NEOFORDEX Tablet Ref.[6767] Active ingredients: Dexamethasone

Treatment must be initiated and monitored under the supervision of physicians experienced in the management of multiple myeloma.

Posology

The dose and administration frequency varies with the therapeutic protocol and the associated treatment(s). Neofordex administration should follow instructions for dexamethasone administration when described in the Summary of Product Characteristics of the associated treatment(s). If this is not the case, local or international treatment protocols and guidelines should be followed. Prescribing physicians should carefully evaluate which dose of dexamethasone to use, taking into account the condition and disease status of the patient.

The usual posology of dexamethasone is 40 mg once per day of administration. At the end of dexamethasone treatment, the dose should be tapered in a stepwise fashion until a complete stop.

Elderly

In elderly and/or frail patients, the daily dose may be reduced to 20 mg of dexamethasone, according to the appropriate treatment regimen.

Hepatic impairment or renal insufficiency

Patients with hepatic impairment or renal insufficiency require appropriate monitoring; patients with hepatic impairment should be dosed with caution as there are no data for this patient population (see sections 4.4 and 5.2).

Paediatric population

There is no relevant use of Neofordex in the paediatric population in the indication multiple myeloma.

Method of administration

Oral use.

In order to minimise insomnia, the tablet should preferably be taken in the morning.

Tablets should be kept in the blister package until administration. Individual tablets in intact packaging should be separated from the blister using the perforation, e.g. for use in multi-compartment compliance aids.

Tablets may be broken in two equal halves using the score line to provide the 20 mg dose. Due to possible stability issues affecting half tablets stored after division, half-tablets that are not taken immediately should be discarded in agreement with local precautions for environmental protection (see also 6.4).

Acute toxicity of dexamethasone is weak and toxic effects have rarely been observed after an acute overdose.

No antidote exists and treatment is symptomatic.

3 years.

This medicinal product does not require any special storage conditions.

Tablets should be kept in the blister package until administration. Individual tablets in intact packaging should be separated from the blister using the perforation, e.g. for use in multi-compartment compliance aids.

Halved tablets that are not taken immediately should be disposed of (see section 6.6).

10 × 1 tablets in OPA/Aluminium/PVC-Aluminium perforated unit dose blister. Pack size of 10 tablets.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Advise patients to not dispose of unused tablets through household waste or wastewater.