Amoxicillin DSM Sinochem Pharmaceuticals 250 mg hard capsules

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

Amoxicillin (as trihydrate)

から入手可能:

Centrient Pharmaceuticals Netherlands B.V

ATCコード:

J01CA; J01CA04

INN（国際名）:

Amoxicillin (as trihydrate)

投薬量:

250 milligram(s)

医薬品形態:

Capsule, hard

処方タイプ:

Product subject to prescription which may not be renewed (A)

治療領域:

Penicillins with extended spectrum; amoxicillin

認証ステータス:

Not marketed

承認日:

2013-07-26

情報リーフレット

2 r5.0
PACKAGE LEAFLET: INFORMATION FOR THE USER
AMOXICILLIN CENTRIENT 250 MG CAPSULES, HARD
AMOXICILLIN CENTRIENT 500 MG CAPSULES, HARD
Amoxicillin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you (or for your child) only. Do
not pass it on to others. It may
harm them, even if their signs of illness are the same as yours.

If you get any side effects talk to your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Amoxicillin Centrient is and what it is used for
2.
What you need to know before you take Amoxicillin Centrient
3.
How to take Amoxicillin Centrient
4.
Possible side effects
5.
How to store Amoxicillin Centrient
6.
Contents of the pack and other information
1.
WHAT AMOXICILLIN CENTRIENT IS AND WHAT IT IS USED FOR
WHAT AMOXICILLIN CENTRIENT IS
Amoxicillin Centrient is an antibiotic. The active ingredient is
amoxicillin. This belongs to a group of
medicines called ‘penicillins’.
WHAT AMOXICILLIN CENTRIENT IS USED FOR
Amoxicillin Centrient is used to treat infections caused by bacteria
in different parts of the body. Amoxicillin
Centrient may also be used in combination with other medicines to
treat stomach ulcers.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMOXICILLIN CENTRIENT
_ _
DO NOT TAKE AMOXICILLIN CENTRIENT

if you are allergic to amoxicillin, penicillins, or any of the other
ingredients of this medicine (listed in
section 6).

if you have ever had an allergic reaction to any antibiotic. This can
include a skin rash or swelling of the
face or throat.
Do not take Amoxicillin Centrient if any of the above apply. If you
are not sure, talk to your doctor or
pharmacist before taking this medicine.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taki

製品の特徴

Health Products Regulatory Authority
30 March 2020
CRN009P56
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amoxicillin DSM Sinochem Pharmaceuticals 250 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains amoxicillin trihydrate equivalent to 250 mg
amoxicillin.
Excipient with known effect
Contains allura red (E129).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsules, hard.
Hard gelatin capsules with red cap and white body, cylindrical, with
rounded ends, smooth, opaque and uniform surface, filled
with white to off white granular powder. The capsule is 18.8 to 19.4
mm long and approximately 6.91 mm wide.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Amoxicillin is indicated for the treatment of the following infections
in adults and children (see sections 4.2, 4.4 and 5.1):

Acute bacterial sinusitis

Acute otitis media,

Acute streptococcal tonsillitis and pharyngitis

Acute exacerbations of chronic bronchitis

Community acquired pneumonia

Acute cystitis

Asymptomatic bacteriuria in pregnancy

Acute pyelonephritis

Typhoid and paratyphoid fever

Dental abscess with spreading cellulitis

_Helicobacter pylori _eradication

Lyme disease

Amoxicillin is also indicated for the prophylaxis of endocarditis.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose of Amoxicillin that is selected to treat an individual
infection should take into account:
• The expected pathogens and their likely susceptibility to
antibacterial agents (see section 4.4)
• The severity and the site of the infection
• The age, weight and renal function of the patient; as shown below
The duration of therapy should be determined by the type of infection
and the response of the patient, and should generally
be as short as possible. Some infections require longer periods of
treatment (see section 4.4