AZOPT 10 mg/ml eye drops, suspension

Do not use AZOPT

• if you have severe kidney problems.
• if you are allergic to any of the ingredients of AZOPT. For a full list of ingredients please see section 6.
• if you are allergic to medicines called sulphonamides. EXAMPLES include medicines used to treat diabetes and infections and also diuretics (water tablets). AZOPT may cause the same allergy.
• if you have too much acidity in your blood (a condition called hyperchloraemic acidosis).

If you have further questions, ask your doctor for advice.

Take special care with AZOPT

Talk to your doctor

• if you have liver problems.
• if you have dry eyes or cornea problems.
• if you are taking other sulphonamide medicines

AZOPT is not to be used by people under 18 of years of age unless advised by your doctor.

Using 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.

If you are taking another carbonic anhydrase inhibitor (acetazolamide or dorzolamide, see section 1 WHAT AZOPT IS AND WHAT IT IS USED FOR), talk to your doctor.

Pregnancy and breast-feeding

You should not use AZOPT if you are pregnant, or might get pregnant. Talk to your doctor before you use AZOPT.

If you are breast-feeding, ask your doctor for advice.

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

Driving or using machines

Do not drive or use machines until your vision is clear. You may find that your vision is blurred for a time just after using AZOPT.

AZOPT may impair the ability of elderly patients to perform tasks requiring mental alertness and/or physical coordination. If affected, take care when driving or using machines.

Important information about some of the ingredients of AZOPT

If you wear soft contact lenses. . AZOPT contains benzalkonium chloride which may cause eye irritation and is known to discolour soft contact lenses. Contact with soft contact lenses is to be avoided. Remove contact lenses prior to the application of AZOPT and wait at least 15 minutes after instillation of the dose before reinsertion.

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

The usual dose is 1 drop in the affected eye or eyes, twice a day-morning and night. Use this much unless your doctor told you to do something different. Only use AZOPT in both eyes if your doctor told you to. Take it for as long as your doctor told you to.

Only use AZOPT for dropping in your eyes.
Turn the page for more advice.

Now turn over.

3. HOW TO USE AZOPT continued 1 2 3

How much to use
see side 1

• Get the AZOPT bottle and a mirror
• Wash your hands
• Shake the bottle and twist off the cap
• Hold the bottle, pointing down, between your thumb and middle finger
• Tilt your head back. Pull down your eyelid with a clean finger, until there is a ?pocket? between the eyelid and your eye. The drop will go in here (picture 1)
• Bring the bottle tip close to the eye. Use the mirror if it helps
• Do not touch your eye or eyelid, surrounding areas or other surfaces with the dropper. It could infect the drops
• Gently press on the base of the bottle to release one drop of AZOPT at a time.
• Do not squeeze the bottle: it is designed so that a gentle press on the bottom is all that it needs (picture 2)
• After using AZOPT, press a finger to the corner of your eye, by the nose (picture 3). This helps to stop AZOPT getting into the rest of the body.
• If you take drops in both eyes, repeat the steps for your other eye.
• Put the bottle cap back on firmly immediately after use
• Use up one bottle before opening the next bottle.

If a drop misses your eye, try again.

If you get too much in your eyes, rinse it all out with warm water. Do not put in any more drops until it?s time for your next regular dose.

If you forget to use AZOPT, use a single drop as soon as you remember, and then go back to your regular routine. Do not use a double dose to make up.

If you stop using AZOPT without speaking to your doctor, the pressure in your eye will not be controlled which could lead to loss of sight.

If you are using other eye drops, leave at least 5 minutes between putting in AZOPT and the other drops.

Like all medicines, AZOPT can cause side effects, although not everyone gets them.
You can usually carry on taking the drops, unless the effects are serious.

Common side effects

(Affects 1 to 10 users in 100)

Effects in the eye: blurred vision, eye irritation, eye pain, eye discharge, itchy eye, dry eye, abnormal eye sensation, redness of the eye, eyelid itching, redness, or swelling.

General side effects: bad taste, headache, dry mouth.

Uncommon side effects

(Affects 1 to 10 users in 1,000)Effects in the eye: increased pressure in eye, damage to the optic nerve, abnormal, double, or reduced vision, sensitivity to light, inflammation or infection of the conjunctiva, eye allergy, eye swelling, corneal disorder, inflammation of the eyelid glands, decreased eye sensation, growth on surface of eye, increased pigmentation of the eye, tired eyes, eyelid crusting, or increased tear production.

General side effects: decreased or irregular heart rate, reduced heart function, palpitations, chest pain, asthma, difficulty breathing, shortness of breath, decreased red blood cell count in blood, increased chlorine level in blood, dizziness, drowsiness, difficulty with memory, depression, difficulty sleeping, nervousness, irritability, fatigue, generalized weakness, feeling abnormal, pain, shaking, ringing in ears, decreased sex drive, male sexual difficulty, cold symptoms, chest congestion, cough, sinus infection, throat irritation, abnormal or decreased sensation in mouth, inflammation of the lining of the oesophagus, abdominal pain, nausea, vomiting, upset stomach, frequent bowel movements, diarrhoea, intestinal gas, digestive disorder, kidney pain, muscle pain, muscle spasms, back pain, nose bleeds, dry nose, runny nose, stuffy nose, sneezing, rash, abnormal skin sensation, itching, loss of hair.

Additional side effects that have been reported include:

Effects in the eye: eyelid abnormality, decreased growth or number of eyelashes.

General side effects: increased allergic symptoms, increased blood pressure, increased heart rate, abnormal liver blood tests, , frequent urination, swelling of the extremities, decreased sensation, decreased taste sensation, joint pain, pain in extremity, skin redness, inflammation, or itching.

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

Keep out of the reach and sight of children.

Do not use AZOPT after the expiry date which is stated on the bottle and box after ?EXP?. The expiry date refers to the last day of the month.

This medicine does not require any special storage conditions.

You must throw away a bottle four weeks after you first opened it, to prevent infections. Write down the date you opened each bottle in the space below and in the space on the bottle label and box. For a pack containing a single bottle, write only one date.

Opened (1):
Opened (2):
Opened (3):

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 protect the environment.

What AZOPT contains

The active substance is brinzolamide 10 mg/ml.

The other ingredients are: benzalkonium chloride, carbomer 974P, edetate disodium, mannitol (E421), purified water, sodium chloride, tyloxapol. Tiny amounts of hydrochloric acid or sodium hydroxide are added to keep acidity levels (pH levels) normal.

What AZOPT looks like and the contents of the pack

AZOPT is a milky liquid (a suspension) supplied in a pack containing a 5 ml or a 10 ml plastic (droptainer) bottle with a screw cap, or in a pack containing three 5 ml plastic (droptainer) bottles with screw caps. Not all pack sizes may be marketed.

Manufacturer Manufacturer S.A. Alcon - Couvreur N.V., Alcon Cusí, S.A., Rijksweg 14, Camil Fabra 58, B-2870 Puurs, 08320 El Masnou, Belgium Spain The marketing authorisation holder Alcon Laboratories UK Ltd., Pentagon Park Boundary Way, Hemel Hempstead, Herts., HP2 7UD, United Kingdom.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

Lietuva Alcon Pharmaceuticals Ltd. atstovyb 370 5 2 314 756 BelgiëBelgiqueBelgien LuxembourgLuxemburg SA Alcon-Couvreur NV 32 03 890 27 11 BelgiëBelgiqueBelgien

359 2 950 15 65 Magyarország Alcon Hungária Gyógyszerkereskedelmi Kft. 36-1-463-9080

eská republika Alcon Pharmaceuticals Czech Republic s.r.o. 420 225 377 333 Nederland Alcon Nederland BV 31 0 183 654321

Danmark Alcon Danmark AS 45 3636 3434 Norge Alcon Norge AS 47 23 25 25 50

Deutschland Alcon Pharma GmbH 49 0761 1304-0 Österreich Alcon Ophthalmika GmbH 43 01 596 69 70

Polska Alcon Polska Sp. z o.o. 48 22 820 3450 30 210 68 78 300

Eesti Alcon Eesti 372 6 313 214 Portugal Alcon Portugal-Produtos e Equipamentos Oftalmológicos, Lda. 351 214 400 300

España Alcon Cusí, S.A. 34 93 497 7000 România S.C. Alcon Romania S.R.L 40 21 203 93 24

France Laboratoires Alcon 33 01 47 10 47 10 Slovenija Alcon d.o.o 386 1 422 5280

Slovenská republika Alcon Pharmaceuticals Ltd oz 421 2 5441 0378 Ireland Malta United Kingdom Alcon Laboratories UK Ltd. 44 0 1442 34 1234 United Kingdom

Ísland Alcon Danmark AS 45 3636 3434 SuomiFinland Alcon Finland Oy 358 207 871 600

Svee griItaliaAlcon Italia S.p.A. 39 02 81803.1Alcon Sverige AB 46 08 634 40 00 E-post receptionenalconlabs.co

Latvija

Alcon Pharmaceuticals Ltd
+ 371 7 321 121

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