Adverse reactions : תופעות לוואי

4.8 Undesirable effects

Fleet Enema 133 is well tolerated when used as indicated. However, adverse events possibly associated with the use of Fleet Enema 133 have been infrequently reported. In some cases, adverse events may occur, especially if the enema is misused.

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Organized by MedDRA System Organ Class the undesirable effects are listed below using the following frequency classification: 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):

Immune System Disorders
Very rare: hypersensitivity e.g. urticaria

Skin and subcutaneous tissue disorders
Very rare: blister, pruritus, stinging.

Metabolism and nutrition disorders

Very rare: dehydration, hyperphosphataemia, hypocalcaemia, hypokalaemia, hypernatraemia, metabolic acidosis.

Gastrointestinal disorders

Very rare: nausea, vomiting, abdominal pain, abdominal distension, diarrhoea, gastrointestinal pain, anal discomfort and proctalgia.

General disorders and administration site conditions
Very rare: rectal irritation, pain, stinging, chills.

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: https://sideeffects.health.gov.il