Apo-Clopidogrel

Maklumat utama

  • Nama dagangan:
  • Apo-Clopidogrel
  • Perubatan domain:
  • Manusia
  • Jenis perubatan:
  • Ubat Allopathic

Dokumen

Penyetempatan

  • Terdapat dalam:
  • Apo-Clopidogrel
    Malaysia
  • Bahasa:
  • Bahasa Melayu

Maklumat lain

Status

  • Sumber:
  • NPRA - National Pharmaceutical Regulatory Agency - Bahagian Regulatori Farmasi Negara
  • Nombor kebenaran:
  • MAL 0709093
  • Kemaskini terakhir:
  • 31-08-2017

Risalah Maklumat Pesakit: ciri produk - komposisi, petunjuk, kesan sampingan, dos, interaksi, tindak balas buruk, kehamilan, penyusuan

Apo-Clopidogrel 75mg film-coated tab

Clopidogrel Bisulfate

Apa kandungan risalah ini

Risalah ini mengandungi jawapan

untuk sesetengah persoalan yang

biasa

ditanya

tentang

ubat

ini.

Bagaimanapun

tidak

mengandungi

semua

maklumat

tentang

ubat

ini.

juga

tidak

boleh

mengambil

alih

tugas

doktor atau ahli farmasi anda.

Setiap ubat mempunyai risiko dan

manfaatnya sendiri. Doktor anda

akan menentukan risiko yang ada

sebalik

manfaatnya

dalam

penggunaan ubat ini.

Sekiranya

anda

mempunyai

sebarang

keraguan

mengenai

pengambilan ubat ini, sila rujuk

kepada doktor atau ahli farmasi

anda.

Sila simpan risalah ini bersama-

sama dengan ubat ini.

Anda mungkin perlu membacanya

semula.

Apa kegunaan ubat ini

Anda telah diperskripsikan APO-

CLOPIDOGREL

kerana

anda

mempunyai

risiko

untuk

mendapat pembekuan darah yang

tidak diingini (trombi).

Pembekuan

darah

boleh

membawa

kepada

simptom-

simptom

yang

berlaku

dalam

pelbagai

bentuk,

seperti

angin

ahmar,

ketakstabilan

angina,

serangan

jantung,

atau

penyakit

arteri

periferal

(sakit

pada

kaki

ketika

berjalan

atau

berehat).

APO-CLOPIDOGREL

diambil

untuk

menghalang

pembekuan

darah

yang

lanjut

justeru

mengurangkan

risiko

untuk

mendapat

ketakstabilan

angina,

serangan

jantung,

atau

angin

ahmar.

Bagaimana

ubat

ini

berfungsi

Tablet

APO-CLOPIDOGREL

tergolong

dalam

kumpulan

ubat

yang dipanggil ubat antiplatelet.

Platelet ialah sejenis struktur kecil

dalam darah, lebih kecil daripada

darah

merah

darah

putih,

yang

bergumpal

semasa

pembekuan

darah.

Dengan

mencegah penggumpalan ini, ubat

antiplatelet

mengurangkan

kemungkinan pembentukan darah

beku

(sejenis

proses

yang

dipanggil trombosis).

Sebelum penggunaan

Bila

anda

tidak

dibenarkan

ambil

Jika

anda

alergik

terhadap

sebarang

bahan

yang

terkandung dalam tablet ini.

Jika

anda

mempunyai

masalah

perubatan

yang

mengakibatkan

pendarahan,

seperti ulser perut.

Jika

anda

mempunyai

penyakit atau kerosakan pada

hati.

Sebelum mula pengambilan

Beritahu doktor atau ahli farmasi

anda jika:

Anda

sedang

hamil

atau

hamil

semasa

mengambil

APO-CLOPIDOGREL,

atau

sedang menyusukan anak.

Anda mempunyai kecederaan

teruk baru-baru ini.

Anda

baru

menjalani

pembedahan

(termasuk

pembedahan gigi).

Anda

akan

menjalani

pembedahan.

Doktor

anda

mungkin akan meminta anda

untuk

menghentikan

pengambilan

APO-

CLOPIDOGREL selama 5-7

hari

sebelum

pembedahan

tersebut.

Anda

mempunyai

gangguan

pendarahan

yang

menyebabkan

anda

cenderung

untuk

mendapat

pendarahan

dalam

(pendarahan

dalam

tisu

badan, organ atau sendi) atau

cenderung untuk mengalami

pendarahan

yang

berlarutan

lebih daripada 10 minit tanpa

mengambil sebarang ubat.

Pengambilan ubat-ubatan lain

Ubat-ubatan

yang

boleh

berinteraksi

dengan

APO-

CLOPIDOGREL

termasuklah:

ASA, NSAIDS, heparin, warfarin,

digoxin, theophylline, antasid.

Bagaimana untuk ambil

Berapa banyak untuk diambil

Dewasa (Termasuk warga emas):

Anda perlu ambil satu tablet 75

mg APO-CLOPIDOGREL setiap

hari,

melalui

mulut.

APO-

CLOPIDOGREL

boleh

diambil

bersama makanan atau tidak. Jika

anda

mempunyai

angina

yang

tidak stabil atau serangan jantung,

dos 300 mg untuk satu kali boleh

diberi diikuti dengan satu tablet

75 mg setiap hari.

Kanak-kanak dan remaja:

Penggunaan

APO-

CLOPIDOGREL tidak disarankan

untuk kanak-kanak dan remaja di

bawah umur 18 tahun.

Bila untuk diambil

Anda

perlu

mengambil

ubat

secara

tetap

pada

waktu

yang

sama setiap hari.

Berapa lama untuk diambil

APO-CLOPIDOGREL

perlu

diambil

dalam

tempoh

jangka

masa

yang

panjang

dibawah

penyeliaan doktor anda.

Jika anda lupa untuk ambil

Jangan

bimbang.

Ambil

jumlah

dos yang disyorkan sebaik sahaja

anda teringat semula, melainkan

sudah

hampir

waktu

untuk

seterusnya. Kemudian, ambil dos

yang seterusnya pada waktu yang

betul. Jangan gandakan dos anda

untuk

menggantikan

yang

sudah terlepas.

Jika anda ambil terlalu banyak

(terlebih dos)

Jika anda terambil lebih daripada

yang

disyorkan,

hubungi

bahagian

kecedaraan

yang

terdekat atau beritahu doktor atau

ahli farmasi anda dengan segera.

Jangan lupa bawa bersama bekas

ubat

dengan

lebihan

tablet

bersama anda.

Dalam masa penggunaan

Perkara yang harus dilakukan

Jika anda perlu berjumpa dengan

doktor

atau

doktor

gigi

lain

semasa dalam pengambilan APO-

CLOPIDOGREL,

anda

perlu

maklumkan

kepada

mereka

bahawa anda sedang mengambil

APO-CLOPIDOGREL.

Perkara yang dilarang

Semasa

pengambilan

APO-

CLOPIDOGREL

adalah

penting

bagi anda untuk tidak mengambil

sebarang

ubat

selain

daripada

yang diperskripsikan oleh doktor

anda.

Perkara yang perlu berhati-hati

Tiada

Kesan sampingan

Kesan

sampingan

yang

telah

dilaporkan

mengenai

APO-

CLOPIDOGREL adalah:

Ruam dan/atau gatal-gatal

Cirit-birit

Kesakitan

pada

bahagian

abdomen

Ketakcernaan atau pedih hulu

hati

Sembelit

Pendarahan

dalam

perut,

dubur atau mata

Gangguan hempedu atau hati

Darah dalam urin

Reaksi

alergi

biasa

seperti

pembengkakan

pada

bahagian

muka,

bibir,

dan/atau

lidah,

kesesakan

nafas

Pendarahan pada salur darah

di dalam kepala

Dalam

yang

jarang

sekali,

sakit

sendi

dan/atau

sakit

otot

pernah dilaporkan.

Hubungi

doktor

anda

dengan

segera sekiranya anda mengalami;

Demam,

tanda-tanda

jangkitan

atau

keletihan

melampau. Hal ini mungkin

disebabkan oleh pengurangan

sesetengah

darah

yang

jarang berlaku.

Tanda-tanda

masalah

pada

hati

seperti

penguningan

warna

kulit

dan/atau

mata

(penyakit kuning), sama ada

berkaitan dengan pendarahan

dan/atau

kekeliruan

atau

tidak.

Jika

anda

terluka

atau

tercerderakan

diri

anda,

mungkin

mengambil

masa

yang

lebih lama daripada biasa untuk

pendarahan berhenti. Keadaan ini

berkaitan dengan fungsi ubat ini.

Untuk luka dan kecederaan kecil,

contohnya,

terluka

ketika

bercukur,

keadaan

tidak

merbahaya.

Bagaimanapun,

jika

anda

mempunyai

sebarang

keraguan,

anda

perlu

hubungi

doktor anda dengan segera.

Keupayaan anda untuk memandu

atau mengemudi peralatan mesin

yang

rumit

tidak

sepatutnya

terjejas.

Selepas

menggunakan

ubat ini

Penyimpanan

Anda

diingatkan

supaya

menyimpan

APO-

CLOPIDOGREL.

semua

ubat-ubat

lain

jauh

daripada

kanak-kanak.

Jangan gunakan ubat ini selepas

tarikh

luput

yang

tertera

pada

bekas ini.

Simpan

APO-CLOPIDOGREL

pada suhu bilik (bawah 25°C).

Pelupusan

Sekiranya anda masih mempunyai

lebihan

ubat

selepas

anda

hentikan

pengambilannya

atas

arahan

doktor

atau

kerana

anda

dapati

ubat

telah

melepasi

tarikh luputnya, sila rujuk kepada

ahli farmasi anda tentang langkah

yang perlu diambil.

Perihal Produk

Bagaimana rupa ubat ini

Tablet

APO-CLOPIDOGREL

berwarna

merah-keperangan,

bulat, bersalut saput, dan berukir

“CL”

diatas

"75"

berukir

"APO"

pada

permukaan

yang

sebaliknya.

Terdapat

dalam

gelembung

berisi 30 tablet.

Bahan Kandungan

Setiap

tablet

APO-

CLOPIDOGREL

mengandungi

clopidogrel

bisulfate

sebagai

bahan aktif.

Bahan

bukan

ubat

lain

ialah

anhydrous

lactose,

methylcellulose,

crospovidone,

colloidal

silikon

dioksida,

zinc

stearate, hydroxypropyl cellulose,

hydroxypropylmethyl

cellulose,

polyethylene

glycol,

titanium

dioksida dan ferric oxide merah

(warna jigga).

Nombor Pendaftaran Malaysia

MAL 07090937A

Pengilang

Apotex Inc.

150 Signet Drive

Weston Toronto Ontario

M9L 1T9 Canada

Pemegang Pendaftaran

Pharmaforte (M) Sdn Bhd

2, Jalan PJU 3/49

Sunway Damansara

47810 Petaling Jaya

Tarikh Semakan

2011

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Clopidogrel Zentiva (Zentiva, k.s.)

Clopidogrel Zentiva (Active substance: Clopidogrel) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)2776 of Thu, 03 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/975/T/60

Europe -DG Health and Food Safety