Germolene antiseptic cream

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Phenol; Chlorhexidine gluconate

Available from:

Bayer Plc

ATC code:

D08AE03

INN (International Name):

Phenol; Chlorhexidine gluconate

Dosage:

12mg/1gram ; 2.5mg/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: 5010605829017 5010605829024

Patient Information leaflet

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CAD Ref No:
PIL 148 x 210 (P041)
Germolene
Antiseptic Cream
Leaflet
UK
Cutter
Guides
Technical & Non Printing Items
BAYER ARTWORK PANEL
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Main Text (body copy):
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_ANTISEPTIC CREAM_
PHENOL AND CHLORHEXIDINE DIGLUCONATE
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
Antiseptic 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 Antiseptic Cream and
what is it used for?
2.
Before you use Germolene Antiseptic
Cream
3.
How to use Germolene Antiseptic Cream
4.
Possible side effects
5.
How to store Germolene Antiseptic Cream
6.
Further information
1. WHAT IS GERMOLENE
®
ANTISEPTIC CREAM AND
WHAT IS IT USED FOR?
Germolene Antiseptic Cream is used to ease pain
and help prevent infections of minor cuts and
grazes, minor burns, scalds, blisters, stings and
insect bites, spots and chapped or rough skin.
The cream contains two active substances,
phenol and chlorhexidine digluconate. Phenol
and chlorhexidine digluconate have antiseptic
properties for the disinfection of skin, wounds
and burns. Phenol also has a local anaesthetic
action for the relief of pain. The cream base
helps to soften the skin and soothe irritation.
2.
BEFORE YOU USE GERMOLENE
®
ANTISEPTIC CREAM
DO NOT USE GERMOLENE ANTISEPTIC
CREAM:
•
If you are allergic (hypersensitive) to
phenol or chlorhexidine digluconate or
any of the other ingredients of

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Germolene Antiseptic Cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Phenol Ph. Eur.
1.2% w/w
Chlorhexidine digluconate solution B.P.
to give Chlorhexidine digluconate
0.25% w/w
3.
PHARMACEUTICAL FORM
Cream for topical administration.
4
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
The product will be recommended as an antiseptic (to help prevent
secondary
infection), local anaesthetic and emollient for minor cuts and grazes,
minor
burns and scalds and blisters, stings and insect bites, spots and
other minor
skin conditions, chapped or rough skin.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
All age groups:
Thoroughly clean the affected area of skin, apply the cream and rub
gently. In
the case of cuts or particularly tender areas, rubbing may be avoided
by
applying on a piece of white lint or gauze.
4.3
CONTRAINDICATIONS
Known hypersensitivity to the product or any of its components,
especially in
those with a history of possible chlorhexidine-related allergic
reactions (see
sections 4.4 and 4.8).
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Consult your doctor if symptoms persist.
Keep out of the reach of children
For external use only
Replace cap firmly after use
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.
The product should not be administered to anyone with a potential
history of
an allergic reaction to a chlorhexidine-containing compound (see
sections 4.3
and 4.8).
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Chlorhexidine is incompatible with anionic agents.
4.6.
PREGNANCY AND LACTATION
The product is not contraindicated during pregnancy and lactation.
Howeve