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POLYFAX OINTMENT

Active substance(s): BACITRACIN ZINC / POLYMYXIN B SULFATE

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TEVA UK Ref:

231-30-87385-E LEA POLYFAX OINT PLIVA
PACKAGE LEAFLET: INFORMATION FOR THE USER

Polyfax Ointment
(polymyxin B sulfate and bacitracin zinc)

Read all of this leaflet carefully before
you start taking this medicine.
• Keep this leaflet. You may need to read it
again.
• If you have any further questions, ask
your doctor or pharmacist.
• This medicine has been prescribed for
you. Do not pass it on to others. It may
harm them, even if their symptoms are
the same as yours.
• If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet. See section 4.
In this leaflet:
1. What Polyfax Ointment is and what it
is used for
2. Before you use Polyfax Ointment
3. How you use Polyfax Ointment
4. Possible side effects
5. How to store Polyfax Ointment
6. Further information

Pregnancy and breast-feeding
Tell your doctor if you are pregnant or
breast-feeding. Polyfax Ointment is not
recommended if large amounts are likely to
be absorbed. Ask your doctor or pharmacist
before taking any medicines.
Driving and using machines
There are no known effects on driving or
using machines.

3

How you use Polyfax Ointment

Dosage
Always use Polyfax Ointment exactly as your
doctor has told you. You should check with
your doctor if you are unsure.
Adults and children
Polyfax Ointment should be applied thinly
over the affected area, which is left
uncovered. Two or more applications a day
may be necessary, depending on how severe
the infection is.
Elderly
It is recommended to check the kidney
function during treatment in the elderly.
If you use more Polyfax Ointment than
you should
If you think you have used more than 200g of
Polyfax Ointment per day, contact your
doctor immediatly.

1

What Polyfax Ointment is and
what it is used for

Version:

2

28 January 2016

• Are allergic (hypersensitive) to polymyxin
B sulfate, bacitracin zinc, other similar
antibiotics, or any of the other
ingredients of Polyfax Ointment (see list
of ingredients in Section 6).

An allergic reaction may include rash, itching,
difficulty breathing or swelling of the face,
lips, throat or tongue.
Take special care with Polyfax Ointment
(and speak to your doctor) if you:
• are an adult using more than 200g of
Polyfax Ointment per day
• have a child using large amounts
• have a kidney disorder
If a large amount of Polyfax Ointment is
absorbed into the body it may cause damage
to the nerves and kidneys.
Long-term use may cause an increased
growth of micro-organisms (germs) that are
not affected by Polyfax Ointment, such as
fungi, and this could lead to an infection.
Taking other medicines
Please tell your doctor or pharmacist if you
are taking, or have recently taken, any other
medicines, including medicines obtained
without a prescription. This is especially
important of the following substances as they
may interact with your Polyfax Ointment:
• neuromuscular blocking drugs
(sometimes used during surgery) – if you
have absorbed a lot of Polyfax Ointment,
these drugs will have a greater effect on
depressing breathing. It may still be all
right for you to be given Polyfax
Ointment and your doctor will be able to
decide what is suitable for you.

If you have any further questions on the use
of this medicine, ask your doctor or
pharmacist.

Do not use Polyfax ointment after the expiry
date which is stated on the carton. The expiry
date refers to the last day of that month.

4

Store below 25 °C

Polyfax Ointment is a skin ointment, which
contains the active ingredients polymyxin B
sulfate and bacitracin zinc. Polymyxin B
sulfate and bacitracin zinc are antibacterials.
Polyfax Ointment is used for the treatment of:






infected wounds
burns
skin grafts
ulcers (on the skin)
pyoderma (a skin disease causing ulcers –
usually on the legs)
• sycosis barbae (barber’s rash)
• impetigo (itchy skin blisters)
It is also used to treat infected skin caused by:
• scabies (infestation of the skin caused by a
mite)
• pediculosis (head lice)
• tinea pedis (athlete’s foot)
• contact and allergic dermatitis
(inflammation of the skin)

2

Before you use Polyfax Ointment

Do not use Polyfax Ointment if you:

Possible side effects

Like all medicines, Polyfax Ointment can cause
side effects, although not everybody gets them.
All medicines can cause allergic reactions,
although serious allergic reactions are very
rare. Tell your doctor straight away if you get
any sudden wheeziness, difficulty in breathing,
swelling of the eyelids, face or lips, rash or
itching (especially affecting your whole body).
The following side effects have been
reported rarely:
• allergic reactions
• anaphylactic reaction (severe allergic
reaction)
Reporting of side effects
If you get any side effects, talk to your doctor
or pharmacist. 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.

5

How to store Polyfax Ointment

Keep Polyfax Ointment out of the reach
and sight of children.

6

Further information

What Polyfax Ointment contains:
The active substances are polymyxin B sulfate
10,000 IU and bacitracin zinc 500 IU per
gram of ointment. The other ingredient is
white soft paraffin.
What Polyfax Ointment looks like and
contents of the pack
Aluminium tubes with screw caps. Pack sizes:
4g, 20g, 90g.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
PLIVA Pharma Ltd,
Ridings Point, Whistler Drive, Castleford,
West Yorkshire, WF10 5HX, UK.
Manufacturer
Istituto Biochimico Nazionale Savio S.R.L.
Via del Mare 36, 00040 Pomezia, Rome,
Italy.
This leaflet was last revised in 01/2016
PL 10622/0155
87385-E
C4411 A/16

REG0061191

Version 2.2

Approved

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THIS IS A REPRESENTATION OF AN ELECTRONIC RECORD THAT WAS SIGNED ELECTRONICALLY AND THIS
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Teva Pharmaceuticals Europe B.V
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mockup-pil-uk-pl-15022-0155-polyfax-polymyxin-b-sulphate-10000iu-and-ba
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APPROVALS
Signed by
Darryl Hill

REG0061191

Meaning of Signature
Regulatory Affairs Approval

Version 2.2

Approved

Server Date
02-Jun-2016 01:22:41 PM

Page 2 of 4

THIS IS A REPRESENTATION OF AN ELECTRONIC RECORD THAT WAS SIGNED ELECTRONICALLY AND THIS
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE

Teva Pharmaceuticals Europe B.V
1.3.2
mockup-pil-uk-pl-15022-0155-polyfax-polymyxin-b-sulphate-10000iu-and-ba
citracin-zinc-500iu-ointment

APPROVALS
Signed by
Darryl Hill

REG0061191

Meaning of Signature
Regulatory Affairs Approval

Version 2.2

Approved

Server Date
02-Jun-2016 01:22:41 PM

Page 3 of 4

THIS IS A REPRESENTATION OF AN ELECTRONIC RECORD THAT WAS SIGNED ELECTRONICALLY AND THIS
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE

Teva Pharmaceuticals Europe B.V
1.3.2
mockup-pil-uk-pl-15022-0155-polyfax-polymyxin-b-sulphate-10000iu-and-ba
citracin-zinc-500iu-ointment

APPROVALS
Signed by
Darryl Hill

REG0061191

Meaning of Signature
Regulatory Affairs Approval

Version 2.2

Approved

Server Date
02-Jun-2016 01:22:41 PM

Page 4 of 4

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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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