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) ≥1/10,000     to
(≥1/10)                           <1/1,000
Immune         System                                                  Hypersensitivity – cross- Disorders                                                              sensitivity may occur with other sympathomimetics
Psychiatric Disorders               Insomnia                           Anxiety Nervousness                        Euphoric mood
Excitability
Hallucinations
Irritability
Paranoid delusions
Restlessness
Sleep disorder
Nervous        System Headache      Dizziness                          Cerebrovascular accident Disorders                                                              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 Tissue                                                    Pruritus 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