616071 MAXITROL 3.5G UK_616071 MAXITROL3.5G UK 02/09/14 07:43 Pagina 1

Package Leaflet - Information for the User

= MAXITROL¹ OINTMENT,

Dexamethasone, Neomycin sulphate, Polymyxin B sulphate

IN THIS LEAFLET

1.    What MAXITROL Ointment is and what it is used for

2.    Before you use MAXITROL Ointment

3.    How to use MAXITROL Ointment

4.    Possible side effects

5.    How to store MAXITROL Ointment

6.    Further information

WHAT MAXITROL® OINTMENT IS AND WHAT IT IS USED FOR

MAXITROL Ointment contains a steroid, dexamethasone and two antibiotics, neomycin sulphate and polymyxin B sulphate.

It is used for the short term treatment of inflammation of the eye, when it is also considered that a bacterial eye infection could develop.

~| BEFORE YOU USE MAXITROL® OINTMENT |

Do not use MAXITROL Ointment...

•    If you have any type of infection

of the eye that is not being treated. Use of steroids may make infections worse.

•    If you have a sticky discharge

from your eye.

•    If you are allergic to neomycin or any of the other ingredients listed in section 6.

Ask your doctor for advice.

Take special care...

•    Do not inject or swallow this medicine.

•    Consult your doctor or pharmacist before using this medicine if you have a disorder causing a thinning of the eye tissues.

The risk of cataract formation is increased in patients with some conditions such as diabetes.

Consult your doctor or pharmacist if your eye pain, redness, swelling or irritation gets worse or persists.

Steroids applied to the eye may delay the healing of your eye wound. Topical NSAIDs (Non-Steroidal Anti Inflammatory Drugs-Medications) are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems.

Pregnancy and breast-feeding

MAXITROL Ointment is not recommended during pregnancy or breast-feeding. If you are pregnant or might get pregnant, or if you are breastfeeding a baby, talk to your doctor before you use MAXITROL Ointment.

Driving and using machines

MAXITROL Ointment may cause brief blurring of vision on instillation. If your sight is affected in any way you should not drive or operate machinery.

Using other medicines

Tell your doctor or pharmacist if

you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Taking MAXITROL Ointment with other medicines may increase the seriousness of any side effects.

Tell your doctor if you are using topical NSAIDs. Concomitant use of topical ¹ steroids and topical NSAIDs may increase corneal healing problems.

Important information if you wear Contact Lenses

Wearing contact lenses is not advisable during the treatment of an eye infection, as they may make the condition worse. If you do continue to wear your lenses, you must remove them before using MAXITROL Ointment and wait at least 15 minutes after use before putting your lenses back in.

Important information about some of the ingredients in MAXITROL Ointment

MAXITROL Ointment contains lanolin which may cause local skin reactions (e.g. contact dermatitis).

MAXITROL Ointment contains parahydroxybenzoates which can cause allergic reactions, possibly delayed.

HOW TO USE MAXITROL® OINTMENT

The usual dose

The usual dose is to apply MAXITROL

Ointment 3 - 4 times daily.

The ointment may also be used at

bedtime while other eye drops are

used during the day.

How to use

•    Wash your hands before you start.

•    Remove the cap from the tube.

•    Tilt your head back.

•    Pull down your lower eyelid with a finger, until there is a 'pocket' between the eyelid and your eye. The ointment will go in here (picture 1).

•    Bring the ointment tube close to the eye. Do this in front of a mirror if it helps.

Always use MAXITROL Ointment exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

•    Do not touch your eye or eyelid, surrounding areas or other surfaces with the tip of the tube. It could infect the ointment.

•    Gently squeeze a small ribbon of ointment into the pocket formed between your lower eyelid and your eye (picture 2).

•    Release the lower eyelid and blink a few times.

•    If you use ointment in both eyes, repeat the steps for your other eye. Replace and tightly close the cap on the tube.

•    If you miss a dose do not worry, just apply the next dose when it is due. Do not use a double dose to make up.

If you are also using other eye drops or eye ointment wait at least 5 minutes after putting in the other medicine before applying MAXITROL Ointment.

If you have any further questions

on the use of MAXITROL Ointment, ask your doctor or pharmacist.

Continued over ^

~j| POSSIBLE SIDE EFFECTS

Like all medicines, MAXITROL Ointment can cause side effects, although not everybody gets them.

You may experience some or all of the following effects in your eyes:

Uncommon (affect 1 to 10 users in

1000):

eye surface inflammation, increased pressure in eye, blurred vision, sensitivity to light, change in pupil size, drooping of eyelid, eye pain, swelling or redness, eye irritation, itching or discomfort, abnormal eye sensation, increased tear production.

Thinning of the surface of the eye has also been reported. It is not known how many users may have experienced this side effect.

You may also experience effects in other parts of your body: Hypersensitivity or general allergy to MAXITROL and headache have also been reported. It is not known how many users may have experienced these side effects.

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 national reporting system (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/vellowcard

~| HOW TO STORE MAXITROL® OINTMENT J

•    Keep out of the reach and sight of children.

•    Do not refrigerate or store above 25°C.

•    Keep the tube tightly closed and keep out of direct sunlight.

•    Do not use the ointment after the expiry date (marked 'Exp') on the tube and the carton. The expiry date refers to the last day of that month.

•    Stop using the tube 4 weeks after first opening, to prevent infections.

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

•    Do not pass this medicine on to others.

•    It may harm them, even if their symptoms are the same as yours.

~6| FURTHER INFORMATION

What MAXITROL Ointment contains

•    The active substances are Dexamethasone 1 mg/g, Neomycin sulphate (as base) 3500 lU/g, Polymyxin B sulphate 6000 lU/g.

•    The other ingredients are methyl parahydroxybenzoate, propyl parahydroxybenzoate, liquid lanolin and white soft paraffin.

What MAXITROL Ointment looks like and contents of the pack

MAXITROL Ointment is a white to very pale yellow ointment supplied in a pack containing a 3.5 g metal tube with a screw cap.

Marketing authorisation holder: Alcon Laboratories (UK) Ltd.

Frimley Business Park Frimley, Camberley Surrey, GU16 7SR,

United Kingdom.

Manufacturer:

Alcon Cusi, S.A.

08320 El Masnou - Barcelona, Spain.

This leaflet was last revised in August 2014.

© 2008, 2014 Novartis    a Novartis company    616071

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   If you use more MAXITROL Ointment than you should do

not worry, it is not likely to do any harm.

•    If this medicine is accidentally

swallowed it is not likely to cause any serious problems.