General information: The patient should be instructed that Symbicort Rapihaler must be used regularly even when asymptomatic for optimal benefit.
The medication from Symbicort Rapihaler is delivered to the lungs as the patient inhales. Therefore a correct handling of Symbicort Rapihaler is very important. The patients should be instructed accordingly (see "Other advices/instruction for use").
The patient should be instructed to use Symbicort Rapihaler regularly, i.e. in asymptomatic times to get the best therapeutic benefit.
Asthma: The dosage of Symbicort Rapihaler should be regularly checked by the doctor, and should be individualised according to disease severity (for this see current guidelines, e.g. GINA, www.ginasthma.com). Initial dose should be adjusted so that effective symptomatic control is obtained. When the desired clinical effect has been achieved, the dose should be titrated to the lowest dose at which effective asthma control is maintained. If so, 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 would be required to maintain control.
In case of discontinuance of Symbicort Rapihaler therapy, it is recommended to reduce the doses step by step.
Repeated assessments by a doctor at regular intervals are indicated in cases of severe asthma in view of the possible onset of life-threatening situations. Patients suffering from severe asthma show continuous symptoms, frequent exacerbations, PEF values (peak flow values) below 60% of normal with a peak flow variability in excess of 30% and which fail to return to normal despite the administration of a bronchodilator. High-dose inhalation therapy or oral corticosteroid therapy is indicated in these patients. A sudden worsening in symptoms may necessitate an increase in the corticosteroid dose, but only under medical supervision. However, this must not be achieved by administration of the combined product more frequently. In unstable situations, a switch to the individual monoproducts must be considered.
Symbicort Rapihaler is for oral inhalation only.
Dosage: Asthma: Symbicort Rapihaler should be used for a daily maintenance dose and a separate rapid-acting bronchodilator is needed for symptom relief.
Children (6 to 11 years): Symbicort Rapihaler 80/4.5: 2 inhalations twice daily. The maximum daily dose is 4 inhalations.
Adolescents 12 to 17 years: Symbicort Rapihaler 80/4.5: 2 inhalations once or twice daily. During worsening of asthma the dose may temporarily (1 week max.) be increased to a maximum of 4 inhalations twice daily.
Symbicort Rapihaler 160/4.5: 2 inhalations once to twice daily. During worsening of asthma the dose may temporarily (1 week max.) be increased to a maximum of 4 inhalations twice daily.
Adults (18 years and older): Symbicort Rapihaler 80/4.5: 2 inhalations once or twice daily. In some cases up to a maximum of 4 inhalations twice daily may be required as maintenance dose or temporarily during worsening of asthma.
Symbicort Rapihaler 160/4.5: 2 inhalations once or twice daily. In some cases up to a maximum of 4 inhalations twice daily may be required as maintenance dose or temporarily during worsening of asthma.
Equivalence between Symbicort Turbuhaler and Symbicort Rapihaler has been confirmed statistically for doses of twice daily 2 inhalations of 80/4.5 or 160/4.5 μg, but has not been proved for all dosages.
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.
Chronic Obstructive Pulmonary Disease (COPD): Adults (18 years and older): Symbicort Rapihaler 160/4.5: 2 inhalations twice daily.
General information: Special patient groups: 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 cirrhosis.
Paediatric Population: There is no relevant use of Symbicort 160 micrograms /4.5 micrograms in children 11 years of age and under or in adolescents 12 to 17 years of age in the symptomatic treatment of COPD.
Switching over of patients who are already receiving oral corticoid therapy see Precautions.
Method of administration: Instructions for use: Before the first use, when the inhaler has not been used for more than one week, or when it has been dropped, shake the inhaler gently and release 2 puffs in the air.
Use: 1. Hold the inhaler between thumb and index finger, and shake it gently.
2. Remove the mouthpiece cover.
3. Breathe out deeply, then put the mouthpiece in the mouth and close the lips around it. The container should be hold upright.
4. While breathing in slowly and deeply, press the container firmly to release the medication. Continue to breathe in.
5. Hold the breath for as long as is comfortable. Take the inhaler away, do not press anymore on the container.
6. Shake the inhaler again, and repeat steps 3,4,5.
7. Replace the protective cap.
For cleaning, the protective cap has to be removed, and the mouthpiece cleaned inside and outside with a dry cloth. Do not put the inhaler into water. Clean at least once a week.
To minimize the risk of oropharyngeal thrush, rinse the mouth with water after inhaling the prescribed dose.
The arrow on the counter on the top of the inhaler points to the number of inhalations (puffs) remaining in the inhaler. The rapihaler must be discarded after the counter reaches zero ("0") even the inhaler may not feel empty. There will not be enough active substance to be released.