Ketoconazole HRA
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
07-06-2021
Charakterystyka produktu
(SPC)
07-06-2021
Sprawozdanie z oceny publicznego
(PAR)
30-01-2015
Składnik aktywny:
Ketoconazole
Dostępny od:
HRA Pharma Rare Diseases
Kod ATC:
J02AB02
INN (International Nazwa):
ketoconazole
Grupa terapeutyczna:
Antimycotics for systemic use
Dziedzina terapeutyczna:
Cushing Syndrome
Wskazania:
Ketoconazole HRA is indicated for the treatment of endogenous Cushing’s syndrome in adults and adolescents above the age of 12 years.
Podsumowanie produktu:
Revision: 10
Status autoryzacji:
Authorised
Data autoryzacji:
2014-11-18
Ulotka dla pacjenta
31
B. PACKAGE LEAFLET
32
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
KETOCONAZOLE HRA 200 MG TABLETS
ketoconazole
This medicine is subject to additional monitoring. This will allow
quick identification of new safety
information. You can help by reporting any side effects you may get.
See the end of section 4 for how to
report side effects.
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 or pharmacist.
-
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 or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Ketoconazole HRA is and what it is used for
2.
What you need to know before you take Ketoconazole HRA
3.
How to take Ketoconazole HRA
4.
Possible side effects
5.
How to store Ketoconazole HRA
6.
Contents of the pack and other information
1.
WHAT KETOCONAZOLE HRA IS AND WHAT IT IS USED FOR
Ketoconazole HRA is a medicine that contains the active substance
ketoconazole with an anticorticosteroid
activity. It is used to treat endogenous Cushing’s syndrome (when
the body produces an excess of cortisol) in
adults and adolescents above the age of 12 years.
Cushing’s syndrome is caused by overproduction of a hormone called
cortisol which is produced by the adrenal
glands. Ketoconazole HRA is able to block the activity of the enzymes
responsible for the synthesis of cortisol
and consequently is able to decrease the over-production of cortisol
by your body and to improve the symptoms
of Cushing’s syndrome.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE KETOCONAZOLE HRA
_ _
DO NOT TAKE KETOCONAZOLE HRA
-
if you are allergic to ketoconazole and/or to any imidazole antifungal
medicine, or to any of the other
ingredients of t
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of new
safety information. Healthcare professionals are asked to report any
suspected adverse reactions. See section
4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Ketoconazole HRA 200 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg ketoconazole.
Excipient with known effect:
Each tablet contains 19 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Off-white to light cream, round, 10 mm diameter, biconvex.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ketoconazole HRA is indicated for the treatment of endogenous
Cushing’s syndrome in adults and adolescents
above the age of 12 years.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated and supervised by physicians experienced
in endocrinology or internal medicine
and having the appropriate facilities for monitoring of biochemical
responses since the dose must be adjusted
to meet the patient’s therapeutic need, based on the normalisation
of cortisol levels.
Posology
_Initiation _
The recommended dose at initiation in adults and adolescents is
400-600 mg/day taken orally in two or three
divided doses and this dose can be increased rapidly to 800-1,200
mg/day in two or three divided doses.
At treatment initiation, 24-hour urinary free cortisol should be
controlled every few days/weeks.
_ _
_Adjustment of the posology _
Ketoconazole daily dose should be periodically adjusted on an
individual basis with the aim to normalise
urinary free cortisol and/or plasma cortisol levels.
-
A dose increase of 200 mg/day every 7 to 28 days may be considered if
urinary free cortisol and/or
plasma cortisol levels are above the normal range, as long as the dose
is tolerated by the patient;
3
-
A maintenance dose from 400 mg/day to a maximal dose of 1,200 mg/day
taken orally in 2 to 3 divided
do
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