Polygynax Vaginal Capsule

Země: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Aktivní složka:

POLYMYXIN B, SULFATE, NYSTATIN, NEOMYCIN SULFATE

Dostupné s:

Laboratoire Innotech International 22 Avenue Aristide Briand, Arcueil 94110, France

ATC kód:

G01AA51

INN (Mezinárodní Name):

POLYMYXIN B SULFATE 35000 IU NYSTATIN 100000 IU NEOMYCIN SULFATE 35000 IU

Léková forma:

VAGINAL CAPSULE

Složení:

POLYMYXIN B SULFATE 35000 IU NYSTATIN 100000 IU NEOMYCIN SULFATE 35000 IU

Druh předpisu:

POM

Terapeutické oblasti:

GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS

Stav Autorizace:

Authorised

Datum autorizace:

2007-01-02

Informace pro uživatele

Page 1
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.
PACKAGE LEAFLET : INFORMATION FOR THE USER
POLYGYNAX
®
, VAGINAL CAPSULE
NEOMYCIN SULFATE, POLYMYXIN SULFATE, NYSTATIN
WHAT IS IN THIS LEAFLET?
1.
What POLYGYNAX, vaginal capsule is and what it is used for?
2.
What you need to know before you use POLYGYNAX, vaginal capsule?
3.
How to use POLYGYNAX, vaginal capsule?
4.
Possible side effects.
5.
How to store POLYGYNAX, vaginal capsule?
6.
Contents of the pack and other information.
1.
WHAT POLYGYNAX, VAGINAL CAPSULE IS AND WHAT IT IS USED FOR?
WHAT POLYGYNAX, VAGINAL CAPSULE IS?
Pharmacotherapeutic group: ANTIINFECTIVES and ANTISEPTICS IN
GYNECOLOGICAL USE
(G. genitourinary system and sex hormones), ATC code: G01AA51.
This medicine is a local anti-infectious. POLYGYNAX, vaginal capsule
combines 3 active substances:
•
Two antibiotics:
•
Neomycin which belongs to the aminoside family.
•
Polymyxin B which belongs to the polypeptide family.
They fight infections due to bacteria.
•
An antifungal: nystatin which belongs to the polyene family. It allows
the destruction of some
microscopic fungus or to block their growth.
WHAT IT IS USED FOR?
This medicine is i
ndicated in the local treatment of vaginal infections sensitive to
active
substances contained in this medicine (neomycin, polymyxin B and
nystatin).
This medicine is intended for adults only.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE POLYGYNAX, VAGINAL CAPSULE?
DO NOT USE POLYGYNAX, VAGINAL CAPSULE:
•
if you are allergic (hypersensitive) to one of the active substan

Charakteristika produktu

1/5
APPENDIX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
POLYGYNAX, VAGINAL CAPSULE
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Neomycin sulfate
.........................................................................................................................
35 000 I.U.
Polymyxin B sulfate
.....................................................................................................................
35 000 I.U.
Nystatin
.....................................................................................................................................
100 000 I.U.
For one vaginal capsule
Excipient with known effect: Hydrogenated soybean oil.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Vaginal capsule.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Local treatment of vaginitis due to sensitive germs (bacterial
vaginitis, vulvo-vaginitis due to _Candida albicans _
and _Candida _non-_albicans_, mixed vaginitis) and treatment of
bacterial vaginosis.
The official recommendations concerning
appropriate
use of antibacterial products must be taken into
consideration.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
FOR ADULTS ONLY
One vaginal capsule in the evening for 12 days.
METHOD OF ADMINISTRATION
Introduce one capsule deep in the vagina, preferably in lying down
position.
Practical advices:
•
The treatment should be associated with hygiene recommendations (wear
cotton underwear, avoid vaginal
douches, using an internal tampon during the treatment…) and
elimination of contributing factors, as much
as possible.
•
Treating the partner must be discussed on a case by case basis.
•
Do not stop the treatment during menstruation periods.
•
Treatment is compatible with latex and polyisoprene male condoms (see
section 4.5).
4.3.
CONTRAINDICATIONS
This medicinal product is contraindicated in the following situations:
•
Hypersensitivity to the active substances or to any excipients listed
in section 6.1 (or group sensitivity),
•
In case