Zenoxone 1% cream

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Hydrocortisone

Available from:

DE Pharmaceuticals

ATC code:

D07AA02

INN (International Name):

Hydrocortisone

Dosage:

10mg/1gram

Pharmaceutical form:

Cutaneous cream

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13040000

Patient Information leaflet

1
ZENOXONE

HYDROCORTISONE 1 % CREAM
PACKAGE LEAFLET: INFORMATION FOR THE USER
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told you.

This medicine is available without prescription. However, you still
need to use Zenoxone carefully to
get the best results from it.

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 your
symptoms worsen or do not improve after 7
days.
WHAT IS IN THIS LEAFLET:
1.
WHAT ZENOXONE IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ZENOXONE
3.
HOW TO USE ZENOXONE
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE ZENOXONE
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT ZENOXONE IS AND WHAT IT IS USED FOR
Zenoxone is the brand name of your medicine. It is sometimes known as
Hydrocortisone, which is the name
of the active ingredient. This medicine will be referred to as
Zenoxone throughout this leaflet.
Zenoxone is a mild topical (applied to the skin) corticosteroid, or
‘steroid’ (not to be confused with
‘anabolic’ or ‘sex’ steroids).
Zenoxone is used for the relief of mild inflammatory skin disorders
including:

mild to moderate eczema

irritant contact dermatitis or allergic contact dermatitis

insect bite reactions.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ZENOXONE
DO NOT USE ZENOXONE IF YOU:

are allergic (hypersensitive) to hydrocortisone or any of the other
ingredients of this medicine

are going to apply the cream to your face, eyes or ano-genital region,
or to broken or infected skin
(including cold sores, acne, athlete’s foot or chickenpox)

are going to apply the cream under occlus

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Zenoxone Hydrocortisone 1% Cream
Hydrocortisone 1% Cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Hydrocortisone BP 1.0%w/w
BAN rINN: Hydrocortisone
Trivial name: Cortisol
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Aqueous cream
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the relief of irritant contact dermatitis, allergic contact
dermatitis,
insect
bite reactions and mild to moderate eczema.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
To be applied topically.
Adults and elderly: To be applied sparingly once or twice daily for a
maximum period of one week.
Children: To be applied as above. Do not use for children under 10
years of
age without medical advice.
4.3
CONTRAINDICATIONS
Hypersensitivity to hydrocortisone or to any of the excipients listed
in section 6.1.
Zenoxone
®
should not be used on the eyes, face, the ano-genital region or on
broken
or infected skin such as; cold sores, athlete's foot, acne or chicken
pox.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Visual disturbance:
Visual disturbance may be reported with systemic and topical
corticosteroid
use. If a patient presents with symptoms such as blurred vision or
other visual
disturbances, the patient should be considered for referral to an
ophthalmologist for evaluation of possible causes which may include
cataract,
glaucoma or rare diseases such as central serous chorioretinopathy
(CSCR)
which have been reported after use of systemic and topical
corticosteroids.
Do not use under an occlusive dressing.
Contains Hydrocortisone. Do not use on the eyes, face or ano-genital
region,
broken or infected skin. Do not use in pregnancy without medical
advice. Do
not use for children under 10 without medical advice. Stop treatment
if
symptoms of hypersensitivity occur. If the condition does not improve
consult
a doctor.
Hydrocortisone Cream contains CHLOROCRESOL which may cause allergic
reactions.
Instruct patients not to smoke or go near naked flames -