Geramox 250 mg Capsules, Hard

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Amoxicillin trihydrate

Boleh didapati daripada:

McDermott Laboratories Ltd., T/A Gerard Laboratories

Kod ATC:

J01CA; J01CA04

INN (Nama Antarabangsa):

Amoxicillin trihydrate

Dos:

250 milligram(s)

Borang farmaseutikal:

Capsule, hard

Kawasan terapeutik:

Penicillins with extended spectrum; amoxicillin

Status kebenaran:

Not marketed

Tarikh kebenaran:

1984-11-28

Risalah maklumat

PACKAGE LEAFLET: INFORMATION FOR THE USER
GERAMOX 250 MG AND 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 Geramox is and what it is used for
2. What you need to know before you take Geramox
3. How to take Geramox
4. Possible side effects
5. How to store Geramox
6. Contents of the pack and other information
1.
WHAT GERAMOX IS AND WHAT IT IS USED FOR
WHAT GERAMOX IS
Geramox contains a medicine called amoxicillin, which belongs to the
Penicillin group of antibiotics.
WHAT GERAMOX IS USED FOR
Geramox can be used to treat a variety of infections in different
parts of the body caused by bacteria.
Geramox may also be used in combination with other medicines to treat
stomach ulcers.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE GERAMOX
DO NOT TAKE GERAMOX:

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, throat or neck.
Do not take Geramox if any of the above apply. If you are not sure,
talk to your doctor or pharmacist before
taking Geramox.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Geramox
•
if you have glandular fever (a viral infection which causes fever,
sore throat, swollen glands and
extreme tiredness)
•
if you suffer from kidney problems
•
if you are not passing water (urinating) regularly
If you are not sure

Ciri produk

Health Products Regulatory Authority
05 September 2019
CRN0091Z4
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Geramox 250 mg Capsules, Hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains amoxicillin trihydrate equivalent to 250 mg
amoxicillin.
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard.
Red cap with yellow body size 2 hard gelatin capsules marked
‘AX250’ and ‘G’ in black ink, containing a white to off white
granular powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Geramox 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
Geramox 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 Geramox 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
05 September 2019
CRN0091Z4
Page 2 of 12
ADULTS AND CHILDREN ≥ 40 KG
INDICATION*
DOSE*
Acute bacterial sinusitis
250 mg to 500