Maxalt 5mg Tablets

国: マルタ

言語: 英語

ソース: Medicines Authority

有効成分:

RIZATRIPTAN

から入手可能:

Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

ATCコード:

N02CC04

INN（国際名）:

RIZATRIPTAN 5 mg

医薬品形態:

TABLET

構図:

RIZATRIPTAN 5 mg

処方タイプ:

POM

治療領域:

ANALGESICS

認証ステータス:

Withdrawn

承認日:

2011-03-17

情報リーフレット

Page 1 of 8 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

MAXALT 5 MG 
MAXALT 5 MG TABLETS 
(RIZATRIPTAN) 
MAXALT 10 MG 
MAXALT 10 MG TABLETS 
(RIZATRIPTAN) 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE, 
- 
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. Do not pass it on to
others. It may harm them, 
even if their symptoms are the same as yours. 
- 
If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, 
please tell your doctor or pharmacist. 

IN THIS LEAFLET: 
1.  
What MAXALT is and what it is used for 
2.  
Before you take MAXALT 
3.  
How to take MAXALT 
4.  
Possible side effects 
5.  
How to store MAXALT 
6.  
Further information 

1. 
WHAT MAXALT IS AND WHAT IT IS USED FOR 

MAXALT belongs to a class of medicines called selective serotonin 5-HT
1B/1D 
receptor agonists. 

MAXALT is used to treat the headache phase of the migraine attack in
adults. 

Treatment with MAXALT: 
Reduces swelling of blood vessels surrounding the brain. This swelling
results in the headache pain 
of a migraine attack. 

_ _
2.  
BEFORE YOU TAKE MAXALT_ _

DO NOT TAKE MAXALT IF: 
- 
you are allergic (hypersensitive) to rizatriptan benzoate or any of
the other ingredients of 
MAXALT 
- 
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) 

Page 2 of 8 
- 
you are taking monoamine ox

製品の特徴

Page 1 of 11 
SUMMARY OF PRODUCT CHARACTERISTICS 
1. 
NAME OF THE MEDICINAL PRODUCT 

MAXALT 5 MG 
MAXALT 5 mg Tablets 

MAXALT 10 MG 
MAXALT 10 mg Tablets 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

MAXALT 5 MG 
Each tablet contains 7.265 mg of rizatriptan benzoate (corresponding
to 5 mg of the rizatriptan). 

Excipients: lactose monohydrate 30.25 mg in the 5 mg tablet. 

MAXALT 10 MG 
Each tablet contains 14.53 mg of rizatriptan benzoate (corresponding
to 10 mg of the rizatriptan). 

Excipients: lactose monohydrate 60.5 mg in the 10 mg tablet. 

For a full list of excipients, see section 6.1. 

3. PHARMACEUTICAL 
FORM 

Tablet 

MAXALT 5 MG 
5 mg tablets are pale pink, capsule shaped, coded MSD on one side and
266 on the other. 

MAXALT 10 MG 
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 

General_ _
_ _
MAXALT should not be used prophylactically. 

The oral tablets should be swallowed whole with liquid. 

Page 2 of 11 
_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). 

MAXALT is also available as an alternative oral lyophilisate. 

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. 

