Rulid

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ROXITHROMYCIN

Available from:

Sanofi Malta Limited

ATC code:

J01FA06

INN (International Name):

ROXITHROMYCIN

Pharmaceutical form:

FILM-COATED TABLET

Composition:

ROXITHROMYCIN 150 mg

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Authorization status:

Authorised

Authorization date:

2005-09-28

Patient Information leaflet

RULID® 150 MG COATED TABLET
_roxithromycin _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
• Keep this leaflet, you may need to read it again.
• If you have any questions, if you have any doubt, ask your doctor
or pharmacist.
• This medicine has been prescribed for you. Never give it to
someone else, even if their
symptoms are the same as yours, it may harm them.
• 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 is and what it is 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 IS AND WHAT IT IS USED FOR?
Pharmacotherapeutic group: Antibacterials for systemic use, ATC code:
J01FA06 (J: anti-
infectives). It is used for the treatment of bacterial infections
caused by sensitive bacteria
(which may be destroyed by this antibiotic).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RULID 150 MG COATED TABLETS?
If your doctor has told you that you have an intolerance to some
sugars, contact your doctor
before using this medicine.
If a widespread, severe skin rash occurs, including skin blistering or
peeling as well as signs
of flu and fever (Steven Johnson syndrome), a general unwell feeling,
fever, chills and
muscle aches (toxic epidermal necrolysis) or a red, scaly rash with
bumps under the skin and
blisters (Acute generalised exanthemaotous pustulosis) refer to a
doctor immediately since
these skin effects may be life threatening.
DO NOT USE RULID 150 MG COATED TABLETS:
- If you are allergic to antibiotics of the macrolide or any component
of the medication. You
can find the list of components in section 6.
- If you are taking any other medicines, make sure that the
combination with Rulid is not
contra-indica

Summary of Product characteristics

Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1.
TRADE NAME OF THE MEDICINAL PRODUCT
Rulid
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 150 mg roxithromycin.
3.
PHARMACEUTICAL FORM
Coated tablets
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The therapeutic indications are based on the antibacterial activity
and pharmacokinetic properties of
roxithromycin.
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 defined as
susceptible to the drug:
•
Proven beta-hemolytic streptococcus A throat infections, as an
alternative to betalactam treatment,
especially when betalactams cannot be administered.
•
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 with no 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 other 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
_ _
Page 2 of 11
_ _
In patients with throat infections, treatment duration is 10 days.
4.3 CONTRAINDICATIONS
This medicine MUST NEVER BE USED in the following situations:

allergy to macrolides.

in combination with:
o
vasoconstrict