Caneclear 150 mg hard capsule

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

Fluconazole

Inapatikana kutoka:

Phoenix Labs

ATC kanuni:

J02AC; J02AC01

INN (Jina la Kimataifa):

Fluconazole

Kipimo:

150 milligram(s)

Dawa fomu:

Capsule, hard

Dawa ya aina:

Product subject to prescription which may be renewed (B)

Eneo la matibabu:

Triazole derivatives; fluconazole

Idhini hali ya:

Not marketed

Idhini ya tarehe:

2012-12-18

Tabia za bidhaa

Health Products Regulatory Authority
04 March 2024
CRN00F3S9
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Caneclear 150 mg hard capsule
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 150 mg of fluconazole
Excipients: each hard capsule also contains 150 mg lactose, 0.384 mg
methyl parahydroxybenzoate (E218) and 0.096 mg propyl
parahydroxybenzoate (E216).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard
Hard gelatin blue coloured capsule, size “1”.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Caneclear is indicated in the following fungal infections in adults
(see section 5.1):
- Acute vaginal candidiasis when local therapy is not appropriate.
- _Candidal balanitis _when local therapy is not appropriate_. _
Therapy may be instituted before the results of the cultures and other
laboratory studies are known; however, once these
results become available, anti-infective therapy should be adjusted
accordingly.
Consideration should be given to official guidance on the appropriate
use of antifungals.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
Single dose 150 mg.
Special populations
_Elderly _
Where there is no evidence of renal impairment, normal dose
recommendations should be adopted.
_ _
_Renal impairment _
Fluconazole is predominantly excreted in the urine as unchanged active
substance. No adjustments in single dose therapy are
necessary.
_Hepatic impairment_
Limited data are available in patients with hepatic impairment,
therefore fluconazole should be administered with caution to
patients with liver dysfunction (see sections 4.4 and 4.8).
_Paediatric population_
Safety and efficacy for genital candidiasis indication in paediatric
population has not been established. Current available data
for other paediatric indications are described in section 4.8.
If treatment is imperative in adolescents (from 12 to 17 years old),
the posology should be the same as adults posology.
Methods of administration
H