Zonisamide Accord 50 mg hard capsules

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Zonisamide

Disponible des:

Accord Healthcare Ireland Ltd.

Codi ATC:

N03AX; N03AX15

Designació comuna internacional (DCI):

Zonisamide

Dosis:

50 milligram(s)

formulario farmacéutico:

Capsule, hard

Área terapéutica:

Other antiepileptics; zonisamide

Estat d'Autorització:

Not marketed

Data d'autorització:

2016-04-15

Fitxa tècnica

Health Products Regulatory Authority
21 June 2019
CRN008KJ7
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zonisamide Accord 50 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 50 mg of zonisamide.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsules.
White to off-white granular powder in hard capsules, size 3 (15.9 mm x
5.82 mm), with a white to off‑white capsule body and a
grey capsule cap. The cap is imprinted with “A735” in black ink.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Zonisamide Accord is indicated as:
- monotherapy in the treatment of partial seizures, with or without
secondary generalisation, in adults with newly diagnosed
epilepsy (see section 5.1).
- adjunctive therapy in the treatment of partial seizures, with or
without secondary generalisation, in adults, adolescents, and
children aged 6 years and above.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
_ _
_Dosageescalation and maintenance_
Zonisamide Accord may be taken as monotherapy or added to existing
therapy in adults. The dose should be titrated on the
basis of clinical effect. Recommended escalation and maintenance doses
are given in Table 1. Some patients, especially those
not taking CYP3A4-inducing agents, may respond to lower doses.
_Withdrawal_
When Zonisamide Accord treatment is to be discontinued, it should be
withdrawn gradually (see section 4.4). In clinical studies
of adult patients, dose reductions of 100 mg at weekly intervals have
been used with concurrent adjustment of other
antiepileptic medicine doses (where necessary).
_Table 1. Adults – recommended dosage escalation and maintenance
regimen_
TREATMENT
REGIMEN
TITRATIONPHASE
​
​
USUALMAINTENANCE
DOSE
MONOTHERAPY - Newly diagnosed adult patients
WEEK 1 +2
WEEK 3 +4
WEEK 5 +6
300 mg per day
(once a day).
If a higher dose is
required: increase
at
two-weekly
intervals in
increments of 100
mg
Health Products Regulatory Authority
21 June 2019
C