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ACRIFLEX 0.25% W/W CREAM

Active substance(s): CHLORHEXIDINE GLUCONATE SOLUTION 20%

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Transcript
Reason for
Change

Update safety information at the
request of the MHRA

C

Issued by
Date

MHRA/IMB
submission Yes
required

18.06.2014

23009806

Date

3
Proof No.

18.06.2014
Date

210 x 148mm flat (27 x 148mm folded)

23009806

3

23009806

Dimensions

Helvetica LT

Approved by
Date

11181

30g

Helvetica

Keyline (non-printing)

PCP Header Box

Artwork No 521738

Fonts Used

Process Black

23009806

CRN

IG Code

Colours Used

MHRA Header Box

• Keep it out of the sight and reach of children.
Acriflex
0.25% w/w
• TProduct
here are no special
conditions
forCream
storing
Title
this
medicine.
• Do not use after the expiry date shown on the
Component
Leaflet
carton. The expiry
date refers to the last day
Pack
of
thatSize
month. 30g
• Medicine should not be disposed of via
IG Code
23009806
wastewater or household waste. Ask your
pharmacist
to dispose
any
x 148mmofflat
(27unused
x 148mm folded)
Dimensions how210
medicine. These measures will help to protect
Proof No.
Date
18.06.2014
the
environment.3

Suf fix

210 x 148mm flat (27 x 148mm folded)



5.
Storing
this medicine
MHRA
Header Box

gill.kennedy

Pack Size

Acriflex is a trade mark of Thornton and Ross
Ltd.

Leaflet

This leaflet was revised in June 2014

Component

Colours Used

Thornton and Ross Ltd., Huddersfield,
HD7 5QH, UK.

Proof No.

Marketing authorisation holder and
manufacturer

Process Black

Acriflex is a pale yellow cream.
It is supplied in 30g tubes.

Helvetica LT

What the medicine looks like

Keyline (non-printing)

The active ingredient is: chlorhexidine
gluconate 20% solution 1.25% v/w.
The other ingredients are: arlatone, cetostearyl
alcohol, liquid paraffin, dimeticone 20, glycerol,
quinoline yellow lake (E104) and purified water.

Acriflex 0.25% w/w Cream

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 in this leaflet. You can
also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide
more information on the safety of this
medicine.

What is in this medicine

Product
Title

Like all medicines, Acriflex can have side
effects, although these don’t affect everyone.
If you experience any of the following reactions
stop use and get immediate medical help:
Swelling of the face, lips, tongue and throat;
a red itchy skin rash; wheezing or difficulty
breathing; feeling faint and dizzy; a strange
metallic taste in the mouth; collapse. You may
be having an allergic reaction.
If you notice any other side effect not included
above, stop use and tell your doctor or
pharmacist. They will tell you what to do.

Operator

Dimensions

Helvetica

Helvetica LT

23009806

23009806

6. Further information

4. Possible side effects

REVERSE FACE TOP

Turn over

Helvetica

• This product contains cetostearyl alcohol
which may cause local skin reactions
(e.g. contact dermatitis).

MHRA Header Box

Important information about some
of the ingredients

30g

Pregnant or breastfeeding….

Ask your doctor or pharmacist for advice before
using this medicine if you are pregnant, might
be pregnant or are breastfeeding.

IG Code

Acriflex may in rare cases cause allergic reactions,
leading to a drop in blood pressure and even to
unconsciousness. Early symptoms of a severe
allergic reaction may be a skin rash or asthma.
If you notice these symptoms, stop using Acriflex
and contact your doctor as soon as possible
(see under section 4: Possible side effects).

Pack Size

If you accidentally swallow some, see
a doctor straight away. Take the pack with you
to show which medicine you have swallowed.

Keyline (non-printing)

Fonts Used

If you swallow some

Fonts Used

Special warnings and precautions

For general use
• Apply freely and smooth gently into the
affected skin.
For cuts, abrasions or burns
• Spread freely and if necessary cover with a
dressing.

Process Black

• If you are allergic (hypersensitive) to
chlorhexidine gluconate or any of the other
ingredients of Acriflex (see section 6).
• If you have an operation, as contact with
the brain or spinal cord, and the middle ear
should be avoided.

Adults, the elderly and children

Leaflet


Do not take/use Acriflex ….

Apply it to the skin as needed.
• Avoid contact with the eyes.
• Do not use in body cavities (e.g. mouth,
vagina, inner ear).

Component

Now read the rest of the leaflet before you
use this medicine. It includes other
information which might be especially
important for you.
• Keep this leaflet. You may need to read it
again.
• Ask your pharmacist if you need any more
information or advice.
• If any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

2. Before you use this
medicine

3. How to use this medicine

Colours Used

FRONT FACE TOP

Important information about Acriflex
• This medicine treats minor burns, cuts,
blisters and infected cracked skin.
• It can be used by adults, the elderly and
children.
Do not use….
• In body cavities (e.g. mouth, vagina, inner
ear).

Acriflex is a cream which contains
chlorhexidine gluconate, an antibacterial agent.
It can be used to treat minor burns and scalds,
abrasions, scratches, sunburn blisters or
infected cracked skin.

Acriflex 0.25% w/w Cream

Chlorhexidine Gluconate

1. What the medicine is for

Product
Title

Acriflex 0.25% w/w Cream

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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