10 mg/ml Suspension, eye drops
Brinzolamide
1. What AZOPT is and what it is used for
AZOPT contains brinzolamide, which belongs to a group of medicines called carbohydrase inhibitors. It lowers the pressure in the eye.
AZOPT eye drops are used to treat high pressure in the eye. Such pressure can lead to a disease called glaucoma.
If the pressure becomes too high, vision may be impaired.
2. What you need to know before using AZOPT
Do not use AZOPT
- if you have severe kidney problems
- if you are allergic to any of the ingredients of AZOPT. See the complete list of ingredients in section 6.
- if you are allergic to medicines belonging to the sulphonamides. Examples can be medicines used to treat diabetes and infections, as well as diuretics ( diuretic tablets). AZOPT can cause the same type of allergy.
- if you have too much acid in your blood (a condition called hyperchloraemic acidosis ).
If you have any further questions, ask your doctor.
Warnings and cautions
Talk to your doctor or pharmacist before using AZOPT:
- if you have kidney or liver problems.
- if you have dry eyes or conjunctival problems.
- if you are taking other sulfonamide medicines.
- if you have a certain type of glaucoma where the pressure in the eye increases due to deposits that block the outflow of fluid (pseudoexfoliative glaucoma or pigmentary glaucoma ) or a certain type of glaucoma where the pressure in the eye increases (sometimes rapidly) due to the eye-bulging forward and blocks the outflow of fluid ( narrow-angle glaucoma ).
Children and young people
AZOPT should not be used by infants, children, or adolescents under 18 years of age unless recommended by your doctor.
Other medicines and AZOPT
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 use other carbonic anhydrase inhibitors (acetazolamide or dorzolamide, see section 1 What AZOPT is and what it is used), tell your doctor.
Pregnancy and breastfeeding
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 taking this medicine.
Women who may become pregnant should use effective contraception while being treated with AZOPT. The use of AZOPT is not recommended during pregnancy or breast-feeding. Do not use AZOPT unless your doctor clearly prescribes it.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Do not drive or use machines until your vision is clear. You may experience blurred vision for a while after using AZOPT.
AZOPT may impair the ability to perform tasks that require mental alertness and/or physical coordination. Do not drive or use machines if you are affected in this way.
AZOPT contains benzalkonium chloride
AZOPT contains a preservative (benzalkonium chloride) which may cause eye irritation and discolor soft contact lenses. Contact with soft contact lenses should be avoided. If you use contact lenses, remove them before using AZOPT and wait at least 15 minutes after administration of one of the drops before reinserting the lenses.
3. How to use AZOPT
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
AZOPT should only be used in the eyes. It must not be swallowed or injected.
The recommended dose is 1 drop in the affected eye or eyes twice daily – morning and evening unless your doctor prescribes otherwise. Use AZOPT in both eyes only if your doctor tells you to. Use the medicine for as long as your doctor prescribes it.
Instructions for use
- Get the AZOPT bottle and a mirror.
- Wash your hands.
- Shake the bottle and unscrew the hat. If the safety collar is loose after removing the hat, remove the collar before using the product.
- Hold the bottle upside down between your thumb and forefinger.
- Tilt your head back. Pull the eyelid down with a clean finger, so that a pocket is formed between the eyelid and the eye. The drop should end up in the pocket (figure 1).
- Move the tip of the bottle close to the eye. Use the mirror if it facilitates.
- Do not touch the eye or eyelid, surrounding areas, or other surfaces with the bottle tip. This can contaminate the drops.
- Gently press the bottom of the bottle with your index finger to release one drop of AZOPT at a time.
- Do not squeeze the bottle; it is designed so that a light pressure at the bottom is sufficient (figure 2).
- After using AZOPT, press lightly with a finger in the corner of the eye (see figure 3) for at least 1 minute. This prevents AZOPT from entering the rest of the body.
- If you drip in both eyes, repeat the procedure in the other eye.
- Screw the cap onto the bottle firmly immediately after use.
- Use one bottle before opening the next.
If the drop misses the eye, try again.
If you are using other eye preparations, wait at least 5 minutes between using AZOPT and the other eye preparations. Eye ointments should be used last.
If you use more AZOPT than you should
If you get too much in your eyes, rinse everything out with lukewarm water. Do not drip in more drops until it is time for your next regular dose.
If you forget to use AZOPT
Use a drop of the drug as soon as possible and then return to your normal routine. Do not take a double dose to make up for a forgotten dose.
If you stop using AZOPT
If you stop using AZOPT without talking to your doctor, the pressure in your eye will not be checked, which could lead to vision loss.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported with AZOPT.
Common side effects are
(may affect up to 1 in 10 users)
- Side effects in the eye: blurred vision, eye irritation, eye pain, discharge from the eye, itchy eyes, dry eyes, abnormal sensation in the eye, red eyes.
- A side effect is in other parts of the body: bad taste in the mouth.
Uncommon side effects are
(may affect up to 1 in 100 people)
- Side effects in the eye: photosensitivity, inflammation or infection of the conjunctiva, eye swelling, itching, redness or swelling of the eyelids, deposits in the eye, glare, burning sensation, growth on the surface of the eye, increased pigmentation in the eye, tired eyes, crusts on the eyelids, increased tear production.
- Side effects are in other parts of the body: decreased or impaired heart function, severe heartbeats that may be fast or irregular, decreased heart rate, difficulty breathing, shortness of breath, cough, decreased red blood cell count, increased blood chlorine content, dizziness, memory difficulties, depression, nervousness, apathy, nightmares, general weakness, fatigue, feeling abnormal, pain, movement disorders, decreased sex drive, male sexual difficulty, cold symptoms, feeling of tightness in the chest, sinus infection, throat irritation, sore throat, abnormal or decreased sensation in the mouth, inflammation the esophagus, abdominal pain, nausea, vomiting, upset stomach, frequent bowel movements, diarrhea, flatulence, digestive problems, kidney pain, muscle aches, muscle spasms, back pain, nosebleeds, runny nose, nasal congestion, sneezing, rash, abnormal rash, itching or itching in the skin redness covered by raised rash, tense skin, headache, dry mouth, foreign objects in the eye.
Rare side effects are
(may affect up to 1 in 1,000 users)
- Side effects in the eye: corneal swelling, double vision or impaired vision, abnormal vision, flashes of light in the visual field, decreased sensitivity in the eye, swelling around the eye, increased pressure in the eye, damage to the optic nerve.
- Side effects are in other parts of the body: impaired memory, drowsiness, chest pain, upper airway obstruction, congested sinuses, nasal congestion, dry nose, ringing in the ears, hair loss, general itching, feeling nervous, irritable, irregular heartbeat, weakness in the body, difficulty sleeping, wheezing, itchy rash.
Has been reported (occurs in an unknown number of users):
- Side effects in the eye: abnormal eyelids, visual disturbance, disease of the cornea, eye allergy, eyelashes grow worse or decrease in number, redness of the eyelids.
- Side effects are in other parts of the body: increased allergic symptoms, decreased sensation, tremors, loss of or decreased taste, decreased blood pressure, high blood pressure, increased heart rate, joint pain, asthma, pain in arm or leg, redness, inflammation, itching, abnormal results in liver function tests, swelling in the arm or leg, frequent urination, decreased appetite, malaise.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store AZOPT
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 carton after “EXP”. The expiration date is the last day of the specified month.
No special storage instructions.
You must discard the bottle four weeks after opening it to protect against infection. Write down the date you opened each bottle in the space below and in the area of each bottle and carton. For packages with only one bottle, only one date needs to be entered below.
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 to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is brinzolamide 10 mg/ml. One milliliter contains 10 mg of brinzolamide.
- The other ingredients are benzalkonium chloride, carbomer 974P, disodium edetate, mannitol (E421), purified water, sodium chloride, and tyloxapol. Small amounts of hydrochloric acid or sodium hydroxide are used to keep the acidity ( pH ) normal.
What the medicine looks like and the contents of the pack
AZOPT is a milk-like liquid ( suspension ) contained in plastic bottles (droptainer) with screw caps in sizes 5 ml or 10 ml or in a package containing three 5 ml plastic bottles (droptainer) with screw caps. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland
Manufacturer
SA Alcon Couvreur NV
Rijksweg 14
B 2870 Puurs
Belgium
Alcon Cusí. SA
Camil Fabra 58
08320 El Masnou
Spain
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienNovartis Pharma NVTel: +32 2 246 16 11 | LithuaniaNovartis Pharma Services Inc.Tel: +370 5 269 16 50 |
| BulgariaNovartis Pharma Services Inc.Tel .: +359 2 489 98 28 | Luxembourg / LuxemburgNovartis Pharma NVTel: +32 2 246 16 11 |
| Czech RepublicNovartis sroTel: +420 225 775 111 | HungaryNovartis Hungary Kft.Tel .: +36 1 457 65 00 |
| DenmarkNovartis Healthcare A / STel: +45 39 16 84 00 | MaltaNovartis Pharma Services Inc.Tel: +356 2122 2872 |
| GermanyNovartis Pharma GmbHTel: +49 911 273 0 | The NetherlandsNovartis Pharma BVTel: +31 26 37 82 111 |
| EestiNovartis Pharma Services Inc.Tel: +372 66 30 810 | NorwayNovartis Norge ASTel: +47 23 05 20 00 |
| GreeceNovartis (Hellas) AEBE:Ηλ: +30 210 281 17 12 | AustriaNovartis Pharma GmbHTel: +43 1 86 6570 |
| SpainNovartis Pharmacéutica, SATel: +34 93 306 42 00 | PolandNovartis Poland Sp. z ooTel .: +48 22 375 4888 |
| FranceNovartis Pharma SASTel: +33 1 55 47 66 00 | PortugalNovartis Farma – Pharmaceutical Products, SATel: +351 21 000 8600 |
| CroatiaNovartis Hrvatska dooTel. +385 1 6274 220 | RomaniaNovartis Pharma Services Romania SRLTel: +40 21 31299 01 |
| IrelandNovartis Ireland LimitedTel: +353 1 260 12 55 | SloveniaNovartis Pharma Services Inc.Tel: +386 1 300 75 50 |
| IcelandVistor hf.Phone: +354 535 7000 | Slovak RepublicNovartis Slovakia sroTel: + 421 2 5542 5439 |
| ItalyNovartis Farma SpATel: +39 02 96 54 1 | Finland / FinlandNovartis Finland OyPuh / Tel: +358 (0) 10 6133 200 |
| ΚύπροςNovartis Pharma Services Inc.:Ηλ: +357 22 690 690 | |
| LatviaNovartis Pharma Services Inc.Tel: +371 67 887 070 | United KingdomNovartis Pharmaceuticals UK Ltd.Tel: +44 1276 698370 |