Claritromycine Sandoz 125 mg/5 ml, granulaat voor orale suspensie

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

CLARITROMYCINE

Beschikbaar vanaf:

Sandoz B.V.

ATC-code:

J01FA09

INN (Algemene Internationale Benaming):

CLARITHROMYCIN

farmaceutische vorm:

Granulaat voor orale suspensie

Samenstelling:

COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; FRUIT-PUNCH SMAAKSTOFPOEDER ; GLYCEROLMONOSTEARAAT (E 471) ; HYPROMELLOSE (E 464) ; KALIUMSORBAAT (E 202) ; MACROGOL 6000 ; MALTODEXTRINE ; MALTOL (E 636) ; NATRIUMZETMEELOCTENYLSUCCINAAT (E 1450) ; POLOXAMEER 188 ; POLYSORBAAT 80 (E 433) ; POVIDON K 30 (E 1201) ; SACCHAROSE ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171) ; TRIETHYLCITRAAT (E 1505) ; XANTHAANGOM (E 415),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Clarithromycin

Product samenvatting:

Hulpstoffen: COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1); FRUIT-PUNCH SMAAKSTOFPOEDER; GLYCEROLMONOSTEARAAT (E 471); HYPROMELLOSE (E 464); KALIUMSORBAAT (E 202); MACROGOL 6000; MALTODEXTRINE; MALTOL (E 636); NATRIUMZETMEELOCTENYLSUCCINAAT (E 1450); POLOXAMEER 188; POLYSORBAAT 80 (E 433); POVIDON K 30 (E 1201); SACCHAROSE; SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171); TRIETHYLCITRAAT (E 1505); XANTHAANGOM (E 415);

Autorisatie datum:

2012-01-20

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CLARITROMYCINE SANDOZ 125 MG/5 ML
, GRANULAAT VOOR ORALE SUSPENSIE
CLARITROMYCINE SANDOZ 250 MG/5 ML
, GRANULAAT VOOR ORALE SUSPENSIE
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 to treat:

Throat and sinus infections

Middle ear infections in children

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
to any of the other ingredients
of this medicine (listed in section 6)

if you have a history of certain abnormal HEART RHYTHMS (ventricular
arrhythmia, including
torsades de pointes) or of changes in the heart activity as measured
in the electro-cardiogram
called “QT prolongation”

if you suffer from severe LIVER failure and KIDNEY problems

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Claritromycine Sandoz 125 mg/5 ml, granulaat voor orale suspensie
Claritromycine Sandoz 250 mg/5 ml, granulaat voor orale suspensie
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution 1 ml oral suspension contains 25 mg
clarithromycin, 5 ml oral suspension
contain 125 mg clarithromycin.
Excipient with known effect:
The product contains 2.4 g sucrose per 5 ml ready-for-use suspension.
After reconstitution 1 ml oral suspension contains 50 mg
clarithromycin, 5 ml oral suspension
contain 250 mg clarithromycin.
Excipient with known effect:
The product contains 2.4 g sucrose per 5 ml ready-for-use suspension.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Granules for oral suspension.
White to beige granules.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
[Nationally completed name] is indicated in adults, adolescents and
children, 6 months to 12
years, for the treatment of the following acute and chronic
infections, when caused by
clarithromycin susceptible organisms.

Infections of the upper respiratory tract such as
tonsillitis/pharyngitis, as an alternative
when beta lactam antibiotics are not appropriate.

Acute otitis media in children.

Infections of the lower respiratory tract such as community acquired
pneumonia.

Sinusitis and acute exacerbation of chronic bronchitis in adults and
adolescents over 12
years of age

Skin infections and soft tissue infections of mild to moderate
severity.
In appropriate combination with antibacterial therapeutic regimens and
an appropriate ulcer
healing medicinal product for the eradication of _Helicobacter pylori_
in adult 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
POSOLOGY AND METHOD OF ADMINISTRATION
The dosage of [Nationally completed name] depends on the clinical
condition of the patient
and has to be defined in any case by the ph