DIZOLE 100 fluconazole 100 mg capsule blister pack

Quốc gia: Úc

Ngôn ngữ: Tiếng Anh

Nguồn: Department of Health (Therapeutic Goods Administration)

Thành phần hoạt chất:

fluconazole, Quantity: 100 mg

Sẵn có từ:

Alphapharm Pty Ltd

INN (Tên quốc tế):

Fluconazole

Dạng dược phẩm:

Capsule, hard

Thành phần:

Excipient Ingredients: lactose monohydrate; maize starch; sodium lauryl sulfate; silicon dioxide; magnesium stearate; titanium dioxide; potable water; Gelatin; patent blue V; propylene glycol; ethanol; butan-1-ol; purified water; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide

Tuyến hành chính:

Oral

Các đơn vị trong gói:

50 capsules, 28 capsules, 30 capsules, 100 capsules, 10 capsules, 7 capsules, 14 capsules

Loại thuốc theo toa:

(S4) Prescription Only Medicine

Chỉ dẫn điều trị:

Treatment of cryptococcal meningitis in patients who are unable to tolerate amphotericin B. Note: Data suggests that the clinical efficacy of fluconazole is lower than that of amphotericin B in the treatment of acute phase cryptococcal meningitis. Maintenance therapy to prevent relapse of cryptococcal meningitis in patients with acquired immune deficiency syndrome (AIDS). Treatment of oropharyngeal and oesophageal canidiasis in AIDS and other immunosuppressed patients. Secondary prophylaxis of oesophageal canidiasis in patients with human immunodeficiency virus (HIV) infection. Serious and life-threatening Candida infections in patients who are unable to tolerate amphotericin B. Note: It remains to be shown that fluconazole is as effective as amphotericin B in the treatment of serious and life-threatening Candida infections. Until such data are available, amphotericin B remains the drug of choice. Vaginal candidiasis, when topical therapy has failed. Treatment of extensive tinea corporis, extensive tinea cruris and extensive tinea pedis infections in immunocompetent patients in whom topical therapy is not a practical treatment option. Usually, topical therapy should be attempted first because oral therapy has a less favourable ratio of benefits to risks. (See Adverse Reactions).

Tóm tắt sản phẩm:

Visual Identification: Size 2, hard gelatin capsule with white opaque body and blue opaque cap; the body has 'FC 100' and the cap has 'G' printed in black.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Tình trạng ủy quyền:

Registered

Ngày ủy quyền:

2009-06-05

Tờ rơi thông tin

DIZOLE
®
_contains the active ingredient fluconazole_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DIZOLE.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking DIZOLE against
the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT DIZOLE IS USED
FOR
DIZOLE capsules containing
fluconazole as the active ingredient
are used to treat certain fungal and
yeast infections that cause:
•
thrush in the mouth, food pipe or
vagina (also called candida or
monilia)
•
tinea of the body, groin or feet
•
meningitis, where the membrane
around the brain and spinal cord
are inflamed due to infection.
Fluconazole belongs to a group of
medicines called azole antibiotics.
It works by preventing the growth of
the fungal and yeasts organisms
causing your infection.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
DIZOLE is available only with a
doctor's prescription.
This medicine is not addictive.
BEFORE YOU TAKE
DIZOLE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE DIZOLE IF YOU HAVE
AN ALLERGY TO:
•
any medicine containing
fluconazole
•
any other azole antifungals
related to fluconazole such as
itraconazole (Sporanox),
ketoconazole (Nizoral),
miconazole (Daktarin),
clotrimazole (Canesten).
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin.
DO NOT TAKE DIZOLE IF YOU ARE
TAKING CISAPRIDE (PREPULSID), A
MEDICINE USED TO TREAT STOMACH
PROBLEMS.
DO NOT TAKE THIS M

Đặc tính sản phẩm

AUSTRALIAN PRODUCT INFORMATION
DIZOLE
®
_Fluconazole capsule, hard _
1
NAME OF THE MEDICINE
Fluconazole
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fluconazole is a white to off-white crystalline powder, which is
sparingly soluble in water and saline.
Each DIZOLE 50 mg hard gelatin capsule contains 50 mg of fluconazole
as the active ingredient.
Each DIZOLE 100 mg hard gelatin capsule contains 100 mg of fluconazole
as the active ingredient.
Each DIZOLE 150 mg hard gelatin capsule contains 150 mg of fluconazole
as the active ingredient.
Each DIZOLE 200 mg hard gelatin capsule contains 200 mg of fluconazole
as the active ingredient.
Excipients with known effect: sulfites and sugars as lactose.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
The capsule is composed of an empty hard gelatin capsule: 50 mg
capsule (PI 10350), 100 mg capsule (PI
10309), 150 mg capsule (PI 10444) and 200 mg capsule (PI 10312),
TekPrint SW-9008 black printing ink,
TekPrint SW-9009 black printing ink, patent blue V CI42051 (50, 100
and 200 mg capsules only), brilliant
scarlet 4R CI16255 (50 mg capsules only).
DIZOLE 50 mg capsule with white opaque body and dark blue opaque cap.
The body has “FC 50” and the
cap has “G” printed in black.
DIZOLE 100 mg capsule with white opaque body and blue opaque cap. The
body has “FC 100” and the cap
has “G” printed in black.
DIZOLE 150 mg capsule with white opaque body and white opaque cap. The
body has “FC 150” and the cap
has “G” printed in black.
DIZOLE 200 mg capsule with white opaque body and blue opaque cap. The
body has “FC 200” and the cap
has “G” printed in black.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Treatment
of
cryptococcal meningitis in patients who are
unable to tolerate
amphotericin B
(amphotericin).
_NOTE: _
Data suggest that the clinical efficacy of fluconazole is lower than
that of amphotericin B
(amphotericin) in the treatment of the acute phase of cryptococcal
meningitis.
•
Maintenance therap