Eumocream 25% cream

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Glycerol

Available from:

Haleon UK Ltd

ATC code:

n/a

INN (International Name):

Glycerol

Dosage:

250mg/1gram

Pharmaceutical form:

Cutaneous cream

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13020100; GTIN: 5000347089992 5000347001024

Patient Information leaflet

PARTICULARS TO APPEAR ON THE OUTER PACKAGING
CARTON
1.
NAME OF THE MEDICINAL PRODUCT
Eumocream
®
25% w/w glycerol
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
ACTIVE INGREDIENT
The cream contains Glycerol 25% w/w.
3.
LIST OF EXCIPIENTS
OTHER INGREDIENTS
Glycerol monostearate 40-55, cetostearyl alcohol,
beeswax substitute 6621 (paraffin wax, vegetable stearic acid, prime
yellow carnauba wax), arlacel 165 (glycerol monostearate,
polyoxyethylene 100 stearate), dimeticone, chlorocresol, sodium
citrate, citric acid monohydrate and purified water.
4.
PHARMACEUTICAL FORM AND CONTENTS
Cream
100 g
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
_ _
HOW TO USE EUMOCREAM
Use this medicine only on your skin.
Apply the cream to the affected skin as needed.
Eumocream can be used on all areas of the body including the face.
6.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED
OUT OF THE REACH AND SIGHT OF CHILDREN
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
7.
OTHER SPECIAL WARNING(S), IF NECESSARY
PLEASE READ RIGHT THROUGH THIS INFORMATION CAREFULLY BEFORE YOU START
USING THIS MEDICINE.
CHECK BEFORE YOU USE
DO NOT USE EUMOCREAM:
•
if you have ever had an
ALLERGIC
reaction to glycerol or to any of the other
ingredients (see Further information).
TAKE SPECIAL CARE WITH EUMOCREAM
•
AVOID CONTACT WITH THE EYES.
•
Talk to your doctor before using the
cream if you are
PREGNANT
or
BREAST-
FEEDING.
If your symptoms persist,
SEE YOUR DOCTOR.
Do not smoke or go near naked flames - risk of severe burns. Fabric
(clothing, bedding,
dressings etc) that has been in contact with this product burns more
easily and is a serious fire
hazard. Washing clothing and bedding may reduce product build-up but
not totally remove it.
POSSIBLE SIDE EFFECTS
Like all medicines, Eumocream can have side effects, such as local
skin reactions, but these are rare.
REPORTING OF SIDE EFFECTS
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed on
this carton. You can also report side effects direc

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Eumocream 25% w/w
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Glycerol 25% w/w
For excipients, see 6.1
3
PHARMACEUTICAL FORM
Cream
Smooth, white cream
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This product is indicated for the management of dry or flaky skin
conditions
which may also be pruritic such as eczema or dermatitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For topical application to the skin.
Adults, the elderly, infants, babies and children:
The cream should be applied to the affected areas as often as
required.
4.3
CONTRAINDICATIONS
Hypersensitivity to any of the ingredients.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Avoid contact with the eyes, as the product may cause irritation to
the epithelial cells of the cornea.
Instruct patients not to smoke or go near naked flames – risk of
severe burns. Fabric (clothing, bedding, dressings etc) that has
been in contact with this product burns more easily and is a serious
fire hazard. Washing clothing and bedding may reduce product
build-up but not totally remove it.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None stated
4.6
PREGNANCY AND LACTATION
Animal studies are insufficient with respect to effects on pregnancy,
foetal
development, parturition or postnatal developments. The potential risk
for
humans is unknown.
Caution should be exercised when prescribing to pregnant women.
4.7
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None stated
4.8
UNDESIRABLE EFFECTS
Hypersensitivity reactions have been rarely reported; they usually
consist of
localised skin reactions.
REPORTING OF SUSPECTED ADVERSE REACTIONS
Reporting suspected adverse reactions after authorisation of the
medicinal
product is important. It allows continued monitoring of the
benefit/risk balance
of the medicinal product. Healthcare professionals are asked to report
any
suspected adverse reactions via the Yellow Card Scheme
at:www.mhra.gov.uk/yellowcard.
4.9
OVERDOSE
Eumocream is of low