Amoxicillin DSM Sinochem Pharmaceuticals 500 mg hard capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Amoxicillin (as trihydrate)

Available from:

Centrient Pharmaceuticals Netherlands B.V

ATC code:

J01CA; J01CA04

INN (International Name):

Amoxicillin (as trihydrate)

Dosage:

500 milligram(s)

Pharmaceutical form:

Capsule, hard

Prescription type:

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

Therapeutic area:

Penicillins with extended spectrum; amoxicillin

Authorization status:

Not marketed

Authorization date:

2013-07-26

Patient Information leaflet

1 r9.0
Classification: CONFIDENTIAL
PACKAGE LEAFLET
2 r9.0
Classification: CONFIDENTIAL
PACKAGE LEAFLET: INFORMATION FOR THE USER
AMOXICILLINE DSM SINOCHEM PHARMACEUTICALS 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 DSM Sinochem Pharmaceuticals is and what it is used
for
2.
What you need to know before you take Amoxicillin DSM Sinochem
Pharmaceuticals
3.
How to take Amoxicillin DSM Sinochem Pharmaceuticals
4.
Possible side effects
5.
How to store Amoxicillin DSM Sinochem Pharmaceuticals
6.
Contents of the pack and other information
1.
WHAT AMOXICILLIN DSM SINOCHEM PHARMACEUTICALS IS AND WHAT IT IS USED
FOR
WHAT AMOXICILLIN DSM SINOCHEM PHARMACEUTICALS IS
Amoxicillin DSM Sinochem Pharmaceuticals is an antibiotic. The active
ingredient is amoxicillin. This
belongs to a group of medicines called ‘penicillins’.
WHAT AMOXICILLIN DSM SINOCHEM PHARMACEUTICALS IS USED FOR
Amoxicillin DSM Sinochem Pharmaceuticals is used to treat infections
caused by bacteria in different parts
of the body. Amoxicillin DSM Sinochem Pharmaceuticals may also be used
in combination with other
medicines to treat stomach ulcers.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMOXICILLIN DSM SINOCHEM
PHARMACEUTICALS
_ _
DO NOT TAKE AMOXICILLIN DSM SINOCHEM PHARMACEUTICALS
•
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 antibi

Summary of Product characteristics

Health Products Regulatory Authority
04 July 2023
CRN00DKW4
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amoxicillin DSM Sinochem Pharmaceuticals 500 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains amoxicillin trihydrate equivalent to 500 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 21.0 to 21.6
mm long and approximately 7.64 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 rega