Adverse reactions : תופעות לוואי

4.8 Undesirable effects

Adults and Children aged ≥12 years
The safety of Loperamide HCl has been evaluated in 2755 adults and children aged ≥12 years who participated in 26 controlled and uncontrolled clinical trials with loperamide HCl used for the treatment of acute diarrhea.

The most commonly reported (i.e. with an incidence ≥1%) adverse drug reactions (ADRs) in clinical trials with loperamide HCl for the treatment of acute diarrhea were the following: constipation (2.7%), flatulence (1.7%), headache (1.2%) and nausea (1.1%).

Table 1 shows the ADRs reported with the use of loperamide HCl from either clinical trials (acute diarrhea) or post-marketing experience.

The frequency of the adverse reactions presented in Table 1 is defined according to the following convention:
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)

Table 1: Adverse drug reactions

System Organ Class
Common            Uncommon           Rare                          Not known Immune System                                                    Hypersensitivity reactiona Disorders                                                        Anaphylactic reaction (including Anaphylactic shock)a Anaphylactoid reactiona
Nervous System            Headache          Dizziness            Loss of consciousnessa Disorders                                   Somnolencea          Stupora, Depressed level of consciousnessa
Hypertoniaa
Coordination abnormalitya
Eye Disorders                                                    Miosisa Gastrointestinal           Constipation      Abdominal pain       Ileusa (including paralytic   Acute pancreatitis Disorders                  Nausea            Abdominal            ileus) Flatulence        discomfort           Megacolona (including
Dry mouth            toxic megacolonb)
Abdominal pain       Abdominal distension upper
Vomiting
Dyspepsiaa
Skin and Subcutaneous                        Rash                 Bullous eruptiona Tissue Disorders                                                  (including Stevens- Johnson syndrome, Toxic epidermal necrolysis and
Erythema multiforme)
Angioedemaa
Urticariaa
Pruritusa
Renal and Urinary                                                 Urinary retentiona Disorders
General Disorders and                                             Fatiguea Administration    Site
Conditions

 a: Inclusion of this term is based on post-marketing reports for loperamide HCl. As the process for determining post marketing ADRs did not differentiate between chronic and acute indications or adults and children, the frequency is estimated from all clinical trials with loperamide HCl (acute and chronic), including trials in children ≤ 12 years (N=3683).
b:     See section 4.4 Special Warnings and Special Precautions for use.


Pediatric population
The safety of loperamide HCl has been evaluated in 607 patients aged between 10 days and 13 years, who participated in 13 controlled and uncontrolled clinical trials with loperamide HCl used for the treatment of diarrhea. In general, the ADR profile in this patient population was similar to that observed in clinical trials with loperamide HCl used in adults and children aged 12 years and older.

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