Adverse reactions : תופעות לוואי

4.8    Undesirable effects
The most common side effects (1-10% of patients) are headache, abdominal pain, constipation, diarrhoea, flatulence and nausea/vomiting.
The following adverse drug reactions have been identified or suspected in the clinical trials programme for omeprazole and post-marketing. None was found to be dose-related. Adverse reactions listed below are classified according to frequency and System Organ Class (SOC).
Frequency categories are defined according to the following convention: 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).

SOC/frequency       Adverse reaction

Blood and lymphatic system disorders
Rare:                Leukopenia, thrombocytopenia
Very rare:           Agranulocytosis, pancytopenia
Immune system disorders
Rare:                Hypersensitivity reactions e.g. fever, angioedema and anaphylactic reaction/shock
Metabolism and nutrition disorders
Rare:                Hyponatraemia
Very rare:           Hypomagnesaemia; severe hypomagnesaemia may result in hypocalcaemia 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 mediastinal disorders
Rare:                Bronchospasm
Gastrointestinal disorders
Common:              Abdominal pain, constipation, diarrhoea, flatulence, nausea/vomiting Rare:                Dry mouth, stomatitis, gastrointestinal candidiasis Not known            Microscopic colitis



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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 tissue disorders
Frequency 'not       Subacute cutaneous lupus erythematosus (see section 4.4).
known'


Uncommon:           Dermatitis, pruritus, rash, urticaria
Rare:               Alopecia, photosensitivity
Very rare:          Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN)
Musculoskeletal and connective tissue disorders
Uncommon            Fracture of the hip, wrist, or spine
Rare:               Arthralgia, myalgia
Very rare:          Muscular weakness
Renal and urinary disorders
Rare:               Interstitial nephritis
Reproductive system and breast disorders
Very rare:          Gynaecomastia
General disorders and administration site conditions
Uncommon:           Malaise, peripheral oedema
Rare:               Increased sweating


Treatment with proton pump inhibitors may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter, and, in hospitalized patients, possibly also Clostridium difficile. . A diagnosis of Clostridium difficile–associated diarrhea (CDAD) should be considered for patients taking PPIs who develop diarrhea that does not improve (see section 5.1)

Paediatric population
The safety of omeprazole has been assessed in a total of 310 children aged 0 to 16 years with acid-related disease. There are limited long term safety data from 46 children who received maintenance therapy of omeprazole during a clinical study for severe erosive oesophagitis for up to 749 days. The adverse event profile was generally the same as for adults in short- as well as in long-term treatment. There are no long term data regarding the effects of omeprazole treatment on puberty and growth.
Reporting 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
(http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffe ctMedic@moh.gov.il ).

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