Rizatriptan Sigillata Disper 10 mg

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

RIZATRIPTANBENZOAAT SAMENSTELLING overeenkomend met ; RIZATRIPTAN

Beschikbaar vanaf:

Sigillata Limited Block A, 15 Castleforbes Square, Sheriff Street DUBLIN 1 (IERLAND)

ATC-code:

N02CC04

INN (Algemene Internationale Benaming):

RIZATRIPTANBENZOAAT COMPOSITION corresponding to ; RIZATRIPTAN

farmaceutische vorm:

Orodispergeerbare tablet

Samenstelling:

ARABISCHE GOM (E 414) ; ASPARTAAM (E 951) ; CALCIUMSILICAAT (E 552) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; MAGNESIUMSTEARAAT (E 470b) ; MALTODEXTRINE ; MANNITOL (D-) (E 421) ; PEPERMUNTSMAAKSTOF AF 1971 Alexander Flavours ; SILICIUMDIOXIDE (E 551),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Rizatriptan

Product samenvatting:

Hulpstoffen: ARABISCHE GOM (E 414); ASPARTAAM (E 951); CALCIUMSILICAAT (E 552); CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); MAGNESIUMSTEARAAT (E 470b); MALTODEXTRINE; MANNITOL (D-) (E 421); PEPERMUNTSMAAKSTOF AF 1971 Alexander Flavours; SILICIUMDIOXIDE (E 551);

Autorisatie datum:

2011-08-18

Bijsluiter

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
RIZATRIPTAN SIGILLATA DISPER 10 MG
(RIZATRIPTAN)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
−
Keep this leaflet. You may need to read it again.
−
If you have further questions, ask your doctor or pharmacist.
−
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
−
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What /.../ is and what it is used for
2.
What you need to know before you take /.../
3.
How to take /.../
4.
Possible side effects
5.
How to store /.../
6.
Contents of the pack and other information
1.
WHAT /.../ IS AND WHAT IT IS USED FOR
/.../ belongs to a class of medicines called selective serotonin
5-HT1B/1D receptor agonists.
Your doctor has prescribed /.../ to treat the headache phase of your
migraine attack.
Treatment with /.../ reduces swelling of blood vessels surrounding the
brain. This swelling results in
the headache pain of a migraine attack.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE /.../
DO NOT TAKE /.../ IF:
-
you are allergic to rizatriptan benzoate or any of the other
ingredients of this medicine (listed in
section 6)
-
you have moderately severe or severe high blood pressure, or mild high
blood pressure that is
not controlled by medication
-
you have or have ever had heart problems including heart attack or
pain on the chest (angina) or
you have experienced heart disease related signs
-
you have severe liver or severe kidney problems
-
you have had a stroke (cerebrovascular accident CVA) or mini stroke
(transient ischaemic
attack TIA)
-
you have blockage problems with your arteries (peripheral vascular
disease)
-
you are taking monoamine oxidase (MAO) inhibitors such as moclobemide,
phenelzine,
tranylcypromine, or pargyl

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Rizatriptan Sigillata Disper 10 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each /…/ 10 mg orodispersible tablet contains 10 mg rizatriptan as
14.53 mg of rizatriptan benzoate.
Excipient with known effect: Each tablet contains 8.8 mg aspartame.
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Orodispersible tablets.
/…/ 10 mg orodispersible tablets are white, round, 9 mm in diameter,
flat, bevel-edged tablets, with
“IZ 10” engraved on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Acute treatment of the headache phase of migraine attacks, with or
without aura.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
/.../ should not be used prophylactically.
Adults 18 years of age and older
The recommended dose is 10 mg.
_ _
_Redosing:_ doses should be separated by at least two hours; no more
than two doses should be taken in
any 24-hour period.
-
_for headache recurrence within 24 hours_: if headache returns after
relief of the initial attack, one
further dose 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. Therefore, if a patient does
not respond to the first dose, a second dose should not be taken for
the same attack.
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.
Some patients should receive the lower (5 mg) dose of /.../
orodispersible tablets, in particular the
following patient groups:
-
Patients on propranolol. Administration of rizatriptan should be
separated by at least two hours
from administration of propranolol (see section 4.5).
-
Patients with mild or moderate renal insufficiency.
-
Patients with mild to moderate hepatic insufficiency.
Doses should be separated by at least two hours; no more than two
doses