Brinzolamide 10mg/ml eye drops, suspension

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or 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.

1. What Brinzolamide is and what it is used for
2. What you need to know before you use Brinzolamide
3. How to use Brinzolamide
4. Possible side effects
5. How to store Brinzolamide
6. Contents of the pack and other information

• if you have severe kidney problems.
• 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). Brinzolamide 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 Brinzolamide:

• 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 brinzolamide or other related medicines.

Take special care with brinzolamide:

Serious skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in association with brinzolamide treatment. Stop using brinzolamide and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Brinzolamide 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.

If you are taking another carbonic anhydrase inhibitor (acetazolamide or dorzolamide, see section 1 ‘What Brinzolamide 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 Brinzolamide treatment. The use of Brinzolamide is not recommended during pregnancy or breast-feeding. Do not use Brinzolamide 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 Brinzolamide.

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

benzalkonium chloride

This medicine contains approximately 3.1μg benzalkonium chloride per drop (=1 dose) which is equivalent to 0.1mg/ml.

Benzalkonium chloride 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.

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 Brinzolamide in both eyes if your doctor told you to. Use it for as long as your doctor told you to.

• Get the Brinzolamide 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 the 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 Brinzolamide 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 Brinzolamide, press a finger to the corner of your eye, by the nose (picture 3) for at least 1 minute. This helps to stop Brinzolamide 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 Brinzolamide 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 is 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 take a double dose to make up for a forgotten dose.

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

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 Yellow Card Scheme (website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store). By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is brinzolamide. Each ml of suspension contains 10mg of brinzolamide.
• The other ingredients are: benzalkonium chloride solution 50%, carbomer 974P, disodium edetate, mannitol (E421), poloxamer 407, water for injections and sodium chloride. Tiny amounts of sodium hydroxide are added to keep acidity levels (pH levels) normal.

Brinzolamide is a milky liquid (a suspension) supplied in a pack containing 1, 3 or 6 plastic (dropper container) bottles with a screw cap which includes 5ml white homogenous suspension.

The following pack sizes are available: outer cartons containing 1 x 5ml, 3 x 5ml, 6 x 5ml.

Not all pack sizes may be marketed.

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