RIZATRIPTAN ACT rizatriptan (as benzoate) 5 mg orodispersible tablet blister pack

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

rizatriptan benzoate, Quantity: 7.265 mg (Equivalent: rizatriptan, Qty 5 mg)

Commercializzato da:

Medis Pharma Pty Ltd

INN (Nome Internazionale):

rizatriptan benzoate

Forma farmaceutica:

Tablet, orally disintegrating

Composizione:

Excipient Ingredients: calcium silicate; aspartame; magnesium stearate; mannitol; crospovidone; microcrystalline cellulose; colloidal anhydrous silica; Flavour

Via di somministrazione:

Oral

Confezione:

2, 3, 6

Tipo di ricetta:

(S4) Prescription Only Medicine

Indicazioni terapeutiche:

RIZATRIPTAN ACT is indicated for the acute treatment of migraine attacks with or without aura.

Dettagli prodotto:

Visual Identification: White, round, flat, bevel-edged tablet embossed with "IZ 5" on one side and plain on the other side; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius

Stato dell'autorizzazione:

Licence status A

Data dell'autorizzazione:

2015-02-19

Scheda tecnica

1
AUSTRALIAN PRODUCT INFORMATION –
RIZATRIPTAN ACT (RIZATRIPTAN BENZOATE)
1
NAME OF THE MEDICINE
Rizatriptan benzoate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orodispersible tablet contains 7.265 of rizatriptan benzoate
(corresponding to 5 mg of
rizatriptan, respectively).
Ingredients with known effects: aspartame.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
5 mg orodispersible tablet - White, round, flat, bevel-edged tablet
embossed with “IZ 5” on one
side and plain on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
RIZATRIPTAN ACT is indicated for the acute treatment of migraine
attacks with or without
aura.
4.2
DOSE AND METHOD OF ADMINISTRATION
The recommended dose is 10 mg. Clinical experience has shown that this
dose provides the
optimal clinical benefit.
Onset of relief (i.e., reduction of headache pain to mild or none) can
occur within 30 minutes
after dosing.
_Re-dosing: _Doses should be separated by at least 2 hours; no more
than 30 mg should be
taken in any 24-hour period.

_for headache recurrence within 24 hours: _If headache returns after
relief of the initial
attack, further doses may be taken. The above dosing limits should be
observed.

_after non-response: _The effectiveness of a second dose for treatment
of the same
attack, when an initial dose is ineffective, has not been examined in
controlled trials.
–
Clinical studies have shown that patients who do not respond to
treatment of an
attack are still likely to respond to treatment for subsequent
attacks.
_Patients receiving propranolol: _Plasma concentrations of rizatriptan
may be increased by
concomitant administration of propranolol (see Section 4.5
Interactions with Other Medicines
and Other Forms of Interactions_). _The 10 mg dose is not appropriate
for these patients. The
physician should consider alternative therapies for these patients,
for example, other 5-
HT
1B/1D
agonists that do not have this drug interaction.
RIZATRIPTAN ACT is a rapidly dissolvi