Tricef 20 mg/mL powder for oral suspension

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 100 mg/5ml

Pharmaceutical form:

POWDER FOR ORAL SUSPENSION

Composition:

CEFIXIME 100 mg/5ml

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 20 mg/mL powder for oral suspension.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 mL of oral suspension contains 100 mg of cefixime.
Excipient with known effect:
Sucrose – 505.022 mg/mL
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Powder for oral suspension.
Powder for oral suspension, white to pale cream colored and strawberry
odor.
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 8 mg/kg, single dose.
In terms of the pharmaceutical form, the dosage is generally as
follows:
-
_Children aged 2-4 years_
: 1 measuring spoon every 24h; ½ measuring spoon every 12 hours.
-
_Children aged 5-8 years_
: 2 measuring spoons every 24h; 1 measuring spoon every 12 hours.
-
_Children aged 9-12 years_
: 3 measuring spoons every 24h; 1½ measuring spoon every 12
hours.
-
_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
Page 2 of 9
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.
In