MIRTAZAPINE Orodispersible tablet Ref.[6994] Active ingredients: Mirtazapine

Posology

Adults

The effective daily dose is usually between 15 and 45 mg; the starting dose is 15 or 30 mg.

Mirtazapine begins to exert its effect in general after 1-2 weeks of treatment. Treatment with an adequate dose should result in a positive response within 2-4 weeks. With an insufficient response, the dose can be increased up to the maximum dose. If there is no response within a further 2-4 weeks, then treatment should be stopped.

Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free from symptoms.

It is recommended to discontinue treatment with mirtazapine gradually to avoid withdrawal symptoms (see section 4.4).

Elderly

The recommended dose is the same as that for adults. In elderly patients an increase in dosing should be done under close supervision to elicit a satisfactory and safe response.

Renal impairment

The clearance of mirtazapine may be decreased in patients with moderate to severe renal impairment (creatinine clearance <40 ml/min). This should be taken into account when prescribing Mirtazapine to this category of patients (see section 4.4).

Hepatic impairment

The clearance of mirtazapine may be decreased in patients with hepatic impairment. This should be taken into account when prescribing Mirtazapine to this category of patients, particularly with severe hepatic impairment, as patients with severe hepatic impairment have not been investigated (see section 4.4).

Paediatric population

Mirtazapine should not be used in children and adolescents under the age of 18 years as efficacy was not demonstrated in two short-term clinical trials (see section 5.1) and because of safety concerns (see sections 4.4, 4.8 and 5.1).

Method of administration

Mirtazapine has an elimination half-life of 20-40 hours and therefore Mirtazapine is suitable for once daily administration. It should be taken preferably as a single night-time dose before going to bed. Mirtazapine may also be given in two divided doses (once in the morning and once at night-time, the higher dose should be taken at night).

The tablets should be taken orally. The tablet will rapidly disintegrate and can be swallowed without water.

Present experience concerning overdose with Mirtazapine alone indicates that symptoms are usually mild. Depression of the central nervous system with disorientation and prolonged sedation have been reported, together with tachycardia and mild hyper- or hypotension. However, there is a possibility of more serious outcomes (including fatalities) at dosages much higher than the therapeutic dose, especially with mixed overdoses. In these cases QT prolongation and Torsade de Pointes have also been reported. Cases of overdose should receive appropriate symptomatic and supportive therapy for vital functions. ECG monitoring should be undertaken. Activated charcoal or gastric lavage should also be considered.

Paediatric population

The appropriate actions as described for adults should be taken in case of an overdose in paediatrics.

Shelf life: 3 years.

Do not store above 25°C.

Blister: Store in the original package in order to protect from light and moisture.

Tablet Container: Keep the tablet container tightly closed in order to protect from light and moisture.

Al/Al Blister, pack sizes: 5, 6, 7, 10, 14, 15, 20, 21, 28, 30, 50, 56, 60, 84, 90, 98 and 100 Tablets.

Al/Al Blister with peel off foil, pack sizes: 5, 6, 7, 10, 14, 15, 20, 21, 28, 30, 50, 56, 60, 84, 90, 98 and 100 Tablets.

PP securitainers, pack sizes: 5, 6, 7, 10, 14, 15, 20, 21, 28, 30, 50, 56, 60, 84, 90, 98 and 100 Tablets.

HDPE containers with LDPE caps, pack sizes: 5, 6, 7, 10, 14, 15, 20, 21, 28, 30, 50, 56, 60, 84, 90, 98 and 100 Tablets.

Not all pack sizes or types may be marketed.

No special precautions.