Fluconazole 150mg capsules

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktif bileşen:

Fluconazole

Mevcut itibaren:

Accord-UK Ltd

ATC kodu:

J02AC01

INN (International Adı):

Fluconazole

Doz:

150mg

Farmasötik formu:

Oral capsule

Uygulama yolu:

Oral

Sınıf:

No Controlled Drug Status

Reçete türü:

Valid as a prescribable product

Ürün özeti:

BNF: 05020100; GTIN: 5060149312612

Bilgilendirme broşürü

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor,
pharmacist or nurse.
This medicine has been prescribed for you only. Do
not pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this Leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Fluconazole 150mg Capsules are and what
they are used for
2. What you need to know before you take
Fluconazole 150mg Capsules
3. How to take Fluconazole 150mg Capsules
4. Possible side effects
5. How to store Fluconazole 150mg Capsules
6. Contents of the pack and other information 1.
WHAT FLUCONAZOLE 150MG
CAPSULES ARE AND WHAT THEY ARE
USED FOR
Fluconazole belongs to a group of medicines called
“antifungals”. The active substance is fluconazole.
Fluconazole is used to treat infections caused by fungi
and may also be used to stop you from getting a
candidal infection. The most common cause of fungal
infection is a yeast called _Candida._
ADULTS
You might be given this medicine by your doctor to
treat the following types of fungal infections:
- Cryptococcal meningitis – a fungal infection in the brain
- Coccidioidomycosis – a disease of the
bronchopulmonary system
- Infections caused by _Candida _and found in the blood
stream, body organs (e.g. heart, lungs) or urinary tract
- Mucosal thrush - infection affecting the lining of the
mouth, throat and denture sore mouth
- Genital thrush – infection of the vagina or penis
- Skin infections - e.g. athlete's foot, ringworm, jock
itch, nail infection
You might also be given Fluconazole capsules to:
- stop cryptococcal meningitis from coming back
- stop mucosal thrush from coming back
- reduce recurrence of vaginal thrush
- stop you from getting an infection caused by Candida
(if your immun

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Fluconazole 150mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains fluconazole 150mg
Excipient(s) with known effects: each hard capsule also contains
157.170 mg lactose
monohydrate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Hard capsule.
Size 1, blue/blue capsules containing white crystalline powder.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fluconazole capsule is indicated in the following fungal infections
(see section 5.1).
Fluconazole capsule is indicated in adults for the treatment of:
•
Cryptococcal meningitis (see section 4.4).
•
Coccidioidomycosis (see section 4.4).
•
Invasive candidiasis.
•
Mucosal candidiasis including oropharyngeal, oesophageal candidiasis,
candiduria
and chronic mucocutaneous candidiasis.
•
Chronic oral atrophic candidiasis (denture sore mouth) if dental
hygiene or topical
treatment are insufficient.
•
Vaginal candidiasis, acute or recurrent; when local therapy is not
appropriate.
•
Candidal balanitis when local therapy is not appropriate.
•
Dermatomycosis including _tinea pedis_, _tinea corporis_, _tinea
cruris_, _tinea _
_versicolor_ and dermal _candida_ infections when systemic therapy is
indicated.
•
_Tinea unguinium (onychomycosis)_ when other agents are not considered
appropriate.
Fluconazole capsule 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 capsule is indicated in term newborn infant