Dioderm 0.1% w/w Cream

Երկիր: Իռլանդիա

Լեզու: անգլերեն

Աղբյուրը: HPRA (Health Products Regulatory Authority)

Ակտիվ բաղադրիչ:

Hydrocortisone

Հասանելի է:

Dermal Laboratories Ltd

ATC կոդը:

D07AA; D07AA02

INN (Միջազգային անվանումը):

Hydrocortisone

Դոզան:

0.1 percent weight/weight

Դեղագործական ձեւ:

Cream

Ռեկվիզորի տեսակը:

Product subject to prescription which may be renewed (B)

Թերապեւտիկ տարածք:

Corticosteroids, weak (group I); hydrocortisone

Լիազորման կարգավիճակը:

Marketed

Հաստատման ամսաթիվը:

1980-12-01

Տեղեկատվական թերթիկ

IN THIS LEAFLET:
1. What Dioderm is and what it is used for
2. Before you use Dioderm
3. How to use Dioderm
4. Possible side effects
5. How to store Dioderm
6. Further information
1. WHAT DIODERM IS AND WHAT IT
IS USED FOR
•
Dioderm is a medicine for application to the
skin to treat eczema and dermatitis (areas of
dry, red, inflamed, itchy skin).
•
Dioderm is suitable for use by ADULTS, THE
ELDERLY, CHILDREN AND INFANTS.
•
The ACTIVE INGREDIENT in this product is
hydrocortisone. This is one of a group of
medicines called corticosteroids (which should
not be confused with ‘anabolic steroid’ tablets
or injections misused by some athletes).
•
The product works by reducing the redness,
inflammation and itching associated with these
skin problems.
2. BEFORE YOU USE DIODERM
DO NOT USE Dioderm:
•
if you are ALLERGIC (HYPERSENSITIVE) to
hydrocortisone or any of the other ingredients
of Dioderm listed in Section 6;
•
to treat any other skin problems, ESPECIALLY
SKIN INFECTIONS, as it may make them worse;
•
on open wounds, ulcers or broken skin.
TAKE SPECIAL CARE when using this product:
•
Tell your doctor if at any stage you think any
of the skin area being treated has become
infected. Your doctor may advise you to stop
using Dioderm for a while and start using an
alternative anti-microbial treatment instead.
•
Keep the product AWAY FROM THE EYES.
•
Although hydrocortisone is generally regarded
as safe, even for long term use, DO NOT USE
THIS PRODUCT EXCESSIVELY:
–
avoid using this product continuously or
frequently for long periods (weeks or months
on end);
–
this is especially important if you are using it
over large areas, on the face or under airtight
bandages or dressings;
– FOR INFANTS AND BABIES it is very important
not to over-use this product, so treatment
should normally be limited to no longer than
7 days.
USING OTHER MEDICINES
Dioderm is not known to affect, or to be affected
by, any other medicines.
PREGNANCY AND BREAST-FEEDING
It is unclear whether this product is safe for use
d

Ապրանքի հատկությունները

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dioderm 0.1% w/w Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Hydrocortisone 0.1% w/w.
For excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream
Smooth white aqueous cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the topical treatment of eczema and dermatitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_For adults, the elderly and children_
Apply to the affected areas twice daily.
_For infants_
Although generally regarded as safe, there is a potential for
overdosage in infancy. Extreme caution is therefore required in
dermatoses in infancy, including napkin eruption. In such patients,
courses of treatment should not normally exceed 7 days.
4.3 CONTRAINDICATIONS
As with all topical steroids, Dioderm is not to be used where there is
bacterial, viral or fungal infection.
Not to be used on open wounds, ulcers or broken skin.
Not to be used in cases of sensitivity to any of the ingredients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Prolonged or extensive uninterrupted application should be avoided,
particularly if used on the face or with occlusive
dressings.
Keep away from the eyes.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known.
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4.6 FERTILITY, PREGNANCY AND LACTATION
The