Adverse reactions : תופעות לוואי

4.8   Undesirable effects
Flatulence may occur with the use of Agiolax, this generally disappears in the course of the treatment. Abdominal distension and risk of intestinal or esophageal obstruction (e.g., dysphagia) and faecal impaction may occur, particularly if swallowed with insufficient fluid. The frequency is not known.

Agiolax contains potent allergens. As a consequence after oral administration or contact with the skin, Agiolax may cause hypersensitivity reactions such as rhinitis, conjunctivitis, bronchospasm and in some cases anaphylaxis.
Cutaneous hypersensitivity reactions such as local or generalized exanthema, urticaria and/or pruritus have also been reported. The frequency is not known.

Agiolax may produce abdominal pain and spasm and passage of liquid stools, in particular in patients with irritable colon. However, these symptoms may also occur generally as a consequence of individual overdosage. In such cases dose reduction is necessary.

Nausea and vomiting may occur. The frequency is not known.

Chronic use may lead to disorders in water equilibrium and electrolyte metabolism and may result in albuminuria and haematuria.
Furthermore, chronic use may cause pigmentation of the intestinal mucosa (pseudomelanosis coli), which usually recedes when the patient stops taking the preparation.

Yellow or red-brown (pH dependent) discolouration of urine by metabolites, which is not clinically significant, may occur during the treatment.
The frequency is not known.

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