CanOral 150mg Capsule
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
19-03-2024
Summary of Product characteristics
(SPC)
19-03-2024
Active ingredient:
Fluconazole
Available from:
Bayer Limited
ATC code:
J02AC; J02AC01
INN (International Name):
Fluconazole
Dosage:
150 milligram(s)
Pharmaceutical form:
Capsule, hard
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Triazole derivatives; fluconazole
Authorization status:
Not marketed
Authorization date:
2005-04-15
Patient Information leaflet
AZURE - FEXOFENADINE TABLETS - 120 MG - 3X10’S - CARTON -
CUTTERGUIDE
DIMENSION: 86 X 70 X 24 MM
LAYOUT NO.: 20120948A-22B
86 MM
70 MM
24 MM
SPACE FOR
PHARMACODE
SPACE FOR
PHARMACODE
86 MM
70 MM
24 MM
fexofenadine
hydrochloride
120 mg film
coated tablets
Braille Content
MA HOLDER: Azure Pharmaceuticals Ltd, 12 Hamilton Drive, The Rock Road
Blackrock, Co. Louth, A91 T997, Ireland
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
PC:
SN:
EXP:
BN:
Fexofenadine Hydrochloride
120 MG
Film-coated Tablets
fexofenadine hydrochloride
30
film-coated tablets
PA22871/004/002
30
film-coated tablets
30
film-coated tablets
30
film-coated tablets
Fexofenadine Hydrochloride
120 MG
Film-coated Tablets
fexofenadine hydrochloride
Fexofenadine Hydrochloride
120 MG
Film-coated Tablets
fexofenadine hydrochloride
Fexofenadine Hydrochloride
120 MG
Film-coated Tablets
fexofenadine hydrochloride
ORAL USE
24-HOUR RELIEF OF:
• Sneezing
• Itchy, runny or blocked nose
• Itchy, red and watery eyes
Each tablet contains 120 mg of fexofenadine hydrochloride. Also
contains lactose.
WHAT FEXOFENADINE HYDROCHLORIDE 120 MG FILM-COATED TABLETS IS USED FOR
Relieves the symptoms associated with hay fever. Starts to work in one
hour and
lasts for 24 hours. Read the package leaflet before use.
HOW TO TAKE
Oral use.
FOR ADULTS AND CHILDREN AGED 12 YEARS AND OVER
The recommended dose is one tablet (120 mg) to be taken daily before a
meal.
CHILDREN UNDER 12 YEARS OF AGE: Not recommended.
DO NOT TAKE IF
You are allergic to fexofenadine or any of the other ingredients in
this medicine.
WARNINGS
Talk to your doctor or pharmacist before taking this medicine if:
- you have problems with your liver
- you have problems with your kidneys
- you have or ever had heart disease
- you are elderly
- you are pregnant or breast-feeding.
Do not exceed the stated dose. If symptoms persist consult your
doctor.
30
film-coated tablets
AZURE JOB NO.:
02
VERSION NO.:
OFF-PACK PHARMACODE
NUMBER: XXX
XXXXXXXXX
AZ22025C
Product Name
Fexofenadine HCI 120 mg FC Tabs 30
Market
Ireland
C
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
19 March 2024
CRN00F4QN
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
CanOral 150mg Capsule
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains Fluconazole 150 mg.
Excipients with known effect
Each hard capsule contains 141.0mg of Lactose Monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard
Opaque light blue capsule (size 1) printed “CAN150”.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
CanOral 150mg Capsule 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
ADULTS
Single dose 150mg
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
Health Products Regulatory Authority
19 March 2024
CRN00F4QN
Page 2 of 17
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.
Method of administration
Read the complete document
