HYDROZOLE hydrocortisone / clotrimazole cream tube

Pajjiż: Awstralja

Lingwa: Ingliż

Sors: Department of Health (Therapeutic Goods Administration)

Ingredjent attiv:

hydrocortisone, Quantity: 1 % w/w; clotrimazole, Quantity: 1 % w/w

Disponibbli minn:

Haleon Australia Pty Ltd

Għamla farmaċewtika:

Cream

Kompożizzjoni:

Excipient Ingredients: cetomacrogol 1000; purified water; lactic acid; chlorocresol; cetostearyl alcohol; white soft paraffin; sodium hydroxide; glycerol; propylene glycol; light liquid paraffin

Rotta amministrattiva:

Topical

Unitajiet fil-pakkett:

50g, 30g, 5g, 2g

Tip ta 'preskrizzjoni:

(S4) Prescription Only Medicine, (S3) Pharmacist Only Medicine

Indikazzjonijiet terapewtiċi:

For dermatophyte and yeast infections of the skin when inflammation is prominent. This includes conditions such as fungal infected dermatitis, intertrigo and Candida nappy rash.

Sommarju tal-prodott:

Visual Identification: White Cream; Container Type: Tube; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

L-istatus ta 'awtorizzazzjoni:

Registered

Data ta 'l-awtorizzazzjoni:

1991-08-13

Fuljett ta 'informazzjoni

HYDROZOLE CREAM
_Hydrocortisone (microfine) 1% w/w and clotrimazole 1% w/w_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
This leaflet answers some common
questions about Hydrozole Cream. It
does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
benefits of you using Hydrozole
Cream against the risks he expects it
may have for you.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE. YOU MAY NEED TO READ IT
AGAIN.
WHAT IS HYDROZOLE
CREAM AND WHAT IS IT
USED FOR?
Hydrozole Cream contains
hydrocortisone (it belongs to the
group of medicines called
corticosteroids) and clotrimazole (it
belongs to a group of medicines
called antifungals).
Hydrozole Cream is used on the skin
to relieve the redness, swelling,
itching and discomfort of many skin
problems such as:
•
Nappy rash.
•
Candidal infections (a yeast-like
micro-organism) where there is
also inflammation on the skin.
•
Fungal-infected dermatitis.
•
Tinea infections such as jock itch
and athlete's foot.
Your doctor may have prescribed
Hydrozole Cream for another
purpose. Ask your doctor if you have
any questions about why Hydrozole
Cream has been prescribed for you.
Hydrozole Cream is not addictive.
Hydrozole Cream is only available
with a doctor's prescription.
BEFORE YOU USE
HYDROZOLE CREAM
_WHEN YOU MUST NOT USE IT_
DO NOT USE HYDROZOLE CREAM IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
hydrocortisone or clotrimazole.
•
any of the ingredients listed at the
end of this leaflet.
•
any other similar medicines (such
as medicines of the same class).
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin
DO NOT USE HYDROZOLE CREAM IF YOU
HAVE:
•
A VIRAL SKIN INFECTION (SUCH AS
COLD S

Karatteristiċi tal-prodott

1
PRODUCT INFORMATION
HYDROZOLE
®
CREAM 1%
NAME OF THE MEDICINE
HYDROZOLE cream contains the active ingredients hydrocortisone and
clotrimazole.
_Hydrocortisone: _Chemical name: 11β, 17α,
21-trihydroxypregn-4-ene-3, 20-dione.
Molecular formula: C
21
H
30
O
5
. MW: 362.5, CAS: 50-23-7. Hydrocortisone is an
odourless, white or almost white crystalline powder. It is practically
insoluble in water,
sparingly soluble in acetone and in alcohol, slightly soluble in
methylene chloride, very
slightly soluble in ether.
_Clotrimazole: _Chemical name: 1-(o-chloro-αα-diphenylbenzyl)
imidazole. Molecular
formula: C
22
H
17
CIN
2
. MW: 344.84. CAS: 23593-75-1. Melting point: 141 to 145°C. It is a
colourless, crystalline, weakly alkaline substance, soluble in
acetone, chloroform and
ethanol and practically insoluble in water. It forms stable salts with
both organic and
inorganic acids. It is not photosensitive but is slightly hygroscopic,
and may be
hydrolysed in acid media. The structural formula is given below:
_ _
2
DESCRIPTION
HYDROZOLE contains the active ingredients hydrocortisone (microfine)
1% w/w and
clotrimazole 1% w/w.
HYDROZOLE also contains cetomacrogol 1000, glycerol, cetostearyl
alcohol, light liquid
paraffin, soft white paraffin, propylene glycol, purified water and
chlorocresol 0.2% as a
preservative. The cream (nonionic) is lanolin free and does not
contain parabens
preservatives.
Topical corticosteroid/ antifungal. On topical application,
corticosteroids (hydrocortisone)
produce anti-inflammatory, antipruritic and vasoconstrictor actions.
The activity of the
drugs is thought to result at least in part from binding with a
steroid receptor.
Clotrimazole is a broad spectrum antifungal agent that is used for the
treatment of
dermal infections caused by various species of pathogenic
dermatophytes, yeast and
_Pityrosporum orbiculare_. The antifungal action appears to be on the
cell membrane of
the fungi, damaging the permeability barrier.
PHARMACOLOGY
_Hydrocortisone. _Corticosteroid, which in general, decreas