GERAMOX

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Nunua Sasa

Shusha Taarifa za kipeperushi (PIL)
10-08-2018
Shusha Tabia za bidhaa (SPC)
10-08-2018

Viambatanisho vya kazi:

AMOXICILLIN TRIHYDRATE

Inapatikana kutoka:

Generics (UK) Limited

ATC kanuni:

J01CA04

INN (Jina la Kimataifa):

AMOXICILLIN TRIHYDRATE

Kipimo:

250 Milligram

Dawa fomu:

Capsules Hard

Dawa ya aina:

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

Eneo la matibabu:

amoxicillin

Idhini hali ya:

Not Marketed

Idhini ya tarehe:

1984-11-28

Taarifa za kipeperushi

                                Keyline
Black
Varnish
Free
Braille
Glue
Area
PMS 186
PMS 306
PMS 108
Colours
Non-Print
Colours
Date:
Time:
Equate CMYK
with
Dimensions
Main Font
Body Text Size
Min Text Size used
Page Count
No. of colours
Pharma Code
SAP No.
Vendor Job No.
Trackwise Proof No.
Client Market
Keyline/Drawing No
.
Barcode Info
Description
Component Type
Affiliate Item Code
Superceded Affiliate Item Code
TrackWise PR No.
MA No.
Packing Site/Printer
Supplier Code
Sign-offs
Times New Roman
8.5 pt
4 pt
Geramox_250mg_100
Label Leaflet
1508833
1273811
1508833
405/5/1
TBC
TBC
N/A
100990348
3
Ireland
55 x 109 mm_2 PART
FoF_KLD_16-05-18
5099151003898
31 May 18
22:00
4
55 x 109 mm
1
3D Render ID
NA
v3/Jul 2017
Keyline
Black
Varnish
Free
Braille
Glue
Area
PMS 186
PMS 306
PMS 108
Medreich Ltd (Unit-I :
Bangalore - IN)
Technical
Info
It is especially important to tell your
doctor if you are taking any of the following:
• if you are taking warfarin or
acenocoumarol (medicines used to thin
the blood or prevent blood clots), you
may need extra blood tests.
• if you are taking probenecid or allopurinol
(medicines used to treat gout), you may
have an allergic skin reaction and your
doctor may adjust your dose of Geramox.
• if you are taking methotrexate
(a chemotherapy medicine used to treat
cancer and severe psoriasis). Geramox
may cause an increase in side effects.
• if you are taking other antibiotics (such
as tetracycline) Geramox may be less
effective.
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.
• dizziness
• hyperactivity
• crystals in the urine,
which may be seen as
                                
                                Soma hati kamili
                                
                            

Tabia za bidhaa

                                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.
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                                Soma hati kamili
                                
                            

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