Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Some of the adverse reactions listed below have been reported in patients with spasticity of spinal origin but could also occur in patients with spasticity of cerebral origin. Adverse reactions that are more frequent in either population are indicated below.
Adverse drug reactions (Table 1) are listed according to system organ classes in MedDRA. Within each system organ class, the adverse drug reactions are ranked under headings of frequency, the most frequent reactions first. Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness. In addition, the corresponding frequency category using the following convention (CIOMS III) is also provided for each adverse drug reaction: 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), and Not known (cannot be estimated from available data).
Table 1 Adverse drug reactions

Metabolism and nutritional disorders
Uncommon:                           Dehydration
Psychiatric disorders
Common:                             Depression, anxiety, agitation.
Uncommon:                           Suicidal ideation (see section 4.4 – Precautions in special patient populations), suicide attempt, hallucinations, paranoia, euphoric mood.
Not known:                          Dysphoria
Nervous system disorders
Very common:                        Somnolence
Common:                             Convulsion, confusional state, sedation, dizziness, headache, paraethesia, dysarthria, lethargy, insomnia, disorientation,
Uncommon:                           Ataxia, memory impairment, nystagmus (Convulsion and headache occur more often in patients with spasticity of cerebral origin than in patients with spasticity of spinal origin).
Eye disorders
Common:                             Accommodation disorder, vision blurred, diplopia.
Cardiovascular disorders
Uncommon:                           Bradycardia,
Vascular disorders
Common:                             Hypotension
Uncommon:                           Hypertension, deep vein thrombosis, flushing, pallor.
Respiratory, thoracic and mediastinal disorders
Common:                             Respiratory depression, pneumonia, dyspnoea .
Not known:                          Bradypnoea
Gastrointestinal disorders
Common:                             Nausea/vomiting, constipation, dry mouth, diarrhoea, decreased appetite,increased salivation.
Uncommon:                            Ileus, dysphagia,hypogeusia.
(Nausea and vomiting occur more often in patients with spasticity of cerebral origin than in patients with spasticity of spinal origin).
Skin and subcutaneous tissue disorders
Common:                              Urticaria/pruritus, facial and/or peripheral oedema.
Uncommon:                            Alopecia,hyperhydrosis.
Musculoskeletal and connective tissue disorders
Very common:                         Hypotonia
Common:                              Hypertonia
Not known:                           Scoliosis (see section 4.4)
Renal and urinary disorders
Common:                              Urinary incontinence, urinary retention (Urinary retention occurs more often in patients with spasticity of cerebral origin than in patients with spasticity of spinal origin).
Reproductive system and breast disorders
Common:                              Sexual dysfunction (Intrathecal baclofen may compromise erection and ejaculation. This effect is usually reversible on withdrawal of Baclofen Sintetica).
Not known:                           Erectile dysfunction
General disorders and administration site conditions
Common:                              Asthenia, pyrexia, pain, chills.
Uncommon:                            Hypothermia.
Rare:                                Life threatening withdrawal symptoms due to drug delivery failure (see section 4.4 – Special warnings and precautions for use “Treatment Withdrawal”).
Immune system disorders
Not known:                           Hypersensitivity

Adverse events associated with the delivery system
Adverse events associated with the delivery system (inflammatory mass at the tip of the catheter, catheter dislocation with possible complications, pocket infection, meningitis, overdose due to wrong manipulation of the device) have been reported.
Device malfunction resulting in altered drug delivery leading to withdrawal symptoms including death has been reported.


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