CYMGEN Delayed release capsule Ref.[115346] Active ingredients: Duloxetine

Posology

Depression

CYMGEN should be initiated and maintained at a dose of 60 mg once daily without regard to meals. Although doses up to 120 mg per day have been used, the efficacy of the 120 mg dose was not statistically different from that of the 60 mg once daily dose and the adverse event rate was higher with the 120 mg dose.

Therapeutic response is usually seen after 2 to 4 weeks of treatment.

Diabetic peripheral neuropathic pain

CYMGEN should be administered at a dose of 60 mg once daily without regard to meals. Although doses up to 120 mg per day have been used the efficacy of the 120 mg dose was not statistically different from that of the 60 mg once daily dose and the adverse event rate was higher with the 120 mg dose.

Response to treatment should be evaluated after 2 months. In patients with inadequate initial response, additional response after this time is unlikely. The therapeutic benefit should be reassessed regularly (at least every three months).

Special populations

Renal impairment

Initial dose should be 30 mg once daily in patients with mild to moderate impairment of renal function (see sections 4.3, 4.4, and 5.2).

Hepatic impairment

Initial dose should be 30 mg once daily in patients with mild to moderate impairment of hepatic function (see sections 4.3, 4.4, and 5.2).

Elderly

No dosage adjustment is recommended for elderly patients on the basis of age. However, caution should be exercised when treating the elderly, especially with 120 mg of CYMGEN per day for depression, for which data are limited (see sections 4.4 and 5.2).

Paediatric population

CYMGEN is not indicated for use in patients under 18 years of age (see section 4.3).

Discontinuation of treatment

Abrupt discontinuation should be avoided. Symptoms associated with discontinuation of CYMGEN, and other selective serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs) have been reported. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. When stopping treatment with CYMGEN 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 sections 4.4 and 4.8).

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 practitioners may continue decreasing the dose, but at a more gradual rate.

Method of administration

For oral use.

Symptoms

Cases of acute ingestions with duloxetine, as in CYMGEN up to 5 400 mg, alone or in combination with other medicines, were reported, none being fatal.

In post marketing experience, fatal outcomes have been reported for acute overdoses, primarily with mixed overdoses, but also with duloxetine only, at doses as low as approximately 1 000 mg. Signs and symptoms of overdose (CYMGEN alone or with mixed medicines) included serotonin syndrome, somnolence, vomiting, coma, tachycardia and seizures. The predicted signs would be related to the central nervous and gastrointestinal systems (e.g. tremors, chronic convulsions, ataxia, emesis and decreased appetite).

Treatment

No specific antidote is known, but if serotonin syndrome ensues, specific treatment, (such as with cyproheptadine and/or temperature control) may be considered. An airway should be established. Monitoring of cardiac and vital signs is recommended, along with appropriate symptomatic and supportive measures. Activated charcoal may be useful in limiting absorption. CYMGEN has a large volume of distribution and forced diuresis, haemoperfusion and exchange perfusion are unlikely to be beneficial.

24 months.

Store at or below 30°C in blister packs.

CYMGEN capsules are supplied in blister packs composed of cold-form aluminium laminate on one side and aluminium foil on the other side and packed in cartons of 28 capsules.

No special requirements.