Adverse reactions : תופעות לוואי

4.8 Undesirable effects

Flatulence may occur during the first few days of treatment. As a rule, it disappears after a couple of days. When dosages higher than instructed are used, abdominal pain and diarrhoea may occur. In such a case the dosage should be decreased. See also overdose section 4.9.

If high doses (normally only associated with hepatic encephalopathy, HE) are used for an extended period of time, the patient may experience an electrolyte imbalance due to diarrhoea.
Dosage should then be adjusted to obtain two or three formed stools per day.

Tabulated list of adverse reactions

The following undesirable effects have been experienced with the below indicated frequencies in lactulose-treated patients in placebo-controlled clinical trials: 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 (frequency cannot be estimated from the available data) 
MedDRA SOC                             Frequency category
Very           Common       Uncommon                Not known common
Gastrointestinal Diarrhoea       Flatulence,
disorders                        abdominal pain,
nausea,
vomiting
Investigations                                      Electrolyte imbalance due to diarrhoea
Immune system                                                            Hypersensitvity disorders                                                                reactions Skin and                                                                 Rash*, subcutaneous                                                             Pruritis*, tissue disorders                                                         urticaria* 

*Post-marketing experience

Paediatric population
The safety profile in children is expected to be similar as in adults.

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 Additionally, you can also report to: Padagis.com.