Apo-Amilzide

Maklumat utama

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

Dokumen

Penyetempatan

  • Terdapat dalam:
  • Apo-Amilzide Tablet
    Malaysia
  • Bahasa:
  • Bahasa Melayu

Maklumat lain

Status

  • Sumber:
  • NPRA - National Pharmaceutical Regulatory Agency - Bahagian Regulatori Farmasi Negara
  • Nombor kebenaran:
  • MAL 1998470
  • Kemaskini terakhir:
  • 31-08-2017

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

APO-AMILZIDE TABLET

Hydrochlorothiazide/ Amiloride Hydrochloride (50/5MG)

1

Risalah Maklumat Ubat untuk Pengguna (RiMUP)

Apakah yang ada pada risalah ini

Apakah kegunaan Apo-Amilzide

Bagaimana Apo-Amilzide berfungsi

Sebelum menggunakan Apo-

Amilzide

Cara menggunakan Apo-Amilzide

Semasa menggunakan Apo-

Amilzide

Kesan-kesan sampingan

Cara penyimpanan dan pelupusan

Apo-Amilzide

Maklumat lanjut

Pengilang dan Pemegang

Pendaftaran Produk

Tarikh kemaskini RiMUP

Apakah kegunaan Apo-Amilzide

Gabungan hydrochlorothiazide dan

amiloride digunakan untuk merawat

pembendungan cecair (edema) dan

tekanan darah tinggi (hipertensi).

Bagaimana Apo-Amilzide berfungsi

Hydrochlorothiazide adalah diuretik

thiazide (pil air) yang membantu

menghalang penyerapan garam semula

yang terlalu banyak oleh buah pinggang

yang boleh menyebabkan pembendungan

cecair.

Amiloride adalah

potassium sparing-

diuretic

yang menghalang penyerapan

garam semula yang terlalu banyak oleh

buah pinggang dan mengekalkan tahap

kalium anda supaya tidak jatuh ke tahap

terlalu rendah.

Sebelum menggunakan Apo-Amilzide

Bila tidak boleh menggunakan

Jangan ambil APO-AMILZIDE jika

anda alergi kepada

hydrochlorothiazide, Amiloride

(hipersensitif) atau mana-mana bahan

lain yang terkandung dalam pil.

Anda tidak patut menggunakan ubat

ini jika anda mempunyai hiperkalemia

(Tahap Kalium Darah Tinggi),

mempunyai masalah fungsi buah

pinggang, atau mempunyai penyakit

kencing manis.

Mengandung dan menyusukan anak

Jangan ambil Apo-Amilzide jika anda

mengandung, sedang merancang untuk

mengandung atau mungkin mengandung.

Jangan ambil Apo-Amilzide jika anda

sedang menyusukan anak. Dapatkan

nasihat doktor atau ahli farmasi sebelum

mengambil sebarang ubat.

Sebelum mula mengambil

Sebelum anda mula menggunakan ubat

ini, anda harus memberitahu doktor

anda jika anda mempunyai sebarang

masalah perubatan.

Jika mengambil ubat-ubat lain

Sesetengah ubat, jika diambil bersama-

Apo Amilzide akan menyebabkan

komplikasi jika tiada langkah berjaga-

jaga diambil. Ubat-ubatan ini termasuk

ubat-ubatan hipertensi (

potentiation

, di

mana kesan ubat hipertensi anda akan

ditingkatkan), Litium (ketoksikan

litium), serta

supplement

seperti

makanan tambahan kalium.

Beritahu doktor jika anda

menggunakan sebarang ubat lain,

termasuk ubat yang dibeli tanpa

preskripsi dari farmasi, pasaraya, atau

kedai makanan kesihatan.

Cara menggunakan Apo-Amilzide

Berapa banyak harus digunakan

Ikut arahan doktor atau ahli farmasi

anda dengan teliti. Doktor anda akan

menyelaras dos anda berdasarkan

kepada keadaan dan tindak balas anda

terhadap ubat ini. Jika anda tidak

memahami arahan pada label ubat

anda, sila rujuk kepada doktor atau ahli

farmasi.

Bila perlu digunakan

Ikut arahan doktor atau ahli farmasi

anda.

Berapa lama perlu digunakan

Teruskan penggunaan ubat ini untuk

tempoh masa yang ditetapkan oleh

doktor anda.

Jika terlupa menggunakan

Rujuk kepada doktor atau ahli farmasi

anda tentang apa yang perlu dilakukan

jika anda terlupa menggunakan ubat

ini.

Ambil dos yang terlepas sebaik sahaja

anda teringat. Sekiranya sudah hampir

masa untuk dos seterusnya, abaikan

dos terlepas dan tunggu untuk

mengambil dos seterusnya pada masa

biasa. Jangan ambil dos berganda

untuk menggantikan dos yang

tertinggal.

Jika mengambil berlebihan (terlebih

dos)

Hubungi doktor anda dengan segera

atau pergi ke Jabatan Kecemasan

hospital terdekat, jika terambil dos

berlebihan. Ini perlu dilakukan

walaupun tiada sebarang kesan

keracunan atau rasa tidak selesa. Anda

mungkin memerlukan perhatian

perubatan segera.

Semasa menggunakan Apo-Amilzide

Perkara yang perlu dilakukan

Ambil ubat anda mengikut arahan

doktor.

Maklumkan kepada semua doktor,

doktor gigi dan ahli farmasi yang

merawat anda bahawa anda sedang

menggunakan Apo-Amilzide.

Beritahu doktor anda dengan segera

jika anda menjadi hamil semasa

menggunakan ubat ini.

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 Apo-Amilzide

dengan sesiapa, walaupun mereka

mempunyai simptom atau penyakit

yang sama.

Perkara yang perlu diberi perhatian

Memandu dan menggunakan jentera

Ubat ini mungkin mengganggu

keupayaan anda untuk memandu atau

mengendalikan jentera, Jika ubat ini

menyebabkan anda terasa loya, pening,

2

Risalah Maklumat Ubat untuk Pengguna (RiMUP)

letih, atau sakit kepala, jangan

memandu atau mengendalikan jentera

dan hubungi doktor anda dengan

segera.

Kesan-kesan sampingan

Seperti ubat-ubatan lain,Apo-Amilzide

boleh menyebabkan kesan sampingan,

walaupun bukan semua orang

mengalaminya.

Kesan sampingan yang kurang serius

mungkin termasuk:

loya atau muntah-muntah ringan;

gas, sakit perut; atau

ruam kulit.

Walaupun jarang berlaku, kesan

sampingan yang paling serius ubat ini

adalah

symptomatic hyperkalemia

(tahap kalium yang tinggi dalam badan

anda, dengan tanda atau gejala-gejala

yang ketara).

Jumpa doktor atau ahli farmasi anda

dengan segera jika anda mengalami

sebarang kesan sampingan selepas

menggunakan ubat ini.

Anda boleh melaporkan sebarang kesan

sampingan atau kesan advers ubat

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

Apo-Amilzide

Penyimpanan

Jauhi semua ubat daripada kanak-

kanak.

Simpan APO-AMILZIDE pada suhu

bilik (bawah 25°C).

Pelupusan

Ubat-ubatan tidak harus dilupuskan

melalui air buangan atau sisa isi

rumah. Sila rujuk kepada ahli farmasi

anda mengenai cara yang betul untuk

melupuskan ubat yang tidak

diperlukan lagi. Langkah-langkah ini

dapat membantu melindungi alam

sekitar.

Maklumat lanjut

Rupa dan warna produk

Warna

kuning

kemerah-merahan,

tablet

berbentuk

berlian,

bergarisan

(scored)

dapat

dikenal

dengan

perkataan "APO" diatas, dan perkataan

"5/50" dibawah garisan.

Bahan-bahan kandungan

Bahan aktif

50mg hydrochlorothiazide dan 5mg

amiloride hydrochloride

Bahan tidak aktif

Lactose monohydrate, sodium

bicarbonate, microcrystalline

cellulose, croscarmellose sodium,

magnesium stearate, colloidal

silicon dioxide

sunset yellow

lake

Nombor MAL

MAL 19984702AR

Pengilang

Apotex Inc.

150 Signet Drive

Weston Toronto Ontario

M9L 1T9 Canada

Pemegang Pendaftaran Produk

Pharmaforte (M) Sdn Bhd

2, Jalan PJU 3/49

Sunway Damansara

47810 Petaling Jaya

Tarikh kemaskini RiMUP

26/1/2015

Serial Number

BPFK(R4/1)130115/00010

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FDA - U.S. Food and Drug Administration

13-7-2018

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc. dba Solco Healthcare LLC. is recalling all lots of Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg to the retail level. This product recall is due to the detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA), made by the manufacturer – Zhejiang Huahai Pharmaceutical Co. Ltd. -- that is used in the manufacture of the subject product ...

FDA - U.S. Food and Drug Administration

9-6-2018

Caito Foods, LLC Voluntarily Recalls Fresh Cut Melon Products Because of Possible Health Risk

Caito Foods, LLC Voluntarily Recalls Fresh Cut Melon Products Because of Possible Health Risk

Caito Foods is voluntarily recalling fresh cut watermelon, honeydew melon, cantaloupe and fresh-cut mixed fruit containing one of these melons, produced at the Caito Foods facility in Indianapolis, because these products have the potential to be contaminated with Salmonella.

FDA - U.S. Food and Drug Administration

8-3-2012

Review concluded regarding general reimbursement for Valsartan/Hydrochlorothiazide "Actavis"

Review concluded regarding general reimbursement for Valsartan/Hydrochlorothiazide "Actavis"

We have completed our review of an application for general reimbursement for Valsartan/Hydrochlorothiazide "Actavis". The product is neither eligible for general nor general conditional reimbursement.

Danish Medicines Agency

20-2-2019


Fosinopril, fosinopril / hydrochlorothiazide: List of nationally authorised medicinal products - PSUSA/00010463/201807

Fosinopril, fosinopril / hydrochlorothiazide: List of nationally authorised medicinal products - PSUSA/00010463/201807

Fosinopril, fosinopril / hydrochlorothiazide: List of nationally authorised medicinal products - PSUSA/00010463/201807

Europe - EMA - European Medicines Agency

11-2-2019

Tolucombi (Krka d. d., Novo mesto)

Tolucombi (Krka d. d., Novo mesto)

Tolucombi (Active substance: telmisartan/hydrochlorothiazide) - Centralised - Yearly update - Commission Decision (2019)1040 of Mon, 11 Feb 2019

Europe -DG Health and Food Safety

18-12-2018

APO-Valsartan (valsartan) tablets

APO-Valsartan (valsartan) tablets

Recall - potential contamination

Therapeutic Goods Administration - Australia

5-12-2018


Cilazapril, cilazapril / hydrochlorothiazide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation -  PSUSA-00000749-201802

Cilazapril, cilazapril / hydrochlorothiazide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA-00000749-201802

Cilazapril, cilazapril / hydrochlorothiazide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA-00000749-201802

Europe - EMA - European Medicines Agency

5-12-2018


Cilazapril, cilazapril / hydrochlorothiazide: List of nationally authorised medicinal products -  PSUSA-00000749-201802

Cilazapril, cilazapril / hydrochlorothiazide: List of nationally authorised medicinal products - PSUSA-00000749-201802

Cilazapril, cilazapril / hydrochlorothiazide: List of nationally authorised medicinal products - PSUSA-00000749-201802

Europe - EMA - European Medicines Agency

12-11-2018

Irbesartan HCT Zentiva (Zentiva k.s.)

Irbesartan HCT Zentiva (Zentiva k.s.)

Irbesartan HCT Zentiva (Active substance: irbesartan / hydrochlorothiazide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7555 of Mon, 12 Nov 2018

Europe -DG Health and Food Safety

22-10-2018

Irbesartan / Hydrochlorothiazide Teva (Teva B.V.)

Irbesartan / Hydrochlorothiazide Teva (Teva B.V.)

Irbesartan / Hydrochlorothiazide Teva (Active substance: irbesartan / hydrochlorothiazide) - Centralised - Yearly update - Commission Decision (2018) 6974 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

CoAprovel (Sanofi Clir SNC)

CoAprovel (Sanofi Clir SNC)

CoAprovel (Active substance: Irbesartan / hydrochlorothiazide) - Centralised - Yearly update - Commission Decision (2018)6465 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

24-9-2018

Karvezide (Sanofi-Aventis groupe)

Karvezide (Sanofi-Aventis groupe)

Karvezide (Active substance: Irbesartan / hydrochlorothiazide) - Centralised - Yearly update - Commission Decision (2018)6222 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

29-8-2018

Rasilez HCT (Noden Pharma DAC)

Rasilez HCT (Noden Pharma DAC)

Rasilez HCT (Active substance: aliskiren hemifumarate / hydrochlorothiazide) - Centralised - Renewal - Commission Decision (2018)5769 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/964/R/87

Europe -DG Health and Food Safety

4-7-2018

Ifirmacombi (Krka d. d., Novo mesto)

Ifirmacombi (Krka d. d., Novo mesto)

Ifirmacombi (Active substance: Irbesartan / hydrochlorothiazide) - Centralised - Yearly update - Commission Decision (2018)4340 of Wed, 04 Jul 2018

Europe -DG Health and Food Safety

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

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