RIZATRIPTAN MSD 10 mg Tablets

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Rizatriptan benzoate

Dostopno od:

Merck Sharp & Dohme Ireland (Human Health) Limited

Koda artikla:

N02CC; N02CC04

INN (mednarodno ime):

Rizatriptan benzoate

Odmerek:

10 milligram(s)

Farmacevtska oblika:

Tablet

Tip zastaranja:

Product subject to prescription which may be renewed (B)

Terapevtsko območje:

Selective serotonin (5HT1) agonists; rizatriptan

Status dovoljenje:

Not marketed

Datum dovoljenje:

2011-06-03

Navodilo za uporabo

PACKAGE LEAFLET: INFORMATION FOR THE USER
RIZATRIPTAN MSD 5 MG TABLETS
RIZATRIPTAN
RIZATRIPTAN MSD 10 MG TABLETS
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 vascular
disease)
-
you

Lastnosti izdelka

Health Products Regulatory Authority
02 November 2020
CRN009Z9D
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
RIZATRIPTAN MSD 10 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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
10 mg tablets are pale pink, capsule-shaped, coded MAXALT on one side
and MSD 267 on the other.
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 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 MSD is also available as an alternative oral lyophilisate.
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 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_._
Health Products Regulatory Authority
02 November 2020
CRN009Z9D
Page 2 of 9
Clinical studies have shown that patients who do not respond to
treatment of an attack