Azocan 50mg capsules

국가: 영국

언어: 영어

출처: MHRA (Medicines & Healthcare Products Regulatory Agency)

유효 성분:

Fluconazole

제공처:

FDC International Ltd

ATC 코드:

J02AC01

INN (International Name):

Fluconazole

복용량:

50mg

약제 형태:

Oral capsule

관리 경로:

Oral

수업:

No Controlled Drug Status

처방전 유형:

Valid as a prescribable product

제품 요약:

BNF: 05020100

환자 정보 전단

Follow the dose prescribed by your doctor (either adults or children
posology).
The maximum dose for children is 400 mg daily.
The dose will be based on the child's weight in kilograms.
Use in children of 3 to 4 weeks of age:
The same dose as above but given once every 2 days. The maximum dose
is 12 mg per kg of body weight every 48 hours.
Use in children less than 2 weeks old:
The same dose as above but given once every 3 days. The maximum dose
is 12 mg per kg of body weight every 72 hours.
The usual adult dose should be given unless you have kidney problems.
Your doctor may modify your dose, depending on your kidney function.
Taking too many capsules at once may make you unwell. Contact your
doctor or your nearest hospital casualty department at
once. The symptoms of a possible overdose may include hearing, seeing,
feeling and thinking things that are not real
(hallucination and paranoid behaviour). Symptomatic treatment (with
supportive measures and gastric lavage if necessary) may
be adequate.
Do not take a double dose to make up for a forgotten dose. If you
forgot to take a dose, take it as soon as you remember. If it is
almost time for your next dose, do not take the dose that you missed.
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.
Like all medicines Fluconazole may sometimes cause side-effects,
although not everybody gets them.
A few people develop
although serious allergic reactions are rare. If you get any side
effects, talk to your
doctor or pharmacist. This includes any possible side effects not
listed in this leaflet. If you get any of the following symptoms,
l
sudden wheeziness, difficulty breathing or tightness in the chest
l
swelling of the eyelids, face or lips
l
itching all over the body, reddening of the skin or itchy red spots
l
hypersensitivity reaction with skin rash, fever, swollen glands,
increase in a type of white blood cell (eosinophilia) and
inflammation of internal organs (liver, lungs, heart, kidneys and
large intestine) (Drug Reaction

제품 특성 요약

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Azocan 50mg Capsules
Fluconazole 50mg Capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains fluconazole
50mg.
Excipient(s) of known effects: each hard capsule also contains 25 mg
lactose.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Hard capsule
A hard gelatin size “4” capsule with a blue cap and white body
containing a
white free flowing powder.
4
CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Fluconazole is indicated for the treatment of the following fungal
infections
(see section 5.1):
Fluconazole is indicated in adults for the treatment of:
• Coccidioidomycosis (see section 4.4).
• Invasive candidiasis.
• Vaginal candidiasis, acute or recurrent; when local therapy is not
appropriate.
• Candidal balanitis when local therapy is not appropriate.
• Mucosal candidiasis including oropharyngeal, oesophageal
candidiasis, candiduria and chronic mucocutaneous candidiasis.
• Chronic oral atrophic candidiasis (denture sore mouth) if dental
hygiene or tropical treatment are insufficient.
• Dermatomycosis including tinea pedis, tinea corporis, tinea
cruris,
tinea versicolor and dermal _candida _infections when systemic therapy
is indicated.
• Cryptococcal meningitis (see section 4.4).
•_ Tinea unguinium (onychomycosis)_ when other agents are not
considered appropriate.
Fluconazole is indicated in adults for the prophylaxis of:
• Relapse of cryptococcal meningitis in patients with high risk of
recurrence.
• Relapse of oropharyngeal or oesophageal candidiasis in patients
infected with HIV who are at high risk of experiencing relapse.
• To reduce the incidence of recurrent vaginal candidiasis (4 or
more
episodes a year).
• Prophylaxis of candidal infections in patients with prolonged
neutropenia (such as patients with haematological malignancies
receiving chemotherapy or patients receiving Hematopoietic Stem
Cell Transplantation (see section 5.1)).
Fluconazole is indicated in term