Ozole

Valsts: Jaunzēlande

Valoda: angļu

Klimata pārmaiņas: Medsafe (Medicines Safety Authority)

Aktīvā sastāvdaļa:

Fluconazole 150mg

Pieejams no:

Douglas Pharmaceuticals Limited

SNN (starptautisko nepatentēto nosaukumu):

Fluconazole 150 mg

Deva:

150 mg

Zāļu forma:

Capsule

Kompozīcija:

Active: Fluconazole 150mg Excipient: Ammonia solution Butyl alcohol Colloidal silicon dioxide Ethanol Gelatin   Iron oxide black Isopropyl alcohol Lactose monohydrate Magnesium stearate Maize starch Patent blue V   Potassium hydroxide Propylene glycol Purified water   Shellac Sodium laurilsulfate Titanium dioxide   Water

Vienības iepakojumā:

Blister pack, PVC/PVDC/Al Foil, 1 capsule

Klase:

Restricted

Receptes veids:

Restricted

Ražojis:

Mylan Laboratories Limited

Ārstēšanas norādes:

OZOLE 150 mg Capsule, given orally, is indicated for vaginal candidiasis.

Produktu pārskats:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC/Al Foil - 1 capsules - 36 months from date of manufacture stored at or below 25°C

Autorizācija datums:

2003-12-01

Lietošanas instrukcija

CONSUMER MEDICINE INFORMATION
1
OZOLE
_fluconazole _
50 mg and 200 mg capsules
WHAT IS IN THIS LEAFLET
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING OZOLE.
This
leaflet
answers
some
common
questions
about Ozole. It does not contain all the available
information. It does not take the place of talking
to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor
has weighed the risks of you taking Ozole against
the benefits they expect it will have for you.
IF
YOU
HAVE
ANY
CONCERNS
ABOUT
TAKING
THIS
MEDICINE, ASK YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE. YOU MAY
NEED TO READ IT AGAIN.
WHAT OZOLE IS USED FOR
Ozole
is used
to
treat
some
fungal
and
yeast
infections and may also be used to stop you from
getting a fungal infection.
Ozole belongs to a group of medicines called azole
antifungals. It works by stopping the growth of the
fungal and yeast organisms causing your infection.
Your
doctor
may
have
prescribed
Ozole
for
another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT
WHY OZOLE HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with a doctor's
prescription.
BEFORE YOU TAKE OZOLE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE OZOLE IF YOU HAVE AN ALLERGY TO:
•
any medicine containing fluconazole, or any
other medicine that is related to fluconazole,
e.g. miconazole, ketoconazole or clotrimazole
•
any of the ingredients listed at the end of this
leaflet
Some of the symptoms of an allergic reaction may
include:
•
difficulty in breathing or wheezing
•
shortness of breath
•
swelling of the face, tongue, lips, or other parts
of the body
•
hives on the skin, rash, or itching
DO NOT TAKE OZOLE IF YOU HAVE EVER DEVELOPED A
SEVERE SKIN RASH OR SKIN PEELING, BLISTERING AND/OR
MOUTH SORES AFTER TAKING FLUCONAZOLE. Serious skin
reactions including drug reaction with eosinophilia
and
systemic
symptoms
(DRESS)
have
been
reported
in
association
with
fluconazole
treatment. STOP TAKING DIFLUCAN AND SEEK MEDICAL
ATTENTION IMMEDIATELY IF YOU NOTICE ANY

Produkta apraksts

1 | P a g e
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Ozole Capsule 50 mg
Ozole Capsule 200 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Ozole 50 mg capsule contains 50 mg of fluconazole.
Each Ozole 200 mg capsule contains 200 mg of fluconazole.
EXCIPIENT(S) WITH KNOWN EFFECT
Ozole 50 mg and 200 mg capsules contain lactose monohydrate. For the
full list of excipients, see
section 6.1.
3.
PHARMACEUTICAL FORM
Ozole 50 mg is available as a size 4 hard gelatin capsule with an
opaque blue cap and opaque white
body. The capsule is printed Ranbaxy on both cap and body.
Ozole 200 mg is available as a size 0 hard gelatin capsule with a
purple opaque cap and white
opaque body. The capsule is printed Ranbaxy on both cap and body.
Ozole capsule contains a white to off-white crystalline powder.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
OZOLE is indicated for the treatment of the following conditions:
1.
Cryptococcosis, including cryptococcal meningitis and infections of
other sites (e.g.
pulmonary, cutaneous). Normal hosts, and patients with AIDS, organ
transplants or other
causes of immunosuppression may be treated. OZOLE can be used as
maintenance
therapy to prevent relapse of cryptococcal disease in patients with
AIDS.
2.
Systemic candidiasis including candidaemia, disseminated candidiasis
and other forms of
invasive candidal infection including infections of the peritoneum,
endocardium and
pulmonary and urinary tracts. Patients with malignancy, in intensive
care units, receiving
cytotoxic or immunosuppressive therapy, or with other factors
predisposing to candidal
infection may be treated.
3.
Mucosal
candidiasis.
These
include
oropharyngeal,
oesophageal,
non-invasive
bronchopulmonary infections, candiduria, mucocutaneous and chronic
oral atrophic
candidiasis (denture sore mouth). Normal hosts and patients with
compromised immune
function may be treated.
4.
Vaginal candidiasis, acute or recurrent.
2 | P a g e
5.
Prevention of fungal infection in immunocompromised patients
considered at risk as a
consequence