Amcor

Maklumat utama

  • Nama dagangan:
  • Amcor
  • Perubatan domain:
  • Manusia
  • Jenis perubatan:
  • Ubat Allopathic

Dokumen

Penyetempatan

  • Terdapat dalam:
  • Amcor
    Malaysia
  • Bahasa:
  • Bahasa Melayu

Maklumat lain

Status

  • Sumber:
  • NPRA - National Pharmaceutical Regulatory Agency - Bahagian Regulatori Farmasi Negara
  • 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)

AMCOR 5MG TABLET

Amlodipine (5mg)

Apa yang ada dalam risalah ini

Apakah kegunaan Amcor

Bagaimana Amcor berfungsi

Sebelum mengambil Amcor

Cara menggunakan Amcor

Semasa anda menggunakan

Amcor

Kesan-kesan sampingan

Cara penyimpanan dan pelupusan

Amcor

Maklumat lanjut

Pengilang dan Pemegang

pendaftaran produk

Tarikh kemaskini RiMUP

Apakah kegunaan Amcor

Amcor digunakan untuk merawat

tekanan darah tinggi dan jenis sakit

dada tertentu yang dinamakan angina.

Bagaimana Amcor berfungsi

Amcor mengandungi bahan aktif

amlodipine yang termasuk dalam

kumpulan ubat dinamakan penyekat

saluran kalsium. Di kalangan pesakit

tekanan darah tinggi, penyekat saluran

kalsium menurunkan tekanan darah

dengan mengendurkan dinding saluran

darah supaya darah dapat melaluinya

dengan lebih mudah. Ia juga memberi

kesan ke atas jantung. Jadi, ia boleh

digunakan untuk angina (angina

pektoris). Di kalangan pesakit angina,

Amcor bertindak dengan membaiki

bekalan darah ke jantung. Apabila

jantung menerima lebih banyak

bekalan darah, lebih banyak oksigen

diterima dan ini dapat mengelakkan

sakit dada.

Sebelum mengambil Amcor

Bila tidak boleh mengambil

Jika anda alah kepada amlodipine

atau penyekat saluran kalsium sama

sepertinya (yang dinamakan

derivatif dihydropyridine ), atau

mana-mana bahan lain.

Jika anda mengalami tekanan darah

terlalu rendah

Jika anda mengalami kegagalan

jantung selepas serangan jantung

Sebelum mula mengambil

Anda hendaklah memberitahu doktor

anda atau pengamal perubatan jika

anda mengalami atau pernah

mengalami mana-mana satu daripada

keadaan berikut

Baru mendapat serangan jantung

Kegagalan jantung

Kenaikan teruk tekanan darah

(krisis hipertensi)

Penyakit hati

Mengambil ubat lain

Jika mengambil ubat-ubat lain

Sila beritahu doktor atau ahli farmasi

anda jika anda mengambil atau baru-

baru ini mengambil sebarang ubat

lain, termasuk ubat tanpa preskripsi.

Amcor boleh menurunkan lagi

tekanan darah anda jika anda sudah

mengambil ubat lain untuk merawat

tekanan darah tinggi.

Cara menggunakan Amcor

Berapa banyak harus diambil

Ambil ubat anda betul-betul mengikut

arahan doktor anda. Tanyalah doktor

atau ahli farmasi anda jika anda tidak

pasti.

Dos permulaan biasa ialah 5 mg sekali

sehari. Jika perlu, doktor boleh

menaikkan dos ini kepada 10 mg

sekali sehari.

Bila perlu diambil

Ubat anda boleh diambil sebelum atau

selepas makan dan minum. Anda

hendaklah mengambil ubat anda

dengan segelas air pada masa yang

sama setiap hari. Jangan ambil Amcor

dengan jus limau gedang.

Berapa lama perlu diambil

Ambil ubat selama dipesan oleh

doktor. Pastikan anda mempunyai

bekalan Amcor yang cukup untuk hari

minggu dan cuti. Amcor membantu

mengawal tekanan darah tinggi tetapi

tidak akan mengubatinya. Maka, anda

mungkin perlu mengambil ubat ini

untuk masa yang lama.

Jika terlupa mengambil

Jika anda terlupa mengambil sebiji pil,

jangan sama sekali mengambil dos itu.

Ambil dos seterusnya pada masa yang

betul. Jangan ambil dua dos untuk

menggantikan dos yang tertinggal.

Jika mengambil berlebihan (terlebih

dos)

Pengambilan terlalu banyak pil boleh

menyebabkan tekanan darah anda

menjadi rendah atau terlalu rendah

hingga membahayakan. Anda boleh

merasa pusing kepala, pening, lemah

atau pengsan. Jika tekanan darah jatuh

dengan cukup teruk, kejutan boleh

berlaku. Kulit anda boleh terasa sejuk

dan berlengas dan anda boleh hilang

kesedaran. Segera dapatkan bantuan

perubatan jika anda terambil terlalu

banyak pil Amcor.

Semasa menggunakan Amcor

Perkara yang perlu dilakukan

Keselamatan amlodipine kepada

kehamilan manusia belum dapat

dipastikan.

Jika anda fikir anda hamil, atau

merancang untuk hamil, anda mesti

memberitahu doktor anda sebelum

anda mengambil Amcor.

Tidak diketahui sama ada amlodipine

meresap ke dalam susu ibu. Jika anda

menyusukan bayi atau berhasrat untuk

mula menyusukan bayi, anda mesti

beritahu doktor anda sebelum

mengambil Amcor.

Minta nasihat daripada doktor atau

ahli farmasi anda sebelum mengambil

sebarang ubat.

Perkara yang tidak boleh dilakukan

Jangan berhenti menggunakan ubat ini

kecuali diarahkan oleh doktor anda.

Jangan mula mengambil sebarang ubat

baru tanpa berbincang dengan doktor

atau ahli farmasi anda.

Jangan berkongsi Amcor dengan

sesiapa, walaupun mereka mempunyai

simptom atau penyakit yang sama.

Risalah Maklumat Ubat untuk Pengguna (RiMUP)

Perkara yang perlu diberi perhatian

Penggunaan Amcor di kalangan

kanak-kanak belum dikaji.

Untuk maklumat lanjut, sila minta

penjelasan daripada doktor anda.

Amcor boleh menjejaskan keupayaan

anda untuk memandu dan

menggunakan mesin. Jika pil ini

membuat anda rasa tidak sihat, pening

atau letih, atau menyebabkan anda

pening, jangan memandu atau

menggunakan mesin. Hubungi doktor

anda dengan segera.

Kesan-kesan sampingan

Seperti semua ubat, Amcor boleh

menyebabkan kesan sampingan,

walaupun bukan semua orang

mengalaminya.

Segera jumpa doktor anda jika anda

mengalami mana-mana satu daripada

kesan sampingan yang sangat jarang

berlaku, atau teruk selepas mengambil

ubat ini.

Kesan sampingan paling biasa

diperhatikan adalah:

Kemerahan kulit

Letih

Buku lali bengkak

Pening, sakit kepala

Sakit abdomen, loya

Palpitasi (Denyutan jantung yang

cepat dan deras)

Mengantuk

Jika mana-mana kesan sampingan ini

menjadi serius, atau jika anda

mendapati sebarang kesan sampingan

yang tidak disenaraikan dalam risalah

ini, sila beritahu doktor atau ahli

farmasi anda.

Anda boleh melaporkan sebarang

kesan sampingan atau kesan advers

ubat terus kepada Pusat Pemantauan

Kesan Advers Ubat Kebangsaan

melalui No. Tel: 03-78835550, atau

laman web portal.bpfk.gov.my

(Consumers→Reporting).

Cara penyimpanan dan pelupusan

Amcor

Penyimpanan

Jauhkan daripada capaian dan

penglihatan kanak-kanak.

Simpan di bawah suhu 30°C.

Jangan gunakan ubat anda selepas

tarikh luput yang dinyatakan pada

pembungkusan. Tarikh luput merujuk

kepada hari akhir bulan yang

dinyatakan.

Pelupusan

Sekiranya doktor memberhentikan

anda daripada mengambil Amcor atau

ubat ini telah luput, sila pulangkan

baki ubat kepada ahli farmasi anda

untuk dilupuskan.

Maklumat lanjut

Rupa dan warna produk

Pil: Pil dwicembung putih, bulat,

dengan garis pemisah di satu

permukaan dan kosong pada satu

permukaan lagi.

Saiz Pek:

Kotak mengandungi 3 papan x 10 pil

Kotak mengandungi 10 papan x 10 pil

Bukan semua saiz pek dijual

Bahan-bahan kandungan

Setiap pil mengandungi amlodipine

besilat 7mg bersamaan amlodipine

5mg.

Exipient: Microcrystalline cellulose,

magnesium stearate, sodium starch

glycollate dan talc.

MAL No: MAL09122027A

Pengilang

PT.Merck Tbk.

JL. TB Simatupang No.8, Pasar Rebo

Jakarta 13760, Indonesia

Pemegang Pendaftaran Produk

Merck Sdn Bhd (178145-V)

Level 3, Menara Sunway Annexe,

Jalan Lagoon Timur

Bandar Sunway

46150, Petaling Jaya

Selangor Darul Ehsan

Tarikh Kemaskini RiMUP:

31/12/2013

1-3-2019

AurobindoPharma USA, Inc. Initiates a Voluntary Nationwide Consumer Level Recall Expansion of 38 Lots of Amlodipine Valsartan Tablets USP and Valsartan Tablets, USP due to the detection of NDEA (N-Nitrosodiethylamine) Impurity.

AurobindoPharma USA, Inc. Initiates a Voluntary Nationwide Consumer Level Recall Expansion of 38 Lots of Amlodipine Valsartan Tablets USP and Valsartan Tablets, USP due to the detection of NDEA (N-Nitrosodiethylamine) Impurity.

AurobindoPharma USA, Inc. is conducting a voluntary recall expansion of 38 lots of Valsartan and Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. This recall is an expansion of the recall initiated 12/31/18 The impurity detected in the finished drug product is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial proc...

FDA - U.S. Food and Drug Administration

1-1-2019

Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Consumer Level Recall of 80 Lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP, Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity

Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Consumer Level Recall of 80 Lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP, Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity

Aurobindo Pharma USA, Inc. is conducting a voluntary recall of 80 lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the finished drug product is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classifi...

FDA - U.S. Food and Drug Administration

4-12-2018

Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylam

Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylam

– Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is expanding its consumer-level voluntary nationwide recall to include all lots of Valsartan-containing products within expiry. The 104 additional lots include 26 lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, 5mg/320mg and 10mg/320mg strengths), 51 lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg and 320 mg strengths), and 27 lots of Valsartan and Hydrochloroth...

FDA - U.S. Food and Drug Administration

27-11-2018

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of All Amlodipine/Valsartan Combination Tablets and Amlodipine/Valsartan/Hydrochlorothiazide Combination Tablets That Are Within Expiry

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of All Amlodipine/Valsartan Combination Tablets and Amlodipine/Valsartan/Hydrochlorothiazide Combination Tablets That Are Within Expiry

Teva Pharmaceuticals has initiated a voluntary recall in the United States, to the patient level, of all lots of Amlodipine / Valsartan combination tablets and Amlodipine / Valsartan / Hydrochlorothiazide combination tablets (see table below) due to an impurity detected above specification limits in an active pharmaceutical ingredient (API) manufactured by Mylan India. The impurity found in Mylan’s valsartan API is known as N-nitroso-diethylamine (NDEA), which has been classified as a probable human carc...

FDA - U.S. Food and Drug Administration

21-11-2018

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall to the consumer level of select lots of Valsartan-containing products, including six lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, and 10mg/320mg strengths), seven lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg, and 320 mg strengths), and two lots of Valsartan and Hydrochlorothiazide Tablets, USP 320mg/25mg strength. ...

FDA - U.S. Food and Drug Administration

22-8-2018

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets

Torrent Pharmaceuticals Limited is voluntarily recalling ALL LOTS within expiry of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industr...

FDA - U.S. Food and Drug Administration

18-8-2018

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets

Torrent Pharmaceuticals Limited is voluntarily recalling 14 lots of Valsartan/Amlodipine/HCTZ tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probabl...

FDA - U.S. Food and Drug Administration

27-2-2019

Amlodipine/Valsartan Mylan (Mylan S.A.S.)

Amlodipine/Valsartan Mylan (Mylan S.A.S.)

Amlodipine/Valsartan Mylan (Active substance: amlodipine/valsartan) - Centralised - Yearly update - Commission Decision (2019)1679 of Wed, 27 Feb 2019

Europe -DG Health and Food Safety

17-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Irbesartan / amlodipine, decision type: , therapeutic area: , PIP number: P/0245/2018

Opinion/decision on a Paediatric investigation plan (PIP): Irbesartan / amlodipine, decision type: , therapeutic area: , PIP number: P/0245/2018

Opinion/decision on a Paediatric investigation plan (PIP): Irbesartan / amlodipine, decision type: , therapeutic area: , PIP number: P/0245/2018

Europe - EMA - European Medicines Agency

6-12-2018


Amlodipine besilate / ramipril: List of nationally authorised medicinal products - PSUSA/00000181/201803

Amlodipine besilate / ramipril: List of nationally authorised medicinal products - PSUSA/00000181/201803

Amlodipine besilate / ramipril: List of nationally authorised medicinal products - PSUSA/00000181/201803

Europe - EMA - European Medicines Agency

27-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Amlodipine / irbesartan, decision type: , therapeutic area: , PIP number: P/0145/2018

Opinion/decision on a Paediatric investigation plan (PIP): Amlodipine / irbesartan, decision type: , therapeutic area: , PIP number: P/0145/2018

Opinion/decision on a Paediatric investigation plan (PIP): Amlodipine / irbesartan, decision type: , therapeutic area: , PIP number: P/0145/2018

Europe - EMA - European Medicines Agency

27-6-2018

Copalia HCT (Novartis Europharm Limited)

Copalia HCT (Novartis Europharm Limited)

Copalia HCT (Active substance: amlodipine besylate / valsartan / hydrochlorothiazide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4082 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1159/T/67

Europe -DG Health and Food Safety

27-6-2018

Exforge (Novartis Europharm Limited)

Exforge (Novartis Europharm Limited)

Exforge (Active substance: amlodipine / valsartan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4085 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/716/T/96

Europe -DG Health and Food Safety

27-6-2018

Dafiro HCT (Novartis Europharm Limited)

Dafiro HCT (Novartis Europharm Limited)

Dafiro HCT (Active substance: amlodipine besylate / valsartan / hydrochlorothiazide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4084 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1160/T/68

Europe -DG Health and Food Safety

11-6-2018

Exforge HCT (Novartis Europharm Limited)

Exforge HCT (Novartis Europharm Limited)

Exforge HCT (Active substance: amlodipine besylate / valsartan / hydrochlorothiazide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3752 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1068/T/66

Europe -DG Health and Food Safety

11-6-2018

Dafiro (Novartis Europharm Limited)

Dafiro (Novartis Europharm Limited)

Dafiro (Active substance: amlodipine / valsartan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3753 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/776/T/99

Europe -DG Health and Food Safety

6-6-2018

Copalia (Novartis Europharm Limited)

Copalia (Novartis Europharm Limited)

Copalia (Active substance: amlodipine / valsartan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3695 of Wed, 06 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/774/T/97

Europe -DG Health and Food Safety

4-6-2018

Twynsta (Boehringer Ingelheim International GmbH)

Twynsta (Boehringer Ingelheim International GmbH)

Twynsta (Active substance: telmisartan / amlodipine) - Centralised - Yearly update - Commission Decision (2018)3625 of Mon, 04 Jun 2018

Europe -DG Health and Food Safety