Azopt 10 mg/ml eye drops in suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

AZOPT 10 mg/ml eye drops, suspension

brinzolamide

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What AZOPT is and what it is used for

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 elevated pressure in the eye. This pressure may lead to a condition called glaucoma.

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

2. What you need to know before using AZOPT

Do not use AZOPT

• if you have severe kidney problems.
• if you are allergic to brinzolamide or to any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to a group of medicines called sulfonamides. Examples: medicines used to treat diabetes and infections, as well as diuretics ("water pills"). AZOPT could cause you to have the same allergic reaction.
• 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

Talk to 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 containing sulfonamides.
• if you have a specific type of glaucoma in which pressure inside the eye increases due to deposits blocking fluid drainage in the eye (pseudoexfoliative glaucoma or pigmentary glaucoma), or a specific type of glaucoma in which pressure inside the eye increases (sometimes rapidly) due to a forward bulging that blocks fluid drainage (narrow-angle glaucoma).
• if you have ever developed a severe skin rash, skin peeling, blisters, 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 immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Children and adolescents

AZOPT should not be used in infants, children, and adolescents under 18 years of age, unless specifically recommended by your doctor.

Other medicines and AZOPT

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

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

Pregnancy and breastfeeding

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

Women who could become pregnant are advised to use effective contraception during treatment with AZOPT. The use of AZOPT during pregnancy or breastfeeding is not recommended. Do not use AZOPT unless clearly indicated by your doctor.

Consult your doctor or pharmacist before using any medicine.

Driving and use of machines

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

AZOPT may impair your ability to perform tasks requiring mental alertness and/or physical coordination. If you experience these effects, be cautious 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 change 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, particularly if you have dry eye or other corneal diseases (the transparent layer at the front of the eye). Consult your doctor if you experience a foreign body sensation, stinging, or pain in the eye after using this medicine.

3. How to use AZOPT

Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

The recommended dose is 1 drop in the affected eye(s) twice daily – in the morning and in the evening.

This is the dosage you should follow unless your doctor has instructed you otherwise. Apply AZOPT to both eyes only if your doctor has specifically recommended it. Continue treatment for the full duration prescribed by your doctor.

How to use

• Take the AZOPT bottle and position yourself in front of a mirror
• Wash your hands
• Shake the bottle and unscrew the cap. After removing the cap, remove the security seal ring if it is loose before using this medicine
• Hold the bottle upside down between your thumb and middle finger
• Tilt your head backward. Gently pull down the eyelid of your eye with one finger to form a pouch, into which the drop should fall (figure 1)
• Bring the tip of the bottle close to your eye. You may use the mirror to assist
• Do not touch the eye, eyelid, surrounding areas, or other surfaces with the dropper tip, as the drops could become contaminated
• Gently press the base of the bottle so that one drop of AZOPT falls at a time
• Do not squeeze the bottle: it is designed so that gentle pressure on the base is sufficient (figure 2)
• After using AZOPT, press your finger against the edge of the eye near the nose (figure 3) for at least 1 minute. This helps prevent AZOPT from passing into the rest of the body
• If applying drops to both eyes, repeat all the previous steps for the other eye
• Screw the cap back on tightly immediately after use
• Finish the bottle you are currently using before opening a new one

If a drop misses the eye, try again.

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

If you use more AZOPT than you should

If too much has been applied, rinse your eyes with lukewarm water. Do not apply further drops until it is time for your next dose.

If you forget to use AZOPT

Apply one drop as soon as you remember, then continue with your regular treatment schedule. Do not apply a double dose to make up for missed doses.

If you stop using AZOPT

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The following adverse effects have been observed with AZOPT.

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

• Flat, red, target-shaped or circular spots on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Common (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 adverse effects: bad taste.

Uncommon (may affect up to 1 in 100 people)

• Eye effects: light sensitivity, inflammation or infection of the conjunctiva, eye swelling, itching, redness or swelling of the eyelid, deposits in the eye, glare, burning sensation, lump on the surface of the eye, increased ocular pigmentation, eye fatigue, crusts on the eyelid, increased tear production.

• Other adverse effects: reduced or impaired heart function, strong heartbeats that may be rapid or irregular, decreased heart rate, difficulty breathing, shortness of breath, cough, decreased number of red blood cells in blood, increased levels of chloride in blood, dizziness, memory problems, depression, nervousness, reduced emotional interest, nightmares, generalised weakness, fatigue, feeling of abnormality, pain, movement problems, decreased sexual behaviour, male sexual problems, cold symptoms, chest congestion, sinus infection, throat irritation, sore throat, abnormal or decreased sensation of stimuli in the mouth, inflammation of the oesophageal mucosa, abdominal pain, nausea, vomiting, stomach pain, frequent bowel movements, diarrhoea, intestinal gas, digestive disorders, kidney pain, muscle pain, muscle spasms, back pain, nosebleeds, nasal discharge (runny nose), nasal congestion, sneezing, rash, abnormal sensation in the skin, itching, flat or raised skin rash or redness covered by bumps, skin tightness, headache, dry mouth, particles in the eye.

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

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

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

Frequency not known (cannot be estimated from available data)

• Eye effects: eyelid abnormalities, vision disturbances, corneal disorders, eye allergy, decreased growth or number of eyelashes, eyelid redness.

• Other adverse effects: worsening of allergy symptoms, decreased sensation of stimuli, tremor, decreased or loss of taste, decreased blood pressure, increased blood pressure, increased heart rate, joint pain, asthma, limb pain, itching, swelling or redness of the skin, abnormal liver blood test results, swelling of the extremities, frequent need to urinate, decreased appetite, general malaise, flat, red, target-shaped or circular spots on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes that may be preceded by fever and flu-like symptoms. These severe skin rashes may be potentially life-threatening (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of AZOPT

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

Do not use this medicine after the expiry date stated on the bottle and carton after "EXP". The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

To avoid infections, you must discard each bottle four weeks after first opening. Record the date of opening for each bottle in the space below and in the space on the label of the bottle and carton. For packaging containing only one bottle, record only one date.

Date of opening (1):

Date of opening (2):

Date of opening (3):

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of AZOPT

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

Nature of the product and contents of the pack

AZOPT is a milky-looking liquid (a suspension) supplied in a carton containing one 5 ml or 10 ml plastic bottle with a screw cap, or in a carton containing three 5 ml plastic bottles with screw caps. Only certain pack sizes may be marketed.

Marketing Authorisation Holder

Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Manufacturer

Novartis Manufacturing NV
Rijksweg 14
2870 Puurs-Sint-Amands
Belgium

Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain

Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nürnberg
Germany

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.