DIFLUCAN fluconazole 100 mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

fluconazole, Quantity: 100 mg

Available from:

Pfizer Australia Pty Ltd

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: patent blue V; colloidal anhydrous silica; titanium dioxide; sodium lauryl sulfate; magnesium stearate; Gelatin; lactose monohydrate; maize starch; erythrosine; butan-1-ol; Shellac; industrial methylated spirit; dimeticone 1510; iron oxide black; lecithin; propylene glycol; isopropyl alcohol; purified water; ethanol; strong ammonia solution; potassium hydroxide

Administration route:

Oral

Units in package:

28 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS AS AT 21 JUNE 2005 : DIFLUCAN, given orally, is indicated for: 1. Treatment of cryptococcal meningitis in patients who are unable to tolerate amphotericin B. NOTE : Data suggest that the clinical efficacy of DIFLUCAN is lower than that of amphotericin B in the treatment of the acute phase of cryptococcal meningitis. 2. Maintenance therapy to prevent relapse of cryptococcal meningitis in patients with AIDS. 3. Treatment of oropharyngeal and oesophageal candidiasis in AIDS and other immunosuppressed patients. 4. Secondary prophylaxis of oropharyngeal candidiasis in patients with HIV infection. 5. Serious and life-threatening candida infections in patients who are unable to tolerate amphotericin B. NOTE : It remains to be shown that DIFLUCAN 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. 6. Vaginal candidiasis when topical therapy has failed. 7. Treatment of exten

Product summary:

Visual Identification: Standard blue opaque cap with a white, opaque body; No.2 size capsules; overprinted with the Pfizer Logo & the code FLU-100 (Batch11292033 "DIFLUCAN 100").; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1994-04-21

Patient Information leaflet

DIFLUCAN
®
_Fluconazole (flu-con-a-zole)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Diflucan. 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 Diflucan
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 YOUR
MEDICINE.
You may need to read it again.
WHAT DIFLUCAN IS USED
FOR
Diflucan capsules (for adults) and
oral suspension (for children) are
used to treat certain fungal and yeast
infections.
Diflucan belongs to a group of
medicines called azole antibiotics.
It works by preventing the growth of
the fungal and yeast organisms
causing your infection.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY DIFLUCAN HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
Diflucan for another reason.
Diflucan is available only with a
doctor's prescription.
This medicine is not addictive.
BEFORE YOU TAKE
DIFLUCAN
_WHEN YOU MUST NOT TAKE IT_
Do not take Diflucan if you have an
allergy to:
•
any medicine containing
fluconazole
•
medicines related to fluconazole
such as miconazole, ketoconazole
or clotrimazole
•
any of the ingredients listed at the
end of this leaflet.
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 DIFLUCAN IF YOU ARE
TAKING ANY OF THE FOLLOWING
MEDICINES:
•
terfenadine or astemizole (a
medicine used to treat allergy)
•
cisapride (a medicine used to treat
stomach problems)
•
erythromycin (a medicine used to
treat infections)
•
pimozide (a medicine used to
treat mental illness)
•
quinidine (a medicine used to
treat irregular heartbeat).
DO NOT TAKE THIS MEDICINE IF THE
EXPIRY DATE (EXP) PRINTED ON THE
PAC

Summary of Product characteristics

Version: pfpdiflb10721
Supersedes: pfpdiflb11020
Page 1 of 25
AUSTRALIAN
PRODUCT
INFORMATION
–
DIFLUCAN
® (FLUCONAZOLE)
1.
NAME OF THE MEDICINE
Fluconazole
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
DIFLUCAN is available as:
1.
Gelatin capsules containing 50 mg, 100 mg, 150 mg or 200 mg
fluconazole.
2.
An intravenous infusion containing fluconazole 2 mg/mL in 0.9% saline
solution. The
pH of the solution is 4.0 - 8.0. Each 100 mL contains 15 mmol each of
sodium and
chloride.
3.
A powder for oral suspension containing fluconazole 50 mg/5 mL.
EXCIPIENT(S) WITH KNOWN EFFECT:
_CAPSULES_:
Lactose monohydrate
_POWDER FOR ORAL SUSPENSION_:
Sodium benzoate and sucrose
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
HARD GELATIN CAPSULES
50 mg light turquoise blue opaque cap and white opaque body, marked
with the Pfizer logo
and FLU-50.
100 mg standard blue opaque cap and white opaque body, marked with the
Pfizer logo and
FLU-100.
150 mg light turquoise blue opaque cap and body, marked with the
Pfizer logo and FLU-150.
200 mg purple opaque cap and white opaque body, marked with the Pfizer
logo and FLU-200.
VIAL
Solution for injection.
POWDER FOR ORAL SUSPENSION
35 mL bottle containing 50 mg/5 mL of orange flavoured suspension when
reconstituted.
Not all presentations may be marketed.
Version: pfpdiflb10721
Supersedes: pfpdiflb11020
Page 2 of 25
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
DIFLUCAN, given orally, is indicated for:
1.
Treatment
of
cryptococcal
meningitis
in
patients
who
are
unable
to
tolerate
amphotericin B.
NOTE: Data suggest that the clinical efficacy of DIFLUCAN is lower
than that of
amphotericin B in the treatment of the acute phase of cryptococcal
meningitis.
2.
Maintenance therapy to prevent relapse of cryptococcal meningitis in
patients with AIDS.
3.
Treatment
of
oropharyngeal
and
oesophageal
candidiasis
in
AIDS
and
other
immunosuppressed patients.
4.
Secondary prophylaxis of oropharyngeal candidiasis in patients with
HIV infection.
5.
Serious and