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

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PROGUANIL HYDROCHLORIDE; Atovaquone

Available from:

LTT Pharma Limited

ATC code:

P01BB; P01BB51

INN (International Name):

PROGUANIL HYDROCHLORIDE; Atovaquone

Dosage:

250/100 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

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

Therapeutic area:

Biguanides; proguanil, combinations

Authorization status:

Authorised

Authorization date:

2016-09-02

Patient Information leaflet

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:
What Atovaquone/Proguanil Hydrochloride is and what it is used for
What you need to know before you take Atovaquone/Proguanil
Hydrochloride
How to take Atovaquone/Proguanil Hydrochloride
Possible side effects
How to store Atovaquone/Proguanil Hydrochloride
Contents of the pack and other information
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 ingredients, 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.
*
WEAR LIGHT COLOURED CLOTHING THAT COVERS MOST OF THE BODY, especially
after sunset as this is the time when mosquitoes are most active.
*
SLEEP IN A SCREENED ROOM or under a mosquito net impregnated with
insecticide.
*
CLO

Summary of Product characteristics

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 film-coated tablet contains
250 mg atovaquone and
100 mg proguanil hydrochloride.
Excipients with known effect: Contains lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from The United Kingdom._
Atovaquone/Proguanil Hydrochloride 250 mg/100 mg film-coated tablets
are 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
As per PA0405/062/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0405/062/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Tablet core:
Cellulose,
Microcrystalline,
Povidone (K-30),
Crospovidone (Type A),
Poloxamer 188,
Magnesium stearate.
Film-coat:
Titanium dioxide (E171),
Lactose monohydrate,
Macrogol 4000,
Hypromellose 15cP (E464),
Hypromellose 50cP (E464),
Hypromellose 3cP (E464),
Iron oxide red (E172),
Iron oxide black (E172),
Iron oxide yellow (E172).
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6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the