Paroxetin-BP

Paroxetinum

Each film-coated tablet of Paroxetin-BP 20 mg contains paroxetine 20 mg (as paroxetine hydrochloride hemihydrate).

Indication: Treatment of: major depressive episodes; obsessive-compulsive disorder; panic disorder, with or without agoraphobia; social anxiety disorder/social phobia; generalised anxiety disorder; post-traumatic stress disorder.

Known hypersensitivity to paroxetine or to any of the excipients listed in section 6.1. • Paroxetine is contraindicated in combination with monoamine oxidase inhibitors (MAOIs). In exceptional circumstances, linezolid (an antibiotic which is a reversible non-selective MAOI) may be given concomitantly with paroxetine provided that facilities are available for close observation of symptoms of serotonin syndrome and monitoring of blood pressure (see section 4.5). Treatment with paroxetine may be started: − two weeks after stopping treatment with an irreversible MAOI, or − at least 24 hours after stopping treatment with a reversible MAOI (e.g. moclobemide, linezolid, methylthioninium chloride [methylene blue; a pre-operative marking agent which is a reversible non-selective MAOI]). At least one week must elapse between discontinuation of paroxetine and initiation of treatment with any MAOI. • Paroxetine must not be used in combination with thioridazine, since, like other medicinal products that inhibit the hepatic enzyme CYP450 2D6, it can cause elevated plasma concentrations of thioridazine (see section 4.5, Interaction with other medicinal products and other forms of interaction). Thioridazine administered alone can lead to QTc-interval prolongation, associated with serious ventricular arrhythmias such as torsade de pointes and sudden death. • Paroxetine must not be used in combination with pimozide (see section 4.5). • Children and adolescents under 18 years of age.

Treatment with paroxetine should be initiated with caution, two weeks after stopping treatment with an irreversible MAOI, or 24 hours after stopping treatment with a reversible MAO inhibitor. The dose of paroxetine should be increased gradually until an optimal response is achieved (see section 4.3 Contraindications and section