Rizatriptan MSD 10 mg, orodispergeerbare tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

RIZATRIPTANBENZOAAT SAMENSTELLING overeenkomend met ; RIZATRIPTAN

Beschikbaar vanaf:

Merck Sharp & Dohme B.V. Waarderweg 39 2031 BN HAARLEM

ATC-code:

N02CC04

INN (Algemene Internationale Benaming):

RIZATRIPTANBENZOAAT COMPOSITION corresponding to ; RIZATRIPTAN

farmaceutische vorm:

Orodispergeerbare tablet

Samenstelling:

ASPARTAAM (E 951) ; DEXTRINE ; GELATINE (E 441) ; GLYCINE (E 640) ; MALTODEXTRINE ; MANNITOL (D-) (E 421) ; PEPERMUNTOLIE ; PEPERMUNTSMAAKSTOF,

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Rizatriptan

Product samenvatting:

Hulpstoffen: ASPARTAAM (E 951); DEXTRINE; GELATINE (E 441); GLYCINE (E 640); MALTODEXTRINE; MANNITOL (D-) (E 421); PEPERMUNTOLIE; PEPERMUNTSMAAKSTOF;

Autorisatie datum:

2013-07-19

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
RIZATRIPTAN MSD 5 MG, ORODISPERGEERBARE TABLETTEN
RIZATRIPTAN MSD 10 MG, ORODISPERGEERBARE TABLETTEN
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 RIZATRIPTAN is and what it is used for
2.
What you need to know before you take RIZATRIPTAN
3.
How to take RIZATRIPTAN
4.
Possible side effects
5.
How to store RIZATRIPTAN
6.
Contents of the pack and other information
1.
WHAT RIZATRIPTAN IS AND WHAT IT IS USED FOR
RIZATRIPTAN belongs to a class of medicines called selective serotonin
5-HT
1B/1D
receptor agonists.
RIZATRIPTAN is used to treat the headache phase of the migraine attack
in adults.
Treatment with RIZATRIPTAN:
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 RIZATRIPTAN_ _
DO NOT TAKE RIZATRIPTAN_ _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 tak

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Rizatriptan MSD 5 mg, orodispergeerbare tabletten
_ _
Rizatriptan MSD 10 mg, orodispergeerbare tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
RIZATRIPTAN MSD 5 MG ORODISPERGEERBARE TABLETTEN
Each oral lyophilisate contains 7.265 mg of rizatriptan benzoate
(corresponding to 5 mg of the
rizatriptan).
Excipient(s) with known effect
Aspartame (E951) 1.88 mg in the 5 mg oral lyophilisate.
RIZATRIPTAN MSD 10 MG ORODISPERGEERBARE TABLETTEN
Each oral lyophilisate contains 14.53 mg of rizatriptan benzoate
(corresponding to 10 mg of the
rizatriptan).
Excipient(s) with known effect
Aspartame (E951) 3.75 mg in the 10 mg oral lyophilisate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral lyophilisate
RIZATRIPTAN MSD 5 MG ORODISPERGEERBARE TABLETTEN
5 mg oral lyophilisates are white to off-white, round with a modified
triangle on one side, with a
peppermint flavour.
RIZATRIPTAN MSD 10 MG ORODISPERGEERBARE TABLETTEN
10 mg oral lyophilisates are white to off-white, round with a modified
square on one side, with a
peppermint flavour.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Acute treatment of the headache phase of migraine attacks with or
without aura in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration
_ _
RIZATRIPTAN oral lyophilisates should not be used prophylactically.
RIZATRIPTAN oral lyophilisates need not be taken with liquid.
The oral lyophilisate is packaged in a blister within an outer
aluminium sachet. Patients should be
instructed not to remove the blister from the outer sachet until just
prior to dosing. The blister pack
2
should then be peeled open with dry hands and the oral lyophilisate
placed on the tongue, where it
will dissolve and be swallowed with the saliva.
RIZATRIPTAN is also available as a tablet formulation.
The oral lyophilisate can be used in situations in which liquids are
not available, or to avoid the
nausea and vomiting that may accompany the ingestion of ta