Amcosol

Maklumat utama

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

Dokumen

Penyetempatan

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

Maklumat lain

Status

  • Sumber:
  • NPRA - National Pharmaceutical Regulatory Agency - Bahagian Regulatori Farmasi Negara
  • Nombor kebenaran:
  • MAL19912103
  • 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)

AMCOSOL TABLET

Ambroxol hydrochloride (30mg)

1

Apakah yang ada pada risalah ini

1. Apakah kegunaan Amcosol

2. Bagaimana Amcosol berfungsi

3. Sebelum menggunakan Amcosol

4. Cara menggunakan Amcosol

5. Semasa menggunakan Amcosol

6. Kesan-kesan sampingan

7. Cara penyimpanan dan pelupusan

Amcosol

8. Maklumat lanjut

9. Pengilang dan Pemegang Pendaftaran

produk

10.Tarikh kemaskini RiMUP

Apakah kegunaan Amcosol

Ia digunakan untuk merawat keadaan

rembesan atau mukus berlebihan di dalam

saluran pernafasan.

Bagaimana Amcosol berfungsi

Amcosol mengandungi ambroxol

hydrochloride yang menghilangkan

rembesan atau mukus di dalam saluran

pernafasan dengan mengurangkan

kelikatannya.

Sebelum menggunakan Amcosol

- Bila tidak boleh menggunakan

Jangan mengambil Amcosol jika terdapat

alahan kepada ambroxol hydrochloride

atau bahan tidak aktif yang terkandung

dalam Amcosol. Dapatkan nasihat doktor

atau ahli farmasi sebelum mengambil

sebarang ubat.

Mengandung dan menyusukan anak

Penggunaan Amcosol harus diberi

perhatian teliti semasa hamil. Kesan baik

dan buruk daripada ubat ini kepada bayi

harus dinilai.

- Sebelum menggunakan

Amcosol

Beritahu doktor jika mempunyai masalah

buah pinggang atau hati.

- Jika mengambil ubat-ubat lain

Beritahu doktor jika anda menggunakan

sebarang ubat lain, termasuk ubat yang

dibeli tanpa preskripsi dari farmasi,

pasaraya, atau kedai makanan kesihatan.

Cara menggunakan Amcosol

- Berapa banyak harus digunakan

Dewasa: Oral, 1 biji tablet tiga kali

sehari. Kanak-kanak 5 – 10 tahun: ½ biji

tablet tiga kali sehari. Kanak-kanak

kurang daripada 5 tahun: Ikut arahan

doktor.

Ikut arahan doktor atau ahli farmasi anda

dengan teliti. Ia mungkin berbeza dari

maklumat di dalam risalah 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 Amcosol

- 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

Amcosol.

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 Amcosol dengan

sesiapa, walaupun mereka mempunyai

simptom atau penyakit yang sama.

- Perkara yang perlu diberi perhatian

Berhati-hati semasa memandu dan

mengendalikan jentera sehingga anda

mengetahui kesan ubat ini terhadap anda.

Kesan-kesan sampingan

Seperti ubat-ubatan lain, Amcosol boleh

menyebabkan kesan sampingan, walaupun

bukan semua orang mengalaminya.

Jumpa doktor atau ahli farmasi anda

dengan segera jika anda mengalami

sebarang kesan sampingan selepas

menggunakan ubat ini.

Gerakbalas alahan mungkin berlaku.

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

npra.moh.gov.my (

Public

Reporting

Medicinal Problems / Side Effects / AEFI /

Vaccine Safety).

Cara penyimpanan dan pelupusan

Amcosol

- Penyimpanan

Simpan di bawah suhu 30

C. Jauhi semua

ubat daripada kanak-kanak.

- 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

Tablet bulat warna putih, dwicembung

dan berskor atas.

- Bahan-bahan kandungan

- Bahan aktif: ambroxol hydrochloride.

- Bahan tidak aktif: laktos, tepung jagung,

polyvinylpyrrolidone dan magnesium

stearate.

- Nombor MAL

MAL19912103XZ

Pengilang dan Pemegang Pendaftaran

Produk

Prime Pharmaceutical Sdn. Bhd.

1505, Lorong Perusahaan Utama 1

Taman Perindustrian Bukit Tengah

14000 Bukit Mertajam, Pulau Pinang,

Malaysia.

Tarikh kemaskini RiMUP

03/04/2017

Nombor siri

BPFK(R4/1)030417/00045

7-3-2019

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13-12-2018


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

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11-12-2018


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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

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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