Suprax 200 mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CEFIXIME TRIHYDRATE

Available from:

Amdipharm Limited

ATC code:

J01DD; J01DD08

INN (International Name):

CEFIXIME TRIHYDRATE

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

Third-generation cephalosporins; cefixime

Authorization status:

Marketed

Authorization date:

1989-01-05

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
SUPRAX 200MG FILM-COATED TABLETS
Cefixime
IS THIS LEAFLET HARD TO SEE OR READ?
PHONE [phone] FOR HELP
READ ALL OF THIS LEAFLET CAREFULLY BEFORE 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 your
pharmacist.
• This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms 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 Suprax is and what it is used for
2. What you need to know before you take Suprax
3. How to take Suprax
4. Possible side effects
5. How to store Suprax
6. Contents of the pack and other information
1. WHAT SUPRAX IS AND WHAT IT IS USED FOR
Suprax 200mg Tablets (called Suprax in this leaflet) contains a
medicine called cefixime. This belongs to a group of
antibiotics called ‘cephalosporins’. Suprax is used to treat
infections caused by bacteria. These include treating infections
in the upper respiratory tract and also in the urinary tract.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SUPRAX
DO NOT TAKE THIS MEDICINE AND TELL YOUR DOCTOR IF :
You are allergic (hypersensitive) to cefixime, any other cephalosporin
antibiotics including penicillin or to any of the other
ingredients of this medicine (listed in Section 6). Signs of an
allergic reaction include: a rash, swallowing or breathing
problems, swelling of the lips, face, throat and tongue.
Do not take this medicine if the above applies to you. If you are not
sure, talk to your doctor or your pharmacist before
taking Suprax.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING SUPRAX IF:
▲
You have ever had colitis
▲
You have allergic tendencies such as asthma, rash or hives
▲
You have kidney problems
▲
The person taking this me

Summary of Product characteristics

Health Products Regulatory Authority
18 August 2023
CRN00DJWP
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Suprax 200 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Cefixime Trihydrate equivalent to cefixime 200
mg.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet
Off-white to cream, circular, convex, embossed ‘ORO’ on one face.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For use in the treatment of infections due to micro-organisms
sensitive to the antibiotic including pathogens such as
_Streptococci pneumoniae_ and _pyogenes_, _E.coli_, Proteus, _H.
influenza_ and_ B. catarrhalis_ (both beta lactamase positive and
negative), Klebsiella and Enterobacter species.
Most Enterococci, Staphylococci, Pseudomonas, Clostridia, _Bacteroides
fragilis_ and_ Listeria monoyctogenes_ are resistant to
Cefixime.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration is oral.
ADULTS AND CHILDREN OF 12 YEARS AND OVER (OR MORE THAN 50KG BODY
WEIGHT):
The usual daily dose is 200-400mg in single or twice daily dosage
regimen.
In uncomplicated upper respiratory tract infections or urinary tract
infections a daily dose of 200 mg may be sufficient.
CHILDREN AGED 9 TO 12 YEARS:
The usual total daily dose is 300mg (15ml of oral suspension) in
single or twice daily regimen.
CHILDREN AGED 5 TO 8 YEARS:
The usual total daily dose is 200 mg (10ml of oral suspension) in
single or twice daily dosage regimen.
CHILDREN AGED 2 TO 4 YEARS:
The usual total daily dose is 100 mg (5ml of oral suspension) in
single or twice daily dosage regimen.
CHILDREN AGED 6 MONTHS TO 2 YEARS:
The usual total daily dose in 8 mg/kg in single or twice daily
regimen.
The safety and efficacy of use in infants less than 6 months of age
has not been established.
ELDERLY:
The usual dosage is as for adults with appropriate modifications on
the basis of renal impairment.
PATIENTS WITH RENAL IMPAIRMENT
Dosage does not require modification in p