RULID 150 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ROXITHROMYCIN

Available from:

SANOFI - AVENTIS ISRAEL LTD

ATC code:

J01FA06

Pharmaceutical form:

FILM COATED TABLETS

Composition:

ROXITHROMYCIN 150 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

SANOFI WINTHROP INDUSTRIE, FRANCE

Therapeutic area:

ROXITHROMYCIN

Therapeutic indications:

For the treatment of infections caused by microorganisms sensitive to roxithromycin e.g: ENT bronchopulmonary, genital and skin manifestations.

Authorization date:

2014-06-30

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
RULID 150 MG
FILM-COATED TABLETS
Active ingredient: each tablet contains roxithromycin 150 mg.
Inactive ingredients – see section 6.
Read this leaflet carefully in its entirety before using the medicine.
Keep this leaflet; you may need to read it again.
This leaflet contains concise information about the medicine. If you
have further questions, refer to the doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if it seems to you that their medical
condition is similar.
If a side effect worsens or if you experience a side effect not
mentioned in this leaflet, please refer to a doctor or pharmacist.
1. WHAT IS THE MEDICINE INTENDED FOR?
This medicine is intended for the treatment of infections caused
by bacteria susceptible to roxithromycin, such as infections of the
respiratory tract, including, nose, ear and throat, skin infections,
and infections of the genitals.
THERAPEUTIC GROUP: Macrolide antibiotic.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
• you are sensitive (allergic) to roxithromycin or to any of the
additional ingredients contained in the medicine (see section
6), or to other antibiotics of the macrolides group (e.g.,
erythromycin).
• you are being treated concomitantly with ergot derivatives
(for treatment of migraine), such as ergotamine and
dihydroergotamine.
• you are being treated concomitantly with colchicine (to treat
gout).
• you are being treated concomitantly with medicines such as:
cisapride (for treatment of reflux [gastroesophageal reflux]),
pimozide (a neuroleptic preparation), or antiallergics containing
terfenadine or astemizole.
• when you are breastfeeding and your baby is being treated with
the medicine cisapride (see PREGNANCY AND BREASTFEEDING
section).
If you are taking other medicines, confirm that there is no
contraindication to their

Summary of Product characteristics

1
RULI-PO-150MG-14.0
RULID TABLETS
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
RULID 150 mg, film coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Roxithromycin 150 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of infections caused by microorganisms sensitive to
roxithromycin
e.g: ENT bronchopulmonary, genital and skin manifestations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults: 300 mg per day, i.e. 1 x 150 mg tablet in the morning and
evening,
preferably before meals.
Treatment duration
Treatment duration for throat infections is 10 days.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to the active substance or to any of the excipients
listed in
section 6.1.
•
Allergy to Macrolides
•
Coadministration with:
o
vasoconstrictive ergot alkaloids: dihydroergotamine, ergotamine (see
section 4.5).
o
Colchicine (see section 4.5).
•
Concomitant therapy with medicines having a narrow therapeutic window
and
being substrates of CYP3A4 (such as, astemizole, terfenadine,
cisapride or
pimozide (see section 4.5).
•
Women breast-feeding an infant who is treated with cisapride (see
section 4.6).
•
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
SPECIAL WARNINGS
2
Excipient with known effect
This medicinal product contains glucose. It should therefore not be
used in patients with
glucose-galactose malabsorption syndrome.
Liver failure
_ _
_ _
Administration of roxithromycin is not recommended in patients with
severe liver failure.
In patients with mild to moderate liver failure, roxithromycin should
be used with caution.
If it must be administered in these subjects, regular liver function
tests are required and
if necessary, the dose should be reduced.
Renal ifailure
The amount of active substance and its metabolites eliminated by the
renal route is small
(10% of the oral dose). No dose adjustment is therefore required in
patients with kidney
failure.
Elderly subjec