Maxalt 5mg Oral Lyophilisate

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:

ORAL LYOPHILISATE

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Withdrawn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 ORAL LYOPHILISATE 
(RIZATRIPTAN) 
MAXALT 10 MG 
MAXALT 10 MG ORAL LYOPHILISATE 
(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

製品の特徴

Page 1 of 12 
SUMMARY OF PRODUCT CHARACTERISTICS 
1. 
NAME OF THE MEDICINAL PRODUCT 

MAXALT 5 MG 
MAXALT 5 mg oral lyophilisates_ _
MAXALT 10 MG 
MAXALT 10 mg oral lyophilisates 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

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

Excipients: aspartame (E951) 1.88 mg in the 5 mg oral
lyophilisate. 

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

Excipients: aspartame (E951) 3.75 mg in the 10 mg oral
lyophilisate. 

For a full list of excipients, see section 6.1. 

3. PHARMACEUTICAL 
FORM 

Oral lyophilisate 

MAXALT 5 MG 
5 mg oral lyophilisates are white to off-white, round with a modified
triangle on one side, with a 
peppermint flavour. 
MAXALT 10 MG 
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. 

Page 2 of 12 
4.2  POSOLOGY AND METHOD OF ADMINISTRATION 

General 
_ _
MAXALT oral lyophilisates should not be used prophylactically. 

MAXALT 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. 

MAXALT 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._ _