Lariam 250mg tablets

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Mefloquine hydrochloride

Tilgjengelig fra:

Neon Healthcare Ltd

ATC-kode:

P01BC02

INN (International Name):

Mefloquine hydrochloride

Dosering :

250mg

Legemiddelform:

Oral tablet

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 05040100; GTIN: 5000471002690

Informasjon til brukeren

PATIENT ALERT CARD
IMPORTANT INFORMATION
ABOUT NEUROPSYCHIATRIC
SIDE EFFECTS, AND OTHER
SAFETY PRECAUTIONS
MARCH 2023
This educational material is
provided by Neon Healthcare
Limited and mandatory as a
condition of the Marketing
Authorisation in order to further
minimise important selected risks.
LARIAM
®
250 MG
(mefloquine)
PATIENT ALERT CARD
IMPORTANT INFORMATION
ABOUT NEUROPSYCHIATRIC
SIDE EFFECTS, AND OTHER
SAFETY PRECAUTIONS
Keep this card with you at all times
during treatment – it tells you about
some important side effects and what
to do if they occur
Tell any health professional you talk to
that you are taking Lariam and show
them this card
Lariam may cause other side effects.
Read the Patient Information Leaflet in
the pack as it gives more information
about Lariam and all the side-effects to
look out for
LARIAM
®
250 MG
(mefloquine)
DO NOT TAKE LARIAM IF YOU HAVE,
OR HAVE EVER HAD:
●
depression, thoughts about suicide
●
other mental problems, including
anxiety disorder, schizophrenia or
psychosis (losing touch with reality)
●
fits (seizures or convulsions)
●
an allergy to quinine, quinidine,
Lariam or any of its ingredients
●
severe liver problems
●
blackwater fever (a complication of
malaria that affects the blood and
kidneys)
●
OR if you are currently taking a
medicine called halofantrine
LARIAM MAY CAUSE SERIOUS SIDE
EFFECTS IN SOME PEOPLE. STOP
TAKING LARIAM IF YOU:
●
feel like harming yourself or
committing suicide
●
feel depressed
●
feel very anxious, restless or
confused
●
feel like you don’t trust other people
around you (paranoia)
●
are seeing or hearing things that are
not there (hallucinations)
●
have nightmares or abnormal
dreams
●
have trouble sleeping (insomnia)
● f
eel your behaviour is unusual
The symptoms listed above could
indicate the start of a serious and/or
persistent neuropsychiatric side
effect. If these symptoms or other
changes to your mental state occur
during treatment you should STOP
TAKING LARIAM AND SPEAK TO
A DOCTOR, PHARMACIST OR NURS

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Lariam 250 mg tablets
Mefloquine 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 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_: Mefloquine 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 mefloquine, 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
mefloquine
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 mefloquine 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 mefloquine should be given
once
weekly, always on the same day.
In order to ensure, before arrival in endemic area, that mefloquine
administration
is well tole