Nizoral 2% cream

देश: यूनाइटेड किंगडम

भाषा: अंग्रेज़ी

स्रोत: MHRA (Medicines & Healthcare Products Regulatory Agency)

सक्रिय संघटक:

Ketoconazole

थमां उपलब्ध:

Janssen-Cilag Ltd

ए.टी.सी कोड:

D01AC08

INN (इंटरनेशनल नाम):

Ketoconazole

डोज़:

20mg/1gram

फार्मास्यूटिकल फॉर्म:

Cutaneous cream

प्रशासन का मार्ग:

Cutaneous

वर्ग:

No Controlled Drug Status

प्रिस्क्रिप्शन प्रकार:

Valid as a prescribable product

उत्पाद समीक्षा:

BNF: 13100200; GTIN: 5012674043035

सूचना पत्रक

- 1 -
PACKAGE LEAFLET: INFORMATION FOR THE USER
NIZORAL
®
2% CREAM
Ketoconazole
Nizoral is a registered trademark
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
•
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 side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
IN THIS LEAFLET
1. What Nizoral cream is and what it is used for
2. What you need to know before you use Nizoral cream
3. How to use Nizoral cream
4. Possible side effects
5. How to store Nizoral cream
6. Contents of the pack and other information
1. WHAT NIZORAL CREAM IS AND WHAT IT IS USED FOR
The name of your medicine is Nizoral 2% cream. It is called ‘Nizoral
cream’ or
just ‘cream’ in this leaflet.
Nizoral cream contains a medicine called ketoconazole. This belongs to
a group
of medicines called ‘antifungals’.
Nizoral cream is used for fungal and yeast infections of the skin in
adults.
Infections may appear on the:
•
Trunk, chest or back
•
Hands or feet
•
Scalp or face
•
Groin or genitals
Nizoral cream works by killing the fungus that causes the infection.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE NIZORAL CREAM
DO NOT USE NIZORAL CREAM:
•
If you are allergic to anything in Nizoral cream (listed in section 6
below)
•
For eye infections
Do not use this medicine if the above applies to you. If you are not
sure, talk to
your doctor or pharmacist before using Nizoral cream.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using this medicine:
•
If you have recently used a cream, ointment or lotion on your skin
infection
that contains a steroid:
- 2 -
•
You should continue to apply a mild steroid (such as hydrocortisone)
cream, ointment or lotion in the morning whilst applyin

उत्पाद विशेषताएं

OBJECT 1
NIZORAL 2% CREAM
Summary of Product Characteristics Updated 31-Mar-2021 | Janssen-Cilag
Ltd
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Nizoral 2% cream
2. Qualitative and quantitative composition
Ketoconazole 2% w/w (each gram of cream contains 20 mg).
Excipient(s) with known effect:
This medicine contains:
200 mg propylene glycol in each gram cream,
75 mg stearyl alcohol in each gram cream,
20 mg cetyl alcohol in each gram cream.
For a full list of excipients, see 6.1.
3. Pharmaceutical form
Cream
4. Clinical particulars
4.1 Therapeutic indications
For topical application in the treatment of dermatophyte infections of
the skin such as tinea corporis, tinea
cruris, tinea manus and tinea pedis infections due to Trichophyton
spp, Microsporon spp and
Epidermophyton spp. Nizoral 2% cream is also indicated for the
treatment of cutaneous candidosis (including
vulvitis), tinea (pityriasis) versicolor and seborrhoeic dermatitis
caused by Malassezia (previously call