AXANUM 81/20 Milligram Capsules Hard

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

ACETYLSALICYLIC ACID ESOMEPRAZOLE MAGNESIUM TRIHYDRATE

זמין מ:

AstraZeneca UK Limited

INN (שם בינלאומי):

ACETYLSALICYLIC ACID ESOMEPRAZOLE MAGNESIUM TRIHYDRATE

כמות:

81/20 Milligram

טופס פרצבטיות:

Capsules Hard

סוג מרשם:

Product subject to prescription which may be renewed (B)

מצב אישור:

Withdrawn

תאריך אישור:

2013-11-30

עלון מידע

BODY TEXT SIZE
9.5 pt
SMALLEST TEXT SIZE
6.0 pt
368229-A02
25-03-13
PS02013
AZL4004A
7817
RR
Axanum 20mg/81mg Leaflet: 
Patient IE-MT
Black
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, 
please ask your doctor or your 
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 gets 
serious, or if you notice any side 
effects not listed in this leaflet, 
please tell your doctor or your 
pharmacist.
IN THIS LEAFLET:
1.  What Axanum is and what it is 
used for
2.  Before you take Axanum
3.  How to take Axanum
4.  Possible side effects
5.  How to store Axanum
6.  Further information
1.  WHAT AXANUM IS AND WHAT 
IT IS USED FOR
WHAT AXANUM IS
Axanum contains two different 
medicines called acetylsalicylic acid 
(aspirin) and esomeprazole.
WHAT AXANUM IS USED FOR 
The two medicines in Axanum are 
used for different things:
•  ACETYLSALICYLIC ACID prevents 
recurrence of heart attacks or 
strokes by thinning the blood. 
In some people it can cause 
stomach ulcers.
•  ESOMEPRAZOLE stops stomach 
ulcers from forming. It belongs 
to a group of medicines called 
“proton pump inhibitors”. 
Esomeprazole works by reducing 
the amount of acid that your 
stomach produces.
Follow your doctor´s advice and if 
you want more information ask your 
doctor or pharmacist.
2.  BEFORE YOU TAKE AXANUM
DO NOT TAKE AXANUM IF:
•  you are allergic to acetylsalicylic
acid, esomeprazole, or any of 
the other ingredients of Axanum 
(listed in Section 6: Further 
information)
•  you are allergic to other proton
pump inhibitor medicines
•  you are taking a medicine
containing nelfinavir (used to 
treat HIV)
•  you have ever had symptoms of
asthma, a runny nose (rhinitis) 
or a raised, red, itchy skin 
rash (urticaria) when

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Axanum 81 mg/20 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains acetylsalicylic acid (aspirin) immediate release and esomeprazole gastro-resistant pellets:
81 mg acetylsalicylic acid (aspirin) and 20 mg esomeprazole (as esomeprazole magnesium trihydrate)
Excipient with known effect: Sucrose (in sugar spheres) max 13.7 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard (capsule)
A two-pieced hard gelatine capsule with reddish pink body and grey cap. Cap is marked E 20 mg and A 81 mg printed
in black in radial format.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prevention of thrombotic cardio- and cerebrovascular events in patients requiring continuous low-dose acetylsalicylic
acid treatment, and who are in need of prophylaxis against acetylsalicylic acid associated gastric and/or duodenal
ulcers.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The usual dose is 1 capsule once daily. The capsule should be swallowed whole with liquid. It should not be chewed or
crushed.
_Impaired renal function_
Due to the acetylsalicylic acid component, Axanum is contraindicated in patients with severe renal disorder (see
section 4.3) and if on concomitant treatment with diuretics, the risk of fluid retention and impaired renal function must
be considered.
_Impaired hepatic function_
Due to the acetylsalicylic acid component, Axanum is contraindicated in patients with cirrhosis of the liver (see
section 4.3) and if on concomitant treatment with diuretics, the risk of fluid retention and impaired renal function must
be considered.
_Elderly (> 65 years)_
Dose adjustment is not required in the elderly.
_Paediatric population_
Axanum should not be used in childr