DUORESP SPIROMAX 160 MCG4.5 MCG

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Principio attivo:

BUDESONIDE MICRONIZED; FORMOTEROL FUMARATE DIHYDRATE

Commercializzato da:

ABIC MARKETING LTD, ISRAEL

Codice ATC:

R03AK07

Forma farmaceutica:

POWDER FOR INHALATION

Composizione:

FORMOTEROL FUMARATE DIHYDRATE 4.5 MCG/DOSE; BUDESONIDE MICRONIZED 160 MCG/DOSE

Via di somministrazione:

INHALATION

Tipo di ricetta:

Required

Prodotto da:

NORTON (WATERFORD) LIMITED T/A TEVA PHARMACEUTICALS, IRELAND

Area terapeutica:

FORMOTEROL AND BUDESONIDE

Indicazioni terapeutiche:

AsthmaDuoResp Spiromax 160/4.5 mcg/dose is indicated in adults and adolescents (12 years and older), for 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.OrPatients already adequately controlled on both inhaled corticosteroids and long acting β2 adrenoceptor-agonists.Chronic Obstructive Pulmonary Disease (COPD)DuoResp Spiromax 160/4.5 mcg/dose is indicated in adults, aged 18 years and older, for the Symptomatic treatment of patients with COPD with forced expiratory volume in 1 second (FEV1)< 70% predicted normal (post-bronchodilator) and an exacerbation history despite regular bronchodilator therapy

Data dell'autorizzazione:

2020-09-30

Foglio illustrativo

SIDE EFFECTS OCCURRING FREQUENTLY )AFFECT UP TO ONE PATIENT
IN 100(:
•
Agitation, nervousness or restlessness
•
Sleep disturbances
•
Dizziness
•
Nausea
•
Rapid heart rate
•
Skin bruises
•
Muscle spasms
•
Blurred vision
SIDE EFFECTS OCCURRING INFREQUENTLY )AFFECT UP TO ONE PATIENT
IN 1,000(:
•
Rash and itching
•
Low levels of potassium in the blood
•
Irregular heartbeat
•
Bronchospasm )narrowing of the muscles in the airways
causing wheezing(. If, immediately after using DuoResp
Spiromax, you suddenly start wheezing, stop using the
inhaler and contact a doctor immediately.
SIDE EFFECTS OCCURRING RARELY )AFFECT UP TO ONE PATIENT IN
10,000(:
•
Depression
•
Behavior disturbances, especially in children
•
Chest pain or tightness )angina pectoris(
•
Increased blood sugar )glucose( levels
•
Taste changes, such as an unpleasant taste in the mouth
•
Changes in blood pressure
Inhaled corticosteroids can affect the normal production of
steroid hormones in your body, particularly if you use high
doses for a long time. This effect may be manifested in:
•
Changes in bone density )thinning of the bones(
•
Cataract )clouding of the lens in the eye(
•
Glaucoma )increased intraocular pressure(
•
Slowed growth rate of children and adolescents, requiring
monitoring by the attending doctor, who may refer the child
to a specialist, if necessary.
•
An effect on the adrenal gland )a small gland located next
to the kidney(.
These side effects are more likely to occur with oral
corticosteroid treatment )e.g., tablets( as compared to inhaled
corticosteroids.
IF A SIDE EFFECT OCCURS, IF ONE OF THE SIDE EFFECTS WORSENS
OR IF YOU SUFFER FROM A SIDE EFFECT NOT MENTIONED IN THE
LEAFLET, CONSULT WITH THE DOCTOR.
Side effects can be reported to the Ministry of Health by
clicking on the link “Report Side Effects of Drug Treatment”
found on the Ministry of Health homepage )www.health.gov.il)
that directs you to the online form for reporting side effects, or
by entering the link:
https://sideeffects.