Adverse reactions : תופעות לוואי

4.8   Undesirable effects

The most common adverse events reported in clinical trials using the combination of sodium picosulfate and magnesium citrate were related to direct effects on the bowel (abdominal pain and nausea) and the consequences of diarrhoea and dehydration (sleep disturbance, dry mouth, thirst, headache and fatigue).

Undesirable effects are presented below by MedDRA System Organ Class and Preferred Term, using the following frequency convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100). The frequency calculations are based on data derived from an analysis of clinical studies. Undesirable effects that were not reported in these clinical trials are described as ‘Frequency not known (cannot be estimated from the available data)’.
Immune system disorders
Not known: Anaphylactoid reaction, hypersensitivity

Metabolism and nutrition disorders
Not known: Hyponatraemia
Not known: Hypokalaemia.

Psychiatric disorders
Common: Sleep disorder
Nervous system disorders
Common: Headache
Uncommon: Dizziness
Not known: Epilepsy, grand mal convulsion, convulsion, confusional state 
Vascular disorders
Uncommon: Orthostatic hypotension

Gastrointestinal disorders
Very common: Abdominal pain
Common: Dry mouth, nausea, abdominal distension, anal discomfort, proctalgia Uncommon: Vomiting, faecal incontinence
Not known: Diarrhoea*, flatulence
* Diarrhoea is the primary clinical effect of CitraFleet

Skin and subcutaneous tissue disorders
Not known: Rash (including erythematous and maculo-papular rash), urticaria, pruritus, purpura 
General disorders and administration site conditions
Common: Thirst, fatigue
Not known: Pain

Hyponatraemia has been reported with or without associated convulsions (see 4.4). In epileptic patients, there have been reports of seizure/grand mal convulsion without associated hyponatraemia (see 4.4 and 4.5).

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://sideeffects.health.gov.il