XANDOL 20TAB

Each film coated tablet contains: Paroxetine hydrochloride hemihydrate 22.76 mg equivalent to 20 mg Paroxetine.

42.00 EGP

Out of stock

XANDOL 20TAB; paroxetine, antidepressants .

ACTIVE-INGREDIENT OF XANDOL 20TAB

Each film coated tablet contains: Paroxetine hydrochloride hemihydrate 22.76 mg equivalent to 20 mg Paroxetine.

INDICATION OF XANDOL 20TAB

Treatment of : Major Depressive episodes. Obsessive Compulsive Disorder. Panic Disorder with and without agoraphobia. Social Anxiety Disorders/Social phobia. Generalised Anxiety Disorder. Post-traumatic Stress Disorder.

DOSAGE OF XANDOL 20TAB

Follow all directions given to you by your pharmacist or doctor carefully . They may differ from the information contained in this leaflet

Ask your pharmacist or doctor for help if you do not understand the instructions on the box .

The recommended dose is : –

It is recommended that Paroxetine be administered once daily in the morning with food. The tablet should be swallowed rather than chewed. Major depressive episode : The recommended dose is 20 mg daily. In general, improvement in patients starts after one week but may only become evident from the second week of therapy. As with all antidepressant medicinal products, dosage should be reviewed and adjusted if necessary within 3 to 4 weeks of initiation of therapy and thereafter as judged clinically appropriate. In some patients, with insufficient response to 20 mg, the dose may be increased gradually up to a maximum of 50 mg a day in 10 mg steps according to the patient’s response. Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free from symptoms. Obsessive-compulsive disorder: The recommended dose is 40 mg daily. Patients should start on 20 mg/day and the dose may be increased gradually in 10 mg increments to the recommended dose. 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. This period may be several months or even longer. Panic disorder : The recommended dose is 40 mg daily. Patients should start on 20 mg/day and the dose gradually increased in 10 mg steps according to the patient’s response up to the recommended dose. A low initial starting dose is recommended to minimise the potential worsening of panic symptomatology, which is generally recognised to occur early in the treatment of this disorder. If after some weeks 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 panic disorder should be treated for a sufficient period to ensure that they are free from symptoms. This period may be several months or even longer. Social anxiety disorder / social phobia: The recommended dose is 20 mg daily. If after some weeks on the recommended dose insufficient response is seen some patients may benefit from having their dise increased gradually in 10 mg steps up to a maximum of 50 mg/day. Long-term use should be regularly evaluated. Generalized anxiety disorder: The recommended dose is 20 mg daily. If after some weeks on the recommended dose insufficient response is seen some patients may benefit from having their dise increased gradually in 10 mg steps up to a maximum of 50 mg/day. Long-term use should be regularly evaluated. Post-traumatic stress disorder: The recommended dose is 20 mg daily. If after some weeks on the recommended dose insufficient response is seen some patients may benefit from having their dise increased gradually in 10 mg steps up to a maximum of 50 mg/day. Long-term use should be regularly evaluated. General information : Withdrawal symptoms seen on discontinuation of paroxetine: Abrupt discontinuation should be avoided. The taper phase regimen used in clinical trials involved decreasing the daily dose by 10 mg at weekly intervals, If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose, but at a more gradual rate. Special populations: Elderly: Increased plasma concentrations of paroxetine occur in elderly subjects, but the ramge of concentrations overlaps with that observed in younger subjects. Dosing should commence at the adult starting doe . Increasing the dose might be useful in some patients, but the maximum dose should not exceed 40 mg daily. Children and adolescents (7-17 years): Paroxetine should not be used for the treatment of children and adolescents as controlled clinical trials have found paroxetine to be associated with increased risk for suicidal behaviour and hostility. In addition, in these trials efficacy has not been adequately demonstrated. Children aged below 7 years: The use of paroxetine has not been studied in children less than 7 years. Paroxetine should not be used, as long as safety and efficacy in this age group have not been established. Renal/hepatic impairment: Increased plasma concentrations of paroxetine occur in patients with severe renal impairment (creatinine clearance less than 30 ml/min) or in those with hepatic impairment. Therefore, dosage should be restricted to the lower end of the dosage range.

OVER-DOSAGE OF XANDOL 20TAB

Symptoms and signs: A wide margin of safety is evident from available overdose information on paroxetine. Experience of paroxetine in overdose has indicated that, in addition to those symptoms mentioned, fever and involuntary muscle contractions have been reported. Patients have generally recovered without serious sequelae even when doses of up to 2000 mg have been taken alone. Events such as coma or ECG changes have occasionally been reported andf, very rarely with a fatal outcome, but generally when paroxetine was taken in conjunction with other psychotropic drugs, with or without alcohol. Treatment: No specific antidote is known . The treatment should consist of those general measures employed in the management of overdose with any antidepressant. Administration of 20-30 g activated charcoal may be considered if possible within a few hours after overdose intake to decrease absorption of paroxetine . Supportive care with frequent monitoring of vital signs and careful observation is indicated. Patient management should be as clinically indicated.

CONTRA-INDICATION OF XANDOL 20TAB

Known hypersensitivity to paroxetine or any of the excipients. Paroxetine is contraindicated in combination with monoamine oxidase inhibitors (MAOIs), In exceptional circumstances, linezolid (an antibiotic which is a reversible nonselective MAOI) can be given in combination with paroxetine provided that there are facilities for close observation of symptoms of serotonin syndrome and monitoring of blood pressure. Treatment with paroxetine can be initiated: Two weeks after discontinuation of an irreversible MAOI. At least 24 hrs after discontinuation of a reversible MAOI (e.g. moclobemide, linezolid). At least one week should elapse between discontinuation of paroxetine and initiation of therapy with any MAOI. Paroxetine should not be used in combination with thioridazine, because, as with other drugs which inhibit the hepatic enzyme CYP450 2D6, paroxetine can elevate plasma levels of thioridazine. Administration of thioridazine alone can lead to QTc interval prolongation with associated serious ventricular arrhythmia such as torsades de pointes, and sudden death. Paroxetine should not be used in combination with pimozlde.

STORAGE OF XANDOL 20TAB

Store at temperature not exceeding 30 ° C, in a dry place. Keep out of reach of children.
PACK OF XANDOL 20TAB
Carton box containing 1 or 2 (AL/PVDC) strips each of 10 tablets and inner leaflet.
XANDOL 20TAB MANUFACTURED BY
EUROPEAN EGYPTIAN PHARMACEUTICAL INDUSTRIES ALEXANDRIA – EGYPT

https://www.webmd.com/drugs/2/drug-6969-9095/paroxetine-oral/paroxetine-oral/details

https://www.gardeniapharmacy.com/category/medicine-2/

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