Rulid 150mg Coated Tablets

Land: Malta

Sprog: engelsk

Kilde: Medicines Authority

Aktiv bestanddel:

ROXITHROMYCIN

Tilgængelig fra:

Sanofi S.R.L Viale L. Bodio, 37/b 20158, Milan, Italy

ATC-kode:

J01FA06

INN (International Name):

ROXITHROMYCIN 150 mg

Lægemiddelform:

COATED TABLET

Sammensætning:

ROXITHROMYCIN 150 mg

Recept type:

POM

Terapeutisk område:

ANTIBACTERIALS FOR SYSTEMIC USE

Autorisation status:

Withdrawn

Autorisation dato:

2005-09-28

Indlægsseddel

RULID® 150 MG COATED TABLET
_roxithromycin _
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 Rulid 150 mg coated tablets are and what they are used for
2. What you need to know before you take Rulid 150 mg coated tablets
3. How to take Rulid 150 mg coated tablets
4. Possible side effects
5. How to store Rulid 150 mg coated tablets
6. Contents of the pack and other information
1. WHAT RULID 150 MG COATED TABLETS ARE AND WHAT THEY ARE USED FOR?
Pharmacotherapeutic group: Antibacterials for systemic use, ATC code:
J01FA06 (J: anti-
infectives). This medicine is used to treat certain bacterial
infections caused by bacteria
sensitive to this antibiotic (bacteria that can be killed by this
antibiotic).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RULID 150 MG COATED TABLETS?
If you have been told by your doctor that you have an intolerance to
some sugars, contact
him/her before taking this medicine.
DO NOT USE RULID 150 MG COATED TABLETS:
• If you are allergic to antibiotics of the macrolide group or to
any of the ingredients of this
medicine. See Section 6 for a full list of ingredients.
• If you are taking other medicines, make sure that combined use
with Rulid is not
contraindicated (see “Other medicines and Rulid 150 mg coated
tablets”), such as
combination with colchicine, ergotamine, dihydroergotamine and
cisapride.
• If you are breast-feeding a child being treated with cisapride
(see "Breast-feeding").
If you are unsure of anything, it is essential that you ask your
doctor or pha

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1.
TRADE NAME OF THE MEDICINAL PRODUCT
Rulid 150 mg coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Roxithromycin.
........................................................................................................................................
150 mg
For one coated tablet.
For the full list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
Coated tablets
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The therapeutic indications of roxithromycin are based on the
antibacterial activity and pharmacokinetic
properties.
They take into account both the clinical studies performed on this
medicinal product, and its position in the
range of currently available antibacterial agents.
Use of roxithromycin is limited to the treatment of infections caused
by microorganisms which have been
shown susceptible to the drug:
•
Proven beta-hemolytic streptococcus A throat infections, as an
alternative to betalactam treatment,
especially in cases where administration of betalactams is not
possible.
•
Acute sinusitis: considering the microbiological characteristics of
these infections, use of macrolides
is indicated when betalactam treatment is not possible.
•
Superinfection of acute bronchitis.
•
Exacerbation of chronic bronchitis.
•
Community-acquired pneumonia in subjects:
o without risk factors,
o with no serious clinical symptoms,
o with no clinical signs indicative of pneumococcal etiology.
If atypical pneumonia is suspected, use of macrolides is indicated,
irrespective of the severity and history.
•
Minor skin infections: impetigo, impetiginization of dermatoses,
ecthyma, infectious dermo-
hypodermitis (especially erysipelas), erythrasma.
•
Non-gonococcal genital infections.
Official recommendations concerning the appropriate use of
antibacterial agents should be taken into
account.
4.2
DOSAGE AND MODE OF ADMINISTRATION
POSOLOGY
Adults: 300 mg/day, i.e. one 150 mg tablet, morning and evening,
preferably before meal
DURATION OF TREATMENT
In patients wit