PATIENT INFORMATION LEAFLET - INFORMATION FOR THE USER

Manx Antiseptic 0.15%w/w Cream

Dibrompropamidine isetionate

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 Manx 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 any of the side effects get serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet

1.    What Manx Antiseptic Cream is and what it is used for

2.    Before using Manx Antiseptic Cream

3.    How to use Manx Antiseptic Cream

4.    Possible side effects

5.    How to store Manx Antiseptic Cream

6.    Further information

1.    What Manx Antiseptic Cream is and what it is used for

Manx Antiseptic Cream contains the active substance dibrompropamidine isetionate. This medicine belongs to a group of medicines called antiseptics which can kill certain types of bacteria and fungi.

Manx Antiseptic Cream is used to treat cuts, grazes, minor burns and other minor skin infections, as well as nappy rash, rashes affecting the moustache and beard areas, outer ear infections and ringworm of the scalp.

2.    Before using Manx Antiseptic Cream

Do not use Manx Antiseptic Cream:

If you are allergic (hypersensitive) to dibrompropamidine or any of the other ingredients of Manx Antiseptic Cream. See section 6 for other ingredients.

Take special care with Manx Antiseptic Cream

Do not use the cream for more than a few days at a time, as long term use can interfere with healing. The cream should not be used for long periods on young children.

Please tell your doctor or pharmacist if you have experienced allergies to creams or ointments in the past.

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.

There are no known interactions with other medications.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medication.

If you are pregnant, or think you may be pregnant please ask your doctor or pharmacist before using the cream. It may not be suitable for you.

Driving and using machines

There are no known effects of this medicine on your

ability to drive or use machinery.

Important information about some of the ingredients of Manx Antiseptic Cream

Methyl parahydroxybenzoate (E218) may cause allergic reactions (possibly delayed)

Castor oil may cause skin reactions Cetostearyl alcohol may cause local skin reactions (eg. contact dermatitis).

If you have been told by your doctor that you are allergic to methyl parahydroxybenzoate, caster oil or cetostearyl alcohol contact your doctor before using this medicine.

3. How to use Manx Antiseptic Cream Adults

Wash your hands each time before you use the cream. Apply a pea size amount of the cream to the area to be treated, either straight onto the skin, or on a light dressing. Wash your hands again when you are finished, unless you are treating the hands. Most patients use the cream two or three times a day.

There are no specific recommendations for use in the elderly and children.

Accidental swallowing of the contents of the tube is unlikely to lead to any serious effects.

If you forget to use Manx Antiseptic Cream

If you forget to apply the cream at the usual time, apply it when you remember, unless it is close to the time for your next dose. Do not apply a double amount to make up for a forgotten application.

(continued overleaf)

WIP URN	y	050515-BR02-PIL-09
APPROVED URN	N/A
Job		Manx Antiseptic Cream PIL - Side 1
Size		210 x 148mm
Date		5 May 2015
BOH Approval Date
Saved as		13891/09 PIL S1.ai M2
Prints		1 colour - Black

4.    Possible side effects

Like all medicines, Manx Antiseptic Cream can cause side effects, although not everybody gets them. If you experience any of the following side effects stop using the cream and contact your doctor or pharmacist immediately:

i rash, itching or redness at or around the area being treated

rash, itching or redness on your fingers and hands after using the 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/vellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.

5.    How to store Manx Antiseptic Cream

Keep out of sight and reach of children Do not store above 25°C. Keep it in the original tube with the top screwed on. Do not use the cream after the expiry date, which is printed on the tube.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Further information

What Manx Antiseptic Cream looks like and contents of the pack

This medicine contains the active ingredient dibrompropamidine isetionate 0.15%w/w. It also contains Castor oil - virgin, Cetostearyl alcohol, Polyethylene glycol 600 monostearate, Methyl parahydroxybenzoate (E218), Silicone MS antifoam A, Purified water.

The cream is available in a 25g, 30g or 50g tube. Not all pack sizes may be marketed.

Marketing Authorisation Holder Manx Pharma Ltd

Taylor Group House, Wedgnock Lane, Warwick, CV34 5YA, UK

Manufacturer

Beltapharm SpA

Via Stelvio 66, 20095 Cusano Milanino, Milan, Italy

Other Formats

To request a copy of this leaflet audio please call 01926 482511

This leaflet was last revised in May 2015

WIP URN: 050515-BR02-PIL-09

WIP URN	y	050515-BR02-PIL-09
APPROVED URN	N/A
Job		Manx Antiseptic Cream PIL - Side 2
Size		210 x 148mm
Date		5 May 2015
BOH Approval Date
Saved as		13891/09 PIL S2.ai M2

Prints

1 colour - Black