Adverse reactions : תופעות לוואי

4.8 Undesirable effects
The following convention has been utilised for the classification of undesirable effects: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, ≤1/100), rare (≥1/10,000, ≤1/1000), very rare (≤1/10,000). Adverse event frequencies have been estimated from spontaneous reports from post- marketing data.

Blood & Lymphatic System Disorders
Very Rare:      Blood count changes (leucopenia, thrombocytopenia). These are usually reversible. Agranulocytosis or pancytopenia, sometimes with marrow hypoplasia or marrow aplasia.

Immune System Disorders
Rare:             Hypersensitivity reactions (urticaria, angioneurotic oedema, fever, bronchospasm, hypotension and chest pain).
Very Rare:        Anaphylactic shock.
Not known:        Dyspnoea.
These events have been reported after a single dose.

Psychiatric Disorders
Very Rare:         Reversible mental confusion, depression and hallucinations.
These have been reported predominantly in severely ill patients, in elderly and in nephropatic patients.

Nervous System Disorders
Very Rare:      Headache (sometimes severe), dizziness and reversible involuntary movement disorders.

Eye Disorders
Very Rare:        Reversible blurred vision.
There have been reports of blurred vision, which is suggestive of a change in accommodation.

Cardiac Disorders
Very Rare:        As with other H2 receptor antagonists bradycardia, A-V Block and tachycardia.

Vascular Disorders
Very Rare:       Vasculitis.

Gastrointestinal Disorders
Uncommon:         Abdominal pain, constipation, nausea (these symptoms mostly improved during continued treatment).
Very Rare:        Acute pancreatitis, diarrhoea.

Hepatobiliary Disorders
Rare:             Transient and reversible changes in liver function tests.
Very Rare:        Hepatitis (hepatocellular, hepatocanalicular or mixed) with or without jaundice, these were usually reversible.

Skin and Subcutaneous Tissue Disorders
Rare:           Skin Rash.
Very Rare:      Erythema multiforme, alopecia.
Musculoskeletal and Connective Tissue Disorders
Very Rare:       Musculoskeletal symptoms such as arthralgia and myalgia.

Renal and Urinary Disorders
Rare:            Elevation of plasma creatinine (usually slight; normalised during continued treatment)
Very Rare:       Acute interstitial nephritis.

Reproductive System and Breast Disorders
Very Rare:       Reversible impotence, breast symptoms and breast conditions (such as gynaecomastia and galactorrhoea).

Paediatric population
The safety of ranitidine has been assessed in children ages 0 to 16 years with acid-related disease and was generally well tolerated with an adverse event profile resembling that in adults. There are limited long term data available, in particular regarding growth and development.

Reporting of suspected adverse reactions
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=Adve rsEffectMedic@moh.gov.il