Rodogyl film coated Tablets 0.75MIU/125mg

Երկիր: Մալթա

Լեզու: անգլերեն

Աղբյուրը: Medicines Authority

Ակտիվ բաղադրիչ:

METRONIDAZOLE, SPIRAMYCIN

Հասանելի է:

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

ATC կոդը:

J01RA04

INN (Միջազգային անվանումը):

METRONIDAZOLE 125 mg SPIRAMYCIN 750000 IU

Դեղագործական ձեւ:

FILM-COATED TABLET

Կազմը:

METRONIDAZOLE 125 mg SPIRAMYCIN 750000 IU

Ռեկվիզորի տեսակը:

POM

Թերապեւտիկ տարածք:

ANTIBACTERIALS FOR SYSTEMIC USE

Լիազորման կարգավիճակը:

Withdrawn

Հաստատման ամսաթիվը:

2008-01-16

Տեղեկատվական թերթիկ

_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
NAME OF THE MEDICINE
RODOGYL FILM-COATED TABLETS
SPIRAMYCIN, METRONIDAZOLE
BOXED TEXT
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 Rodogyl film-coated tablets are and what they are used for
2. What you need to know before you take Rodogyl film-coated tablets
3. How to take Rodogyl film-coated tablets
4. Possible side effects
5. How to store Rodogyl film-coated tablets
6. Contents of the pack and other information
1.
WHAT RODOGYL FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR
PHARMACOTHERAPEUTIC GROUP: COMBINATIONS OF ANTIBACTERIALS, SPIRAMYCIN
AND METRONIDAZOLE,
ATC CODE: J01RA04.
This medicine is a combination of two antibiotics, one belonging to
the group of macrolides and the other
belonging to the group of imidazoles. The active substances are
spiramycin and metronidazole,
respectively.
This medicine is for use in adults and children to treat oral and
dental infections such as certain tooth
abscesses.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RODOGYL FILM-COATED TABLETS
If your doctor has told you that you are intolerant to certain sugars,
contact your doctor before taking
this medicine.
DO NOT TAKE RODOGYL FILM-COATED TABLETS:
if you are allergic to spiramycin and/or metronidazole and/or other
antibiotics in the imidazole group
(the group of antibiotics that includes metronidazole) or any of the
other ingredients of this medicine
(listed in section 6).
if the patient is a child under 6 years of age, as these are tablets.
IF YOU ARE NOT SURE, YOU M

Ապրանքի հատկությունները

_ _
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
RODOGYL FILM-COATED TABLETS
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Spiramycin
...................................................................................................................................
0.75 MIU
Metronidazole
................................................................................................................................
125 mg
For one film-coated tablet.
Excipient with known effect: 8 mg of sorbitol (E420) per tablet
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Rodogyl film-coated tablets are indicated for the curative treatment
of oral-dental infections such as
dental abscesses in adults and children, after weighing the
benefit/risk ratio of treatment with the fixed
dose combination containing spiramycin-metronidazole and when another
antibiotic treatment cannot
be used (see sections 4.2, 4.4 and 5.1).
The official recommendations on the proper use of antibacterial agents
must be taken into account.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_Adults _
•
4 to 6 tablets per day as 2 or 3 divided doses (i.e. 3 to 4.5 MIU of
spiramycin and 500 to 750 mg of
metronidazole).
•
In severe cases, the dosage may be increased to 8 tablets daily.
_Pediatric population _
•
From 6 to 10 years of age: 2 tablets daily (i.e. 1.5 MIU of spiramycin
and 250 mg of
metronidazole).
•
From 10 to 15 years of age: 3 tablets daily (i.e. 2.25 MIU of
spiramycin and 375 mg of
metronidazole).
The optimal dose for this fixed-drug combination remains uncertain
(see section 5.1).
METHOD OF ADMINISTRATION
Oral use.
The tablets must be swallowed with a large glass of water.
The tablets should be taken with meals.
4.3.
CONTRAINDICATIONS
•
Hypersensitivity to spiramycin and/or metronidazole and/or any other
antibiotic of the imidazole
group or to any of the excipients listed in section 6.1.
•
Children under 6 years