TEVA UK Ref: 231-30-87385-E LEA POLYFAX OINT PLIVA <SEG Version: 2    28 January 2016

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

^ What Polyfax Ointment is and what it is used for

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)

^ Before you use Polyfax Ointment Do not use Polyfax Ointment if you:

•    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.

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.

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.

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

4 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.

T5 How to store Polyfax Ointment

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

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.

Store below 25 °C

s 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

$ PLIVA

C4411 A/16