LARIAM 250 Base Milligrams Tablets
Country: Իռլանդիա
language: անգլերեն
source: HPRA (Health Products Regulatory Authority)
PIL active_ingredient:
MEFLOQUINE HYDROCHLORIDE
MAH:
Roche Products Limited
INN:
MEFLOQUINE HYDROCHLORIDE
dosage:
250 Base Milligrams
pharmaceutical_form:
Tablets
prescription_type:
Product subject to prescription which may be renewed (B)
authorization_status:
Authorised
authorization_date:
0000-00-00
PIL
-1-
Lariam-PIL-IE-1306-250-Tab
PATIENT INFORMATION LEAFLET
IRELAND
LARIAM
®
250 MG
ROCHE
TABLETS
Mefloquine
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE YOUR
MEDICINE. IF YOU HAVE ANY
QUESTIONS OR ARE NOT SURE ABOUT ANYTHING,
ASK YOUR DOCTOR OR PHARMACIST.
In this leaflet you will find:
1. What is Lariam?
2. Things you should know before taking Lariam
3. How to take this medicine
4. Possible side effects
5. Storing your medicine
6. Other information
1. WHAT IS LARIAM?
This medicine is used to treat malaria and to help prevent you from
catching malaria.
Malaria is a life threatening disease and a major health risk
for travellers visiting tropical
countries.
It occurs when small parasites are passed from one person to
another by the bites of certain
mosquitoes. Lariam is especially useful if you are travelling to
countries where there is a type
of malaria which is particularly difficult to treat. No single
medicine is effective against all
malaria parasites. The choice of a particular
medicine depends on the sensitivity of the
malaria parasites found in the area to be visited. Your doctor
will advise you whether Lariam
is suitable for the area to which you wish to go.
TO HELP MINIMISE YOUR CHANCE OF CATCHING THE DISEASE AND TO
PROTECT YOU FROM POSSIBLE
SERIOUS SIDE EFFECTS IT IS IMPORTANT THAT YOU READ THIS
LEAFLET CAREFULLY. ASK YOUR DOCTOR TO
EXPLAIN ANYTHING YOU DO NOT UNDERSTAND.
2. THINGS YOU SHOULD KNOW BEFORE TAKING LARIAM
DO NOT TAKE LARIAM IF YOU HAVE, OR HAVE EVER HAD:
depression, thoughts about suicide and
self-endangering behaviour
any other mental problem, including anxiety disorder,
schizophrenia or psychosis (losing
touch with reality)
fits (seizures or convulsions)
an allergy to quinin
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SPC
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lariam 250 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250 mg mefloquine (as 274.09 mg mefloquine hydrochloride).
Each tablet contains 50.61 mg of lactose monohydrate
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Tablets
White to off-white cylindrical biplanar tablets, cross-scored and imprinted Roche on one face.
The tablet can be divided into equal halves to facilitate dosing.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Therapy and prophylaxis of malaria.
_Therapy_: Lariam is especially indicated for therapy of _P. falciparum _malaria in which the pathogen has become
resistant to other antimalarial agents.
Following treatment of _P. vivax _malaria with Lariam, relapse prophylaxis with an 8-amino-quinoline derivative, for
example primaquine, should be considered in order to eliminate parasites in the hepatic phase.
_Prophylaxis_: Malaria prophylaxis with Lariam is particularly recommended for travellers to malarious areas in which
multiple resistant _P. falciparum _strains occur.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
When chemoprophylaxis with Lariam fails, physicians should carefully evaluate which antimalarial to use for therapy.
Regarding the use of halofantrine, see sections 4.3, 4.4 and 4.5.
_CHEMOPROPHYLAXIS_
In order to ensure, before arrival in endemic area, that Lariam administration is well tolerated, it is recommended to start
chemoprophylaxis with Lariam 10 days before departure (i.e. first intake 10 days before departure and 2
nd
intake 3 days
before departure). Subsequent doses should be taken once a week (at a fixed day).
IRISH MEDICINES BOARD
__________________________________________________________________________________________________________________
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