LEXAMIL Film-coated tablet Ref.[115213] Active ingredients: Escitalopram

Adults

Major depressive episodes

In otherwise healthy adult patients LEXAMIL should be administered as a single oral dose of 10 mg daily. This dose may be increased to a maximum of 20 mg daily depending on individual patient response. It usually takes 2 to 4 weeks for an antidepressant response to become evident.

Panic disorder with or without agoraphobia

A single oral 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 obtained after about 3 months and the treatment lasts several months.

Social anxiety disorder

Usual dose is 10 mg once daily. This dose may be increased to a maximum of 20 mg daily depending on individual patient response. Usually, 2 to 4 weeks of treatment are necessary to obtain symptom relief. Treatment for three 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.

Generalised anxiety disorder

The recommended dosage is 10 mg once daily. The dose may be increased to a maximum of 20 mg daily depending on individual patient response. Long-term treatment of responders has been studied for at least 6 months and can be considered on an individual basis to prevent relapse.

Obsessive-compulsive disorder

Usual dose is 10 mg once daily. The dose may be increased to a maximum of 20 mg daily depending on individual patient response. Long-term treatment of patients responding to a 16-week open treatment phase has been studied for at least 24 weeks in patients receiving 10 mg or 20 mg a day. Because OCD is a chronic disease, patients should be treated for a sufficient period to ensure that they are symptom free, which may be several months or even longer.

Elderly patients (>65 years of age)

Lower initial and maximum dosages should be considered in elderly patients due to a longer half-life and a decreased clearance.

Children and adolescents (<18 years of age)

Safety and efficacy have not been investigated in this population (see “CONTRAINDICATIONS”).

Reduced renal function

It is not necessary to adjust the dosage in patients who suffer from mild or moderate renal impairment. No information is available on the treatment of patients who have severe renal impairment (creatinine clearance <30 mL/min).

Reduced hepatic function

In patients who have hepatic impairment, dosages should be halved to the lower end of the dose range.

LEXAMIL is given as a single daily dose.

LEXAMIL may be taken with or without food.

Discontinuation of treatment

When LEXAMIL is to be discontinued, gradual dose reduction should be considered. Abrupt discontinuation of LEXAMIL should be avoided. When discontinuing LEXAMIL the dose should be gradually reduced over a period of at least one to two weeks, thereby reducing the risk of discontinuation symptoms (see “WARNINGS AND SPECIAL PRECAUTIONS” and “SIDE-EFFECTS”). Should unpleasant symptoms occur following treatment discontinuation or when the dose is decreased, then the doctor may consider resuming the previously prescribed dose. Thereafter, the doctor may continue decreasing the dose, but more gradually.

Symptoms

Doses of 190 mg have been ingested without any reports of adverse reactions.

Treatment

LEXAMIL does not have a specific antidote. Treatment of an overdose is supportive and symptomatic.

Management should include monitoring of cardiac and vital signs along with general symptomatic supportive measures.

Store at or below 30ºC.

Keep the blisters in the outer carton until required for use.

KEEP OUT OF REACH OF CHILDREN.

LEXAMIL 5: Outer carton containing Aluminium foil/PVC/PVDC blister strips of 10 tablets packed in 30’s.

LEXAMIL 10: Outer carton containing Aluminium foil/PVC/PVDC blister strips of 10 tablets packed in 30’s.

LEXAMIL 20: Outer carton containing Aluminium foil/PVC/PVDC blister strips of 10 tablets packed in 30’s.