesonide and formoterol administered via Symbicort Rapihaler was lower than when given via the monoproducts Pulmicort Turbuhaler and Oxis Turbuhaler. Collectively, the pharmacokinetic data from clinical efficacy and safety studies indicate that Symbicort Rapihaler delivers a comparable amount of budesonide to the systemic circulation, and thus the lungs, as do budesonide pMDI and Pulmicort Turbuhaler. The results of the systemic exposure for formoterol were generally similar when administered via Symbicort Rapihaler and Oxis Turbuhaler.
Symbicort Turbuhaler: The systemic bioavailability of budesonide and formoterol was comparable for the two treatments Symbicort Rapihaler and Symbicort Turbuhaler.
Distribution and metabolism: Plasma protein binding is approximately 50% for formoterol and 90% for budesonide. Volume of distribution is about 4 L/kg for formoterol and 3 L/kg for budesonide. Formoterol is inactivated via conjugation reactions (active O-demethylated and deformylated metabolites are formed, but they are seen mainly as inactivated conjugates). Budesonide undergoes an extensive degree (approximately 90%) of biotransformation on first passage through the liver to metabolites of low glucocorticosteroid activity. The glucocorticosteroid activity of the major metabolites, 6 beta-hydroxy-budesonide and 16α-hydroxy-prednisolone, is less than 1% of that of budesonide. There are no indications of any metabolic interactions or any displacement reactions between formoterol and budesonide.
Elimination: The major part of a dose of formoterol is eliminated by metabolism in the liver followed by renal excretion. After inhalation of formoterol via Turbuhaler, 8% to 13% of the delivered dose of formoterol is excreted unmetabolised in the urine. Formoterol has a high systemic clearance (approximately 1.4 L/min) and the terminal elimination half-life averages 17 hours.
Budesonide is eliminated via metabolism mainly catalysed by the enzyme CYP3A4. The metabolites of budesonide are excreted in urine as such or in conjugated form. Only negligible amounts of unchanged budesonide have been detected in the urine. Budesonide has a high systemic clearance (approximately 1.2 L/min) and the plasma elimination half-life after i.v. dosing averages 4 hours.
Budesonide has a systemic clearance of approximately 0.5 L/min in 4-6 years old asthmatic children. Per kg body weight children have a clearance, which is approximately 50% greater than in adults. The terminal half-life of budesonide after inhalation is approximately 2.3 hours in asthmatic children. The pharmacokinetics of formoterol in children has not been studied.
The pharmacokinetics of budesonide or formoterol in elderly and in patients with renal failure are unknown. The exposure of budesonide and formoterol may be increased in patients with liver disease.
Toxicology: Preclinical Safety Data: The toxicity observed in animal studies with budesonide and formoterol was similar whether budesonide or formoterol were given in combination or separately. The effects were associated with pharmacological actions and dose dependent.
In animal reproduction studies, glucocorticosteroids such as budesonide have been shown to induce malformations (cleft palate, skeletal malformations). However, these animal experimental results do not seem to be relevant in humans at the recommended doses (see Use in Pregnancy & Lactation). Animal reproduction studies with formoterol have shown a somewhat reduced fertility in male rats at high systemic exposure and implantation losses, as well as decreased early postnatal survival and birth weight at considerably higher systemic exposures than those reached during clinical use. However, these animal experimental results do not seem to be relevant to man.
Symbicort Rapihaler contains the excipients povidone (polyvinylpyrrolidone) K25, macrogol (polyethylene glycol) 1000 and the pressurised liquid propellant apaflurane (HFA 227). The safe use of apaflurane has been fully evaluated in preclinical studies. Povidones have a history of safe use in man for many years, which supports the view that povidones are essentially biologically inert. Macrogols are recognized as safe excipients in pharmaceuticals, food and cosmetic products. Furthermore, toxicity studies carried out using Symbicort Rapihaler have shown no evidence of any local or systemic toxicity or irritation attributable to the excipients.

Asthma: Symbicort Rapihaler is indicated in the regular treatment of asthma where use of a combination (inhaled corticosteroid and long-acting β₂ adrenoceptor agonist) is appropriate: patients not adequately controlled with inhaled corticosteroids and "as needed" inhaled short acting β₂ adrenoceptor agonists; or patients already adequately controlled on both inhaled corticosteroids and long acting β₂ adrenoceptor agonists.
Note: Symbicort Rapihaler (80/4.5 micrograms/actuation) is not appropriate in patients with severe asthma.
Chronic Obstructive Pulmonary Disease (COPD): Symbicort Rapihaler is indicated in the regular treatment of patients with moderate to severe COPD, with frequent symptoms and a history of exacerbations.
Note: Symbicort Rapihaler (80/4.5 micrograms/actuation) is not appropriate in patients with COPD.

Asthma: Symbicort Rapihaler is not intended for the initial management of asthma. The dosage of the components of Symbicort Rapihaler is individual and should be adjusted to the severity of the disease. This should be considered not only when treatment with combination products is initiated but also when the maintenance dose is adjusted. If an individual patient should require a combination of doses other than those available in the combination inhaler, appropriate doses of β₂ adrenoceptor agonists and/or corticosteroids by individual inhalers should be prescribed.
When control has been achieved, the dose should be titrated to the lowest dose at which effective control of symptoms is maintained.
Symbicort maintenance therapy: Patients use Symbicort Rapihaler for a daily maintenance dose and use a separate rapid-acting bronchodilator for symptom relief. Patients should be advised to have this rapid-acting bronchodilator available at all times. (See Table 1.)

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Children under 6 years: Symbicort is not recommended for children under 6 years of age.
Patients should be regularly reassessed by a doctor, so that the dosage of Symbicort Rapihaler remains optimal. The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. When control of symptoms is maintained with the lowest recommended dosage, then the next step could include a test of inhaled corticosteroid alone.
In usual practice when control of symptoms is achieved with the twice daily regimen, titration to the lowest effective dose could include Symbicort Rapihaler given once daily, when in the opinion of the prescriber, a long acting bronchodilator should be required to maintain control.
A separate inhaler for rescue use is required. Patients should be advised to have their rapid acting bronchodilator available at all times. Increasing use of rescue bronchodilators indicates a worsening of the underlying condition and warrants a reassessment of the asthma therapy.
COPD: See Table 2.

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General information: The patients should be instructed that Symbicort Rapihaler must be used even when asymptomatic for optimal benefit.
There are no special dosing requirements for elderly patients.
There are no data available for use of Symbicort in patients with hepatic or renal impairment. As budesonide and formoterol are primarily eliminated via hepatic metabolism, an increased exposure can be expected in patients with severe liver diseases.
Instructions for correct use of Symbicort Rapihaler: On actuation of Symbicort Rapihaler, a volume of the suspension is expelled from the canister at high velocity. When the patient inhales through the mouthpiece at the same time as actuating the inhaler, the substance will follow the inspired air into the airways.
Note: It is important to instruct the patient to: Carefully read the instructions for use in the monograph which is packed together with each inhaler.
Shake the inhaler gently prior to each use to mix its contents properly.
Prime the inhaler by actuating it twice into the air when the inhaler is new, has not been used for more than one week or if it has been dropped.
Place the mouthpiece in the mouth. While breathing in slowly and deeply, press the device firmly to release the medication. Continue to breathe in and hold the breath for approximately 10 seconds or as long as is comfortable.
Shake the inhaler again and repeat.
Rinse the mouth with water after inhaling the maintenance dose to minimise the risk of oropharyngeal thrush.
Clean the mouthpiece of the inhaler regularly, at least once a week with a clean dry cloth.
Do not put the inhaler into water.
For instructions on the correct use of Symbicort with Spacer Device to enable patients with difficulty in coordinating inhalation with actuation, such as young children or the elderly, see Instructions for use, handling and disposal under Cautions for Usage.

An overdose of formoterol would likely lead to an exaggeration of effects that are typical for β₂ adrenoceptor agonists: tremor, headache, palpitations, and tachycardia. Hypotension, metabolic acidosis, hypokalaemia and hyperglycemia may also occur. Supportive and symptomatic treatment may be indicated. A dose of 90 micrograms administered during three hours in patients with acute bronchial obstruction and when given three times daily as a total of 54 micrograms/day for 3 days to stable asthmatics raised no safety concerns.
Acute overdosage with budesonide, even in excessive doses, is not expected to be a clinical problem. When used chronically in excessive doses, systemic glucocorticosteroid effects may appear.

Hypersensitivity (allergy) to budesonide, formoterol or any of the excipients.

Please read all of this monograph carefully start taking/using this medicine.
This monograph contains information about Symbicort Rapihaler and how to use and clean the device. Please read the monograph carefully before using the inhaler and refer to it when using the medicine. The patient may find the need to clean the inhaler regularly (at least weekly). Please follow the cleaning instructions at the end of this monograph.
This medicine has been prescribed personally and should not pass it on to others. It may harm them, even if their symptoms are the same.
For further questions, please ask the doctor, nurse or the pharmacist.
The doctor, nurse or pharmacist will instruct the correct use if the inhaler.

It is recommended that the dose is tapered when the treatment is discontinued and should not be stopped abruptly.
If patients find the treatment ineffective, or exceed the highest recommended dose of the Symbicort Rapihaler, medical attention must be sought. Increasing use of rescue bronchodilators indicates a worsening of the underlying condition and warrants a reassessment of the asthma therapy. Sudden and progressive deterioration in control of asthma or COPD is potentially life threatening and the patient should undergo urgent medical assessment. In this situation consideration should be given to the need for increased therapy with corticosteroids or addition of systemic anti-inflammatory therapy, such as a course of oral corticosteroids, or antibiotic treatment if an infection is present.
Patients should be advised to have their rescue inhaler available at all times.
Patients should be reminded to take Symbicort Rapihaler daily as prescribed even when asymptomatic. The prophylactic use of Symbicort Rapihaler e.g. before exercise, has not been studied. For such use, a separate rapid-acting bronchodilator should be considered.
Once asthma symptoms are controlled, consideration may be given to gradually reducing the dose of Symbicort Rapihaler. Regular review of patients as treatment is stepped down is important. The lowest effective dose of Symbicort Rapihaler should be used (see Dosage & Administration).
Patients should not be initiated on Symbicort Rapihaler during an exacerbation, or if they have significantly worsening or acutely deteriorating asthma.
Serious asthma-related adverse events and exacerbations may occur during treatment with Symbicort Rapihaler. Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation with Symbicort Rapihaler.
As with other inhalation therapy, paradoxical bronchospasm may occur, with an immediate increase in wheezing after dosing. Symbicort Rapihaler should then be discontinued; treatment should be re-assessed and alternative therapy instituted if necessary.
Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods. These effects are much less likely to occur with inhalation treatment than with oral corticosteroids. Possible systemic effects include adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma.
It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroids is regularly monitored. If growth is slowed, therapy should be re-evaluated with the aim of reducing the dose of inhaled corticosteroid. The benefits of the corticosteroid therapy and the possible risks of growth suppression must be carefully weighed. In addition consideration should be given to referring the patient to a paediatric respiratory specialist.
Limited data from long-term studies suggest that most children and adolescents treated with inhaled budesonide will ultimately achieve their adult target height. However, an initial small but transient reduction in growth (approximately 1 cm) has been observed. This generally occurs within the first year of treatment.
Potential effects on bone density should be considered particularly in patients on high doses for prolonged periods that have coexisting risk factors for osteoporosis. Long-term studies with inhaled budesonide in children at mean daily doses of 400 micrograms (metered dose) or in adults at daily doses of 800 micrograms (metered dose) have not shown any significant effects on bone mineral density. No information regarding the effect of Symbicort at higher doses is available.
If growth is slowed, and to minimise the risk of possible systemic effects, it is important that therapy is reviewed and the dose of inhaled corticosteroid is adjusted to the lowest dose at which effective control is maintained.
If there is any reason to suppose that adrenal function is impaired from previous systemic steroid therapy, care should be taken when transferring patients to Symbicort Rapihaler therapy.
The benefits of inhaled budesonide therapy would normally minimise the need for oral steroids, but patients transferring from oral steroids may remain at risk of impaired adrenal reserve for a considerable time. Patients who have required high dose emergency corticosteroid therapy in the past or prolonged treatment with high doses of inhaled corticosteroids may also be at risk. Additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.
To minimise the risk of oropharyngeal candida infection the patient should be instructed to rinse the mouth with water after each dosing occasion.
Concomitant treatment with itraconazole, ritonavir or other potent CYP3A4 inhibitors should be avoided. If this is not possible the time interval between administration of the interacting drugs should be as long as possible.
Symbicort Rapihaler should be administered with caution in patients with thyrotoxicosis, phaeochromocytoma, diabetes mellitus, untreated hypokalaemia, hypertrophic obstructive cardiomyopathy, idiopathic subvalvular aortic stenosis, severe hypertension, aneurysm or other severe cardiovascular disorders, such as ischaemic heart disease, tachyarrhythmias or severe heart failure.
Caution should be observed when treating patients with prolongation of the QTc-interval. Formoterol itself may induce prolongation of the QTc-interval.
The need for, and dose of inhaled corticosteroids should be re-evaluated in patients with active or quiescent pulmonary tuberculosis, fungal and viral infections in the airways.
Potentially serious hypokalaemia may result from high doses of β₂ adrenoceptor agonists. Concomitant treatment of β₂ adrenoceptor agonist with drugs which can induce hypokalaemia or potentiate a hypokalemic effect, e.g. xanthine-derivatives, steroids and diuretics, may add to a possible hypokalaemic effect of the β₂ adrenoceptor agonist. Particular caution is recommended in unstable asthma with variable use of rescue bronchodilators, in acute severe asthma as the associated risk may be augmented by hypoxia and in other conditions when the likelihood for hypokalaemia adverse effects is increased. It is recommended that serum potassium levels are monitored during these circumstances.
As for all β₂ adrenoceptor agonists, additional blood glucose controls should be considered in diabetic patients.
Clinical studies and meta-analyses indicate that maintenance treatment of COPD with inhaled corticosteroids may lead to an increased risk of pneumonia.
Physician should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of pneumonia and exacerbations frequently overlap.
Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes, which may include cataract, glaucoma, or rare diseases such as central serous chorioretinopathy (CSCR), which have been reported after use of systemic and topical corticosteroids.
Effects on ability to drive and use machines: Symbicort Rapihaler is not expected to adversely affect the ability to drive or use machines.

For Symbicort Rapihaler or the concomitant treatment with budesonide and formoterol no clinical data on exposed pregnancies are available. Data from an embryo-fetal development study in the rat showed no evidence of any additional effect from the combination.
There are no adequate data from use of formoterol in pregnant women. In animal studies formoterol has caused adverse effects in reproduction studies at very high systemic exposure levels (see Pharmacology: Toxicology: Preclinical Safety Data under Actions).
Data in more than 17000 exposed pregnancies indicate no increased teratogenic risk associated with the use of inhaled budesonide. In animal studies glucocorticosteroids have been shown to induce malformations. This is not likely to be relevant for humans given recommended doses.
Animal studies have also identified an involvement of excess prenatal glucocorticoids in increased risks for intrauterine growth retardation, adult cardiovascular disease and permanent changes in glucocorticoid receptor density, neurotransmitter turnover and behaviour at exposures below the teratogenic dose range.
During pregnancy, Symbicort Rapihaler should only be used when the benefits outweigh the potential risks, especially during the first 3 months and shortly before delivery. The lowest effective dose of budesonide needed to maintain adequate asthma control should be used.
Budesonide is excreted in breast milk. However, at therapeutic doses no effects on the nursing infant are anticipated. It is not known whether formoterol passes into human breast milk. In rats, small amounts of formoterol have been detected in maternal milk.
Administration of Symbicort to women who are breastfeeding should only be considered if the expected benefit to the mother is greater than any possible risk to the child.

Since Symbicort Rapihaler contains both budesonide and formoterol, the same pattern of undesirable effects as reported for these substances may occur. No increased incidence of adverse reactions has been seen following concurrent administration of the two compounds. The most common drug related adverse reactions are pharmacologically predictable side effects of β₂ adrenoceptor agonist therapy, such as tremor and palpitations. These tend to be mild and usually disappear within a few days of treatment.
Adverse reactions, which have been associated with budesonide or formoterol, are given in Table 3: See Table 3.

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As with other inhalation therapy, paradoxical bronchospasm may occur in very rare cases.
Systemic effects of inhaled corticosteroids may occur particularly at high doses prescribed for prolonged periods.
Treatment with β₂ adrenoceptor agonists may result in an increase in blood levels of insulin, free fatty acids, glycerol and ketone bodies.

Pharmacokinetic interactions: The metabolism of budesonide is primarily mediated by the enzyme CYP3A4. Potent CYP3A4 inhibitors may therefore increase systemic exposure to budesonide. This is of limited clinical importance for short-term (1-2 weeks) treatment with potent CYP3A4 inhibitors but should be taken into consideration during long-term treatment.
If a patient requires long-term concomitant treatment with Symbicort and a potent CYP3A4 inhibitor, the benefit should be weighed against the increased risk of systemic corticosteroid side effects, patients should be monitored for corticosteroid side effects and/or a reduction of the inhaled corticosteroid dose could be considered.
Pharmacodynamic interactions: Beta-adrenergic blockers can weaken or inhibit the effect of formoterol. Symbicort Rapihaler should therefore not be given together with beta-adrenergic blockers (including eye drops) unless there are compelling reasons.
Concomitant treatment with quinidine, disopyramide, procainamide, phenothiazines, antihistamines (terfenadine), monoamine oxidase inhibitors and tricyclic anti-depressants can prolong the QTc-interval and increase the risk of ventricular arrhythmias.
In addition L-Dopa, L-thyroxine, oxytocin and alcohol can impair cardiac tolerance towards β₂-sympathomimetics.
Concomitant treatment with monoamine oxidase inhibitors including agents with similar properties such as furazolidone and procarbazine may precipitate hypertensive reactions.
There is an elevated risk of arrhythmias in patients receiving concomitant anaesthesia with halogenated hydrocarbons.
Concomitant use of other beta-adrenergic drugs can have a potentially additive effect.
Hypokalaemia may increase the disposition towards arrhythmias in patients who are treated with digitalis glycosides.
Budesonide and formoterol have not been observed to interact with any other drugs used in the treatment of asthma.

Incompatibilities: Not applicable.
Instructions for use, handling and disposal: See Dosage & Administration. The canister should not be broken, punctured or burnt, even when apparently empty.
The canister contains a pressurised liquid. Do not expose to temperatures above 50°C.
Instructions for the correct use of Symbicort Rapihaler with a spacer device: The use of Symbicort Rapihaler with a spacer device is recommended to enable patients with difficulty in coordinating inhalation with actuation, such as young children or the elderly, to derive greater therapeutic benefit.
Note: It is important to instruct the patient to: Carefully read the instructions for use in the Leaflet, which is packed with each inhaler.
Carefully read the instructions for use in the instruction leaflet which is packed with each spacer device.
On actuation of the aerosol, the dose is released into the inhalation chamber. The inhalation chamber is then emptied by two slow deep breaths. Young children may need to breathe 5-10 times through the mouthpiece. For further actuations, the procedure is repeated. For young children who are unable to breathe through the mouthpiece, a face mask can be used. Compatible face masks are available separately and care should be taken to ensure a good fit is achieved.

Store below 30°C. Store the inhaler with the mouthpiece down.
Always replace the mouthpiece cover after using Symbicort Rapihaler.
Shelf-life: The shelf life after removal from the foil pouch is 3 months.

YOUR INHALER: Your inhaler will already be assembled when you first receive it. Please do not take your inhaler apart. If it becomes loose, then place it back and continue to use it as instructed.
PREPARING YOUR INHALER FOR USE: Take your inhaler out of the moisture-protective foil before you use it for the first time and throw away the foil. If your inhaler is new, if it has not been used for a week or more, or it has been dropped, shake it gently and release 2 puffs in the air to prepare it for use.
TAKING YOUR MEDICINE: 1. Shake the inhaler gently before each use.
2. Remove the mouthpiece cover by squeezing gently at both sides, then pulling out.
3. Hold the inhaler upright in front of your mouth, using your thumb(s) at the base of the inhaler and your index finger(s) on the top. Then breathe out as far as you can and put the mouthpiece gently in your mouth, between your teeth, and close your lips around it.
4. Start to breathe in deeply, comfortably and slowly through your mouth, press firmly down on the inhaler to release a puff of medicine.
5. Continue to breathe in and hold breath for approximately 10 seconds or as long as it is comfortable, take the inhaler from your mouth and your finger from the top of the inhaler.
6. Take another puff, as directed by your doctor, shake the inhaler gently then repeat steps 3 to 5.
7. Put the mouthpiece cover back to keep dust and other debris from getting into your medicine.
8. Rinse your mouth with water to remove any excess medicine. Do not swallow.
IMPORTANT INFORMATION: CLEANING INSTRUCTIONS: Your inhaler mouthpiece will need to be cleaned regularly, at least once a week and to do this you will need to: 1. Remove the mouthpiece cover.
2. Wipe the inside and outside of the mouthpiece opening with a clean, dry cloth.
3. Replace the mouthpiece cover.
4. Do not put the inhaler in water.
5. Do not try to take the inhaler apart.
READING THE COUNTER: The arrow on the counter on the top of the inhaler points to the number of puffs remaining in your inhaler. It starts with 120 puffs when it is full.
The counter will count down toward zero ("0") each time you release a puff of medicine (either when preparing your inhaler for use or when taking the medicine).
When the arrow on the counter enters the yellow area, this means that there are about 20 puffs left.
It is very important that you note the number of puffs remaining in your SYMBICORT inhaler by reading the counter. Discard SYMBICORT after the counter reaches zero ("0"), indicating that you have used the number of puffs on the product label and box. Your inhaler may not feel empty and it may continue to operate, but you will not get the right amount of medicine if you keep using it.

Antiasthmatic & COPD Preparations

R03AK07 - formoterol and budesonide ; Belongs to the class of adrenergics in combination with corticosteroids or other drugs, excluding anticholinergics. Used in the treatment of obstructive airway diseases.

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