LORIEN Capsule / Tablet Ref.[115290] Active ingredients: Fluoxetine

Posology

Adults

Major depressive episodes

A dose of 20 mg (one capsule or tablet) per day is recommended, preferably in the morning. Doses of up to 80 mg (four capsules or tablets) daily in divided doses may be employed if necessary.

Bulimia nervosa

A dose of 60 mg (three capsules or tablets) per day is recommended.

Obsessive-compulsive disorder

A dose of 20 mg to 60 mg (one to three capsules or tablets) per day is recommended.

Doses above 80 mg (four capsules or tablets) per day are not recommended for any indication.

Special populations

Elderly population

The effect of age upon the metabolism of LORIEN has not been fully investigated. LORIEN should be used with caution in the elderly, particularly if they have systemic illnesses or are receiving multiple medicines for concomitant diseases Dosages over 20 mg (one capsule or tablet) per day are not recommended.

Renal impairment

Lower doses or alternate-day dosing are recommended in patients with significant renal impairment.

Hepatic impairment

Lower doses or alternate-day dosing are recommended in patients with significant hepatic impairment.

Paediatric population

The safety and efficacy of LORIEN in children have not been established (see section 4.4)

Method of administration

For oral administration.

LORIEN may be administered with or without food. The tablets may be swallowed whole or be dispersed in approximately 100 ml of water.

Withdrawal symptoms seen on discontinuation of LORIEN: Abrupt discontinuation should be avoided. When stopping treatment with LORIEN, the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of withdrawal reactions (see section 4.4). If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the medical practitioner may continue to decrease the dose, but at a more gradual rate.

Discontinuation of LORIEN may lead to withdrawal symptoms, including dizziness, paraesthesia, headache, insomnia, tremor, confusion, sensory disturbances, agitation, anxiety and nausea (see section 4.4).

Symptoms

Cases of overdose of LORIEN alone usually have a mild course.

Symptoms of overdose included nausea, vomiting, seizures, cardiovascular dysfunction ranging from asymptomatic dysrhythmias to cardiac arrest (including nodal rhythm and ventricular dysrhythmias) or ECG changes indicative of QTc prolongation to cardiac arrest (including very rare cases of Torsade de Pointes), pulmonary dysfunction and signs of altered CNS status ranging from excitation to coma.

Fatality attributed to overdose of LORIEN alone has been extremely rare.

Treatment

Treatment of overdosage is symptomatic and supportive.

Cardiac and vital signs monitoring is recommended

There are no specific antidotes for LORIEN.

Due to the large volume of distribution of LORIEN, forced diuresis, dialysis, haemoperfusion and exchange transfusions are unlikely to be of benefit.

Activated charcoal, which may be used with sorbitol, may be as or more effective than emesis. In managing overdosage, consider the possibility of multiple medicines involvement. An extended time for close medical observation may be needed in patients who have taken excessive quantities of a tricyclic antidepressant if they are also taking or have recently taken LORIEN.

LORIEN:

49 months securitainer
24 months blister
15 months metalised patient ready packs

LORIEN TABLETS:

24 months

Store at or below 25°C.

Protect from light and moisture.

Keep the plastic container tightly closed.

Keep in original packaging until required for use.

LORIEN: 28 and 112 capsules are packed in a clear, polyvinylchloride/polyethylene/Aclar blister strip sealed with an aluminium foil backing. The blister strips are packed into an outer cardboard carton together with a leaflet.

The capsules are packed in a white polypropylene container with a white, round, flat-topped linear low density polyethylene cap, with ridges on the side and a tamper evident seal, together with a silica gel sachet and a leaflet.

The capsules are packed in a metallised polyester/laminant/opaque white linear low density polyethylene lay flat bag with a low density polyethylene zip.

LORIEN TABLETS: 28 or 30 tablets are packed in a clear polyvinylchloride/polyethylene/Aclar blister strip sealed with an aluminium foil backing. The blister strips are packed into an outer cardboard carton together with a leaflet.

28 or 30 tablets are packed in a white polypropylene container with a linear low density polyethylene tamper proof snap cap together with a white foam insert or silica gel sachet and a leaflet.

Not all packs and pack sizes are necessarily marketed.

No special requirements.