Malarone 250mg/100mg film-coated tablets

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

PROGUANIL HYDROCHLORIDE; Atovaquone

Saatavilla:

IMED Healthcare Ltd.

ATC-koodi:

P01BB; P01BB51

INN (Kansainvälinen yleisnimi):

PROGUANIL HYDROCHLORIDE; Atovaquone

Annos:

250/100 milligram(s)

Lääkemuoto:

Film-coated tablet

Prescription tyyppi:

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

Terapeuttinen alue:

Biguanides; proguanil, combinations

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2014-03-28

Pakkausseloste

PACKAGE LEAFLET: INFORMATION FOR THE USER
MALARONE 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 MALARONE IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MALARONE
3. HOW TO TAKE MALARONE
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE MALARONE
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT MALARONE IS AND WHAT IT IS USED FOR
Malarone belongs to a group of medicines called _antimalarials. _It
contains two active ingredients, atovaquone and proguanil
hydrochloride.
WHAT MALARONE IS USED FOR
MALARONE HAS TWO USES:
• TO PREVENT MALARIA
• TO TREAT MALARIA
Dosage instructions for each use are in Section 3, _How to take _
_Malarone. _
Malaria is spread by the bite of an infected mosquito, which passes
the
malaria parasite _(Plasmodium falciparum) _into the bloodstream.
Malarone prevents malaria by killing this parasite. For people who are
already infected with malaria, Malarone 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 well as taking Malarone, 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
•

Valmisteyhteenveto

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Malarone 250mg/100mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Malarone tablet contains 250 mg atovaquone and 100 mg proguanil
hydrochloride.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from the Netherlands_
Round, bioconvex, pink tablets engraved 'GX CM3'
on one side.
4 CLINICAL PARTICULARS
As per PA1077/111/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1077/111/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Core
Poloxamer 188
Microcrystalline Cellulose
Hydroxypropyl Cellulose
Povidone K30
Sodium Starch Glycolate (Type A)
Magnesium Stearate
Coating
Hypromellose
Titanium Dioxide E 171
Iron Oxide Red E 172
Macrogol 400
Polyethylene Glycol 8000
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the container and outer package of the product on the market
in the country of origin.
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6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicinal product does not require any special storage
conditions.
6.5 NATURE AND CONTENTS OF CONTAINER
PVC aluminium foil blister pack/s containing 12 tablets in an
overlabelled outer carton.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PR