Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Clinical Trial Data
The safety of pseudoephedrine from clinical trial data is based on data from 6 randomised, placebo-controlled single dose clinical trials and 6 randomised, placebo- controlled multiple dose clinical trials for the treatment of nasal congestion with allergic rhinitis or common cold or prevention of sinus symptoms/infection after a natural cold.
Table 1 includes adverse events from clinical trial and post-marketing experience.
Adverse events included from clinical trials are those that occurred where greater than one event was reported, and the incidence was greater than placebo and in 1% of patients or more.
Post-marketing Data
Adverse drug reactions (ADRs) identified during post-marketing experience with pseudoephedrine are included in Table 1 below.
The adverse drug reactions are ranked by frequency, using the following convention.
Very common ≥1/10
Common         ≥1/100 and <1/10
Uncommon ≥1/1,000 and <1/100
Rare           ≥1/10,000 and <1/1,000
Very rare      <1/10,000
Not known      (cannot be estimated from the available data)
Table 1: Adverse Reactions Reported in Clinical Trials and Post-marketing Experience
Adverse Reactions
Frequency Category
System        Organ
Class                 Very          Common            Rare               Not known Common        (≥1/100        to ≥1/10,000       to
(≥1/10)       <1/10)            <1/1,000
Immune       System                                                      Hypersensitivity          – Disorders                                                                cross-sensitivity     may occur        with    other sympathomimetics
Psychiatric                         Insomnia                             Anxiety Disorders                           Nervousness                          Euphoric mood Excitability
Hallucinations
Irritability
Paranoid delusions
Restlessness
Sleep disorder
Nervous      System Headache        Dizziness                            Cerebrovascular Disorders                                                                accident Paraesthesia
Posterior        reversible encephalopathy syndrome
(PRES)/reversible cerebral vasoconstriction syndrome (RCVS)
Psychomotor hyperactivity
Somnolence
Tremor
Eye Disorders                                                            Ischaemic             optic neuropathy
Cardiac Disorders                                                        Dysrhythmias Myocardial infarction/myocardial ischaemia
Palpitations
Tachycardia
Vascular Disorders                                                        Hypertension Gastrointestinal                    Dry mouth                             Ischaemic colitis Disorders                           Nausea                                Vomiting Skin           and                                                        Angioedema Subcutaneous                                                              Pruritus Tissue Disorders                                                          Rash Severe skin reactions,
including         acute generalised exanthematous pustulosis (AGEP)
Renal and Urinary                                                         Dysuria Disorders                                                                 Urinary retention (in men in whom prostatic enlargement       could have been an important predisposing factor)
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/. It can also be reported to safty@trima.co.il