Nizoral 20 mg/g Cream

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ketoconazole

Available from:

Lexon (UK) Ltd

ATC code:

D01AC; D01AC08

INN (International Name):

Ketoconazole

Dosage:

20 milligram(s)/gram

Pharmaceutical form:

Cream

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Imidazole and triazole derivatives; ketoconazole

Authorization status:

Authorised

Authorization date:

2017-06-16

Patient Information leaflet

NIZORAL 20MG/G CREAM
ketoconazole
Read all of this leaflet carefully because it contains important
information for
you.
*
Keep this leaflet. You may need to read it again.
*
Ask your pharmacist if you need more information or advice.
*
You must contact a doctor if your symptoms worsen or do not improve.
*
If any of the side effects get serious or if you notice any side
effects not
listed in this leaflet, please contact your doctor or pharmacist.
IN THIS LEAFLET:
What Nizoral Cream is and what it is used for.
Before you use Nizoral Cream
How to use Nizoral Cream
Possible side effects
How to store Nizoral Cream
Contents of the pack and other information
WHAT NIZORAL CREAM IS AND WHAT IT IS USED FOR
Nizoral Cream is used to treat fungal infections of the skin which may
appear on the hands, feet, genital area, trunk, groin, scalp, face,
chest or
back. These can be caused by a variety of fungi or yeasts and Nizoral
Cream works by destroying the fungus that causes the infection.
BEFORE YOU USE NIZORAL CREAM
This product is suitable for most adults, but a few people should not
use it.
If you are in any doubt, talk to your doctor or pharmacist.
DO NOT USE THIS PRODUCT.
*
If you have ever had an allergic (hypersensitivity) reaction to any of
the
ingredients.
If this applies to you, GET ADVICE FROM A DOCTOR OR PHARMACIST WITHOUT
USING NIZORAL CREAM.
PREGNANCY AND BREAST-FEEDING
*
You can use Nizoral Cream if you are pregnant, think you might be
pregnant or are breast-feeding.
TAKE SPECIAL CARE WITH NIZORAL CREAM
*
If you have been regularly using a lotion or cream, which contains a
steroid (such as_ betamethasone or hydrocortisone_) to control your
skin
infection, you should wait for two weeks before starting treatment
with
Nizoral Cream. This will stop your condition flaring up while Nizoral
Cream
starts to work. If you have any questions about stopping your steroid
lotion
or cream, SPEAK TO YOUR DOCTOR OR PHARMACIST.
DRIVING AND USING MACHINES
*
Using Nizoral Cream will not affect your ability to drive or use
machines.
N

Summary of Product characteristics

Health Products Regulatory Authority
27 January 2020
CRN009KR7
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nizoral 20 mg/g Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Ketoconazole 2% w/w (each gram of cream contains 20mg).
Excipients with known effect:
propylene glycol,
stearyl alcohol,
cetyl alcohol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream
_Product imported from Romania_
White odourless cream
4 CLINICAL PARTICULARS
As per PA0330/041/002
5 PHARMACOLOGICAL PROPERTIES
As per PA0330/041/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
purified water,
propylene glycol
cetyl alcohol,
stearyl alcohol,
sorbitan monostearate,
polysorbate 60 and 80
suphite anhydrous sodium (E221)
isopropyl myristate
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the tube and outer package of the product on the market
in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Health Products Regulatory Authority
27 January 2020
CRN009KR7
Page 2 of 2
Do not store above 25°C
6.5 NATURE AND CONTENTS OF CONTAINER
A lined aluminium tube, with a screw cap, containing 2 x15g of cream
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Lexon (UK) Ltd
Unit 18, Oxleasow Road
East Moons Moat
Redditch
Worcestershire
B98 0RE
United Kingdom
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1097/017/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 16
th
June 2017
10 DATE OF REVISION OF THE TEXT