Rizatriptan MSD 5 mg, 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:

Tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; ZETMEEL, GEPREGELATINEERD,

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Rizatriptan

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); IJZEROXIDE ROOD (E 172); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); ZETMEEL, GEPREGELATINEERD;

Autorisatie datum:

2013-07-19

Bijsluiter

Rizatriptan MSD tabletten / WS 284
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
RIZATRIPTAN MSD 5 MG, TABLETTEN
RIZATRIPTAN MSD 10 MG, 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 taking

Productkenmerken

Rizatriptan MSD tabletten / WS 284
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Rizaptripan MSD 5 mg, tabletten
Rizatriptan MSD 10 mg, tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
RIZATRIPTAN MSD 5 MG, TABLETTEN
Each tablet contains 7.265 mg of rizatriptan benzoate (corresponding
to 5 mg of the rizatriptan).
Excipient(s) with known effect
Lactose monohydrate 30.25 mg in the 5 mg tablet.
RIZATRIPTAN MSD 10 MG, TABLETTEN
Each tablet contains 14.53 mg of rizatriptan benzoate (corresponding
to 10 mg of the rizatriptan).
Excipient(s) with known effect
Lactose monohydrate 60.5 mg in the 10 mg tablet.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
RIZATRIPTAN MSD 5 MG, TABLETTEN
5 mg tablets are pale pink, capsule shaped, coded 266 on one side,
plain on the other side.
RIZATRIPTAN MSD 10 MG, TABLETTEN
10 mg tablets are pale pink, capsule-shaped, coded 267 on one side,
plain on the other side.
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 should not be used prophylactically.
The oral tablets should be swallowed whole with liquid.
_Effect of Food: _
The absorption of rizatriptan is delayed by approximately 1 hour when
administered
together with food. Therefore, onset of effect may be delayed when
rizatriptan is administered in the
fed state (see also Pharmacokinetic properties, Absorption).
RIZATRIPTAN is also available as an alternative oral lyophilisate.
Rizatriptan MSD tabletten / WS 284
2
Posology
Adults 18 years of age and older
_ _
_ _
The recommended dose is 10 mg.
_ _
_Redosing: _
Doses should be separated by at least 2
hours; no more than 2 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.
