HETLIOZ Hard capsule Ref.[114772] Active ingredients: Tasimelteon

Posology

Dose and timing

The recommended dose is 20 mg (1 capsule) tasimelteon per day taken one hour before bedtime, at the same time every night.

HETLIOZ is intended for chronic use.

Elderly

No dose adjustment is recommended for individuals older than 65 years of age (see section 5.2).

Renal impairment

No dose adjustment is recommended for patients with renal impairment (see section 5.2).

Hepatic impairment

No dose adjustment is necessary for patients with mild or moderate hepatic impairment (see section 5.2). Tasimelteon has not been studied in patients with severe hepatic impairment (Child-Pugh Class C); therefore caution is recommended when prescribing tasimelteon to patients with severe hepatic impairment.

Paediatric population

The safety and efficacy of tasimelteon in children and adolescents aged 0 to 18 years have not been established. No data are available.

Method of administration

Oral use. Hard capsules should be swallowed whole. Avoid breaking as the powder has an unpleasant taste.

Tasimelteon should be taken without food; if patients eat a high-fat meal, it is recommended to wait at least 2 hours before taking tasimelteon (see section 5.2).

There is limited clinical experience with the effects of an overdose of tasimelteon.

As with the management of any overdose, general symptomatic and supportive measures should be used, along with immediate gastric lavage, where appropriate. Intravenous fluids should be administered as needed. Respiration, pulse, blood pressure, and other appropriate vital signs should be monitored, and general supportive measures employed.

While haemodialysis was effective at clearing tasimelteon and the majority of its major metabolites in patients with renal impairment, it is not known if hemodialysis will effectively reduce exposure in the case of overdose.

4 years.

After first opening of the bottle: 30 days.

This medicinal product does not require any special temperature storage conditions.

Store in the original container and keep the bottle tightly closed in order to protect from moisture and light.

High density polyethylene (HDPE) bottle containing 30 hard capsules with polypropylene child-resistant closures containing polypropylene resin induction seals. Each bottle also contains a 1.5 g silica gel desiccant canister and polyester dunnage.

Pack size: 30 hard capsules.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.