Oramox 250 mg/5 ml Powder for Oral Suspension

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Amoxicillin

Dostupno od:

Athlone Laboratories Ltd

ATC koda:

J01CA; J01CA04

INN (International ime):

Amoxicillin

Doziranje:

250 mg/5ml

Farmaceutski oblik:

Powder for oral suspension

Tip recepta:

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

Područje terapije:

Penicillins with extended spectrum; amoxicillin

Status autorizacije:

Marketed

Datum autorizacije:

1988-09-27

Uputa o lijeku

0011 PRAC CCRF23052
PACKAGE LEAFLET: INFORMATION FOR THE USER
ORAMOX 125MG / 5ML POWDER FOR ORAL SUSPENSION
ORAMOX 250MG / 5ML POWDER FOR ORAL SUSPENSION
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 Oramox is and what it is used for
2. What you need to know before you take Oramox
3. How to take Oramox
4. Possible side effects
5. How to store Oramox
6. Contents of the pack and other information
1.
WHAT ORAMOX IS AND WHAT IT IS USED FOR
WHAT ORAMOX IS
Oramox is an antibiotic. The active ingredient is amoxicillin
trihydrate. This belongs to a group of
medicines called ‘penicillins’.
WHAT ORAMOX IS USED FOR
Oramox is used to treat infections caused by bacteria in different
parts of the body. Oramox may also be
used in combination with other medicines to treat stomach ulcers.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ORAMOX
DO NOT TAKE ORAMOX
•
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 if any of the above apply. If you are not sure,
talk to your doctor or pharmacist
before taking Oramox
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Oramox if you:
•
have glandular fever (fever, sore throat, swollen glands and extreme
tiredness)
•
have kidney problems
•
are not urinating regularly
If you are not sure if

Svojstava lijeka

Health Products Regulatory Authority
16 March 2023
CRN00DGQH
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Oramox 250 mg/5 ml Powder for Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of reconstituted suspension contains amoxicillin trihydrate,
equivalent to 250 mg of Amoxicillin.
Excipient(s) with known effect:
Each 5ml dose contains 2.7 g of sucrose, 6.47 mg of sodium and 4.82 mg
of sodium benzoate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral suspension
A pale yellow crystalline powder for oral suspension with the odour
and flavour of lemon
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
Health Products Regulatory Authority
16 March 2023
CRN00DGQH
Page 2 of 14
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
tr