[ 6B : Mau hp: PhilClonestyl Ngay 02 thang 2ignm 2012. ANAL AGA BD a OYT CUC QU ¥ DUOC] DA PHE DUY. ec Prescrpion only medcine SKELETAL MUSCLE RELAXANT 50 Tabs.(5xt0Tabs.) PHILCLONESTYL crn READ CAREFULLY THE PACKAGE INSERT BEFORE USING Lain div: QE Indl D ALA) AEE OUT OF REACH OF CHILOREN | 7 Méivignnén bao évong chia CClorphenesin carbaMatrcrvnnnnner 25M Th chubnSpeetneston: 1ocsin-ouse ‘Ta duge vita di cho... 1 vign nén bao dudng SOW/Reg No Chiginn, cch cing, ching chi ainh va ede thing tink: xem rong to hudng dn si dung thuée $618 SXBatch No kemtheo, NSKIMIg.Oae: Bao quan: foea tk Noikhe, dudi 30°C, trnh ann sang. x Thue kd dom ‘THUOC GIAN CO Hop 50 viin( hop vix 1ovén nn bo dna) #[ super PHILCLONESTYL OQNHL DE XA TAM TAY TRE EM 20C KY HUONG DAN SU’ DUNG TRUGC KH DUNG ONYID (Buanp og ugu uaa ob xins 464) tuoi os dH TALSANO TITHE ach ugar coated tablet contains CChorprenesncaramate, na5m0 Ercipionts 9. fr. 1 sxgarcoated abet Indications, acministation, contsinaicatone. and other Information: see the package inser. Storeinacy place, velow0°C, protoatromlsh Thiét ké P. KD (kiéu dang) P. QA (ndi dung)| & au vi: PhilClonestyl Naty stn nam 201 S\ BOSTON. NU ‘Dang Minh Duc a fe. WB Pantone 232C¢ WB Pantone 3282c A Qui cach: 110 x 45 mm Thiét ké P. KD (kiéu dang) P. QA (néi dung)TO HUONG DAN SU’ DUNG THUOC PHILCLONESTYL xa ‘tim tay tré em. Doc kp hwéng dan sie dung trwéc khi ding. THANH PHAN CONG THUC THUOC Méi vién nén bao dig cé chtra: Thénh phn hoat chdt:Clorphenesin carbamat... ...125 mg Thanh phan té dwgc: Cellulose vi tinh thé (type 101), lactose monohydrat, pregelatinized starch, polysorbat 80, natri croscarmellose, magnesi stearat, silicon dioxyd, hypromellose 615, hypromellose 606, polyethylen glycol 6000, during tring, gdm arabic, povidon K30, b9t tale, titan dioxyd, mau dé sé 3, mau xanh sé 1, sp carnauba. DANG BAO CHE Vién nén bao duong. M6 ta sén pham: Vién nén bao duéng mau héng dai an. CHI DINE Digu tri dau do co cting co trong ede bénh lién quan dén co xong nhur dau et séng that mele \ |, hai mat khum, canh va thanh vién lanh thoai ha dét song, thoat vi dia dm, mia giat, viém edt séng, hoi chimg cé vai cénh tay. 3 \) CACH DUNG, LIEU DUNG Cach dimg: PHILCLONESTYL duge ding bing dudng uéng. Liéu ding. Ligu théng thing & ngudi 1én 1 2 vién/lin x 3 Lin/ngay Thoi gian diéu trj thude khong qua 8 tua 6 an toan va higu qua ciia thudc khi str dung cho tré em chura due ching minh. Khong c6 nghién eiru ey thé duge tién hanh trén bénh nhdn suy giém chite nang than, suy gidm chiie nang gan, ngudi cao tudi, vi vay khéng dura ra khuyé tugng bénh nhan nay. CHONG CHi DINH Qua man v6i bat ky thanh phan nao ctia thudc. CANH BAO VA THAN TRONG KHI DUNG THUOC Than trong ding thuée cho bénh nhan bj bénh gan hode suy giém chtte nang gan, bénh nhin suy than. dicu chinh liéu trén nhing déi SS Khong nén ding thude qua 8 tuan. Khéng ding thudc cho tré em do d@ an toan va higu qua cia thuée déi véi déi tuong nay chura duge xée dinh.Trong thanh phan c6 chita duéng tring nén khéng phit hop cho bénh nhan khéng dung nap fructose, kém hap thu glucose/galactose hay thiéu hut sucrase-isomaltase. Khéng nén sir dung cho bénh nhan 6 van dé vé di tru hiém gap khong dung nap galactose, thiéu hut lactase hoaic kém thu glucose-galactose vi thudc ¢é chita lactose. Can than trong khi ding thudc vi thudc cé chita ta durge mau dé s6 3, mau xanh sé 1 nén c6 thé gay ra cdc phan img dij img. SU DUNG THUOC CHO PHY NU CO THAI VA CHO CON BU D6 an toan khi ding clorphenesin carbamat & phu nit c6 thai va cho con bit chura durge xae h. Do dé khdng nén ding thuéc trong thai ky mang thai va cho con bi trir khi Igi ich cla igc digu tri vugt tri so vi nguy co. ANH HUONG CUA THUOC LEN KHA NANG LAI XE VA VAN HANH MAY MOC Thude gay budn ngit, giém chi y, tap trung, do vay tranh ding cho ngudi li xe va van hanh may méc. TUONG TAC, TUONG KY CUA THUOC Twong tac cia thuéc Cae twong tée ciia thudc voi cdc thude khéc Cée din xuét phenothiazin (nhur elopromazin), chat tre ché than kinh trang wong (nur din xudt acid barbituric), chat ire ché MAO: Cé thé lam ting téc dung cila clophenesin va nguge lai. Do d6 can chi ¥ dé gidm lidu. Cae teong téc khéc Tée dung tte ché than kinh trung wong cita thuée ¢6 thé ting khi ding ding thoi voi rugu. Tuong ky cia thude Do khéng cé cae nghién ctu vé tinh tuong ky ciia thuée, khdng tn Hin thude nay véi cac thude khac. TAC DUNG KHONG MONG MUON CUA THUOC Trong 16.400 bénh nhan duge diéu tri c6 431 tac dung khong mong muén gap 6 391 bénh nhan (2,38%). Cac tac dung phy chinh nhu dau bung (109 trudng hop). khé tigu (63 truong hop), phat ban (46 trurong hgp), budn nén (45 trong hop). Céc tac dung phy nghiém trong: ‘6c thude cé6 thé xay ra, bénh nhdn can durge theo doi cdn thin. ngung thuée va str dung cdc bign phdp thich hop. * Hoai tir thuong bi nhiém doc-h9i chimg Lyell (tan suat chura rd): Bai vi hi ching Lyell 6 thé xay ra, bénh nhan cin durge theo déi cdn thén.Néu phat hign thdy bat thudng, can ngung thudc va sir dung cae bign phap thich hop. 6c (tn suat chua 13): Boi vi phat hién thay bat thudng, Cfc téc dung phy khae: (© 1/100 dén < 1/10), it gap (<1/10.000), Tan suat diroe phan loai nhur sau: Rat thudng gap (= 1/10), thudng g: gap (= 1/1.000 dén < 1/100), hiém gap (© 1/10.000 dén < 1/1.000), chura r6 (khong thé wéc tinh tir dir ligu c6 sin). Y oa wu C WeTan suat 1H co quan - it gap Hiém gap Chua r6 Chong mat Dau dau Héthankinh | Choang Khé chiu Budn ngi Yéu ot Bau bung (dau da day, khé chiu | Tiéu chay da day) : Tao bon He tiéu hoa Kho tigu (day hoi, mang bung. ¢ | Kis migng néng, mat cim gide ngon miéng) iain Réi loan tigu hoa Nong!lu0t Buén non Hé théng tao Giam bach cau mau Giam tiéu cau 2 Pha, sung sepaN Netra Qué man (ban dan, phat ban) Viém migng XM Khi xay ra qua liu, lam sach da day bing cach gy nén va rita nude mudi dé Lam gidm hép PS thu, ding thai phai 4p dung cde bién phap diéu tri hd tr thich hop. Tich cue theo doi bign phap xirtri kip thoi. DAC TINH DUQC LUC HOC Clorphenesin carbamat 1a mét chat gin co lién quan dén mephenesin, co ché tae dung cia 3 thude c6 thé do téc dung tre ché than kink trung wong. DAC TINH DUQC DONG HOC Clorphenesin carbamat due hép thu nhanh va hoin toan qua dung tigu hoa. Nong d6 dinh trong huyét tuong dat durgc trong huyét tuong dat duge trong khoang tir | dén 3 gid. M6t phan thuéc due chuyén héa 6 gan chii yéu dudi dang chat chuyén héa glucuronid. Clorphenesin carbamat duge QUY CACH DONG GOI Ep vi bam AI/PVC. H6p 05 vi « 10 vién nén bao dung. ix : ao thai qua than. Théi gian ban thai cita thudc khoang 2,3-5 gid. iDIEU KIEN BAO QUAN Noi khd, dusi 30°C, tranh anh sang. HAN DUNG CUA THUOC 36 thang ké tir ngay san xuat. Khéng ding thudc qua thoi han sir dung. TIEU CHUAN CHAT LUQNG CUA THUOC Tiéu chuan co sé. TEN, DIA CHi CUA CO SO SAN XUAT THUOC Co sé sin xudt: CONG TY CO PHAN DUGC PHAM BOSTON VIET NAM. Dia chi: $6 43, Duong s6 8, KCN Viét Nam - Singapore, phurong Binh Hoa, thj xa Thuan An tinh Binh Duong, Viét Nam. Dién thoai: 02743 769 606 Fax: 02743 769 601 Email: boston@bostonpharma.com.vn. Binh Dirong, ngay.42.thang 0M..ndm 2018 2 f TUQ.CUC TRUONG P-TRUGNG PHONG Nguyen Ngge Anh