Posology : מינונים

4.2 Posology and method of administration
Route of administration: For inhalation use.

Posology
Asthma
Symbicort Turbuhaler can be used according to different treatment approaches: A. Symbicort anti-inflammatory reliever therapy (patients with mild disease).
B. Symbicort maintenance therapy (fixed dose).
C. Symbicort anti-inflammatory reliever plus maintenance therapy.
A. Symbicort anti-inflammatory reliever therapy (patients with mild disease) Symbicort Turbuhaler 160/4.5 is taken as needed for the relief of asthma symptoms when they occur, and as a preventative treatment of symptoms in those circumstances recognised by the patient to precipitate an asthma attack. Patients should be advised to always have Symbicort Turbuhaler 160/4.5 available for relief of symptoms.
Preventative use of Symbicort Turbuhaler 160/4.5 for allergen- or exercise-induced bronchoconstriction (AIB/EIB) should be discussed between physician and patient; the recommended dose frequency should take into consideration both allergen exposure and exercise patterns.
Adults and adolescents (12 years and older)
Patients should take 1 inhalation of Symbicort Turbuhaler 160/4.5 as needed in response to symptoms.
If symptoms persist after a few minutes, an additional inhalation should be taken. No more than 6 inhalations should be taken on any single occasion.A total daily dose of more than 8 inhalations is normally not needed, however a total daily dose of up to 12 inhalations can be used temporarily. If the patient experiences a three-day period of deteriorating symptoms after taking additional as needed inhalations, the patient should be reassessed for alternative explanations of persisting symptoms.
B. Symbicort maintenance therapy (Fixed dose)
When maintenance treatment with a combination of ICS and LABA is required, Symbicort Turbuhaler is taken as a fixed daily dose treatment, with a separate short-acting bronchodilator for relief of symptoms. Patients should be advised to have their separate short-acting bronchodilator available for relief of symptoms at all times.
Increasing use of short-acting bronchodilators indicates a worsening of the underlying condition and warrants reassessment of the asthma therapy. The dosage of Symbicort Turbuhaler should be individualised according to disease severity. When control of asthma has been achieved, the maintenance dose should be titrated to the lowest dose at which effective asthma control is maintained.
Recommended doses:
Adults (18 years and older): 1-2 inhalations twice daily. Some patients may require up to a maximum of 4 inhalations twice daily.

Adolescents (12-17 years): 1-2 inhalations twice daily.

Children (6 years and older): A lower strength (80 micrograms/4.5 micrograms/inhalation) is available for children 6-11 years.

Children under 6 years: As only limited data are available, Symbicort Turbuhaler 160/4.5 mcg/dose is not recommended for children younger than 6 years.

C. Symbicort anti-inflammatory reliever plus maintenance therapy
When maintenance treatment with a combination of inhaled corticosteroid (ICS) and long acting β2 agonist (LABA) is required patients take Symbicort anti-inflammatory reliever therapy and in addition take a daily maintenance dose of Symbicort Turbuhaler 160/4.5 mcg/dose. The as-needed inhalations provide both rapid relief of symptoms and improved overall asthma control. Patients should be advised to always have Symbicort Turbuhaler 160/4.5 mcg/dose available for relief of symptoms.
Preventative use of Symbicort Turbuhaler 160/4.5 for AIB/EIB should be discussed between physician and patient; the recommended dose frequency should take into consideration both allergen exposure and exercise patterns.

Recommended doses:
Adults and adolescents (12 years and older):
Patients should take 1 inhalation of Symbicort Turbuhaler /160/4.5 as needed in response to symptoms to control asthma. If symptoms persist after a few minutes, another inhalation should be taken. No more than 6 inhalations should be taken on any single occasion.
Patients also take the recommended maintenance dose of Symbicort Turbuhaler, which is 2 inhalations per day, given either as one inhalation in the morning and evening or as 2 inhalations in either the morning or evening. For some patients, a maintenance dose of 2 inhalations twice daily may be appropriate.
The maintenance dose should be titrated to the lowest dose at which effective control of asthma is maintained
A total daily dose of more than 8 inhalations is not normally needed; however, a total daily dose of up to 12 inhalations could be used for a limited period. Patients using more than 8 inhalations daily should be strongly recommended to seek medical advice. They should be reassessed and their maintenance therapy should be reconsidered.

Children under 12 years: Symbicort Turbuhaler 160/4.5 mcg/dose maintenance and reliever therapy is not recommended for children.
General information
If patients take Symbicort Turbuhaler as an anti-inflammatory reliever (either alone or in combination with maintenance therapy) physicians should discuss allergen exposure and exercise patterns with the patients and take these into consideration when recommending the dose frequency for asthma treatment.
If patients take Symbicort Turbuhaler as a maintenance therapy, they should be instructed to take the maintenance dose of Symbicort Turbuhaler even when asymptomatic for optimal benefit.

COPD
Recommended doses:
Adults: 2 inhalations twice daily.

Special patient populations:
There are no special dosing requirements for elderly patients. There are no data available for use of Symbicort Turbuhaler 160/4.5 mcg/dose 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.

Method of Administration
Instructions for correct use of Symbicort Turbuhaler 160/4.5 mcg/dose: The inhaler is inspiratory flow-driven, which means that when the patient inhales through the mouthpiece, the substance will follow the inspired air into the airways.

Note: It is important to instruct the patient:
- Check the expiry dateTo carefully read the instructions for use in the patient information leaflet which is packed together with each Symbicort Turbuhaler 160/4.5 mcg/dose inhaler - To breathe in forcefully and deeply through the mouthpiece to ensure that an optimal dose is delivered to the lungs.
- Never to breathe out through the mouthpiece.
- To replace the cover of the Symbicort Turbuhaler Inhaler after use.
- To rinse their mouth out with water after inhaling the maintenance dose to minimise the risk of oropharyngeal thrush. If oropharyngeal thrush occurs, patients should also rinse their mouth with water after the as-needed inhalations.

The patient may not taste or feel any medication when using Symbicort Turbuhaler 160/4.5 mcg/dose Inhaler due to the small amount of drug dispensed.