Atimos Pressurised Inhalation Solution 12mcg inhalation

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Formoterol fumarate dihydrate

Available from:

HYPHENS PHARMA PTE. LTD.

ATC code:

R03AC13

Dosage:

0.012mg/inhalation

Pharmaceutical form:

AEROSOL, METERED

Composition:

Formoterol fumarate dihydrate 0.012mg/inhalation

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

Prescription Only

Manufactured by:

Chiesi Farmaceutici S.p.A.

Authorization status:

ACTIVE

Authorization date:

2010-02-03

Patient Information leaflet

ATIMOS 12 MCG  
PRESSURISED INHALATION SOLUTION 

Formoterol fumarate 

COMPOSITION 
Each actuation contains: 
Active ingredient: Formoterol Fumarate Dihydrate 12 mcg 
Excipients: anhydrous ethanol, 1N hydrochloric acid, HFA 134a
(norfluran) 

PHARMACEUTICAL FORM AND CONTENT 
Pressurised solution for inhalation. 
Pressurised container with standard actuator, sufficient for 100
inhalations. 
The product does not contain any substances that might be harmful for
stratospheric ozone. 

THERAPEUTIC CLASS: selective agonist of beta
2
-adrenergic receptors 

THERAPEUTIC INDICATIONS 
1.  Prophylaxis and treatment of bronchoconstriction in patients
with asthma as an add-on to 
inhaled glucocorticosteroid treatment. 

2.  Prophylaxis of bronchospasm induced by inhaled allergens, cold
air, or exercise. 

CONTRAINDICATIONS 
Hypersensitivity to the active ingredient, or to any of the
excipients, or any other chemically related 
substances. Tachyarrhythmiae, 3
rd
 grade atrioventricular block, idiopathic hypertrophic subaortal 
stenosis, hypertrophic obstructive cardiomyopathy, idiopathic or
drug-induced long-QT syndrome 
(QTc > 0.44 seconds), severe hyperthyroidism. 
Generally contraindicated during pregnancy and lactation (see also
“Special Warnings”). 

PRECAUTIONS FOR USE 
_ANTIINFLAMMATORY THERAPY _
In general, if a regular therapy with beta
2
-agonists is required, asthmatic patients should receive a 
regular antiinflammatory therapy. Therefore, if treatment with
ATIMOS is recommended, the 
additional necessity to prescribe an antiinflammatory therapy should
also be evaluated. 
When patients are already undergoing this therapy (inhaled or oral
corticosteroids), this should be 
continued without any change, even when an improvement of symptoms
occurs. 
Should symptoms persist, or should a dose increase of ATIMOS
become necessary, the possibility 
of worsening of the base disease and the need to revise the therapy
should be considered. 
_CONCOMITANT�

Summary of Product characteristics

ATIMOS 12 MCG
PRESSURISED INHALATION SOLUTION
Formoterol fumarate
COMPOSITION
Each actuation contains:
Active ingredient: Formoterol Fumarate Dihydrate 12 mcg
Excipients: anhydrous ethanol, 1N hydrochloric acid, HFA 134a
(norfluran)
PHARMACEUTICAL FORM AND CONTENT
Pressurised solution for inhalation.
Pressurised container with standard actuator, sufficient for 100
inhalations.
The product does not contain any substances that might be harmful for
stratospheric ozone.
THERAPEUTIC CLASS
: selective agonist of beta
2
-adrenergic receptors
THERAPEUTIC INDICATIONS
1.
Prophylaxis and treatment of bronchoconstriction in patients with
asthma as an add-on to
inhaled glucocorticosteroid treatment.
2.
Prophylaxis of bronchospasm induced by inhaled allergens, cold air, or
exercise.
CONTRAINDICATIONS
Hypersensitivity to the active ingredient, or to any of the
excipients, or any other chemically related
substances. Tachyarrhythmiae, 3
rd
grade atrioventricular block, idiopathic hypertrophic subaortal
stenosis, hypertrophic obstructive cardiomyopathy, idiopathic or
drug-induced long-QT syndrome
(QTc > 0.44 seconds), severe hyperthyroidism.
Generally contraindicated during pregnancy and lactation (see also
“Special Warnings”).
PRECAUTIONS FOR USE
_ANTIINFLAMMATORY THERAPY _
In general, if a regular therapy with beta
2
-agonists is required, asthmatic patients should receive a
regular antiinflammatory therapy. Therefore, if treatment with ATIMOS
is recommended, the
additional necessity to prescribe an antiinflammatory therapy should
also be evaluated.
When patients are already undergoing this therapy (inhaled or oral
corticosteroids), this should be
continued without any change, even when an improvement of symptoms
occurs.
Should symptoms persist, or should a dose increase of ATIMOS become
necessary, the possibility
of worsening of the base disease and the need to revise the therapy
should be considered.
_CONCOMITANT DISEASES _
Particular caution should be paid, in particular as far as the dose of
ATIMOS is concerned, in
patie