Hydrocortisone 1 % w/w Cream

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

Hydrocortisone

Inapatikana kutoka:

Ovelle Limited

ATC kanuni:

D07AA; D07AA02

INN (Jina la Kimataifa):

Hydrocortisone

Kipimo:

1 percent weight/weight

Dawa fomu:

Cream

Dawa ya aina:

Product not subject to medical prescription

Eneo la matibabu:

Corticosteroids, weak (group I); hydrocortisone

Idhini hali ya:

Marketed

Idhini ya tarehe:

1998-03-20

Taarifa za kipeperushi

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
HYDROCORTISONE 1% W/W CREAM
Hydrocortisone 1% w/w
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 have told
you.
-
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 you feel
worse.
WHAT IS IN THIS LEAFLET
1.
What Hydrocortisone 1% w/w Cream is and what it is used for
2.
What you need to know before you use Hydrocortisone 1% w/w Cream
3.
How to use Hydrocortisone 1% w/w Cream
4.
Possible side effects
5.
How to store Hydrocortisone 1% w/w Cream
6.
Contents of the pack and other information
1.
WHAT HYDROCORTISONE 1% W/W CREAM IS AND WHAT IT IS USED FOR
The name of your treatment is Hydrocortisone 1% w/w Cream. It is a
smooth white aqueous cream.
Hydrocortisone 1% w/w Cream contains hydrocortisone 1% w/w as the
active ingredient.
Hydrocortisone 1% w/w Cream is one group of medicines called
corticosteroids. It works by lowering
the production of substances that cause inflammation.
It is used to relieve the itching, redness, swelling, dryness,
inflammation and discomfort of various skin
conditions (contact dermatitis, irritant dermatitis, insect bite
reactions and mild to moderate eczema).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE HYDROCORTISONE 1% W/W CREAM
_ _
DO NOT USE HYDROCORTISONE 1% W/W CREAM
-
-On the eyes or face, the ano-genital region or the broken or infected
skin including cold sores,
acne and athletes foot.
-
- In the presence of untreated infections of bacterial, viral,
tuberculosis or fungal origin.
-
- In the presence of acne, rosacea or on dermatitis affecting the area
around the mouth or nose.
-
- If you are allercic to hydr

Tabia za bidhaa

Health Products Regulatory Authority
20 January 2023
CRN00D6H2
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Hydrocortisone 1 % w/w Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Hydrocortisone 1 % w/w Cream contains Hydrocortisone 1% w/w.
Excipient(s) with known effect
Contains 0.1% w/w chlorocresol and 7.2% w/w cetostearyl alcohol.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream
Smooth white aqueous cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hydrocortisone 1 % w/w Cream is recommended for the topical treatment
of contact dermatitis, irritant dermatitis, insect bite
reactions, mild to moderate eczema.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Hydrocortisone 1 % w/w Cream is applied topically.
_Recommended dosage schedules:_
_Adults: _Use sparingly over a small area once or twice daily for a
maximum period of one week.
_Children: _Hydrocortisone 1 % w/w Cream is not recommended for use in
children under 12 years without medical supervision.
4.3 CONTRAINDICATIONS
Hydrocortisone 1 % w/w Cream is contraindicated for use on the eyes or
face, the ano-genital area or on broken or infected
skin including cold sores, acne and athletes' foot.
Use in the presence of untreated infections of bacterial, viral,
tuberculous or fungal origin.
Use in acne vulgaris, acne rosacea or in perioral dermatoses.
Hypersensitivity to the preparation.
Use in plaque psoriasis.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Hydrocortisone 1 % w/w Cream is not recommended for use in children
under 12 years, except under medical supervision.
Prolonged use of uninterrupted occlusion or use with extensive
occlusive dressings may suppress adrenocortical function.
Continuous application without interruption will result in local
atrophy of the skin, striae, and superficial vascular dilatation,
particularly on the face.
Long term continuous or inappropriate use of topical steroids can
result in the development of rebound flares after stopping
treatment (topical steroid withdr