Adverse reactions : תופעות לוואי

4.8 Undesirable effects

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); not known (cannot be estimated from the available data).

Blood and lymphatic system disorders
Uncommon: abnormal bleeding, predominantly of the skin and mucous membranes (including ecchymoisis and gynaecological bleeding), leukopenia.
Very rare: thrombocytopenia.

Immune system disorders
Very rare: severe and potentially fatal allergic reactions (including anaphylactoid reactions and angioedema).

Endocrine disorders
Very rare: syndrome of inappropriate anti-diuretic hormone secretion (SIADH).

Metabolism and nutrition disorders
Common: increases in cholesterol levels, decreased appetite.
Uncommon: altered glycaemic control has been reported in diabetic patients (see section 4.4).
Rare: hyponatraemia.
Hyponatraemia has been reported predominantly in elderly patients and is sometimes due to syndrome of inappropriate anti-diuretic hormone secretion (SIADH).

Psychiatric disorders
Common: somnolence, insomnia, agitation, abnormal dreams (including nightmares).
Uncommon: confusion, hallucinations.
Rare: manic reactions, anxiety, depersonalisation, panic attacks, akathisia (see section 4.4).
Not known: suicidal ideation, suicidal behaviour, aggression, bruxism.
Cases of suicidal ideation and suicidal behaviour have been reported during paroxetine therapy or early after treatment discontinuation (see section 4.4).
Cases of aggression were observed in post marketing experience.
These symptoms may also be due to the underlying disease

Nervous system disorders
Common: dizziness, tremor, headache, concentration impaired.
Uncommon: extrapyramidal disorders.

9/15
Rare: convulsions, restless legs syndrome (RLS).
Very rare: serotonin syndrome (symptoms may include agitation, confusion, diaphoresis, hallucinations, hyperreflexia, myoclonus, shivering, tachycardia and tremor).
Reports of extrapyramidal disorder 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.
Uncommon: mydriasis (see section 4.4).
Very rare: acute glaucoma.

Ear and labyrinth disorders
Not known: tinnitus.
Cardiac disorders
Uncommon: sinus tachycardia.
Rare: bradycardia.

Vascular disorders
Uncommon: transient increases or decreases in blood pressure, postural hypotension.
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, vomiting, dry mouth.
Very rare: gastrointestinal bleeding.
Not known: colitis microscopic.
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 and subcutaneous tissue disorders
Common: sweating.
Uncommon: skin rashes, pruritus
Very rare: severe cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis), urticaria, photosensitivity reactions.

Renal and urinary disorders
Uncommon: urinary retention, urinary incontinence.

Reproductive system and breast disorders
Very common: sexual dysfunction.
Rare: hyperprolactinaemia/galactorrhoea, menstrual disorders (including menorrhagia, metorrhagia, amenorrhoea, menstruation delayed and menstruation irregular)
Very rare: priapism.
Not known: postpartum haemorrhage


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Postpartum haemorrhage has been reported for the therapeutic class of SSRIs/SNRIs (see sections 4.4 and 4.6).

Musculoskeletal and connective tissue disorders
Rare: arthralgia, myalgia
Epidemiological studies, mainly conducted in patients 50 years of age and older, show an increased risk of bone fractures in patients receiving SSRIs and TCAs. The mechanism leading to this risk is unknown.

General disorder 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, electric shock sensations and tinnitus), 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 should be carried out (see sections 4.2 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
Additionally, you should also report to GSK Israel (il.safety@gsk.com)