Land: Israel
Språk: engelska
Källa: Ministry of Health
BUDESONIDE MICRONIZED; FORMOTEROL FUMARATE DIHYDRATE
ABIC MARKETING LTD, ISRAEL
R03AK07
POWDER FOR INHALATION
FORMOTEROL FUMARATE DIHYDRATE 4.5 MCG/DOSE; BUDESONIDE MICRONIZED 160 MCG/DOSE
INHALATION
Required
NORTON (WATERFORD) LIMITED T/A TEVA PHARMACEUTICALS, IRELAND
FORMOTEROL AND BUDESONIDE
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
2020-09-30
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. Läs hela dokumentet