Hydrocortisone Cream 1% (Noumed)

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Hydrocortisone 1%{relative} (synthesis uses no animal materials);  ;  

Available from:

Noumed Pharmaceuticals Limited

INN (International Name):

Hydrocortisone 1% w/w (synthesis uses no animal materials)

Dosage:

1 %

Pharmaceutical form:

Topical cream

Composition:

Active: Hydrocortisone 1%{relative} (synthesis uses no animal materials)     Excipient: Cetomacrogol 1000 Cetostearyl alcohol Chlorocresol Liquid paraffin Purified water White soft paraffin

Units in package:

Jar, plastic, dispensing pack, 2 kg

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Sanofi Chimie

Product summary:

Package - Contents - Shelf Life: Jar, plastic, dispensing pack - 2 kg - 36 months from date of manufacture stored at or below 25°C - Jar, plastic, dispensing pack - 500 g - 36 months from date of manufacture stored at or below 25°C - Tube, aluminium, - 100 g - 36 months from date of manufacture stored at or below 25°C

Authorization date:

1980-05-29

Patient Information leaflet

New Zealand Consumer Medicine Information
1
CONSUMER MEDICINE INFORMATION
HYDROCORTISONE CREAM 1 % (NOUMED)
_ _
_Hydrocortisone 1 % w/w topical cream _
WHAT IS IN THIS LEAFLET
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START USING
HYDROCORTISONE CREAM
1% (NOUMED).
This leaflet answers some common questions about Hydrocortisone Cream
1%
(Noumed). It does not contain all the available information. It does
not take the place
of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you using
Hydrocortisone Cream 1% (Noumed) against the benefits they expect it
will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
Keep this leaflet with the medicine. You may need to read it again.
WHAT HYDROCORTISONE CREAM 1% (NOUMED) IS USED
FOR
Hydrocortisone Cream 1% (Noumed) is a topical cream used to treat
redness,
swelling, itching and discomfort of various skin conditions.
Hydrocortisone Cream 1% (Noumed) contains hydrocortisone, which
belongs to a
group of medicines called corticosteroids.
Your doctor may have prescribed Hydrocortisone Cream 1% (Noumed) for
another
reason.
Ask your doctor if you have any questions about why Hydrocortisone
Cream 1%
(Noumed) has been prescribed for you.
This medicine is available only with a doctor's prescription.
Hydrocortisone is not addictive.
New Zealand Consumer Medicine Information
2
BEFORE YOU USE HYDROCORTISONE CREAM 1% (NOUMED)
_ _
_WHEN YOU MUST NOT USE IT _
Do not use Hydrocortisone Cream 1% (Noumed) if you have:
•
you have an allergy to
o
any medicines containing hydrocortisone or class of medicines called
corticosteroids;
o
any of the ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include:
o
difficulty in breathing or wheezing;
o
shortness of breath;
o
swelling of the face, tongue, lips, or other parts of the body;
o
hives on the skin, rash, or itching.
•
you have an infection at the site of application, including a fungal

Summary of Product characteristics

NEW ZEALAND DATA SHEET
Page 1 of 5
1.
PRODUCT NAME
Hydrocortisone Cream 1% (Noumed)
Topical Cream
1% w/w
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Name and strength of the active substance
Hydrocortisone Cream 1% (Noumed) contains Hydrocortisone 1% w/w
Excipient(s) with known effect
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Cream, topical
Presentation
Hydrocortisone Cream 1% (Noumed) is a smooth white viscous cream.
4.
CLINICAL PARTICULARS
4.1.
Therapeutic indications
HYDROCORTISONE is indicated for the relief of the inflammatory and
pruritic manifestations of
corticosteroid responsive dermatoses.
4.2.
Dose and method of administration
A thin film should be applied to the affected area three to four times
daily.
Atopic dermatitis (eczema)
Rebound of pre-existing dermatoses can occur with abrupt
discontinuation of topical
corticosteroid preparations. See Section 4.8.
4.3.
Contraindications
HYDROCORTISONE is contraindicated in patients with a history of
hypersensitivity to the product
or any of its constituent ingredients, patients with tuberculosis or
fungal infection and/or herpes
infections of the eyes, lips or genitals.
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
NEW ZEALAND DATA SHEET
Page 2 of 5
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.
Although extensive use of HYDROCORTISONE has not revealed evidence
that enough
HYDROCORTISONE is absorbed to have systemic effects, greater
absorption because of misuse or
individual variability or unusual sensitivity could lead, at least
theoretically, to a systemic effect.
Patients are advised to contact their physician i