Anpromide

Maklumat utama

  • Nama dagangan:
  • Anpromide Tablet
  • Perubatan domain:
  • Manusia
  • Jenis perubatan:
  • Ubat Allopathic

Dokumen

Penyetempatan

  • Terdapat dalam:
  • Anpromide Tablet
    Malaysia
  • Bahasa:
  • Bahasa Melayu

Maklumat lain

Status

  • Sumber:
  • NPRA - National Pharmaceutical Regulatory Agency - Bahagian Regulatori Farmasi Negara
  • Nombor kebenaran:
  • MAL19985186
  • Kemaskini terakhir:
  • 31-08-2017

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

Risalah Maklumat Ubat untuk Pengguna (RiMUP)

ANPROMIDE TABLET

Loperamide Hydrochloride (2mg)

Apakah yang ada pada risalah ini:

Apakah

kegunaan

Anpromide

Tablet

Bagaimana

Anpromide

Tablet

berfungsi

Sebelum

menggunakan

Anpromide Tablet

Cara

menggunakan

Anpromide

Tablet

Semasa menggunakan Anpromide

Tablet

Kesan-kesan sampingan

Cara penyimpanan dan pelupusan

Anpromide Tablet

Maklumat lanjut

Pengilang

Pemegang

Pendaftaran Produk

Tarikh kemaskini RiMUP

Apakah

kegunaan

Anpromide

Tablet

Loperamide

digunakan

untuk

mengawal

melegakan

simptom

cirit-birit

akut

kronik

serta

mengurangkan

jumlah

pengeluaran

daripada

ileostomi

(usus

kecil

disalurkan melalui lubang di dinding

perut yang dibuat semasa pembedahan).

Bagaimana

Anpromide

Tablet

berfungsi

Loperamide

hydrochloride

adalah

kandungan

aktif

Anpromide

Tablet.

Loperamide

tergolong

dalam

kumpulan

ubat

Antidiarrheal.

berfungsi untuk melegakan gejala cirit-

birit

dengan

menjadikan

tinja

lebih

padat.

Sebelum

menggunakan

Anpromide

Tablet

Bila tidak boleh menggunakan

Jika anda alergi (hipersensitif)

terhadap

loperamide

bahan-bahan

kandungan

lain

dalam Anpromide Tablet.

Jika

anda

mempunyai

toxic

megacolon

(kolon

mengembang akibat daripada

komplikasi

penyakit

keradangan

atau

jangkitan

pada usus besar).

Jika

anda

mempunyai

masalah

disentri

atau

jika

ingin

mengelakkan

masalah

sembelit, kerana ia mungkin

menyebabkan penakungan air

dalam usus dan ini mungkin

menerukkan

menutup

simptom-simptom

dehidrasi

kekurangan

elektrolit,

terutamanya

dalam

kalangan

kanak-kanak.

Jika anda mempunyai kolitis

teruk

(masalah

radang

yang

teruk pada lapisan usus besar).

Untuk kanak-kanak di bawah

6 tahun.

Sebelum menggunakan Anpromide

Tablet

Anda mesti beritahu doktor anda

jika:

Anda

alergi

terhadap

mana-

mana

ubat-ubatan

yang

diambil

sebelum

untuk

merawat keadaan sekarang.

Anda

hamil,

sedang

cuba

untuk

hamil

atau

menyusu.

Ubat

harus

digunakan

semasa

hamil

menyusu

apabila jelas diperlukan.

Jika mengambil ubat-ubat lain

Sila beritahu doktor anda atau ahli

farmasi

anda

jika

anda

sedang

mengambil atau telah mengambil

mana-mana ubat berikut baru-baru

ini:

Analgesik

opiod,

juga

dikenali

sebagai

analgesik

narkotik

(penahan

sakit)

penggunaan

serentak

mungkin

meningkatkan

risiko sembelit.

Sila

beritahu

doktor

atau

ahli

farmasi

anda

sekiranya

anda

sedang

mengambil

mana-mana

ubat,

termasuk

tonik

herba,

pelengkap

tambahan

ubat

yang dibeli tanpa preskripsi.

Cara

menggunakan

Anpromide

Tablet

Sentiasa

mengambil

ubat

seperti

yang

diberitahu

oleh

doktor.

Anda

sepatutnya merujuk kepada doktor atau

ahli farmasi anda sekiranya anda tidak

pasti.

Ambil

ubat

melalui

mulut

sahaja.

Berapa banyak harus digunakan

Cirit-birit

akut:

pada

permulaan,

diikuti

dengan

selepas

setiap

kali

cirit-birit

sehingga 5 hari, dos biasa 6-8mg

sehari.

Cirit-birit kronik:

Pada

permulaan:

diikuti

dengan

selepas

setiap

kali

cirit-birit

sehingga

cirit-birit

terkawal

Dos kawalan: 4-8mg sehari sekali

atau

dibahagikan

beberapa

kali

mengikut keperluan.

Bila perlu digunakan

Ikut

arahan

doktor

atau

ahli

farmasi anda.

Tablet ini boleh diambil dengan

makanan ataupun tanpa makanan.

Berapa lama perlu digunakan

Cirit-birit akut: sehingga 5 hari.

- Jika terlupa menggunakan

Sekiranya

anda

terlupa

satu

dos,

ambil

dengan

segera sebaik sahaja teringat.

Tetapi, sekiranya telah hampir

masa

untuk

berikutnya,

abaikan dos yang terlepas.

Jangan

mengambil

berganda untuk menggantikan

dos yang terlupa.

Jika

mengambil

berlebihan

(terlebih dos)

Simptom-simptom

terlebih

termasuk

sembelit,

irritasi

gastrousus dan penekanan sistem

saraf pusat.

Risalah Maklumat Ubat untuk Pengguna (RiMUP)

Jika

anda

berasa

anda

telah

mengambil

terlebih

Anpromide

Tablet,

sila

beritahu

doktor anda dan doktor anda akan

membuat keputusan apa langkah-

langkah yang perlu diambil.

Semasa

menggunakan

Anpromide

Tablet

Perkara yang perlu dilakukan

Hubungi doktor jika gejala anda

bertambah

buruk

atau

tiada

perubahan.

Hubungi

doktor

sekiranya

anda

hamil

semasa

mengambil

Anpromide Tablet.

Perkara

yang

tidak

boleh

dilakukan

Jangan

beri

Anpromide

Tablet

kepada

orang

lain

walaupun

simptom

atau

keadaan

mereka

serupa seperti anda. Doktor anda

mempreskrib

Anpromide

Tablet

untuk anda dan keadaan anda.

Perkara

yang

perlu

diberi

perhatian

Gunakan

secara

berhati-hati

untuk orang yang mempunyai

masalah hati.

Gunakan

secara

berhati-hati

untuk

kanak-kanak

muda

kerana perubahan tindak balas

yang lebih berbeza.

Orang

yang

menghidapi

penyakit

keradangan

usus

besar

atau

orang

yang

mengalami

keradangan

usus

yang

diisebabkan

oleh

antibiotik perlu diawasi untuk

kejadian toxic megacolon.

Cecair

elektrolit

yang

sesuai

perlu

diambil

untuk

semua

cirit-birit

untuk

mengelakkan dehidrasi.

Kesan-kesan sampingan

Seperti

ubat-ubat

lain,

Anpromide

Tablet

mempunyai

kesan

sampingan

walaupun

bukan

semua

orang

mengalaminya.

Kesan

sampingan

berikut

mungkin

berlaku

dengan

penggunaan ubat ini.

Sakit perut dan gangguan gastrousus

lain termasuk toxic megacolon, mulut

kering, pening dan letih. Ruam pada

kulit

(reaksi

hipersensitiviti)

juga

pernah dilaporkan.

Sekiranya

mana-mana

kesan

sampingan menjadi serius, atau anda

mengalami

kesan

sampingan

yang

tidak

disenaraikan

dalam

risalah

ini,

sila beritahu doktor atau ahli farmasi

anda.

Berjumpa

dengan

doktor

atau

ahli

farmasi anda jika anda was-was atau

untuk

mendapatkan

maklumat

selanjutnya.

Anda

boleh

melaporkan

sebarang

kesan

sampingan

atau

kesan

advers

ubat kepada Pusat Pemantauan Kesan

Advers Ubat Kebangsaan melalui No.

Tel:

03-78835550,

atau

laman

portal.bpfk.gov.my

(Consumers→Reporting)

Cara penyimpanan dan pelupusan

Anpromide Tablet

Penyimpanan

Jangan guna selepas tarikh tamat

tempoh

yang

dinyatakan

pada

bungkusan. Tarikh tamat tempoh

merujuk

kepada

hari

terakhir

bulan tersebut.

Tablet Anpromine perlu disimpan

dalam bekas plastik tertutup rapat

di tempat yang kering.

Simpan

pada

suhu

kurang

daripada 30ºC.

Jauhi daripada kanak-kanak.

Pelupusan

Ubat-ubatan

tidak

seharusnya

dilupuskan

melalui

sisa

atau

sisa isi rumah.

Tanya ahli farmasi anda cara-cara

pelupusan ubat-ubatan yang tidak

lagi

diperlukan.Langkah-langkah

akan

membantu

melindungi

alam sekitar.

Maklumat lanjut

Rupa dan warna produk

Tablet

berwarna

merah

jambu,

rata, diameter 7mm dengan garis

skor serta tanda ‘MPI’.

dibekalkan

dalam

blister

100 x 10’s

Bahan-bahan Kandungan

Bahan aktif

Setiap

biji

tablet

mengandungi

bahan

aktif,

loperamide

hydrochloride.

Bahan tidak aktif

Bahan-bahan kandungan lain

termasuk lactose, corn starch,

microcrystalline

cellulose

pH101,

potato

starch,

magnesium

stearate

colchineal Red A.

Nombor MAL

MAL19985186AZ

Pengilang

dan

Pemegang

Pendaftaran Produk

Malaysian

Pharmaceutical

Industries

Sdn Bhd.

Plot 14, Lebuhraya Kampung Jawa,

11900

Bayan

Lepas,

Pulau

Pinang,

Malaysia

Tarikh kemas kini RiMUP

06/11/2015

Nombor siri:

BPFK(R4/1)051115/00405

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29-1-2019


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28-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Sarizotan (hydrochloride), decision type: , therapeutic area: , PIP number: P/0287/2018

Opinion/decision on a Paediatric investigation plan (PIP): Sarizotan (hydrochloride), decision type: , therapeutic area: , PIP number: P/0287/2018

Opinion/decision on a Paediatric investigation plan (PIP): Sarizotan (hydrochloride), decision type: , therapeutic area: , PIP number: P/0287/2018

Europe - EMA - European Medicines Agency

28-1-2019

Clomicalm (Elanco GmbH)

Clomicalm (Elanco GmbH)

Clomicalm (Active substance: Clomipramine hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)720 of Mon, 28 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/000039/T/0030

Europe -DG Health and Food Safety

23-1-2019


Orphan designation: 3-(5-Amino-2-methyl-4-oxoquinazolin-3(4H)-yl)piperidine-2,6-dione hydrochloride-, Treatment of diffuse large B-cell lymphoma, 27/06/2016, Positive

Orphan designation: 3-(5-Amino-2-methyl-4-oxoquinazolin-3(4H)-yl)piperidine-2,6-dione hydrochloride-, Treatment of diffuse large B-cell lymphoma, 27/06/2016, Positive

Orphan designation: 3-(5-Amino-2-methyl-4-oxoquinazolin-3(4H)-yl)piperidine-2,6-dione hydrochloride-, Treatment of diffuse large B-cell lymphoma, 27/06/2016, Positive

Europe - EMA - European Medicines Agency

22-1-2019


Orphan designation: Doxorubicin hydrochloride (in heat-sensitive liposomes), Treatment of hepatocellular carcinoma, 23/02/2011, Positive

Orphan designation: Doxorubicin hydrochloride (in heat-sensitive liposomes), Treatment of hepatocellular carcinoma, 23/02/2011, Positive

Orphan designation: Doxorubicin hydrochloride (in heat-sensitive liposomes), Treatment of hepatocellular carcinoma, 23/02/2011, Positive

Europe - EMA - European Medicines Agency

16-1-2019

EU/3/18/2125 (Isabelle Ramirez)

EU/3/18/2125 (Isabelle Ramirez)

EU/3/18/2125 (Active substance: Benserazide hydrochloride) - Orphan designation - Commission Decision (2019)221 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000001719

Europe -DG Health and Food Safety

16-1-2019

EU/3/10/833 (FGK Representative Service GmbH)

EU/3/10/833 (FGK Representative Service GmbH)

EU/3/10/833 (Active substance: Doxorubicin hydrochloride (in heat-sensitive liposomes)) - Transfer of orphan designation - Commission Decision (2019)237 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003113

Europe -DG Health and Food Safety

16-1-2019

EU/3/16/1672 (Celgene Europe B.V.)

EU/3/16/1672 (Celgene Europe B.V.)

EU/3/16/1672 (Active substance: 3-(5-amino-2-methyl-4-oxoquinazolin-3(4H)-yl)piperidine-2,6-dione hydrochloride) - Transfer of orphan designation - Commission Decision (2019)236 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003283

Europe -DG Health and Food Safety

11-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), decision type: , therapeutic area: , PIP number: P/0240/2018

Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), decision type: , therapeutic area: , PIP number: P/0240/2018

Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), decision type: , therapeutic area: , PIP number: P/0240/2018

Europe - EMA - European Medicines Agency

13-12-2018


Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Europe - EMA - European Medicines Agency

13-12-2018


Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

11-12-2018


Epinephrine mepivacaine hydrochloride, mepivacaine norepinephrine, mepivacaine: List of nationally authorised medicinal products - PSUSA/00001979/201803

Epinephrine mepivacaine hydrochloride, mepivacaine norepinephrine, mepivacaine: List of nationally authorised medicinal products - PSUSA/00001979/201803

Epinephrine mepivacaine hydrochloride, mepivacaine norepinephrine, mepivacaine: List of nationally authorised medicinal products - PSUSA/00001979/201803

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0177/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0177/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0177/2018

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Mexiletine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0210/2018

Opinion/decision on a Paediatric investigation plan (PIP): Mexiletine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0210/2018

Opinion/decision on a Paediatric investigation plan (PIP): Mexiletine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0210/2018

Europe - EMA - European Medicines Agency

28-11-2018

Econor (Elanco GmbH)

Econor (Elanco GmbH)

Econor (Active substance: Valnemulin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8038 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/42/T/54

Europe -DG Health and Food Safety

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-gu

Opinion/decision on a Paediatric investigation plan (PIP): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-gu

Opinion/decision on a Paediatric investigation plan (PIP): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-guanidino-1-hexanone hexahydrochloride, decision type: , therapeutic area: , PIP number: P/0134/2018

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): naloxone (hydrochloride), decision type: , therapeutic area: , PIP number: P/0146/2018

Opinion/decision on a Paediatric investigation plan (PIP): naloxone (hydrochloride), decision type: , therapeutic area: , PIP number: P/0146/2018

Opinion/decision on a Paediatric investigation plan (PIP): naloxone (hydrochloride), decision type: , therapeutic area: , PIP number: P/0146/2018

Europe - EMA - European Medicines Agency

27-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

Europe - EMA - European Medicines Agency

26-11-2018

Wakix (Bioprojet Pharma)

Wakix (Bioprojet Pharma)

Wakix (Active substance: Pitolisant hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7974 of Mon, 26 Nov 2018

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Active substance: 5-{(1R,2R)-2-[(cyclopropylmethyl)amino]cyclopropyl}-N-(tetrahydro-2H-pyran-4-yl)thiophene-3-carboxamide monohydrochloride) - Orphan designation - Commission Decision (2018)7791 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/040/18

Europe -DG Health and Food Safety

13-11-2018

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7576 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/233/16/T/01

Europe -DG Health and Food Safety

13-11-2018

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7575 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/140/13/T/01

Europe -DG Health and Food Safety

1-11-2018

Dexdomitor (Orion Corporation)

Dexdomitor (Orion Corporation)

Dexdomitor (Active substance: dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7380 of Thu, 01 Nov 2018

Europe -DG Health and Food Safety

31-10-2018

Evista (Daiichi Sankyo Europe GmbH)

Evista (Daiichi Sankyo Europe GmbH)

Evista (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7342 of Wed, 31 Oct 2018

Europe -DG Health and Food Safety

26-9-2018

Sileo (Orion Corporation)

Sileo (Orion Corporation)

Sileo (Active substance: Dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)6325 of Wed, 26 Sep 2018

Europe -DG Health and Food Safety

10-8-2018

Brinavess (Correvio)

Brinavess (Correvio)

Brinavess (Active substance: vernakalant hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5523 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1215/T/31

Europe -DG Health and Food Safety

30-7-2018

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Active substance: ertugliflozin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5103 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4314/T/2

Europe -DG Health and Food Safety

30-7-2018

Ceplene (Noventia Pharma Srl)

Ceplene (Noventia Pharma Srl)

Ceplene (Active substance: Histamine dihydrochloride) - Centralised - Renewal - Commission Decision (2018)5116 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/796/R/36

Europe -DG Health and Food Safety