Adverse reactions : תופעות לוואי

4.8          Undesirable effects
Many of the following adverse reactions are clearly dose-dependent and variable from one person to another.
Table 4-4 provides a listing of adverse reactions from 16 single-dose clinical studies on the efficacy and safety of Excedrin in the treatment of migraine, headache or dental pain associated with tooth extraction, involving 4809 Excedrin-treated subjects, and from post- marketing spontaneous reports. The adverse reactions included in the table were those regarded as at least possibly related to the administration of Excedrin and are listed in descending order of frequency within MedDRA System Organ Classification.
For adverse reactions from the spontaneous reporting system, the frequencies cannot be reliably determined and therefore, is not known.
Adverse reactions are listed below by system organ class and frequency, using 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), including isolated reports and not known (cannot be estimated from the available data).

Table 4-4 Adverse reactions reported from clinical studies and from post- marketing spontaneous reports
System Organ Class            Frequency                Preferred Term Infections and infestations   Rare                     Pharyngitis
Immune system disorders       Not Known                Hypersensitivity, anaphylactic reaction, Stevens Johnson syndrome*, toxic epidermal necroysis*
Metabolism and nutrition      Rare                     Decreased appetite disorders
Psychiatric disorders         Common                   Nervousness
Uncommon                 Insomnia
Rare                     Anxiety, euphoric mood, tension
Not Known                Restlessness
Nervous system disorders      Common                   Dizziness
Uncommon                 Tremor, paraesthesia, headache
Rare                     Dysgeusia, disturbance in attention, amnesia, coordination abnormal, hyperaesthesia, sinus headache
Not Known                Migraine, somnolence
Eye disorders                 Rare                     Eye pain, visual disturbance Ear and labyrinth disorders   Uncommon                 Tinnitus
Cardiac disorders             Uncommon                 Arrhythmia
Not Known                Palpitations
Vascular disorders            Rare                     Flushing, peripheral vascular disorder Not Known                Hypotension
Respiratory, thoracic and     Rare                     Epistaxis, hypoventilation,rhinorrhoea mediastinal disorders         Not Known                Dyspnoea, asthma Gastrointestinal disorders    Common                   Nausea, abdominal discomfort Uncommon                 Dry mouth, diarrhoea, vomiting
Rare                     Eructation, flatulence, dysphagia,
paraesthesiaoral, salivaryhypersecretion

Not Known                Abdominal pain upper, dyspepsia, abdominal pain, GI haemorrhage (including upper GI haemorrhage, gastric haemorrhage, gastric ulcer haemorrhage, duodenal ulcer haemorrhage,
rectal haemorrhage), GI ulcer (including gastric ulcer, duodenal ulcer, largeintestinal ulcer, peptic ulcer)
Hepatobiliary disorders      Not Known                 Hepatic failure, hepatic enzymeincreased Skin and subcutaneous tissue Rare                      Hyperhidrosis, pruritus, urticaria disorders                    Not Known                 Erythema, rash, angioedema, erythema multiforme
Musculoskeletal and           Rare                     Musculoskeletal stiffness, neck pain, back pain, connective tissue disorders                            muscle spasms
General disorders and         Uncommon                 Fatigue, feeling jittery administration site conditions
Rare                     Asthenia, chest discomfort
Not Known                Malaise, feeling abnormal


*Very rare cases of serious skin reactions have been reported.

There is no information available to suggest that the extent and type of adverse events of the individual substances is enhanced or the spectrum broadened when the fixed combination is used as instructed.
Increase of the risk of bleeding can persist for 4-8 days after the intake of acetylsalicylic acid. Very rarely severe bleeding (e.g. intracerebral bleeding) especially in patients with untreated hypertension and / or concomitant treatment with anticoagulants. In single cases these can be life threatening.

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/