Claritromycine Sandoz 250 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

CLARITROMYCINE 250 mg/stuk

Beschikbaar vanaf:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-code:

J01FA09

INN (Algemene Internationale Benaming):

CLARITROMYCINE 250 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CHINOLINEGEEL (E 104) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON K 30 (E 1201) ; PROPYLEENGLYCOL (E 1520) ; SILICIUMDIOXIDE (E 551) ; SORBITANMONOOLEAAT (E 494) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; VANILLINE, CELLULOSE, MICROKRISTALLIJN (E 460) ; CHINOLINEGEEL (E 104) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON K 30 (E 1201) ; PROPYLEENGLYCOL (E 1520) ; SILICIUMDIOXIDE (E 551) ; SORBITANMONOOLEAAT (E 494) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; VANILLINE,

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Clarithromycin

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CHINOLINEGEEL (E 104); CROSCARMELLOSE NATRIUM (E 468); HYPROLOSE (E 463); HYPROMELLOSE (E 464); MAGNESIUMSTEARAAT (E 470b); POVIDON K 30 (E 1201); PROPYLEENGLYCOL (E 1520); SILICIUMDIOXIDE (E 551); SORBITANMONOOLEAAT (E 494); TALK (E 553 B); TITAANDIOXIDE (E 171); VANILLINE;

Autorisatie datum:

2011-09-23

Bijsluiter

Sandoz B.V.
Page 1/9
Claritromycine Sandoz
®
250/500 mg,
filmomhulde tabletten
RVG 107886-902
1311-V4
1.3.1.3 Bijsluiter
Maart 2021
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CLARITROMYCINE SANDOZ
® 250 MG, FILMOMHULDE TABLETTEN
CLARITROMYCINE SANDOZ
® 500 MG, FILMOMHULDE TABLETTEN
clarithromycin
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
Clarithromycin is an antibiotic which belongs to the group of
macrolide antibiotics. It stops the growth
of certain bacteria.
[Nationally completed name] is used in adults and adolescents (12
years and older)to treat infections
caused by bacteria which are sensitive to clarithromycin, for example:
•
THROAT
and SINUS
infections
•
CHEST
infections, such as bronchitis and pneumonia
•
SKIN
and
SOFT-TISSUE
infections
•
GASTRIC ULCERS
caused by the bacterium
_Helicobacter pylori_
.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME]
DO NOT TAKE [NATIONALLY COMPLETED NAME]
•
if you are
ALLERGIC
to clarithromycin, other macrolide antibiotics or any of the other
ingredients
of this medicine (listed in section 6),
Sandoz B.V.
Page 2/9
Claritromycine Sandoz
®
250/500 mg,
filmomhulde tabletten
RVG

Productkenmerken

Sandoz B.V.
Page 1/23
Claritromycine Sandoz 250/500 mg, filmomhulde
tabletten
RVG 107886-902
1311-V5
1.3.1.1 Samenvatting van de Productkenmerken
Maart 2021
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Claritromycine Sandoz 250 mg, filmomhulde tabletten
Claritromycine Sandoz 500 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 250 mg of clarithromycin.
Excipient with known effect
Each film-coated tablet contains 0.13 mmol (3.06 mg) sodium.
Each film-coated tablet contains 500 mg of clarithromycin.
Excipient with known effect
Each film-coated tablet contains 0.13 mmol (3.06 mg) sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
_ _
_250 mg film-coated tablets: _
Dark yellow, film-coated, capsule shaped tablets (15.6 x 7.9 mm).
_500 mg film-coated tablets: _
Light yellow, film-coated, oval shaped tablets (18.8 x 8.8 mm).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Clarithromycin is indicated in adults and adolescents 12 years and
older for the treatment of the
following infections, when caused by clarithromycin-susceptible
bacteria (see sections 4.4 and 5.1).
•
Bacterial pharyngitis
•
Acute bacterial sinusitis
•
Acute bacterial exacerbation of chronic bronchitis
•
Mild to moderate community acquired pneumonia
Sandoz B.V.
Page 2/23
Claritromycine Sandoz 250/500 mg, filmomhulde
tabletten
RVG 107886-902
1311-V5
1.3.1.1 Samenvatting van de Productkenmerken
Maart 2021
•
Skin infections and soft tissue infections of mild to moderate
severity, for example folliculitis,
cellulitis and erysipelas.
[Nationally completed name] 250 mg/ 500 mg film-coated tablets can
also be used in appropriate
combination with antibacterial therapeutic regimens and an appropriate
ulcer healing agent for the
eradication of
_H. pylori_
in patients with
_H. pylori_
associated ulcers (see section 4.2).
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2
P