Label: information for the user

AZOPT 10 mg/ml eye drop suspension

brinzolamide

Read this label carefully before starting to use this medication,because it contains important information for you.

-Keep this label, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1.What AZOPT is and for what it is used

2.What you need to know before starting to use AZOPT

3.How to use AZOPT

4.Possible adverse effects

5.Storage of AZOPT

6.Contents of the package and additional information

AZOPT contains brinzolamide which belongs to a group of medicines called carbonic anhydrase inhibitors and reduces the pressure inside the eye.

AZOPT eye drops are used to treat high eye pressure. This pressure may lead to a disease called glaucoma.

If the pressure in the eye is too high, it may damage your vision.

No use AZOPT

-If you have severe kidney problems.

-If you are allergic to brinzolamide or to any of the other ingredients of this medication (listed in section 6).

-If you are allergic to a group of medicines called sulfonamides. Examples: medicines used to treat diabetes and infections, and also diuretics (tablets to urinate). AZOPT could cause the same allergy.

-If you have too much acid in your blood (a condition called hyperchloremic acidosis).

If you have any doubts, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to use AZOPT:

-If you have kidney or liver problems.

-If you have dry eye or corneal problems.

-If you are using other medicines that contain sulfonamides.

-If you have a specific type of glaucoma where the pressure inside the eye increases due to deposits that block the drainage of fluid in the eye (pseudoexfoliative glaucoma or pigmentary glaucoma) or a specific type of glaucoma where the pressure inside the eye increases (sometimes rapidly) due to a bulging towards the front of the eye that blocks the drainage of fluid (narrow-angle glaucoma).

-If you have ever developed a severe skin rash or skin peeling, blisters, and/or mouth sores after using AZOPT or other related medicines.

Be especially careful with AZOPT:

Severe 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 severe skin reactions described in section 4.

Children and adolescents

AZOPT should not be used in infants, children, and adolescents under 18 years old, unless your doctor recommends it.

Other medicines and AZOPT

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine, including those purchased without a prescription.

Consult your doctor if you are using another carbonic anhydrase inhibitor (acetazolamide or dorzolamide, see section 1 What is AZOPT and what is it used for).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Women of childbearing potential should use effective contraceptive methods during treatment with AZOPT. AZOPT is not recommended during pregnancy or breastfeeding. Do not use AZOPT unless clearly indicated by your doctor.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

Do not drive or operate machinery until your vision is clear. Immediately after applying AZOPT, you may notice that your vision becomes blurry.

AZOPT may impair your ability to perform tasks that require mental sharpness and/or physical coordination. If you notice these effects, be careful when driving or operating machinery.

AZOPT contains benzalkonium chloride

This medicine contains 3.35 µg of benzalkonium chloride per drop (= 1 dose), equivalent to 0.01% or 0.1 mg/ml.

AZOPT contains a preservative (benzalkonium chloride) that can be absorbed by soft contact lenses and may alter the color of contact lenses. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them. Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases (transparent layer at the front of the eye). Consult your doctor if you feel a strange sensation, burning, or pain in the eye after using this medicine.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Use AZOPT only in your eye(s). Do not swallow or inject.

The recommended dose is1drop in the affected eye(s) two times a day‑in the morning and at night.

This is the dosage you should follow unless your doctor has indicated otherwise. AZOPT should only be applied in both eyes if your doctor has recommended it. Follow the treatment for the entire period of time indicated by your doctor.

How to use

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• Take the AZOPT bottle and stand in front of a mirror
• Wash your hands
• Shake the bottle and unscrew the cap. After removing the cap, you should remove the safety seal ring if it is loose before using this medication
• Hold the bottle, upside down, between your thumb and index finger
• Incline your head back. Gently separate your eyelid from your eye with a finger, until a pouch forms, in which the drop should fall (figure 1)
• Bring the tip of the bottle close to your eye. You can help yourself with the mirror
• Do not touch your eye, eyelid, nearby areas, or other surfaces with the dropper, because the drops could become contaminated
• Press gently on the base of the bottle for adrop of AZOPT to fall each time
• Do not squeeze the bottle: it is designed for a gentle pressure on the base to be sufficient (figure2)
• After using AZOPT, press with your finger the edge of your eye, next to your nose (figure3) for at least 1minute. This helps to prevent AZOPT from passing to the rest of your body
• If you apply drops in both eyes, repeat all the previous steps with the other eye
• Tighten the cap on the bottle immediately after using the product
• Finish thebottle you are using before opening the next one

If a drop falls outside the eye, try again.

If you are using another eye drop, wait at least 5minutes between the application of AZOPT and the other drops. Eye ointments should be administered last.

If you use more AZOPT than you should

If too much has been applied, you can remove it by washing your eyes with warm water. Do not apply more drops until it is time for the next dose.

If you forgot to use AZOPT

Apply a drop as soon as you remember and then continue with your regular treatment schedule. Do not apply a double dose to compensate for the missed dose.

If you interrupt the treatment with AZOPT

If you stop using AZOPT without consulting your doctor, the pressure in your eye will not be controlled, which could cause vision loss.

Like all medicines, this medicine may causeside effects,although not everyone will experience them.

The following side effects have been observed with AZOPT.

Stop using AZOPT and seek medical attention immediately if you notice any of the following symptoms:

•flat red spots, in the shape of a target or circles on the trunk, often with central blisters, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin eruptions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Frequent(may affect up to 1 in 10 people)

• Eye effects:blurred vision, eye irritation, eye pain, eye discharge, eye itching, dry eye, abnormal sensation in the eye, eye redness.

• Other side effects: bad taste.

Infrequent(may affect up to 1 in 100 people)

• Eye effects:light sensitivity, conjunctival inflammation or infection, eye swelling, eye itching, eyelid redness or swelling, eye deposits, glare, burning sensation, bulge on the surface of the eye, increased eye pigmentation, tired eyes, crusts on the eyelid, increased tear production.

• Other side effects:reduced cardiac function or decreased heart rate, strong or irregular heartbeats, decreased heart rate, shortness of breath, lack of breath, cough, decreased red blood cell count in blood, increased blood chlorine levels, dizziness, memory problems, depression, nervousness, decreased emotional interest, nightmares, generalized weakness, fatigue, abnormal sensation, pain, movement problems, decreased sexual behavior, male sexual problems, cold symptoms, chest congestion, nasal sinus infection, throat irritation, sore throat, abnormal perception of stimuli in the mouth, esophageal mucosa inflammation, abdominal pain, nausea, vomiting, stomach pain, frequent intestinal movements, diarrhea, intestinal gas, digestive problems, kidney pain, muscle pain, muscle spasms, back pain, nasal bleeding, nasal discharge (runny nose), nasal congestion, sneezing, rash, abnormal skin sensation, itching, smooth or red skin rash with bumps, skin tightness, headache, dry mouth, particles in the eye.

Rare(may affect up to 1 in 10,000 people)

• Eye effects:corneal swelling, double vision or reduced vision, abnormal vision, flashes of light in the field of vision,decreased eye sensitivity,swelling around the eye, increased eye pressure, optic nerve damage.

• Other side effects:memory loss,drowsiness, chest pain, upper respiratory tract congestion, sinus congestion, nasal congestion, dry nose, tinnitus in the ears, hair loss, generalized itching, restlessness, irritability, irregular heart rate, generalized weakness, difficulty sleeping, wheezing, skin rash with itching.

Frequency unknown(cannot be estimated from available data)

• Eye effects:eyelid abnormality, vision alterations, corneal alterations, eye allergy, decreased eyelash growth or number, eyelid redness.

• Other side effects:increased allergy symptoms, decreased perception of stimuli, tremor, decreased taste, decreased blood pressure, increased blood pressure, increased heart rate, joint pain, asthma, pain in limbs, itching, skin inflammation or redness, abnormal liver function test results, limb swelling, frequent urination, decreased appetite, general discomfort, flat red spots, in the shape of a target or circles on the trunk, often with central blisters, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers that may be preceded by fever and flu-like symptoms. These severe skin eruptions may be potentially fatal (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theAnnex V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the bottle and on the box after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

To prevent infections,you must discard each bottle four weeks after opening it for the first time.Note the opening date of each bottle in the space below and on the label of the bottle and the box. In the packaging that only contains one bottle, note only one date.

Opening date (1):

Opening date (2):

Opening date (3):

Medications should not be thrown down the drain or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you do not need. In this way, you will help protect the environment.

Composition of AZOPT

• The active ingredient is brinzolamide. Each milliliter contains 10 mg of brinzolamide.
• The other components are benzalkonium chloride, carbomer 974P, disodium edetate, mannitol (E421), purified water, sodium chloride, tiloxapol. Small amounts of hydrochloric acid or sodium hydroxide are added to maintain normal pH levels.

Appearance of the product and contents of the package

AZOPT is a milky liquid (suspension) that is presented in a box containing a 5 ml or 10 ml plastic bottle with a screw cap, or in a box containing three 5 ml plastic bottles with screw caps. Only some package sizes may be marketed.

Holder of the marketing authorization

Marketing authorization holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Responsible for manufacturing

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nuremberg

Germany

Novartis Manufacturing NV

Rijksweg 14

2870 Puurs-Sint-Amands

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

Novartis Pharma GmbH

Sophie-Germain-Strasse 10

90443 Nürnberg

Germany

To obtain more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of the summary of product characteristics

For detailed information about this medicinal product, please visit the website of the European Medicines Agency:

http://www.ema.europa.eu/