Pinamox 500mg hard Capsules
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
09-03-2023
Summary of Product characteristics
(SPC)
09-03-2023
Active ingredient:
Amoxicillin
Available from:
Athlone Laboratories Ltd
ATC code:
J01CA; J01CA04
INN (International Name):
Amoxicillin
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:
Marketed
Authorization date:
1988-06-29
Patient Information leaflet
00010 CCRF23053 PRAC
PACKAGE LEAFLET: INFORMATION FOR THE USER
PINAMOX 250 MG HARD CAPSULES
PINAMOX 500 MG 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 Pinamox hard capsules are and what they are used for
2.
What you need to know before you take Pinamox hard capsules
3.
How to take Pinamox hard capsules
4.
Possible side effects
5.
How to store Pinamox hard capsules
6.
Contents of the pack and other information
1.
WHAT PINAMOX HARD CAPSULES ARE AND WHAT THEY ARE USED FOR
WHAT PINAMOX HARD CAPSULES ARE
Pinamox hard capsules are antibiotics. The active ingredient is
amoxicillin. This
belongs to a group of medicines called ‘penicillins’.
WHAT PINAMOX HARD CAPSULES ARE USED FOR
Pinamox hard capsules are used to treat infections caused by bacteria
in different parts
of the body. Pinamox hard capsules may also be used in combination
with other
medicines to treat stomach ulcers.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PINAMOX HARD CAPSULES
DO NOT TAKE PINAMOX 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.
00010 CCRF23053 PRAC
Do not take Pinamox hard capsules if any of the above apply. If you
are not sure, talk to
your doctor or pharmacist before taking Pinamox hard capsules.
WARNINGS AND PRECAUTIONS
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
08 March 2023
CRN00DG9T
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pinamox 500mg hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains amoxicillin trihydrate equivalent to 500mg
of amoxicillin.
For a full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Capsules, hard.
Size zero elongated hard gelatin capsules with scarlet caps and ivory
bodies, printed in black with a ‘P’ logo and ‘Pinamox 500’
and containing an off-white granular powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Pinamox 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
Pinamox 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 Pinamox 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
08 March 2023
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Page 2 of 13
ADULTS AND CHILDREN ≥ 4
Read the complete document
