Tricef 400 mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Bialport Produtos Farmaceuticos S.A. A Avenida Da Siderurgia Nacional Sao Mamede De Coronado Trofa,Porto, Portugal

ATC code:

J01DD08

INN (International Name):

CEFIXIME 400 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

CEFIXIME 400 mg

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Authorization status:

Authorised

Authorization date:

2024-02-16

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
TRICEF 400 MG FILM-COATED TABLETS
TRICEF 20 MG/ML POWDER FOR ORAL SUSPENSION
Cefixime
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 or
nurse.
-
This medicine has been prescribed for you 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 or
nurse. This includes
any possible side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Tricef is and what it is used for
2.
What you need to know before you take Tricef
3.
How to take Tricef
4.
Possible side effects
5.
How to store Tricef
6.
Contents of the pack and other information
1.
WHAT TRICEF IS AND WHAT IT IS USED FOR
The active substance of TRICEF (film-coated tablets and powder for
oral suspension) is
cefixime, an antibiotic belonging to the 3rd generation cephalosporin
group.
TRICEF acts causing the death of bacteria that develop infections. Its
use is indicated in
the following infections, when those bacteria are thought to be
susceptible to the drug:
- Acute otitis media;
- Upper respiratory tract infections (pharyngitis, tonsillitis, acute
sinusitis);
-
Lower
respiratory
tract
infections
(acute
exacerbations
of
chronic
bronchitis,
community acquired pneumonia);
- Urinary tract infections (acute cystitis, uncomplicated acute
pyelonephritis);
- Uretritis and uncomplicated gonococcal cervicitis.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRICEF
DO NOT TAKE TRICEF
-
if you are allergic (hypersensitive) to cefixime or any antibiotics
belonging to the
penicillin group (beta-lactam).There is a rare chance to occur a
severe allergic, and
sudden, reaction (anaphylaxis/anaphylactic shock) even with the first
dose of this
class of antibiotics.
The symptoms can be chest tightness, dizziness, malaise,
fa

Summary of Product characteristics

Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF MEDICINAL PRODUCT
Tricef 400 mg film-coated tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 400 mg of cefixime.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablets.
White film-coated tablets, oblong, and debossed with "Bial" and
"TF/400" on opposite sides.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Tricef is indicated for the treatment of the following infections
caused by susceptible agents (see
section 4.4 and 5.1):
- Acute otitis media
- Upper respiratory tract infections (pharyngitis, tonsillitis, acute
sinusitis)
- Lower respiratory tract infections (acute exacerbations of chronic
bronchitis, community acquired
pneumonia);
- Urinary tract infections (acute cystitis, uncomplicated acute
pyelonephritis);
- Uretritis and uncomplicated gonococcal cervicitis.
Consideration should be given to national and/or local guidelines on
the appropriate use of
antibiotics.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The usual recommended posology is as follows:
-
_Adults and children older than 12 years_
(or weighing more than 30 kg): 400 mg in a single daily
dose. For the uncomplicated urinary tract infections a dose of 200 mg
per day is effective.
-
_Elderly_
: The same dose as recommended for adults, unless there is a severe
renal impairment (see
ahead).
-
_Patients with renal impairment_
: The medicine may be administered to patients with impaired
renal function. Doses indicated above may be given in patients with
creatinine clearance of 20
mL/min or above. In patients whose creatinine clearance is less than
20 mL/min, it is recommended
not to exceed a daily dose of 200 mg. This dose should also not be
exceeded in patients undergoing
chronic peritoneal dialysis or hemodialysis, since cefixime is slowly
removed from circulation by
dialysis.
Page 2 of 9
In patients with impaired liver function, there is an increase on time
required for reaching the
maximum serum concentration of c