They usually occur within the first few days of discontinuing treatment, but there have been very rare reports of such symptoms in patients who have inadvertently missed a dose. Insulin and/or oral hypoglycaemic dosage may need to be adjusted. In addition, long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking.Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events). Due to the narrow therapeutic index of pimozide and its known ability to prolong QT interval, concomitant use of pimozide and paroxetine is contraindicated (see Section 4.3 Contraindications).The metabolism and pharmacokinetics of paroxetine may be affected by the induction or inhibition of drug metabolising enzymes.When paroxetine is to be co–administered with a known drug metabolising enzyme inhibitor, consideration should be given to using paroxetine doses at the lower end of the range.No initial dosage adjustment is considered necessary when the drug is to be co–administered with known drug metabolising enzyme inducers (e.g. The occurrence of withdrawal symptoms is not the same as the drug being addictive or dependence producing.The risk of withdrawal symptoms may be dependent on several factors including the duration and dose of therapy and the rate of dose reduction.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. In addition, these conditions may be co-morbid with major depressive disorder. A dangerous drug interaction could occur. If after some weeks on the recommended dose insufficient response is seen some patients may benefit from having their dose increased gradually up to a maximum of 60 mg / day.Patients with OCD should be treated for a sufficient period to ensure that they are free from symptoms. Paroxetine should be discontinued in any patient entering a manic phase.Caution is recommended in patients with severe renal impairment or in those with hepatic impairment. Discontinuation of paroxetine should be considered if there is prolonged elevation of liver function test results.Very rare: severe cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis), urticarial, photosensitivity reactions.Rare: hyperprolactinaemia/galactorrhoea, menstrual disorders (including menorrhagia, metrorrhagia, amenorrhoea, menstruation delayed and menstruation irregular).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. Paroxetine should only be used during pregnancy when strictly indicated. Elderly patients may be at an increased risk for non-menses related events of bleeding. Due to first-pass metabolism, the amount of paroxetine available to the systemic circulation is less than that absorbed from the gastrointestinal tract.
Do not take two doses at one time.Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. The prescribing physician will need to weigh the option of alternative treatments in women who are pregnant or are planning to become pregnant. ]Hyponatraemia has been reported predominantly in elderly patients and is sometimes due to syndrome of inappropriate anti–diuretic hormone secretion (SIADH).Common: somnolence, insomnia, agitation, abnormal dreams (including nightmares).Rare: manic reactions, anxiety, depersonalisation, panic attacks, akathisia (see section 4.4).Frequency not known: suicidal ideation, suicidal behavior and 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.Common: dizziness, tremor, headache, concentration impaired.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.Uncommon: mydriasis (see section 4.4 Special warnings and precautions for use).Uncommon: transient increases or decreases of blood pressure, postural hypotension.Transient increases or decreases in blood pressure have been reported following treatment with paroxetine, usually in patients with pre-existing hypertension or anxiety.Common: constipation, diarrhoea, vomiting, dry mouth.Very rare: hepatic events (such as hepatitis, sometimes associated with jaundice and/or liver failure).Elevation of hepatic enzymes have been reported. If, based on clinical need, a decision to treat is nevertheless taken, the patient should be carefully monitored for the appearance of suicidal symptoms. Abrupt discontinuation should be avoided during pregnancy (see “Withdrawal Symptoms Seen on Discontinuation of Paroxetine”, section 4.2 Posology and method of administration).Neonates should be observed if maternal use of paroxetine continues into the later stages of pregnancy, particularly the third trimester.The following symptoms may occur in the neonate after maternal paroxetine use in later stages of pregnancy: respiratory distress, cyanosis, apnoea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycaemia, hypertonia, hypotonia, hyperreflexia, tremor, jitteriness, irritability, lethargy, constant crying, somnolence and difficulty in sleeping. The maximum licensed dose for the treatment of generalized anxiety disorder (GAD) is 50 mg/day.