Quest for the right Drug
נקסיום טבליות 20 מ"ג NEXIUM TABLETS 20 MG (ESOMEPRAZOLE)
תרופה במרשם
תרופה בסל
נרקוטיקה
ציטוטוקסיקה
צורת מתן:
פומי : PER OS
צורת מינון:
טבליה : TABLETS
עלון לרופא
מינוניםPosology התוויות
Indications תופעות לוואי
Adverse reactions התוויות נגד
Contraindications אינטראקציות
Interactions מינון יתר
Overdose הריון/הנקה
Pregnancy & Lactation אוכלוסיות מיוחדות
Special populations תכונות פרמקולוגיות
Pharmacological properties מידע רוקחי
Pharmaceutical particulars אזהרת שימוש
Special Warning עלון לרופא
Physicians Leaflet
Adverse reactions : תופעות לוואי
4.8 Undesirable effects Summary of the safety profile Headache, abdominal pain, diarrhoea and nausea are among those adverse reactions that have been most commonly reported in clinical trials (and also from post-marketing use). In addition, the safety profile is similar for different formulations, treatment indications, age groups and patient populations. No dose-related adverse reactions have been identified. Tabulated list of adverse reactions The following adverse drug reactions have been identified or suspected in the clinical trials programme for esomeprazole and post-marketing. None was found to be dose- related. The reactions are classified according to frequency: very common >1/10; common >1/100 to <1/10; uncommon >1/1,000 to <1/100; rare >1/10,000 to <1/1,000; very rare <1/10,000; not known (cannot be estimated from the available data). System Organ Class Frequency Undesirable Effect Blood and lymphatic Rare Leukopenia, thrombocytopenia system disorders Very rare Agranulocytosis, pancytopenia Immune system disorders Rare Hypersensitivity reactions e.g. fever, angioedema and anaphylactic reaction/shock Metabolism and nutrition Uncommon Peripheral oedema disorders Rare Hyponatraemia Not known Hypomagnesaemia (see section 4.4); severe hypomagnesaemia can correlate with hypocalcaemia. Hypomagnesaemia may also be associated with hypokalaemia. Psychiatric disorders Uncommon Insomnia Rare Agitation, confusion, depression Very rare Aggression, hallucinations Nervous system disorders Common Headache Uncommon Dizziness, paraesthesia, somnolence Rare Taste disturbance Eye disorders Rare Blurred vision Ear and labyrinth disorders Uncommon Vertigo Respiratory, thoracic and Rare Bronchospasm mediastinal disorders Gastrointestinal disorders Common Abdominal pain, constipation, diarrhoea, flatulence, nausea/vomiting, fundic gland polyps (benign) Uncommon Dry mouth Rare Stomatitis, gastrointestinal candidiasis Not known Microscopic colitis Hepatobiliary disorders Uncommon Increased liver enzymes Rare Hepatitis with or without jaundice Very rare Hepatic failure, encephalopathy in patients with pre-existing liver disease Skin and subcutaneous Uncommon Dermatitis, pruritus, rash, urticaria tissue disorders Rare Alopecia, photosensitivity Very rare Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS) Not known Subacute cutaneous lupus erythematosus (see section 4.4) Musculoskeletal and Uncommon Fracture of the hip, wrist or spine (see connective tissue section 4.4) disorders Rare Arthralgia, myalgia Very rare Muscular weakness Renal and urinary Very rare Interstitial nephritis; in some patients, disorders renal failure has been reported concomitantly Reproductive system and Very rare Gynaecomastia breast disorders General disorders and Rare Malaise, increased sweating administration site conditions Reporting of suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il
שימוש לפי פנקס קופ''ח כללית 1994
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נקסיום טבליות 20 מ"ג