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Paroksetin

Paroxetine

Film-coated tablets 20 mg; 30 mg                   

ATC N06A B05
Prescription-only medicine
Reimburse by Health Insurance Fund

POSOLOGY AND METHOD OF ADMINISTRATION

Paroxetine film-coated tablets are administered once daily in the morning with the meal. The tablet should be swallowed and not to be chewed.

Depression: the recommended dosage is 20 mg daily. For patients with an inadequate response, the dosage might be increased for 10 mg in two weeks intervals or more. The maximum recommended dosage is 50 mg daily.

Obsessive-compulsive disorder: the recommended dosage is 40 mg daily. The treatment starts with 20 mg daily, and the dosage might be increased for 10 mg in two weeks intervals. The maximum daily dosage is 60 mg.

Panic disorder: the recommended dosage is 40 mg daily. The treatment starts with 10 mg daily and the dosage is increased for 10 mg in two weeks intervals, according to the patient response on the treatment. The dosage might be increased mostly up to 60 mg daily. The low initial dosage is recommended in order to avoid the possible aggravation of the panic symptomatology that comes in the early treatment stage of this disorder.

Social phobia: the recommended dosage is 20 mg daily. In case there is no improvement after two weeks of therapy, the dosage is increased for 10 mg in two weeks intervals. The maximum recommended dosage is 50 mg daily.

Post-traumatic stress disorder: the recommended dosage is 20 mg daily. Patients that do not respond to the therapy of 20 mg daily, the dosage is gradually increased for 10 mg, according to the therapeutic effect of the medicine, up to a maximum dosage of 50 mg daily.

Generalized anxious disorder: the recommended dosage is 20 mg daily. Patients that do not respond to the therapy of 20 mg daily, the dosage is gradually increased for 10 mg, according to the therapeutic effect of the medicine, up to a maximum dosage of 50 mg daily.

Kidney insufficiency: the recommended dosage is 10 mg daily up to a maximum of 40 mg daily. In case the creatinine clearance is smaller than 30 ml/min the minimum dosage should be significantly decreased.

Liver insufficiency: the recommended dosage is 10 mg daily up to a maximum of 40 mg daily. Patients with heavy liver damages might have increased serum concentrations of paroxetine, therefore the minimum dosage should be significantly decreased.

Elderly persons: higher serum concentration and smaller elimination of paroxetine have been noticed in elderly patients compared to younger patients. The recommended dosage is 10 mg daily up to a maximum of 40 mg daily.

Children: it is not recommended administration of paroxetine at children and adolescents up to 18 years of age since the efficiency and safety of the medicine are still in an examination stage.


Medicine’s information on this web page is only a short description of its characteristics. Do not take them as recommendations for self-treatment of your health condition.

You must inform your physician and pharmacist and follow their recommendations before you use the medicine for treatment. Always read carefully the patient information leaflet.

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Description

COMPOSITION

Each film-coated tablet contains paroxetine hydrochloride hemihydrate equivalent to paroxetine 20 mg.
Each film-coated tablet contains paroxetine hydrochloride hemihydrate equivalent to paroxetine 30 mg.

THERAPEUTIC INDICATIONS

Paroxetine is used for the treatment of:
– all types of depression, including reactive and heavy depressions;
– obsessive-compulsive disorder and prevention of its recidives;
– panic disorder with or without agoraphobia and prevention of recidives;
– social phobias;
– post-traumatic stress disorder;
– generalized anxiety disorder.

CONTRAINDICATIONS

Known hypersensitivity to paroxetine or to any of the compound components of the medicine, the concomitant administration with unselective inhibitors of monoamine oxidase (MAO inhibitors).


PACKAGING

Box with 30 film-coated tablets of 20 mg
Box with 30 film-coated tablets of 30 mg