Claritromycine ratiopharm 500 mg, filmomhulde tabletten

Pays: Pays-Bas

Langue: néerlandais

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

Ingrédients actifs:

CLARITROMYCINE 500 mg/stuk

Disponible depuis:

Ratiopharm GmbH Graf-Arco-Strasse 3 89079 ULM (DUITSLAND)

Code ATC:

J01FA09

DCI (Dénomination commune internationale):

CLARITROMYCINE 500 mg/stuk

forme pharmaceutique:

Filmomhulde tablet

Composition:

ALLURAROOD AC ALUMINIUM LAK (E 129) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; MACROGOL 400 ; MAGNESIUMHYDROXIDE (E 528) ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; STEARINEZUUR (E 570) ; TARTRAZINE ALUMINIUMLAK (E 102) ; TITAANDIOXIDE (E 171) ; VANILLINE, ALLURAROOD AC ALUMINIUM LAK (E 129) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; MACROGOL 400 ; MAGNESIUMHYDROXIDE (E 528) ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; STEARINEZUUR (E 570) ; TARTRAZINE ALUMINIUMLAK (E 102) ; TITAANDIOXIDE (E 171) ; VANILLINE, ALLURAROOD AC ALUMINIUM LAK (E 129) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; MACROGOL 400 ; MAGNESIUMHYDROXIDE (E 528) ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT (E468) ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; STEARINEZUUR (E 570) ; TARTRAZINE ALUMINIUMLAK (E 102) ; TITAANDIOXIDE (E 171) ; VANILLINE,

Mode d'administration:

Oraal gebruik

Domaine thérapeutique:

Clarithromycin

Descriptif du produit:

Hulpstoffen: ALLURAROOD AC ALUMINIUM LAK (E 129); CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); INDIGOKARMIJN ALUMINIUMLAK (E 132); MACROGOL 400; MAGNESIUMHYDROXIDE (E 528); MAGNESIUMSTEARAAT (E 470b); NATRIUMZETMEELGLYCOLAAT (E468); POVIDON K 30 (E 1201); SILICIUMDIOXIDE (E 551); STEARINEZUUR (E 570); TARTRAZINE ALUMINIUMLAK (E 102); TITAANDIOXIDE (E 171); VANILLINE;

Date de l'autorisation:

1900-01-01

Notice patient

Clarithromycin, NL/H/2597/001-002, 25.01.24
Rvg 111801-2 EU PIL IA/027 met NL info-clean
PACKAGE LEAFLET: INFORMATION FOR THE USER
CLARITROMYCINE RATIOPHARM 250 MG, FILMOMHULDE T
ABLETTEN
CLARITROMYCINE RATIOPHARM 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 {Product name} is and what it is used for
2.
What you need to know before you take {Product name}
3.
How to take {Product name}
4.
Possible side effects
5.
How to store {Product name}
6.
Contents of the pack and other information
1.
WHAT {PRODUCT NAME} IS AND WHAT IT IS USED FOR
{Product name} belongs to a group of drugs called macrolide
antibiotics. It stops the growth of certain
bacteria.
{Product name} is used to treat:
•
Chest infections, such as bronchitis and pneumonia
•
throat and sinus infections
•
skin and soft tissue infections
•
gastric ulcers caused by the bacterium_ Helicobacter pylori_ infection
associated with duodenal ulcer.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE {PRODUCT NAME}
DO NOT TAKE {PRODUCT NAME}
•
if you are allergic to clarithromycin, to other macrolide antibiotics
(e.g. erythromycin, azithromycin) or
to any of the other ingredients of this medicine (listed in section
6).
•
if you are taking any of the following medicines:
-
astemizole or terfenadine (for hay fever or allergies), cisapride or
domperidone (for stomach
disorders) or pimozide (to treat certain psychiatric diseases) as
taking theses medicines with
{Product name} can cause serious disturbances

Résumé des caractéristiques du produit

Clarithromycin, NL/H/2597/001-002, 25.01.24
Rvg 111801-2 EU SPC IA/027 met NL info-clean
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Claritromycine ratiopharm 250 mg, filmomhulde tabletten
Claritromycine ratiopharm 500 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
{Product name} 250 mg
Each film-coated tablet contains 250 mg clarithromycin.
{Product name} 500 mg
Each film-coated tablet contains 500 mg clarithromycin.
Excipients with known effect:
{Product name} 250 mg contains 0.30 mg tartrazine aluminium lake
(E102) and 0.008 mg allura red
aluminium lake (E129).
{Product name} 500 mg contains 0.14 mg tartrazine aluminium lake
(E102) and 0.001 mg allura red
aluminium lake (E129).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
{Product name} 250 mg
Yellow, film-coated oval shaped tablet, debossed with “93” on one
side and “7157” on the other.
Length: 17 mm Width: 8 mm Thickness: 5-6 mm
{Product name} 500 mg
Light yellow, film-coated oval shaped tablet, debossed with “93”
on one side and “7158” on the other.
Length: 22 mm Width: 11 mm Thickness: 6.7-7.7 mm
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
{Product name} 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
-
Skin infections and soft tissue infections of mild to moderate
severity, for example folliculitis, cellulites
and erysipelas.
{Product name} 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).
Clarithromycin, NL/H/2597/001-002, 25.01.24
Rvg 111801-2 EU SPC IA/027 met NL info-clean
Conside