Atovaquone/Proguanil Hydrochloride 250 mg/100 mg film-coated tablets

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Atovaquone; PROGUANIL HYDROCHLORIDE

Предлага се от:

McDermott Laboratories Ltd., T/A Gerard Laboratories

АТС код:

P01BB; P01BB51

INN (Международно Name):

Atovaquone; PROGUANIL HYDROCHLORIDE

дозиране:

250/100 milligram(s)

Лекарствена форма:

Film-coated tablet

Вид предписание :

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

Терапевтична област:

Biguanides; proguanil, combinations

Статус Оторизация:

Marketed

Дата Оторизация:

2013-05-31

Листовка

PAGE 1 OF 8
PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ATOVAQUONE/PROGUANIL HYDROCHLORIDE 250 MG/100 MG FILM-COATED TABLETS
atovaquone/proguanil hydrochloride
PAGE 2 OF 8
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 mosquito, which passes
the malaria parasite (
_Plasmodium _
_falciparum_
) into the bloodstream. Atovaquone/Proguanil Hydrochloride prevents
malaria by killing
this parasite. For people who are already infected with malaria,
Atovaquone/Proguanil Hydrochloride
also kills these parasites.
PROTECTING YOURSELF FROM CATCHING MALARIA
People of any age can get malaria. It is a serious disease, but is
preventable.
As well as taking Atovaquone/Proguanil Hydrochloride, it is very
important that you also take steps to
avoid being bitten by mosquitoes.
▪
USE INSECT REPELLENT ON EXPOSED AREAS OF THE SKIN
▪
WEA

Данни за продукта

Health Products Regulatory Authority
12 February 2019
CRN008WHC
Page 1 of 17
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.
Health Products Regulatory Authority
12 February 2019
CRN008WHC
Page 2 of 17
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.
In non-i