Maa: Yhdistynyt kuningaskunta
Kieli: englanti
Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Mefloquine hydrochloride
Neon Healthcare Ltd
P01BC02
Mefloquine hydrochloride
250mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05040100; GTIN: 5000471002690
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 Lue koko asiakirja
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 Lue koko asiakirja