Fluconazole 150mg capsules

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Fluconazole

Disponibil de la:

FDC International Ltd

Codul ATC:

J02AC01

INN (nume internaţional):

Fluconazole

Dozare:

150mg

Forma farmaceutică:

Oral capsule

Calea de administrare:

Oral

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 05020100; GTIN: 5050135001224

Prospect

Adolescents from 12 to 17 years old
Follow the dose prescribed by your doctor (either adults or children
posology).
Children to 11 years old
The maximum dose for children is 400 mg daily.
The dose will be based on the child's weight in kilograms
Use in children 0 to 4 weeks of age
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.
Elderly
The usual adult dose should be given unless you have kidney problems.
Patients with kidney problems
Your doctor may change your dose, depending on your kidney function.
If you take more Fluconazole 150 than you should
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.
If you forget to take Fluconazole 150
Do not take a double dose to make up for a forgotten dose. If you
forget 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.
4. POSSIBLE SIDE-EFFECTS
Like all medicines Fluconazole 150 may sometimes cause side-effects,
although not everybody gets them.
A few people develop allergic reactions 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, tell your
doctor immediately.
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sudden wheeziness, difficulty breathing or tightness in the chest
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swelling of the eyelids, face o

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Azocan 150
Fluconazole 150mg Capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains fluconazole
150mg.
Excipient(s) of known effects: each hard capsule also contains 75 mg
lactose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Hard capsule.
A hard gelatin size “1” capsule with a blue cap and blue body
containing a
white free flowing powder.
4.1. THERAPEUTIC INDICATIONS
Azocan 150 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 newborn infants, infants, todd