LEPAX FILM-COATED TABLET 10MG [SIN13780P]

Product Info

LEPAX FILM-COATED TABLET 10MG

[SIN13780P]

4.1 Therapeutic indications
Treatment of major depressive episodes.
Treatment of panic disorder with or without agoraphobia.
Treatment of generalised anxiety disorder.
Treatment of obsessive-compulsive disorder.

4.2 Posology and method of administration
Safety of daily doses above 20 mg has not been demonstrated.
Lepax is administered as a single daily dose and may be taken with or without food.

Major depressive episodes
Usual dosage is 10 mg once daily. Depending on individual patient response, the dose may be increased to a maximum of 20 mg daily.
Usually 2–4 weeks are necessary to obtain antidepressant response. After the symptoms resolve, treatment for at least 6 months is required for consolidation of the response.

Panic disorder with or without agoraphobia
An initial dose of 5 mg is recommended for the first week before increasing the dose to 10 mg daily. The dose may be further increased, up to a maximum of 20 mg daily, dependent on individual patient response.
Maximum effectiveness is reached after about 3 months. The treatment lasts several months.

Generalised anxiety disorder
Usual dosage is 10 mg once daily. Depending on individual patient response, the dose may be increased to a maximum of 20 mg daily.

Treatment for 3 months is recommended to consolidate response. Long-term treatment of responders for 6 months has been shown to prevent relapse and can be considered on an individual basis; treatment benefits should be re-evaluated at regular intervals.

Obsessive-compulsive disorder (OCD)
Usual dosage is 10 mg once daily. Depending on individual patient response, the dose may be increased to 20 mg daily.

Long-term treatment has been studied for a maximum of 40 weeks. Patients responding to a 16-week open-label treatment phase were randomized to a 24-week placebo-controlled relapse prevention phrase, receiving 10 or 20 mg escitalopram daily. As OCD is a chronic disease, patients should be treated for a sufficient period to ensure that they are symptom free. This period may be several months or even longer.

Elderly patients (> 65 years of age)
Initial treatment with half the usually recommended dose and a lower maximum dose should be considered (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Children and adolescents (<18 years)
Lepax should not be used in the treatment of children and adolescents under the age of 18 years (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Reduced renal function
Dosage adjustment is not necessary in patients with mild or moderate renal impairment. Caution is advised in patients with severely reduced renal function (CL_CR less than 30 ml/min.) (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Reduced hepatic function
An initial dose of 5 mg daily for the first two weeks of treatment is recommended.
Depending on individual patient response, the dose may be increased to 10 mg daily (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Poor metabolisers of CYP2C19
For patients who are known to be poor metabolisers with respect to CYP2C19, an initial dose of 5 mg daily during the first two weeks of treatment is recommended. Depending on individual patient response, the dose may be increased to 10 mg daily (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Discontinuation symptoms
When stopping treatment with Lepax the dose should be gradually reduced over a period of at least one to two weeks in order to avoid possible discontinuations symptoms (see section 4.4 and 4.8 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients, listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Concomitant treatment with non-selective, irreversible monoamine oxidase inhibitors (MAO-inhibitors) (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Concomitant treatment with pimozide.