Maxitrol ointment – patient leaflet, side effects, dosage

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.

2. 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 dexamethasone,

  neomycin, polymyxin B 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.

• Consult your doctor or pharmacist if

  your eye pain, redness, swelling or

  irritation gets worse or persists.

• If you experience allergic reactions with

  Maxitrol, discontinue use and consult

  your doctor. Allergic reactions may vary

  from localized itching or skin redness to

  severe allergic reactions (anaphylactic

  reaction) or serious skin reactions.

  These allergic reactions may occur with

  other topical or systemic antibiotics of

  the same family (aminoglycosides).

• 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.

• If you use MAXITROL Ointment for a

  long time you may.

• Have increased pressure in your eye(s).

  You should have your eye pressure

  checked regularly while using Maxitrol.

  This is especially important in children,

  as the risk of corticosteroid-induced

  increased pressure in the eye may

  be greater in children and may occur

  earlier than in adults. The risk of

  corticosteroid-induced increase

  intraocular pressure and/or cataract

  formation is increased in predisposed

  patients (e.g. diabetes).

• Develop cataract.

• Become more susceptible to eye

  infections.

• Talk to your doctor if you experience

  swelling and weight gain around the

  trunk and in the face as these are

  usually the first manifestations of a

  syndrome called Cushing’s syndrome.

  Suppression of the adrenal gland

  function may develop after stopping a

  long-term or intensive treatment with

  MAXITROL. Talk to your doctor before

  stopping the treatment by yourself.

  These risks are especially important in children and patients treated with a drug called ritonavir or cobicistat.

  • Contact your doctor if you experience blurred vision or other visual disturbances.
  • Talk to your doctor before using Maxitrol Ointment if you have diabetes or have a family history of diabetes.

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. Especially tell your doctor if you are using:

• Topical NSAIDs. Concomitant use of topical steroids and topical NSAIDs may increase corneal healing problems. Tell your doctor if you are using ritonavir or cobicistat, as this may increase the amount of dexamethasone in the blood. Tell your doctor if you are diabetic and you are taking, having recently taken or might take medicines for treatment of diabetes such as insulin, metformin or sulfonylureas such as chlorpropamide, as Maxitrol Ointment may decrease the blood glucose lowering effect of these medicines.

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.

3. 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.

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

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.

• 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 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.

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.

L616079 02 GB Technical approval by Packaging Site not using OneArt: electronic or handwritten signature. (If handwritten, it must be legible, include the approver’s full name and date of approval)

4. 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, eye irritation, itching or discomfort.

Not Known (cannot be estimated from the available data):

corneal ulcer, blurred vision, sensitivity to light, increase in pupil size, drooping of eyelid, eye pain, eye swelling, abnormal sensation in the eye, eye redness, increased tear production, thinning of the surface of the eye.

You may also experience effects in other parts of your body:

Not known (cannot be estimated from the available data): allergy. Headache, serious skin reactions (Steven-Johnson syndrome).

Hormone problems: growth of extra body hair (particularly in women), muscle weakness and wasting, purple stretch marks on body skin, increased blood pressure, irregular or missing periods, changes in the levels of protein and calcium in your body, stunted growth in children and teenagers and swelling and weight gain of the body and face (called `Cushing's syndrome') (see section 2, "Warnings and precautions").

Steroids may be associated with an increase of blood glucose levels and diabetes.

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/yellowcard

5. HOW TO STORE MAXITROL^® OINTMENT

• 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 IU/g, Polymyxin B sulphate 6000 IU/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 and

manufacturer:

Novartis Pharmaceuticals UK Limited, 2nd Floor, The WestWorks Building, White City Place,

195 Wood Lane,

London,

W12 7FQ

United Kingdom.

This leaflet was last revised in 12/2021

L616079 02 GB