Adverse reactions : תופעות לוואי

4.8     Undesirable effects
Undesirable effects are for the majority dose dependent. The frequency and severity are most pronounced in the early phase of treatment and decline during continued treatment.

Extrapyramidal reactions may occur, especially during the first few days after injection and in the early phase of treatment. In most cases these side effects can be satisfactorily controlled by reduction of dosage and/or use of antiparkinsonian drugs. The routine prophylactic use of antiparkinsonian drugs is not recommended. Antiparkinsonian drugs do not alleviate tardive dyskinesia and may aggravate them. Reduction in dosage or, if possible, discontinuation of flupentixol therapy is recommended. In persistent akathisia a benzodiazepine or propranolol may be useful.

Frequencies are taken from the literature and spontaneous reporting. 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), or not known (can not be estimated from the available data).

Cardiac disorders                         Common                    Tachycardia, palpitations.

Electrocardiogram QT
Rare                      prolonged.
Blood and lymphatic system disorders      Rare                      Thrombocytopenia, neutropenia, leukopenia,
agranulocytosis

Very common               Somnolence, akathisia,
Nervous system disorders                                            hyperkinesia, hypokinesia.

Common                    Tremor, dystonia, dizziness,
headache.
Uncommon to Rare          Tardive dyskinesia, dyskinesia,
parkinsonism, speech disorder,
convulsion.

Very rare                 Neuroleptic malignant syndrome.

Common                    Accommodation disorder, vision
Eye disorders                                                       abnormal.
Uncommon                  Oculogyration.

Respiratory, thoracic and mediastinal     Common                    Dyspnoea.
disorders

Gastrointestinal disorders                Very common               Dry mouth.
Common                    Salivary hypersecretion,
constipation, vomiting,
dyspepsia, diarrhoea.

Uncommon                  Abdominal pain, nausea,
flatulence.

Renal and urinary disorders               Common                    Micturition disorder, urinary retention.

Pregnancy, puerperium and perinatal       Not known                 Drug withdrawal syndrome conditions                                                          neonatal (see 4.6) Skin and subcutaneous tissue              Common                     Hyperhidrosis, pruritus.
disorders
Uncommon                   Rash, photosensitivity reaction,
dermatitis.

Musculoskeletal and connective tissue     Common                     Myalgia.
disorder
Uncommon                   Muscle rigidity.

Endocrine disorders                       Rare                       Hyperprolactinaemia.
Common                     Increased appetite, weight
Metabolism and nutrition disorders                                   increased.

Uncommon                   Decreased appetite.

Rare                       Hyperglycaemia, glucose tolerance abnormal.
Vascular disorders                        Uncommon                   Hypotension, hot flush.
Very rare                  Venous thromboembolism
General disorders and administration      Common                     Asthenia, fatigue.
site conditions

Uncommon                   Injection site reaction.
Immune system disorders                   Rare                       Hypersensitivity, anaphylactic reaction.

Uncommon                   Liver function test abnormal.
Hepatobiliary disorders
Very rare                  Jaundice.

Reproductive system and breast                                       Ejaculation failure, erectile disorders                                 Uncommon                   dysfunction.

Rare                       Gynaecomastia, galactorrhoea,
amenorrhoea.

Common                     Insomnia, depression,
Psychiatric disorders                                                nervousness, agitation, libido decreased.

Uncommon                   Confusional state.

As with other drugs belonging to the therapeutic class of antipsychotics, rare cases of QT prolongation, ventricular arrythmias - ventricular fibrillation, ventricular tachycardia, Torsade de Pointes and sudden unexplained death have been reported for flupentixol decanoate (see section 4.4).

Abrupt discontinuation of flupentixol decanoate may be accompanied by withdrawal symptoms.
The most common symptoms are nausea, vomiting, anorexia, diarrhoea, rhinorrhoea, sweating, myalgias, paraesthesias, insomnia, restlessness, anxiety, and agitation. Patients may also experience vertigo, alternate feelings of warmth and coldness, and tremor. Symptoms generally begin within 1 to 4 days of withdrawal and abate within 7 to 14 days.