Fluconazole 200mg capsules

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Fluconazole

Dostopno od:

FDC International Ltd

Koda artikla:

J02AC01

INN (mednarodno ime):

Fluconazole

Odmerek:

200mg

Farmacevtska oblika:

Oral capsule

Pot uporabe:

Oral

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 05020100; GTIN: 5050135001217

Navodilo za uporabo

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

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Azocan 200mg Capsules
Fluconazole 200mg Capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains fluconazole
200mg.
Excipient(s) of known effects: each hard capsule also contains 100 mg
lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Hard capsule.
A hard gelatin size “0” capsule with a violet 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 (se