Azopt
brinzolamide
brinzolamide
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or your pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness 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.
What AZOPT is and what it is used for
What you need to know before you use AZOPT
How to use AZOPT
Possible side effects
How to store AZOPT
Contents of the pack and other information
AZOPT contains brinzolamide which belongs to a group of medicines called carbonic anhydrase inhibitors. It reduces pressure within the eye.
AZOPT eye drops are used to treat high pressure in the eye. This pressure can lead to an illness called glaucoma.
If the pressure in the eye is too high, it can damage your sight.
if you are allergic to brinzolamide or any of the other ingredients of this medicine (listed in 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.
Talk to your doctor or pharmacist before using AZOPT:
if you have kidney or liver problems.
if you have dry eyes or cornea problems.
if you are taking other sulphonamide medicines
if you have a specific form of glaucoma in which the pressure inside the eye rises due to deposits that block fluid draining out (pseudoexfoliative glaucoma or pigmentary glaucoma) or a specific form of glaucoma in which the pressure inside the eye (sometimes rapidly) rises because the eye bulges forward and blocks fluid draining out (narrow-angle glaucoma)
if you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after using AZOPT or other related medicines.
Take special care with AZOPT:
Serious skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in association with brinzolamide treatment. Stop using AZOPT and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
AZOPT is not to be used by infants, children or adolescents under 18 years of age unless advised by your doctor.
Tell your doctor or pharmacist if you are taking, have recently taken or might take 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.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Women who may become pregnant are advised to use effective contraception during AZOPT treatment. The use of AZOPT is not recommended during pregnancy or breast-feeding. Do not use AZOPT unless clearly indicated by your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
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 to perform tasks requiring mental alertness and/or physical coordination. If affected, take care when driving or using machines.
This medicine contains 3.35 µg benzalkonium chloride per drop (= 1 dose) which is equivalent to 0.01% or 0.1 mg/ml.
AZOPT contains a preservative (benzalkonium chloride) which may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove contact lenses before using this medicine and put them back 15 minutes afterwards. Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor.
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Only use AZOPT for your eyes. Do not swallow or inject.
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.
1 2 3
Get the AZOPT bottle and a mirror
Wash your hands
Shake the bottle and twist off the cap. After the cap is removed, if the tamper evident snap collar is loose, remove before using product.
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) for at least 1 minute. 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 are using other eye drops, leave at least 5 minutes between putting in AZOPT and the other drops. Eye ointments should be administered last.
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.
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 for a forgotten dose.
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.
Like all medicines, this medicine can cause side effects, although not everyone gets them. The following side effects have been seen with AZOPT.
Stop using AZOPT and seek medical attention immediately if you notice any of the following symptoms:
reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
Not known (frequency cannot be estimated from the available data)
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 listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine 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.
Opened (1):
Opened (2):
Opened (3):
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is brinzolamide. Each millilitre contains 10 mg of brinzolamide.
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.
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.
Novartis Europharm Limited Vista Building
Elm Park, Merrion Road
Dublin 4 Ireland
Novartis Pharma GmbH Roonstraße 25
D-90429 Nuremberg
Germany
S.A. Alcon - Couvreur N.V. Rijksweg 14
B-2870 Puurs
Belgium
Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764 08013 Barcelona
Spain
Siegfried El Masnou, S.A. Camil Fabra 58
El Masnou 08320 Barcelona Spain
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
SIA Novartis Baltics Lietuvos filialas Tel: +370 5 269 16 50
Novartis Bulgaria EOOD Тел.: +359 2 489 98 28
Novartis s.r.o.
Tel: +420 225 775 111
Novartis Healthcare A/S Tlf: +45 39 16 84 00
Novartis Pharma Services Inc. Tel: +356 2122 2872
Novartis Pharma GmbH Tel: +49 911 273 0
Novartis Pharma B.V. Tel: +31 88 04 52 111
SIA Novartis Baltics Eesti filiaal Tel: +372 66 30 810
Novartis Norge AS Tlf: +47 23 05 20 00
Novartis (Hellas) A.E.B.E. Τηλ: +30 210 281 17 12
Novartis Pharma GmbH Tel: +43 1 86 6570
Novartis Farmacéutica, S.A. Tel: +34 93 306 42 00
Novartis Poland Sp. z o.o. Tel.: +48 22 375 4888
Novartis Pharma S.A.S. Tél: +33 1 55 47 66 00
Novartis Farma - Produtos Farmacêuticos, S.A. Tel: +351 21 000 8600
Novartis Hrvatska d.o.o. Tel. +385 1 6274 220
Novartis Pharma Services Romania SRL Tel: +40 21 31299 01
Novartis Ireland Limited Tel: +353 1 260 12 55
Novartis Pharma Services Inc. Tel: +386 1 300 75 50
Vistor hf.
Sími: +354 535 7000
Novartis Farma S.p.A. Tel: +39 02 96 54 1
Novartis Finland Oy
Puh/Tel: +358 (0)10 6133 200
Novartis Pharma Services Inc. Τηλ: +357 22 690 690
Novartis Sverige AB Tel: +46 8 732 32 00
SIA Novartis Baltics Tel: +371 67 887 070
Novartis Ireland Limited Tel: +44 1276 698370
Taking into account the PRAC Assessment Report on the PSUR(s) for brinzolamide, the scientific conclusions of CHMP are as follows:
In view of available data on Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) from spontaneous reports including several cases highly suggestive of causal association with brinzolamide, and the fact that topical brinzolamide is absorbed systemically, and therefore, the same types of ADRs (including SJS and TEN) associated with sulphonamides may occur with topical administration, the PRAC Rapporteur considers a causal relationship between brinzolamide and SJS/TEN is at least a reasonable possibility. Therefore, an update of sections 4.4 and 4.8 of the SmPC to add the ADR SJS/TEN with a frequency ‘not known’ and a warning on SJS/TEN is considered warranted. The package leaflet should be updated accordingly.
The CHMP agrees with the scientific conclusions made by the PRAC.
On the basis of the scientific conclusions for brinzolamide the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing brinzolamide is unchanged subject to the proposed changes to the product information.
The CHMP recommends that the terms of the Marketing Authorisation(s) should be varied.