RIZATRIPTAN MSD 10 mg oral lyophilisates

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Rizatriptan benzoate

Available from:

Merck Sharp & Dohme Ireland (Human Health) Limited

ATC code:

N02CC; N02CC04

INN (International Name):

Rizatriptan benzoate

Dosage:

10 milligram(s)

Pharmaceutical form:

Oral lyophilisate

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Selective serotonin (5HT1) agonists; rizatriptan

Authorization status:

Not marketed

Authorization date:

2011-06-03

Patient Information leaflet

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

Summary of Product characteristics

Health Products Regulatory Authority
01 October 2020
CRN009LNT
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
RIZATRIPTAN MSD 10 mg oral lyophilisates
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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 lyophylisate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral lyophilisate
10 mg oral lyophilisates are white to off-white, round with a modified
square on one side, with a peppermint flavor.
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 MSD oral lyophilisates should not be used
prophylactically.
RIZATRIPTAN MSD 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 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 MSD 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 tablets with liquids.
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.

_after non-response: _The effectiveness of a second dose for treatment
of the same attack, when an initial d