גניקומסטיה.

Some of the adverse drug reactions listed below may decrease in intensity AND frequency with continued treatment AND do not generally lead to cessation of therapy.Adverse drug reactions are listed below by system organ class AND frequency. Frequencies are defined as: very common (1/10), common (1/100, <1/10), uncommon (1/1,000, <1/100), rare (1/10,000, <1/1,000), very rare (<1/10,000), including isolated reports. Blood AND lymphatic system disorders Uncommon: abnormal bleeding, predominantly of the skin AND mucous membranes (mostly ecchymosis). Very rare: thrombocytopenia. Immune system disorders Very rare: allergic reactions (including urticaria AND angioedema). Endocrine disorders Very rare: syndrome of inappropriate anti-diuretic hormone secretion (SIADH). Metabolism & nutrition disorders Common: decreased appetite Rare: hyponatraemia. Hyponatraemia has been reported predominantly in elderly patients AND is sometimes due to the syndrome of inappropriate anti-diuretic hormone secretion (SIADH). Psychiatric disorders Common: somnolence, insomnia. Uncommon: confusion, hallucinations Rare: manic reactions, agitation, anxiety, depersonalisation, panic attacks, akathisia (see section 4.4 Special Warnings AND Special Precautions for use). These symptoms may also be due to the underlying disease. Nervous system disorders Common: dizziness, tremor. Uncommon: extrapyramidal disorders. Rare: convulsions. Very rare: serotonin syndrome (symptoms may include agitation, confusion, diaphoresis, hallucinations, hyperreflexia, myoclonus, shivering, tachycardia AND tremor). Reports of extrapyramidal disorders including oro-facial dystonia have been received in patients sometimes with underlying movement disorders OR who were using neuroleptic medication. Eye disorders Common: blurred vision. Very rare: acute glaucoma. Cardiac disorders Uncommon: sinus tachycardia. Rare: bradycardia. Vascular disorders Uncommon: transient increases OR decreases in blood pressure. Transient increases OR decreases of blood pressure have been reported following treatment with paroxetine, usually in patients with pre-existing hypertension OR anxiety. Respiratory, thoracic AND mediastinal disorders Common: yawning. Gastrointestinal disorders Very common: nausea. Common: constipation, diarrhoea, dry mouth. Very rare: gastrointestinal bleeding. Hepato-biliary disorders Rare: elevation of hepatic enzymes. Very rare: hepatic events (such as hepatitis, sometimes associated with jaundice and/or liver failure). Elevation of hepatic enzymes have been reported. Post-marketing reports of hepatic events (such as hepatitis, sometimes associated with jaundice and/or liver failure) have also been received very rarely. Discontinuation of paroxetine should be considered if there is prolonged elevation of liver function test results. Skin & subcutaneous tissue disorders Common: sweating. Uncommon: skin rashes, pruritus. Very rare: photosensitivity reactions. Renal & urinary disorders Uncommon: urinary retention. Reproductive system & breast disorders Very common: sexual dysfunction Rare: hyperprolactinaemia/galactorrhoea. Very rare: priapism. Musculoskeletal disorders Very rare: arthralgia, myalgia. General disorders AND administration site conditions Common: asthenia, body weight gain. Very rare: peripheral oedema. WITHDRAWAL SYMPTOMS SEEN ON DISCONTINUATION OF PAROXETINE TREATMENT Common: Dizziness, sensory disturbances, sleep disturbances, anxiety, headache. Uncommon: Agitation, nausea, tremor, confusion, sweating, emotional instability, visual disturbances, palpitations, diarrhoea, irritability. Discontinuation of paroxetine (particularly when abrupt) commonly leads to withdrawal symptoms. Dizziness, sensory disturbances (including paraesthesia AND electric shock sensations), sleep disturbances (including intense dreams), agitation OR anxiety, nausea, tremor, confusion,sweating, headache, diarrhoea, palpitations, emotional instability, irritability, AND visual disturbances have been reported. Generally these events are mild to moderate AND are self-limiting, however, in some patients they may be severe and/or prolonged. It is therefore advised that when paroxetine treatment is no longer required, gradual discontinuation by dose tapering be carried out (see sections 4.2 Posology AND Method of Administration and, 4.4 Special warnings AND precautions for use). Adverse events from paediatric clinical trials In short term (up to 10-12 weeks) clinical trials in children AND adolescents, the following adverse events were observed in paroxetine treated patients at a frequency of at least 2% of patients AND occurred at a rate of at least twice that of placebo were: increased suicidal related behaviours (including suicide attempts AND suicidal thoughts), self-harm behaviours AND increased hostility. Suicidal thoughts AND suicide attempts were mainly observed in clinical trials of adolescents with Major Depressive Disorder. Increased hostility occurred particularly in children with obsessive compulsive disorder, AND especially in younger children less than 12 years of age. Additional events that were more often seen in the paroxetine compared to placebo group were: decreased appetite, tremor, sweating, hyperkinesia, hostility, agitation, emotional lability (including crying AND mood fluctuations). In studies that used a tapering regimen, symptoms reported during the taper phase OR upon discontinuation of paroxetine at a frequency of at least 2% of patients AND that occurred at a rate of at least twice that of placebo were: emotional lability (including crying, mood fluctuations, self-harm, suicidal thoughts AND attempted suicide), nervousness, dizziness, nausea AND abdominal pain (see section 4.4 Special warnings AND special precautions for use)