Cefuroximaxetil 250, omhulde tabletten 250 mg

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

CEFUROXIMAXETIL SAMENSTELLING overeenkomend met ; ; CEFUROXIM 250 mg/stuk

Beschikbaar vanaf:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-code:

J01DC02

INN (Algemene Internationale Benaming):

CEFUROXIMAXETIL SAMENSTELLING overeenkomend met ; ; CEFUROXIM 250 mg/stuk

farmaceutische vorm:

Omhulde tablet

Samenstelling:

AARDAPPELZETMEEL, OPLOSBAAR ; ASPARTAAM (E 951) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; COPOVIDON (E 1208) ; CROSCARMELLOSE NATRIUM (E 468) ; CROSPOVIDON (E 1202) ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; NATRIUMLAURILSULFAAT ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), AARDAPPELZETMEEL, OPLOSBAAR ; ASPARTAAM (E 951) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOVIDON ; CROSCARMELLOSE NATRIUM (E 468) ; CROSPOVIDON (E 1202) ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; NATRIUMLAURILSULFAAT (E 487) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), AARDAPPELZETMEEL, OPLOSBAAR ; ASPARTAAM (E 951) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOVIDON ; CROSCARMELLOSE NATRIUM (E 468) ; CROSPOVIDON (E 1202) ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; NATRIUMLAURILSULFAAT (E 487) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Cefuroxime

Product samenvatting:

Hulpstoffen: AARDAPPELZETMEEL, OPLOSBAAR; ASPARTAAM (E 951); CELLULOSE, MICROKRISTALLIJN (E 460); COPOVIDON; CROSCARMELLOSE NATRIUM (E 468); CROSPOVIDON (E 1202); MAGNESIUMSTEARAAT (E 470b); MANNITOL (D-) (E 421); NATRIUMLAURILSULFAAT (E 487); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisatie datum:

1900-01-01

Bijsluiter

Sandoz B.V.
Page 1/8
Cefuroximaxetil 125, 250 en 500, omhulde tabletten
125, 250 en 500 mg
RVG 26702-3-4
1313-v11b
1.3.1.3 Bijsluiter
October 2023
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CEFUROXIMAXETIL 125, OMHULDE TABLETTEN 125 MG
CEFUROXIMAXETIL 250, OMHULDE TABLETTEN 250 MG
CEFUROXIMAXETIL 500, OMHULDE TABLETTEN 500 MG
CEFUROXIME 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 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 [Nationally completed name] is and what it is used for
2.
What you need to know before you take [Nationally completed name]
3.
How to take [Nationally completed name]
4.
Possible side effects
5.
How to store [Nationally completed name]
6.
Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[Nationally completed name] is an antibiotic used in adults and
children. It works by killing
bacteria that cause infections. It belongs to a group of medicines
called
_cephalosporins_
.
[Nationally completed name] is used to treat infections of:
•
the throat
•
sinus
•
middle ear
•
the lungs or chest
•
the urinary tract
•
the skin and soft tissues.
[Nationally completed name] can also be used:
•
to treat Lyme disease (an infection spread by parasites called ticks).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
[
NATIONALLY COMPLETED NAME]
DO NOT TAKE
[
NATIONALLY COMPLETED NAME]:
Sandoz B.V.
Page 2/8
Cefuroximaxetil 125, 250 en 500, omhulde tabletten
125, 250 en 500 mg
RVG 26702-3-4
1313-v11b
1.3.1.3 Bijsluiter
October 2023
-
IF YOU ARE ALLERGIC
to cefuroxime, to
A

Productkenmerken

Sandoz B.V.
Page 1/14
Cefuroximaxetil 125, 250 en 500, omhulde tabletten 125,
250 en 500 mg
RVG 26702-3-4
1311-v11b
1.3.1.1 Samenvatting van de Productkenmerken
October 2023
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Cefuroximaxetil 125, omhulde tabletten 125 mg
Cefuroximaxetil 250, omhulde tabletten 250 mg
Cefuroximaxetil 500, omhulde tabletten 500 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 125 mg coated tablet contains 150.36 mg cefuroxime (as axetil).
Excipients with known effect
Each coated tablet contains 0.2 mg aspartame (E951).
Each 250 mg coated tablet contains 300.72 mg cefuroxime (as axetil).
Each 500 mg coated tablets contain 601.44 mg cefuroxime (as axetil).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Coated tablets.
_125 mg coated tablets: _
White to slightly yellowish, biconvex, oblong tablets.
_250 mg coated tablets: _
White to slightly yellowish, biconvex, oblong tablets, scored on both
sides.
_500 mg coated tablets: _
White to slightly yellowish, biconvex, oblong tablets.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Sandoz B.V.
Page 2/14
Cefuroximaxetil 125, 250 en 500, omhulde tabletten 125,
250 en 500 mg
RVG 26702-3-4
1311-v11b
1.3.1.1 Samenvatting van de Productkenmerken
October 2023
[Nationally completed name] is indicated for the treatment of the
infections listed below in adults and
children from the age of 3 months (see sections 4.4 and 5.1).
- Acute streptococcal tonsillitis and pharyngitis.
- Acute bacterial sinusitis.
- Acute otitis media.
- Acute exacerbations of chronic bronchitis.
- Cystitis
- Pyelonephritis.
- Uncomplicated skin and soft tissue infections.
- Treatment of early Lyme disease.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The usual course of therapy is seven days (may range from five to ten
days).
_Table 1. Adults and children (≥40 kg) _
INDICATION
DOSAGE
Acute tonsillitis and pharyngitis, acut