Eurartesim 320mg40mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Artenimol; Piperaquine phosphate

Available from:

Logixx Pharma Solutions Ltd

INN (International Name):

Artenimol; Piperaquine phosphate

Dosage:

40mg ; 320mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05040100; GTIN: 5060184960038

Patient Information leaflet

ST-2012-010
Created April 2012
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
EURARTESIM
®
▼
320 MG/40 MG FILM-COATED TABLETS
Piperaquine tetraphosphate/dihydroartemisinin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE
-
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. 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 pharmacist.
IN THIS LEAFLET
:
1.
What Eurartesim is and what it is used for
2.
Before you or your child takes Eurartesim
3.
How to take Eurartesim
4.
Possible side effects
5.
How to store Eurartesim
6.
Further information
1.
WHAT EURARTESIM IS AND WHAT IT IS USED FOR
Eurartesim contains the ingredients piperaquine tetraphosphate and
dihydroartemisinin. It is used to
treat uncomplicated malaria when use of a medicine given by mouth is
appropriate.
Malaria is caused by infection with a parasite called
_Plasmodium_
, spread by the bite of an infected
mosquito.There are different types of
_Plasmodium_
parasite. Eurartesim kills the
_Plasmodium _
_falciparum_
parasite.
The medicine can be taken by adults, children and infants over 6
months old who weigh 5 kilograms
or more.
2.
BEFORE YOU OR YOUR CHILD TAKE EURARTESIM
DO NOT TAKE EURARTESIM IF YOU OR YOUR CHILD:
•
is allergic (hypersensitive) to the active substances, piperaquine
tetraphosphate or
dihydroartemisinin, or to any of the other ingredients of Eurartesim
(see section 6 for a list of
these);
•
has a severe type of malaria infection which has affected parts of
your body such as the brain,
lungs or kidneys;
•
has a heart condition, such as changes to the rhythm or rate of your
heart beat, or heart disease;
•
knows that any member of your family (parents, grandparents, brothers
or sisters) died suddenly
due to a heart problem or was

Summary of Product characteristics

OBJECT 1
EURARTESIM 320 MG/40 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 10-Apr-2017 | Logixx Pharma
Solutions Ltd
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1. Name of the medicinal product
Eurartesim 320 mg/40 mg film-coated tablets.
2. Qualitative and quantitative composition
Each film-coated tablet contains 320 mg piperaquine tetraphosphate (as
the tetrahydrate; PQP) and 40 mg
artenimol (artenimol).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet (tablet).
White oblong biconvex film-coated tablet (dimension 16x8mm / thickness
5.5mm) with a break-line and
marked on one side with two “σ” letters.
The tablet can be divided into equal doses.
4. Clinical particulars
4.1 Therapeutic indications
Eurartesim is indicated for the treatment of uncomplicated _Plasmodium
falciparum _malaria in adults,
adolescents, children and infants 6 months and over and weighing 5 kg
or more.
Consideration should be given to official guidance on the appropriate
use of antimalarial medicinal
products.
4.2 Posology and method of administration
Posology
Eurartesim should be administered over three consecutive days for a
total of three doses taken at the same
time each day.
Dosing should be based on body weight as shown in the table below.
BODY WEIGHT
(KG)
DAILY DOSE (MG)
TABLET STRENGTH AND NUMBER OF TABLETS PER DOSE
PQP
Artenimol
5 to <7
80
10
½ x 160 mg / 20 mg tablet
7 to <13
160
20
1 x 160 mg / 20 mg tablet
13 to <24
320
40
1 x 320 mg / 40 mg tablet
24 to <36
640
80
2 x 320 mg / 40 mg tablets
36 to <75
960
120
3 x 320 mg / 40 mg tablets
75 to 100
1,280
160
4 x 320 mg / 40 mg tablets
>100
There are no data on which to base a dose recommendation in patients
weighing >100
kg.
If a patient vomits within 30 minutes of taking Eurartesim, the whole
dose should b