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

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Atovaquone; PROGUANIL HYDROCHLORIDE

Available from:

Glenmark Arzneimittel GmbH

ATC code:

P01BB; P01BB51

INN (International Name):

Atovaquone; PROGUANIL HYDROCHLORIDE

Dosage:

250 mg/100 milligram(s)

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

Biguanides; proguanil, combinations

Authorization status:

Not marketed

Authorization date:

2017-07-07

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
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 250 mg/100 mg Film-coated tablets
belong to a group of
medicines called
_antimalarials. _
It contains two active ingredients, atovaquone and proguanil
hydrochloride.
Atovaquone/Proguanil Hydrochloride 250 mg/100 mg Film-coated tablets
have two uses:
•
to prevent malaria in adults and children who weigh more than 40 kg
•
to treat malaria in adults and children who weigh more than 11 kg
Malaria is spread by the bite of an infected
mosquito,
which
passes
the malaria parasite
_(Plasmodium falciparum) _
into the bloodstream. Atovaquone/Proguanil Hydrochloride 250 mg/100 mg
Film-coated tablets prevent malaria by killing this parasite. For
people who are already infected
with malaria, Atovaquone/Proguanil Hydrochloride 250 mg/100 mg
Film-coated tablets also kills these
parasites.
PROTECT YOURSELF FROM CATCHING MALARIA
People of any age can get malaria. It is a serious disease, but is
preventable. As

Summary of Product characteristics

Health Products Regulatory Authority
02 January 2024
CRN00DXXN
Page 1 of 9
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 Atovaquone/Proguanil Hydrochloride tablet contains 250 mg
atovaquone and 100 mg proguanil hydrochloride.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Pinkish brown to brown coloured, circular, biconvex beveled edge
film-coated tablets with ‘404’ debossed on one side and ‘G’
debossed 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 in adults and in
children weighing more than 40 kg.

Treatment of acute, uncomplicated _Plasmodium falciparum_ malariain
adults and in children weighing 11 kg or
more.
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 drugs should be taken into
consideration. Official guidelines will normally include World Health
Organisation (WHO) and public health authorities'
guidelines.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_Prophylaxis:_
Prophylaxis should:
• commence 24 to 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 Hydrochloride 250 mg/100 mg film-coated tablets
has been e