Lariam 250mg tablets

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Mefloquine hydrochloride

Commercializzato da:

Sigma Pharmaceuticals Plc

Codice ATC:

P01BC02

INN (Nome Internazionale):

Mefloquine hydrochloride

Dosaggio:

250mg

Forma farmaceutica:

Oral tablet

Via di somministrazione:

Oral

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 05040100

Foglio illustrativo

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LARIAM® 250MG TABLETS
(mefloquine)
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,
pharmacist or nurse.

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, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. See section 4.
The name of your medicine is Lariam 250mg Tablets but will be
referred to as Lariam throughout the remainder of this leaflet.
WHAT IS IN THIS LEAFLET
1. What Lariam is and what it is used for
2. What you need to know before you take Lariam
3. How to take Lariam
4. Possible side effects
5. How to store Lariam
6. Contents of the pack and other information
1. WHAT LARIAM IS AND WHAT IT IS USED FOR
Lariam tablets contain the active ingredient mefloquine. Lariam 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. WHAT YOU NEED TO K

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Lariam 250mg 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 the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet. White to off-white cylindrical biplanar tablets, cross scored
and
imprinted with LA-RI-AM-CP on one face.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Therapy and chemoprophylaxis 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.
_Chemoprophylaxis_: Malaria chemoprophylaxis with Lariam is
particularly
recommended for travellers to malarious areas in which multiply
resistant _P. _
_falciparum_ strains occur.
Official guidelines and local information on the prevalence of
resistance to
antimalarial drugs should be taken into consideration. Official
guidelines will
normally include WHO and public health authorities. For current advice
on
geographical resistance patterns and appropriate chemoprophylaxis,
current
guidelines or the National Travel Health Network and Centre (NaTHNaC)
should
be
consulted,
which
can
be
found
at
http://travelhealthpro.org.uk/diseases/malaria.
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 _
For malaria prophylaxis the stated dose of Lariam should be given once
weekly,
always on the same day.
In order to ensure, before arrival in endemic area, that Lariam
administration is
well tolerated, it is recommended to start chemoprophylax