ATOVAQUONE/PROGUANIL HYDROCHLORIDE

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

ATOVAQUONE ; PROGUANIL HYDROCHLORIDE

Beschikbaar vanaf:

Generics (UK) Limited

ATC-code:

P01BB51

INN (Algemene Internationale Benaming):

ATOVAQUONE ; PROGUANIL HYDROCHLORIDE

Dosering:

250/100 Milligram

farmaceutische vorm:

Film Coated Tablet

Prescription-type:

Product subject to prescription which may not be renewed (A)

Therapeutisch gebied:

proguanil, combinations

Autorisatie-status:

Marketed

Autorisatie datum:

2013-05-31

Bijsluiter

Colours
Non-Print
Colours
Date:
Time:
Equate CMYK
with
Dimensions
Main Font
Body Text Size
Min Text Size used
Page Count
No. of colours
Pharma Code
SAP No.
Vendor Job No.
Trackwise Proof No.
Client Market
Keyline/Drawing No.
Barcode Info
Description
Component Type
Affiliate Item Code
Superceded Affiliate Item Code
TrackWise PR No.
MA No.
Packing Site/Printer
Supplier Code
Sign-offs
v2/Oct 2016
1/2
1
Myriad pro
9 pt
9 pt
170 x 360mm
Atovaquone Proguanil Hydrochloride 250 mg / 100 mg 12
Leaflet
1184432
877487
1184432
PL 04569/1271
PA0405/062/001
Komarom
50063246
5233
NA
310051
4
United Kingdom, Ireland
NA
NA
Black
13 Jun 2017
19:23
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ATOVAQUONE/PROGUANIL
HYDROCHLORIDE 250 MG/100 MG
FILM-COATED TABLETS
atovaquone/proguanil hydrochloride
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 any 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 Atovaquone/Proguanil hydrochloride is and what
it is used for
2.
What you need to know before you take Atovaquone/
Proguanil hydrochloride
3.
How to take Atovaquone/Proguanil hydrochloride
4.
Possible side effects
5.
How to store Atovaquone/Proguanil hydrochloride
6.
Contents of the pack and other information
1.
WHAT ATOVAQUONE/PROGUANIL HYDROCHLORIDE
IS AND WHAT IT IS USED FOR
Atovaquone/Proguanil hydrochloride belongs to a group
of medicines called antimalarials. It contains two active
substances, atovaquone and proguanil hydrochloride.
Atovaquone/Proguanil hydrochloride is used to:
• Prevent malaria
• Treat malaria
Malaria is spread by the bite of an infected m

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atovaquone/Proguanil Hydrochloride 250 mg/100 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 250 mg atovaquone and 100 mg
proguanil hydrochloride.
Excipient with known effect:
Each film-coated tablet also contains 3.82 mg of lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Buff coloured, round, biconvex, film-coated tablets debossed with
‘A-P’ over ‘2’ on one side and ‘M’ on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Atovaquone/Proguanil Hydrochloride is a fixed dose combination of
atovaquone and proguanil hydrochloride which
acts as a blood schizonticide and also has activity against hepatic
schizonts of_ Plasmodium falciparum_. It is indicated
for:
Prophylaxis of_ Plasmodium falciparum_ malaria.
Treatment of acute, uncomplicated_ Plasmodium falciparum_ malaria.
Because Atovaquone/Proguanil Hydrochloride is effective against drug
sensitive and drug resistant_ P. falciparum_ it is
especially recommended for prophylaxis and treatment of_ P.
falciparum_ malaria where the pathogen may be resistant to
other antimalarials.
Official guidelines and local information on the prevalence of
resistance to antimalarial medicinal
products should be taken into consideration. Official guidelines will
normally include WHO and public health
authorities_'_ guidelines.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Prophylaxis
Prophylaxis should
• commence 24 or 48 hours prior to entering a malaria-endemic area,
• continue during the period of the stay
• continue for 7 days after leaving the area.
In residents (semi-immune subjects) of endemic areas, the safety and
effectiveness of atovaquone/proguanil has been
established in studies of up to 12 weeks.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___