KETOCONAZOLE HRA 200 MG

Země: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktivní složka:

KETOCONAZOLE

Dostupné s:

CTS LTD

ATC kód:

H02CA03

Léková forma:

TABLETS

Složení:

KETOCONAZOLE 200 MG

Podání:

PER OS

Druh předpisu:

Required

Výrobce:

HRA PHARMA RARE DISEASES, FRANCE

Terapeutické oblasti:

KETOCONAZOLE

Terapeutické indikace:

Treatment of endogenous Cushing's syndrome in adults and adolescents above the age of 12 years.

Datum autorizace:

2023-06-30

Informace pro uživatele

1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor's prescription only
KETOCONAZOLE HRA 200 MG TABLETS
Each Ketoconazole HRA 200 mg tablet contains:
Ketoconazole 200 mg
For a list of inactive ingredients in the preparation - see section 6.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This
leaflet
contains concise information about the medicine. If you have any other
questions, refer to the doctor or the pharmacist.
This medicine has been prescribed for treatment of your illness. Do
not pass it
on to others. It may harm them even if it seems to you that their
medical
condition is similar.
The medicine is not intended for children under the age of 12.
1. WHAT IS THE MEDICINE INTENDED FOR?
Ketoconazole HRA is used to treat endogenous Cushing’s syndrome in
adults
and adolescents above the age of 12 years.
Therapeutic class: Imidazole derivatives.
2. BEFORE USING THE MEDICINE:
X DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient ketoconazole
and\or
to any imidazole antifungal, or to any of the other ingredients (see
section 6 - Additional Information).
•
You are suffering from liver problems.
•
You are pregnant.
•
You are breastfeeding.
•
You have a history of an irregular heartbeat.
•
You are taking any of the following medicines:
o
Certain medicines for lowering blood cholesterol: simvastatin,
atorvastatin, lovastatin.
o
Certain heart medicines: eplerenone, dronedarone, disopyramide,
felodipine, nisoldipine, ranolazine.
o
Certain medicines used for treatment of the paludism: quinidine,
halofantrine.
2
o
Certain medicines used for treatment of severe mental health
disorders and severe depression: pimozide, sertindole,
lurasidone, quetiapine.
o
Certain medicines used for treatment of allergies: mizolastine.
o
Dabigatran - a medicine used to prevent the formation of blood
clots.
o
Certain medicines for sleep induction and treatment of anxiety:
triazolam, alprazolam, midazolam

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