Adverse reactions : תופעות לוואי

4.8    Undesirable effects

The safety of Fampyra has been evaluated in randomised controlled clinical studies, in open label long term studies and in the post marketing setting.

Adverse reactions identified are mostly neurological and include seizure, insomnia, anxiety, balance disorder, dizziness, paraesthesia, tremor, headache and asthenia. This is consistent with fampridine’s pharmacological activity. The highest incidence of adverse reactions identified from placebo- controlled trials in multiple sclerosis patients with Fampyra given at the recommended dose, are reported as urinary tract infection (in approximately 12% of patients).

Adverse reactions are presented below by system organ class and absolute frequency. Frequencies are defined as: 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).

Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.



MedDRA SOC                        Adverse Reaction               Frequency category Urinary tract infection1          Very Common
Influenza1                        Common
Infections and infestations
Nasopharyngitis1                  Common
Viral infection1                  Common
Anaphylaxis                       Uncommon
Immune system disorders              Angioedema                        Uncommon Hypersensitivity                  Uncommon
Insomnia                          Common
Psychiatric disorders
Anxiety                           Common
Dizziness                         Common
Headache                          Common
Balance disorder                  Common
Vertigo                           Common
Nervous system disorders
Paraesthesia                      Common
Tremor                            Common
Seizure2                          Uncommon
Trigeminal neuralgia3             Uncommon
Palpitations                      Common
Cardiac disorders
Tachycardia                       Uncommon
Vascular disorders                   Hypotension4                      Uncommon 4
Respiratory, thoracic and        Dyspnoea                 Common mediastinal disorders            Pharyngolaryngeal pain   Common
Nausea                   Common
Vomiting                 Common
Gastrointestinal disorders
Constipation             Common
Dyspepsia                Common
Skin and subcutaneous tissue     Rash                     Uncommon disorders                        Urticaria                Uncommon
Musculoskeletal and connective   Back pain                Common tissue disorders
General disorders and            Asthenia                 Common administration site conditions   Chest discomfort2        Uncommon



5
1
See section 4.4
2
See sections 4.3 and 4.4
3
Includes both de novo symptoms and exacerbation of existing trigeminal neuralgia 4
These symptoms were observed in the context of hypersensitivity

Description of selected adverse reactions

Hypersensitivity
In post-marketing experience, there have been reports of hypersensitivity reactions (including anaphylaxis) which have occurred with one or more of the following: dyspnoea, chest discomfort, hypotension, angioedema, rash and urticaria. For further information on hypersensitivity reactions, please refer to sections 4.3 and 4.4.

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/