Medoflucon 150mg capsules

国: マルタ

言語: 英語

ソース: Medicines Authority

有効成分:

FLUCONAZOLE

から入手可能:

Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus

ATCコード:

J02AC01

INN（国際名）:

FLUCONAZOLE 150 mg

医薬品形態:

HARD CAPSULE

構図:

FLUCONAZOLE 150 mg

処方タイプ:

OTC

治療領域:

ANTIMYCOTICS FOR SYSTEMIC USE

認証ステータス:

Authorised

承認日:

2006-12-28

情報リーフレット

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MEDOFLUCON 150 MG CAPSULES
Fluconazole
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told
you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
-
You must talk to a doctor if you do not feel better or if you feel
worse after 7 days.
WHAT IS IN THIS LEAFLET
1.
What Medoflucon is and what it is used for
2.
What you need to know before you take Medoflucon
3.
How to take Medoflucon
4.
Possible side effects
5.
How to store Medoflucon
6.
Contents of the pack and other information
1.
WHAT MEDOFLUCON IS AND WHAT IT IS USED FOR
Medoflucon is a full course of treatment for thrush.
ONLY USE THIS PRODUCT IF YOU HAVE BEEN PREVIOUSLY DIAGNOSED BY YOUR
DOCTOR AS HAVING THRUSH.
The active substance in Medoflucon is fluconazole. Fluconazole belongs
to a group of medicines called
azoles and is an antifungal agent which fights the cause of infections
such as thrush.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEDOFLUCON
DO NOT TAKE MEDOFLUCON:
•
If you are allergic to fluconazole or to any of the other ingredients
of this medicine (listed in section
6).
•
If you are taking the antihistamine terfenadine, the medicine
cisapride or an ergot-derivative (e.g.
ergotamine used for migraine).
2
DO NOT USE MEDOFLUCON WITHOUT FIRST CONSULTING YOUR DOCTOR:
•
If you are under 16 or over 60 years of age.
•
If you are allergic to any of the ingredients in Medoflucon or other
antifungals and other thrush
treatments.
•
If you are taking any other medicine other than the capsule.
•
If you are taking the antihistamine terfenadine or the prescription
medicine cisapride.
•
If you have had thrush more than twice

製品の特徴

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Medoflucon 150mg capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Medoflucon 150mg capsule contains 150mg of fluconazole.
Excipients with known effect: lactose.
Each Medoflucon 150mg capsule contains 145.0 mg lactose.
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
Hard gelatin capsules with a powder blue cap and powder blue body,
containing a white, free flowing
powder.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Medoflucon is recommended for the treatment of candida vaginitis,
acute or recurrent.
It should also be used for the treatment of partners with associated
candidal balanitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults (16 to 60 years) _
One capsule should be swallowed whole.
_Children (under 16 years) _
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Paediatric use is not recommended.
_Elderly _
Not recommended in patients over 60 years.
_Renal impairment _
There is no separate dosage schedule in patients with renal impairment
for single dose therapy.
Method of administration
Medoflucon may be administered orally.
The capsules should be swallowed whole and independent of food intake.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance, to related azole substances,
or to any of the excipients listed
in section 6.1).
Fluconazole
should
not
be
administered
concomitantly
with
terfenadine,
cisapride
or
ergot-
derivatives (see section 4.5).
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The product available from pharmacies without prescription will
include a leaflet that advises the
patient -
_Do not use Medoflucon without first consulting your doctor_
:
•
If you are under 16 or over 60 years of age.
•
If you are allergic to any of the ingredients in Medoflucon or other
antifungals and other thrush
treatments.
•
If you are taking any other medicine other than the contraceptive
pill.
•
If you are taking the antihistamine terfenadine or the prescription
medicine cisapride.
•
I