Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Summary of the safety profile

The most frequently observed adverse drug reactions (ADRs) are related to administration site conditions (transient local reactions at the application site), reported as common.

Tabulated list of adverse reactions
The incidences of the Adverse Drug Reactions (ADRs) associated with EMLA Cream therapy is tabulated below. The table is based on adverse events reported during clinical trials, and/or post-marketing use. Their frequency of Adverse Reactions is listed by MedDRA System Organ Class (SOC) and at the preferred term level.
Within each System Organ Class, adverse reactions are listed under frequency categories of: 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). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Table 3 Adverse reactions

System Organ Class      Common                   Uncommon                Rare Blood and lymphatic                                                      Methaemoglobinaem system disorders                                                         ia1 Immune system                                                            Hypersensitivity1, 2, 3 disorders
Eye disorders                                                            Corneal irritation1 Skin and                                                                 Purpura1, Petechiae1 subcutaneous                                                             (especially after tissue disorders                                                         longer application times in children with atopic dermatitis or mollusca contagiosa)
General disorders and administration      Burning sensation2, 3    Burning sensation1 site conditions
Application site         Application site pruritus2, 3             irritation3


Application site erythema1,             Application site
2, 3                   pruritus1
Application site oedema1, 2, 3          Application site paraesthesia2 such as tingling
Application site warmth2, 3             Application site warmth1
Application site pallor1, 2, 3
1
Skin
2
Genital Mucosa
3
Leg ulcer

Paediatric population
In clinical trials 298 neonates and infants aged up to 12 months were treated with EMLA (Table 3). A large number of infants and children aged 1 year and older have been treated with EMLA in clinical trials and in clinical practice since 1984. Table 3.
Number of paediatric patients, up to 12 months old, included in clinical studies with EMLA, by age group

Group                Number of patients
Pre-term neonates 21
Age 0–1 months       148
Age 1–3 months       55
Age 3–12 months 74
Total number         298
Frequency, type and severity of adverse reactions are similar in the paediatric and adult age groups, except for methaemoglobinaemia, which is more frequently observed, often in connection with overdose, in neonates and infants aged 0 to 12 months.

Rare cases of clinically significant methaemoglobinaemia in children have been reported in literature. Prilocaine, one of the components of EMLA, may in high doses cause an increase in the methaemoglobin level, particularly in susceptible individuals (Section 4.4) and in conjunction with other methaemoglobin-inducing agents. Clinically significant methaemoglobinaemia should be treated with a slow intravenous injection of methylthioninium chloride (Section 4.9).


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
Additionaly, you can also report to Padagis via the following address: Padagis.co.il