PACKAGE LEAFLET: INFORMATION FOR THE USER

Transcription

1 (Sanfi-Aventis France), NT001 Suppliers submissin f the SRA apprved text Octber 2016 Name f the medicinal prduct Text bx PACKAGE LEAFLET: INFORMATION FOR THE USER NOTEZINE 100 mg, scred tablets Diethylcarbamazine citrate Read all f this leaflet carefully befre yu start using this medicine because it cntains imprtant infrmatin fr yur treatment. If yu have any further questins, ask yur dctr r pharmacist. Keep this leaflet. Yu may need t read it again. Ask yur pharmacist if yu need mre infrmatin r advice. Yu must cntact a dctr if yur symptms wrsen r d nt imprve. If any f the side effects gets serius, r if yu ntice any side effect nt listed in this leaflet, please tell yur dctr r pharmacist. Leaflet summary What is in this leaflet: 1. WHAT NOTEZINE 100 mg, scred tablets IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE NOTEZINE 100 mg, scred tablets 3. HOW TO USE NOTEZINE 100 mg, scred tablets 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE NOTEZINE 100 mg, scred tablets 6. FURTHER INFORMATION 1. WHAT NOTEZINE 100 mg, scred tablets IS AND WHAT IT IS USED FOR Pharmactherapeutic grup ANTHELMINTHICS. Therapeutic indicatins This medicine is an antiparasitic agent. It is recmmended fr the treatment f: certain lymphatic frms f filariasis (infestatin by Wuchereria bancrfti, Brugia malayi, Brugia timri), liasis (infestatin by La la), and nchcerciasis (infestatin with Onchcerca vlvulus). 2. WHAT YOU NEED TO KNOW BEFORE YOU USE NOTEZINE 100 mg, scred tablets List f infrmatin necessary befre taking the medicinal prduct If yu have been tld by yur dctr that yu have an intlerance t sme sugars, cntact yur dctr befre taking this medicinal prduct. Cntraindicatins D nt use NOTEZINE 100 mg, scred tablets: if yu are allergic t any f the ingredients, if yu have serius eye damage in the cntext f nchcerciasis, if yu have gluten intlerance, as this medicine cntains wheat starch (gluten). Yu shuld check with yur dctr r pharmacist if yu are nt sure. Precautins fr use; special warnings Special warnings This medicine shuld nly be used if yu have a parasitic infestatin r if ne is strngly suspected. It is nt effective as preventive treatment fr individual parasitic infestatin.

2 (Sanfi-Aventis France), NT001 Suppliers submissin f the SRA apprved text Octber 2016 This medicinal prduct cntains lactse. It shuld nt be used in patients with galactsemia, glucse r galactse malabsrptin syndrme r lactase deficiency (rare metablic diseases). Precautins fr use If yu suffer frm kidney disrders, INFORM YOUR DOCTOR wh will adjust yur dse. Yu shuld check with yur dctr r pharmacist if yu are nt sure. Interactins with ther medicinal prducts Other medicines and NOTEZINE 100 mg, scred tablets Please tell yur dctr r pharmacist if yu are taking r have recently taken any ther medicines, including medicines btained withut a prescriptin. Interactins with fd and drink Interactins with herbal r alternative therapies shuld be addressed where necessary Use by pregnant r breast-feeding wmen Pregnancy and breast-feeding This medicine shuld preferably nt be used during pregnancy. If yu discver that yu are pregnant while taking this medicine, cnsult yur dctr wh will be able t determine whether yu shuld cntinue this treatment. As a precautin, yu shuld avid taking this medicine while breast-feeding. As a general rule, during pregnancy r breast-feeding, yu shuld always ask yur dctr r pharmacist fr advice befre taking a medicine. Athletes Effects n the ability t drive r t use machines Driving and using machines If yu drive r use machines, yu shuld be aware that this medicine can cause drwsiness. List f excipients with specific effects Imprtant infrmatin abut sme f the ingredients f NOTEZINE: This medicine cntains: Wheat starch (gluten), lactse. 3. HOW TO USE NOTEZINE 100 mg, scred tablets Instructins fr prper use Dsage, Methd and/r rute(s) f administratin, Frequency f administratin and Duratin f treatment Dsage Fllw yur dctr s prescriptin. Treatment f lymphatic filariasis (Wüchereria bancrfti, Brugia malayi, Brugia timri): Treatment shuld preferably be administered in divided dses, after meals. Individual treatment: 3 mg/kg/day f diethylcarbamazine base fr 12 t 14 cnsecutive days. The curse f treatment can be repeated if necessary, after an interval f at least 10 days. In the event f mass treatment, yur dctr will prescribe yu a single annual dse f 3 mg/kg f diethylcarbamazine base as cmbined treatment, as per the WHO recmmendatins.

3 (Sanfi-Aventis France), NT001 Suppliers submissin f the SRA apprved text Octber 2016 Occult filariasis (trpical pulmnary esinphilia): 3 mg/kg/day fr 14 t 21 days. The curse f treatment can be repeated if symptms reappear. Treatment f liasis (infestatin with La la): The treatment shuld be started under strict medical supervisin. The higher the numbers f micrfilariae in the bld, the lwer the dse f diethylcarbamazine base(3 mg). As an indicatin: 1 st day: 1/32 nd f a tablet (the dilutin shuld be perfrmed by a pharmacist), the dse shuld be dubled n subsequent days, until a daily dse f 3 mg/kg f diethylcarbamazine base, is reached after ne week, taken as 2 divided dses. The effective dse shuld be maintained ver 21 days. Crticsterids can be given alng with diethylcarbamazine t minimise r prevent side effects. Treatment f nchcerciasis (infestatin with Onchcerca vlvulus): T limit the ccurrence f side effects t the treatment (Mazztti reactin), the treatment can be started at lw, prgressively increasing dses. As an indicatin: 1 st day f treatment: 0.5 mg/kg f diethylcarbamazine base as a single dse, depending n the patient s clinical cnditin, the dse can be dubled n subsequent days until an effective dse f 3 mg/kg/day f diethylcarbamazine base is reached, taken as 2 divided dses. The effective dse shuld be maintained fr abut 10 days. Crticsterids can be given alng with diethylcarbamazine t minimise r prevent side effects. Rute and methd f administratin Oral use. Symptms in case f verdse and actins t be taken If yu take mre NOTEZINE than yu shuld: Cnsult a dctr prmptly. Actins t be taken when ne r mre dses have been missed Indicatin f the risk f withdrawal effects 4. POSSIBLE SIDE EFFECTS Descriptin f side effects Like all medicines, Ntezine can cause side effects, althugh nt everybdy gets them. The incidence and seriusness f the side effects mst ften depend n parasite levels and the dse f diethylcarbamazine administered. When administered in patients with lymphatic filariasis r liasis: general reactins: fever, headaches, dizziness, lss f appetite, hives, vmiting, asthma attack, pssible nervus system disrders, smetimes serius, in patients with liasis when the parasitic infestatin is severe, inflammatin f lymphatic vessels in patients with lymphatic filariasis. When administered in patients with nchcerciasis: general reactins: fever, headaches, dizziness, lss f appetite, hives, vmiting, asthma attack, skin disrders: itching, hives, edema,

4 (Sanfi-Aventis France), NT001 Suppliers submissin f the SRA apprved text Octber 2016 eye disrders: tears, glare, superficial inflammatin f the eye, iris and eyelashes, increased pressure inside the eye in patients with massive infestatin, damage t the retina and ptic nerve during prlnged treatment. Reprting f side effects If yu get any side effects, talk t yur dctr r pharmacist. This includes any pssible side effects nt listed in this leaflet. Yu can als reprt side effects directly via the natinal reprting system: French natinal Agency fr the Safety f Medicinal and Health Prducts (ANSM) and the netwrk f Reginal Pharmacvigilance Centers - Website: By reprting side effects yu can help prvide mre infrmatin n the safety f this medicine. 5. HOW TO STORE NOTEZINE 100 mg, scred tablets Keep this medicine ut f the reach and sight f children. Expiry date D nt use NOTEZINE 100 mg, scred tablets after the expiry date which is stated n the uter packaging. Strage cnditins N special strage cnditins. Where apprpriate, warning against certain visible signs f deteriratin D nt thrw away any medicines via wastewater r husehld waste. Ask yur pharmacist hw t thrw away medicines yu n lnger use. These measures will help t prtect the envirnment. 6. FURTHER INFORMATION Cmplete list f active substances and excipients What NOTEZINE 100 mg, scred tablets cntains The active substance is: Diethylcarbamazine citrate mg (equivalent t diethylcarbamazine mg) The ther ingredients are: Fr ne scred tablet Wheat starch, lactse mnhydrate, cllidal hydrated silica, magnesium stearate. Pharmaceutical frm and cntents What NOTEZINE 100 mg, scred tablets lks like and cntents f the pack This medicine is in the frm f scred tablets. Bx f 20. Name and address f the marketing authrisatin hlder and f the manufacturing authrisatin hlder respnsible fr batch release, if different Marketing Authrisatin Hlder SANOFI-AVENTIS 1-13, bulevard Rmain Rlland PARIS Operating cmpany SANOFI-AVENTIS 1-13, bulevard Rmain Rlland PARIS

5 (Sanfi-Aventis France), NT001 Suppliers submissin f the SRA apprved text Octber 2016 Manufacturer FAMAR LYON AVENUE DU GENERAL DE GAULLE SAINT GENIS LAVAL Names f the medicinal prduct in the Member States f the Eurpean Ecnmic Area Date f leaflet apprval This leaflet was last apprved in {date}. Fr prducts apprved under "exceptinal circumstances" Infrmatin n the internet Detailed infrmatin n this medicine is available n the ANSM website (France). Infrmatin intended fr healthcare prfessinals Other