Apo-Ramipril

Maklumat utama

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

Dokumen

Penyetempatan

  • Terdapat dalam:
  • Apo-Ramipril Capsules
    Malaysia
  • Bahasa:
  • Bahasa Melayu

Maklumat lain

Status

  • Sumber:
  • NPRA - National Pharmaceutical Regulatory Agency - Bahagian Regulatori Farmasi Negara
  • Nombor kebenaran:
  • MAL10021796
  • 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)

APO-RAMIPRIL CAPSULES

Ramipril (5mg)

Apakah yang ada pada risalah

ini

Apakah kegunaan Apo-

Ramipril

Bagaimana Apo-Ramipril

berfungsi

Sebelum menggunakan Apo-

Ramipril

Cara menggunakan Apo-

Ramipril

Semasa menggunakan Apo-

Ramipril

Kesan-kesan sampingan

Cara penyimpanan dan

pelupusan Apo-Ramipril

Maklumat lanjut

Pengilang dan Pemegang

Pendaftaran Produk

Tarikh kemaskini RiMUP

Apa kegunaan Apo-Ramipril

Apo-Ramipril tergolong dalam

kumpulan perencat ACE

Angiotensin Converting Enzyme

Ramipril digunakan untuk

rawatan tekanan darah tinggi jenis

ringan atau sederhana. Ia juga

digunakan untuk mengurangkan

risiko serangan jantung, strok,

kematian kardio vaskular atau

keperluan untuk prosedur

revascularization

(pemulihan

peredaran darah ke suatu organ

atau bahagian badan) untuk

pesakit berumur 55 tahun keatas

yang mempunyai faktor risiko

tertentu.

Bagaimana Apo-Ramipril

berfungsi

Ramipril berfungsi dengan

menyekat enzim dalam badan

yang diperlukan untuk

menghasil sejenis bahan yang

menyebabkan pengecuran saluran

darah. Akibatnya, saluran darah

menjadi kurang tegang dan ini

merendahkan tekanan darah.

Sebelum menggunakan Apo-

Ramipril

- Bila tidak boleh menggunakan

Jangan ambil ubat ini jika anda

alah kepada ramipril atau mana-

mana perencat ACE yang lain.

Jangan gunakan ramipril jika anda

hamil. Berhenti menggunakan

ramipril dan beritahu doktor

dengan segera jika anda hamil.

Ramipril boleh menyebabkan

kecederaan atau kematian kepada

bayi dalam kandungan jika ia

diambil semasa trimester kedua

atau ketiga. Gunakan kawalan

kelahiran yang berkesan semasa

mengambil ubat ini. Ramipril

boleh dirembes dalam susu ibu

dan mungkin boleh

membahayakan bayi yang disusui

susu ibu. Jangan menyusu anak

semasa pengambilan ramipril.

- Sebelum mula menggunakan

Apo-Ramipril

Untuk memastikan anda boleh

mengambil ramipril dengan

selamat, beritahu doktor jika anda

mempunyai keadaan-keadaan

seperti berikut:

Penyakit buah pinggang (atau

jika anda bergantung kepada

dialisis);

Penyakit hati;

Penyakit jantung atau

kegagalan jantung kongestif;

kencing manis;

Penyakit tisu penghubung

seperti sindrom Marfan,

sindrom

Sjogren

, lupus,

scleroderma

, atau artritis

reumatoid.

- Jika mengambil ubat-ubat lain

Apabila diberikan bersama-

sama dengan Apo-Ramipril,

sesetengah jenis ubat boleh

menyebabkan komplikasi.

Ubat-ubatan termasuk ubat-

ubatan antihipertensi

(contohnya, diuretik),

allopurinol,

immunosuppressant

kortikosteroid, supplemen

litium atau kalium, pengganti

garam yang mengandungi

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-

Ramipril

- Berapa banyak harus digunakan

Bergantung kepada dos dan

keadaan individu seperti tindak

balas kepada ubat-ubatan, dos

yang dicadangkan untuk orang

dewasa bermula dari 2.5 hingga

10 mg sehari. Ambil ubat ini

betul-betul seperti mana yang

diarahkan oleh doktor anda.

- Bila perlu digunakan

APO-RAMIPRIL boleh diambil

bila-bila masa mengikut arahan

doktor anda.

-Berapa lama perlu digunakan

Jangan berhenti mengambil APO-

RAMIPRIL tanpa terlebih dahulu

berbincang dengan doktor anda.

Menghentikan pengambilan APO-

RAMIPRIL secara tiba-tiba

mungkin boleh memburukkan lagi

keadaan anda.

- Jika terlupa menggunakan

Ambil dos yang terlepas secepat

mungkin bila anda teringat.

Jika ia sudah hampir masa untuk

dos seterusnya, terus ambil dos

seterusnya mengikut jadual masa

yang ditetapkan tanpa menghirau

Risalah Maklumat Ubat untuk Pengguna (RiMUP)

dos yang terlepas. Jangan

gandakan dos untuk ubat ini.

Jika mengambil berlebihan

(terlebih dos)

Jika dos berlebihan berlaku,

dalam semua kes, terapi dengan

APO-RAMIPRIL harus

dihentikan dengan serta-merta dan

anda perlu menghubungi doktor

atau pergi ke bahagian kecemasan

di hospital yang terdekat.

Semasa menggunakan Apo-

Ramipril

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-

Ramipril.

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-Ramipril

dengan sesiapa, walaupun mereka

mempunyai simptom atau

penyakit yang sama.

Perkara yang perlu diberi

perhatian

Minum alkohol boleh

merendahkan lagi tekanan darah

anda dan mungkin meningkatkan

kesan-kesan sampingan ramipril

yang tertentu. Jangan gunakan

garam gantian atau suplemen

kalium semasa mengambil

ramipril, melainkan jika doktor

mengarahkan anda.

Keadaan-keadaan yang mungkin

boleh menyebabkan tekanan

darah yang sangat rendah

termasuk: muntah, cirit-birit, kuat

berpeluh, sakit jantung, dialisis,

diet garam yang rendah, atau

mengambil diuretik (pil air). Ikut

arahan doktor mengenai jenis dan

jumlah cecair anda perlu minum

semasa mengambil ramipril.

Beritahu doktor jika anda

mempunyai penyakit yang

berpanjangan yang menyebabkan

cirit-birit atau muntah-muntah.

Kesan-kesan sampingan

Seperti ubat-ubatan lain, Apo-

Ramipril boleh menyebabkan

kesan sampingan, walaupun

bukan semua orang

mengalaminya.

Hubungi

doktor

serta-merta

jika

anda mengalami kesan sampingan

yang serius seperti berikut semasa

mengambil ramipril:

Rasa ringan kepala, pengsan;

Membuang

kecil

lebih

atau

kurang

daripada

biasa,

atau tidak sama sekali;

Demam,

menggigil,

sakit

badan, tanda-tanda selesema;

Kulit

pucat,

kesukaran

bernafas;

Mudah

lebam,

pendarahan

luar biasa, bintik ungu atau

merah di bawah kulit anda;

Degupan jantung yang cepat,

berdebar-debar,

atau

tidak

sekata;

Sakit dada;

Bengkak

Kesan

sampingan

Ramipril

lain

yang jarang tapi mungkin berlaku

termasuk:

batuk;

Pening,

mengantuk,

sakit

kepala;

Mulut

kering,

kudis

dalam

mulut

anda

atau

pada

bibir

anda;

Loya, cirit-birit, sembelit;

Kulit

gatal-gatal

atau

ruam

ringan.

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-Ramipril

- Penyimpanan

Anda diingatkan supaya

menyimpan APO-RAMIPRIL dan

semua ubat-ubat lain jauh

daripada kanak-kanak.

Jangan gunakan ubat ini selepas

tarikh bulan dan tahun seperti

mana yang ditulis pada EXP di

bekas.

Simpan APO-RAMIPRIL pada

suhu bilik (di bawah 25 ° C).

- Pelupusan

Tanya ahli farmasi apa yang perlu

dilakukan dengan baki tablet jika

doktor anda mengarah anda

berhenti mengambilnya, atau telah

lupus tarikh penggunaannya.

Maklumat Lanjut

- Rupa dan warna produk

Kapsul berwarna putih, badan

legap dengan penutup gelatin

keras warna merah, tertera dengan

"APO 5" dalam dakwat hitam.

Diisi dengan serbuk putih ke

keputih-putihan.

- Bahan-bahan Kandungan

- Bahan Aktif: Ramipril

- Bahan tidak aktif:

Lactose

monohydrate, magnesium

stearate, talc, Caps#4 White-Red

Opaque (FD&C Blue #1, FD&C

Red #40, D&C Red #28, D&C

yellow #10

titanium dioxide)

- Nombor MAL

MAL10021796A

Risalah Maklumat Ubat untuk Pengguna (RiMUP)

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

Nombor Siri

BPFK(R4/1)130115/00016

13-3-2019

Pest categorisation of Phymatotrichopsis omnivora

Pest categorisation of Phymatotrichopsis omnivora

Published on: Tue, 12 Mar 2019 The Panel on Plant Health performed a pest categorisation of Phymatotrichopsis omnivora, the causal agent of Phymatotrichum root rot of more than 2,000 dicotyledonous plant species, for the EU. The pest is listed as Trechispora brinkmannii in Annex IAI of Directive 2000/29/EC. P. omnivora is a well‐defined fungal species and reliable methods exist for its detection and identification. It is present in south‐western USA, northern Mexico, Libya and Venezuela. The pest is not...

Europe - EFSA - European Food Safety Authority EFSA Journal

7-3-2019

Pest survey card on Popillia japonica

Pest survey card on Popillia japonica

Published on: Wed, 06 Mar 2019 This pest survey card was prepared in the context of the mandate on plant pest surveillance (EFSA‐Q‐2017‐00831), upon request by the European Commission. The purpose of this document is to assist the Member States in planning annual survey activities of quarantine organisms using a statistically sound and risk‐based pest survey approach, in line with the current international standards. The data requirements for such activity include the pest distribution, its host range, ...

Europe - EFSA - European Food Safety Authority EFSA Journal

7-3-2019

Safety and efficacy of Robenz® 66G (robenidine hydrochloride) for chickens for fattening and turkeys for fattening

Safety and efficacy of Robenz® 66G (robenidine hydrochloride) for chickens for fattening and turkeys for fattening

Published on: Tue, 05 Mar 2019 Following a request from European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Robenz® 66G (robenidine hydrochloride (HCl)) when used as a feed additive for chickens for fattening and turkeys for fattening. The coccidiostat Robenz®66G is considered safe for chickens for fattening at the highest proposed level of 36 mg robenidine HCl/kg complete feed with a ...

Europe - EFSA - European Food Safety Authority EFSA Journal

5-3-2019

Safety and efficacy of Beltherm MP/ML (endo-1,4-betaxylanase) as a feed additive for piglets, pigs for fattening and other porcine species

Safety and efficacy of Beltherm MP/ML (endo-1,4-betaxylanase) as a feed additive for piglets, pigs for fattening and other porcine species

Published on: Mon, 04 Mar 2019 Beltherm MP/ML contains endo-1,4-beta-xylanase and it is to be used as a zootechnical additive for weaned piglets, pigs for fattening and minor porcine species for fattening. The safety and efficacy of the additive when used for poultry species have been evaluated previously by the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel). In that assessment, the safety for the consumers, environment and the users was assessed. The applicant has ...

Europe - EFSA - European Food Safety Authority EFSA Journal

5-3-2019

Safety and efficacy of Beltherm MP/ML (endo‐1,4‐beta‐xylanase) as a feed additive for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding, turkeys for breeding purposes and minor poultry species

Safety and efficacy of Beltherm MP/ML (endo‐1,4‐beta‐xylanase) as a feed additive for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding, turkeys for breeding purposes and minor poultry species

Published on: Fri, 01 Mar 2019 Beltherm MP/ML contains endo‐1,4‐beta‐xylanase and is intended to be used as a zootechnical additive for poultry species. The safety and efficacy of the additive have been evaluated by the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) in 2017. In that assessment, the additive and the production strain, a genetically modified strain of Bacillus subtilis, were characterised in full. No viable cells of the production strain were detecte...

Europe - EFSA - European Food Safety Authority EFSA Journal

5-3-2019

Safety and efficacy of Calsporin® (Bacillus subtilis DSM 15544) for all poultry species

Safety and efficacy of Calsporin® (Bacillus subtilis DSM 15544) for all poultry species

Published on: Fri, 01 Mar 2019 The additive Calsporin® is a preparation of viable spores of Bacillus subtilis DSM 15544, at a minimum declared concentration of 1 × 1010 colony forming units (CFU)/g additive. The additive is authorised as a zootechnical additive (functional group: gut flora stabiliser) for use in chickens for fattening, weaned piglets, chickens reared for laying, turkeys, minor avian species and other ornamental and game birds, laying hens and ornamental fish, dogs, in sows and in suckli...

Europe - EFSA - European Food Safety Authority EFSA Journal

26-2-2019

Safety and efficacy of TYFER™ (ferric tyrosine chelate) as a zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breading

Safety and efficacy of TYFER™ (ferric tyrosine chelate) as a zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breading

Published on: Mon, 25 Feb 2019 Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the product TYFER™ (ferric tyrosine chelate) as zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breeding. The additive is safe for chickens for fattening at the maximum expected level of 200 mg TYFER™/kg complete feed; this conclusion can be extended to chickens reared for laying/breedin...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-1-2019

Safety and efficacy of B‐Act® (Bacillus licheniformis DSM 28710) as a feed additive for turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening or raised for laying

Safety and efficacy of B‐Act® (Bacillus licheniformis DSM 28710) as a feed additive for turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening or raised for laying

Published on: Mon, 14 Jan 2019 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of B‐Act® when used in feed for turkeys for fattening, reared for breeding and minor poultry species for fattening or raised for laying. B‐Act® is a preparation containing viable spores of a Bacillus licheniformis strain. This species is considered by EFSA to be suitable for the qua...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-1-2019

Voluntary Recall Notice of El Guapo Chile Habanero and Chile Pasilla-Ancho Pouches Due to Unlabeled Peanut Allergen

Voluntary Recall Notice of El Guapo Chile Habanero and Chile Pasilla-Ancho Pouches Due to Unlabeled Peanut Allergen

Mojave Foods Corporation is initiating a voluntary recall of El Guapo Chile Habanero and Chile Pasilla-Ancho pouches due to an unlabeled peanut allergen.

FDA - U.S. Food and Drug Administration

18-12-2018

Apo-Prednisone 5 mg Tablet (2018-12-18)

Apo-Prednisone 5 mg Tablet (2018-12-18)

Health Canada

11-12-2018

International Lubricants, Inc. recalls Kool-It Evaporator & Heater Foam Cleaner

International Lubricants, Inc. recalls Kool-It Evaporator & Heater Foam Cleaner

The recalled product does not have proper consumer chemical hazard labelling as required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

27-11-2018

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 1: Compendium of Representative Processing Techniques investigated in regulatory studies for pesticides

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 1: Compendium of Representative Processing Techniques investigated in regulatory studies for pesticides

Published on: Mon, 26 Nov 2018 EFSA is conducting pan‐European dietary exposure and risk assessments related to actual levels of pesticide residues in food commodities. These assessments use the pesticide occurrence data generated under the official monitoring programs of Member States, the consumption data from EFSA's comprehensive food consumption database and pesticide‐specific information such as processing factors. Currently no harmonised list of processing factors is available within Europe and wo...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Published on: Mon, 12 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF Agro BV submitted a request to the competent national authority in the United Kingdom to set import tolerances for the active substance teflubenzuron in grapefruits and mandarins imported from Brazil and for broccoli imported from Paraguay. The data submitted were found to be sufficient to derive maximum residue level (MRL) proposals for grapefruits and broccoli. The MRL derived ...

Europe - EFSA - European Food Safety Authority Publications

10-11-2018

Pest categorisation of Popillia japonica

Pest categorisation of Popillia japonica

Published on: Thu, 08 Nov 2018 00:00:00 +0100 The Panel on Plant Health performed a pest categorisation of Popillia japonica(Coleoptera: Scarabaeidae) for the EU. P. japonica is a distinguishable species listed in Annex IAII of Council Directive 2000/29/EC. It is native to Japan but established in the USA in the early 20th century. It spreads from New Jersey to most US states east of the Mississippi, some to the west and north into Canada. P. japonica feeds on over 700 plant species. Adults attack folia...

Europe - EFSA - European Food Safety Authority Publications

7-8-2018

Voluntary Recall Notice of El Guapo Jamaica Hibiscus Flower Pouches Due to Unlabeled Peanut Allergen

Voluntary Recall Notice of El Guapo Jamaica Hibiscus Flower Pouches Due to Unlabeled Peanut Allergen

Mojave Foods Corporation is initiating a voluntary recall of four sizes of El Guapo Jamaica Hibiscus Flower packages in flexible packaging due to an unlabeled peanut allergen

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

18-12-2018

APO-Valsartan (valsartan) tablets

APO-Valsartan (valsartan) tablets

Recall - potential contamination

Therapeutic Goods Administration - Australia

11-12-2018


Felodipine / ramipril: List of nationally authorised medicinal products - PSUSA/00001358/201803

Felodipine / ramipril: List of nationally authorised medicinal products - PSUSA/00001358/201803

Felodipine / ramipril: List of nationally authorised medicinal products - PSUSA/00001358/201803

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