Germolene Wound Care cream

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Chlorhexidine hydrochloride

Available from:

Bayer Plc

ATC code:

D08AC02

INN (International Name):

Chlorhexidine hydrochloride

Dosage:

5mg/1gram

Pharmaceutical form:

Cutaneous cream

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13100500; GTIN: 5010605830822

Patient Information leaflet

_WOUND CARE CREAM_
CHLORHEXIDINE DIHYDROCHLORIDE 0.5% W/W
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
This medicine is available without prescription.
However, you still need to use Germolene
Wound Care Cream carefully to get the best
results from it.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more
information or advice.
•
You must contact a doctor if your
symptoms worsen or do not improve.
•
If you have any unusual effects after using
this product, tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What is Germolene Wound Care Cream
and what is it used for?
2. Before you use Germolene Wound Care Cream
3. How to use Germolene Wound Care Cream
4. Possible side effects
5. How to store Germolene Wound Care
Cream
6. Further information
1. WHAT IS GERMOLENE
® WOUND
CARE CREAM AND WHAT IS IT USED
FOR?
Germolene Wound Care Cream is a gentle but
effective treatment for minor abrasions, cuts,
scratches, burns, bites and stings.
The cream contains chlorhexidine
dihydrochloride which has a gentle antiseptic
action to help prevent infection.
The cream base helps to soften the skin and
soothe irritation.
2. BEFORE YOU USE GERMOLENE
®
WOUND CARE CREAM
DO NOT USE GERMOLENE WOUND CARE
CREAM:
•
If you are allergic (hypersensitive) to
chlorhexidine dihydrochloride or any of the
other ingredients of Germolene Wound Care
Cream (_See section 6, Further information_).
WARNINGS AND PRECAUTIONS
Rare but serious allergic reactions including
anaphylaxis have been reported with use of
chlorhexidine containing antiseptic products.
If symptoms of a serious allergic reaction appear
(e.g. wheezing or difficulty breathing, swelling of
the face, hives that can quickly progress to more
serious symptoms, severe rash, or shock),
immediately stop using this product and tell your
doctor straight away or contact the Accident and
Emergency Department of your nearest hospital.
PREGNANCY AND BREAST-FEEDING:
You may use the cream if you are pregnant or
breast

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Germolene Wound Care Cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Chlorhexidine Dihydrochloride
0.5 % w/w
A 10% overage is included.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
White cream for cutaneous use.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the topical treatment of minor skin trauma such as abrasions,
cuts,
scratches, burns, bites or stings, when there is a risk of bacterial
infection. As a
topical antiseptic in minor surgery.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
For topical administration.
Adults:
Germolene Wound Care Cream should be applied once or several times
daily,
as required, to cleaned wounds or affected areas of the skin. Wounds
may be
treated in the usual manner, i.e. either by application of a dressing
or by being
left uncovered.
Elderly:
As for adults.
Children:
As for adults.
4.3
CONTRAINDICATIONS
Known hypersensitivity to the product or its components, especially
chlorhexidine.
Must not be applied to a perforated eardrum.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Avoid contact with the eyes, ears or mucous membranes. Application
over
extensive skin areas should be avoided.
If infection persists or the condition worsens, consult a doctor.
Rare but serious allergic reactions including anaphylaxis have been
reported
with use of chlorhexidine containing antiseptic products. If symptoms
of a
serious allergic reaction appear (e.g. wheezing or difficulty
breathing,
swelling of the face, hives that can quickly progress to more serious
symptoms, severe rash, or shock), use must be discontinued immediately
and
doctor should be consulted.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Chlorhexidine is incompatible with soaps and other anionic compounds.
As a
precaution against the possibility of interference (antagonism or
inactivation),
Germolene Wound Care Cream should not be used concurrently with other
antiseptics
4.6
PREGNANCY AND LACTAT