Oramox 250mg Hard Capsules

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Amoxicillin

Disponible desde:

Athlone Laboratories Ltd

Código ATC:

J01CA; J01CA04

Designación común internacional (DCI):

Amoxicillin

Dosis:

250 milligram(s)

formulario farmacéutico:

Capsule, hard

tipo de receta:

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

Área terapéutica:

Penicillins with extended spectrum; amoxicillin

Estado de Autorización:

Marketed

Fecha de autorización:

1988-09-27

Información para el usuario

0015 CCRF23051 PV PRAC Variation Mar 23
PATIENT INFORMATION LEAFLET
ORAMOX 250MG HARD CAPSULES
ORAMOX 500MG HARD CAPSULES
Amoxicillin (as amoxicillin trihydrate)
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 Oramox hard capsules are and what they are used for
2. What you need to know before you take Oramox hard capsules
3. How to take Oramox hard capsules
4. Possible side effects
5. How to store Oramox hard capsules
6. Contents of the pack and other information
1. WHAT ORAMOX HARD CAPSULES ARE AND WHAT THEY ARE USED FOR
WHAT ORAMOX HARD CAPSULES ARE
Oramox hard capsules are antibiotics. The active ingredient is
amoxicillin trihydrate. This belongs to a group
of medicines called ‘penicillins’.
WHAT ORAMOX HARD CAPSULES ARE USED FOR
Oramox hard capsules are used to treat infections caused by bacteria
in different parts of the body. Oramox
hard capsules may also be used in combination with other medicines to
treat stomach ulcers.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ORAMOX HARD CAPSULES
DO NOT TAKE ORAMOX HARD CAPSULES:
•
if you are allergic to amoxicillin, penicillin 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 Oramox hard capsules if any of the above apply. If you are
not sure, talk to your doctor or
pharmacist before taking Oramox hard capsules
WARNINGS AND PRECAUTIONS
Talk to your doctor or

Ficha técnica

Health Products Regulatory Authority
23 March 2023
CRN00DGQ9
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Oramox 250mg Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains amoxicillin trihydrate equivalent to 250 mg of
amoxicillin.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Capsules, hard
Size 2 hard gelatin capsules with scarlet caps and ivory bodies,
printed in black with ‘Amox 250’ and containing an off-white
granular powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oramox 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

Prosthetic joint infections

_Helicobacter pylori_ eradication

Lyme disease
Oramox 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 Oramox 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
regarding prolonged therapy)
Health Products Regulatory Authority
23 March 2023
CRN00DGQ9
Page 2 of 13
ADULTS AND CHILDREN ≥ 40KG
INDICATION*
DOSE*
Acute bacterial sinusit