Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - azopt

Document Subject

Generated Narrative: MedicinalProductDefinition mp831dc32174e3de65bc27162f5e1c766f

identifier: http://ema.europa.eu/identifier/EU/1/00/129/001-3

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: AZOPT 10 mg/ml eye drops, suspension

type: Full name

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part: nan

type: Invented name part

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part: nan

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-831dc32174e3de65bc27162f5e1c766f

identifier: http://ema.europa.eu/identifier/EU/1/00/129/001-3

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - azopt

Attesters

What is in this leaflet

1. What AZOPT is and what it is used for
2. What you need to know before you use AZOPT
3. How to use AZOPT
4. Possible side effects
5. How to store AZOPT
6. 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.

Do not use AZOPT

• 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). 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.

Warnings and precautions 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. Children and adolescents AZOPT is not to be used by infants, children or adolescents under 18 years of age unless advised 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 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.

Pregnancy and breast-feeding 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.

Driving and using machines 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.

AZOPT contains benzalkonium chloride

This medicine contains 3.35 g 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.

The recommended dose is 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.

How to use

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 use more AZOPT than you should 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.

If you forget to use AZOPT 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 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).

Common (may affect up to 1 in 10 people)

• Effects in the eye: blurred vision, eye irritation, eye pain, eye discharge, itchy eye, dry eye, abnormal eye sensation, redness of the eye.

• General side effects: bad taste.

Uncommon (may affect up to 1 in 100 people)

• Effects in the eye: sensitivity to light, inflammation or infection of the conjunctiva, eye swelling, eyelid itching, redness or swelling, deposits in eye, glare, burning sensation, growth on surface of eye, increased pigmentation of the eye, tired eyes, eyelid crusting, or increased tear production.

• General side effects: decreased or reduced heart function, a forceful heartbeat that may be rapid or irregular, decreased heart rate, difficulty breathing, shortness of breath, cough, decreased red blood cell count in blood, increased chlorine level in blood, dizziness, difficulty with memory, depression, nervousness, decreased emotional interest, nightmare, generalized weakness, fatigue, feeling abnormal, pain, movement problems, decreased sex drive, male sexual difficulty, cold symptoms, chest congestion, sinus infection, throat irritation, throat pain, abnormal or decreased sensation in mouth, inflammation of the lining of the oesophagus, abdominal pain, nausea, vomiting, upset stomach, frequent bowel movements, diarrhoea, intestinal gas, digestive disorder, kidney pain, muscle pain, muscle spasms, back pain, nose bleeds, runny nose, stuffy nose, sneezing, rash, abnormal skin sensation, itching, smooth skin rash or redness covered by elevated bumps, skin tightness, headache, dry mouth, debris in eye.

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

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

• General side effects: memory impairment, drowsiness, chest pain, upper respiratory tract congestion, sinus congestion, nasal congestion, dry nose, ringing in ears, hair loss, generalized itching, feeling jittery, irritability, irregular heart rate, body weakness, difficulty sleeping, wheezing, itchy skin rash.

Not known (frequency cannot be estimated from the available data)

• Effects in the eye: eyelid abnormality, visual disturbance, corneal disorder, eye allergy, decreased growth or number of eyelashes, eyelid redness.

• General side effects: increased allergic symptoms, decreased sensation, tremor, loss or decrease in taste, decreased blood pressure, increased blood pressure, increased heart rate, joint pain, asthma, pain in extremity, skin redness, inflammation, or itching, abnormal liver blood tests, swelling of the extremities, frequent urination, decreased appetite, feeling unwell, 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, which can be preceded by fever and flu-like symptoms. These serious skin rashes can be potentially life-threatening (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Reporting of side effects 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.

You must throw away a bottle four weeks after you first opened it, to prevent infections. Write down the date you opened each bottle in the space below and in the space on the bottle label and box. For a pack containing a single bottle, write only one date.

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.

What AZOPT contains

• 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.

What AZOPT looks like and contents of the pack AZOPT is a milky liquid (a suspension) supplied in a pack containing a 5 ml or a 10 ml plastic bottle with a screw cap, or in a pack containing three 5 ml plastic bottles 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

Novartis Pharma GmbH Roonstra e D-90429 Nuremberg Germany

S.A. Alcon - Couvreur N.V. Rijksweg B-2870 Puurs Belgium

Novartis Farmac utica, S.A. Gran Via de les Corts Catalanes, 08013 Barcelona Spain

Siegfried El Masnou, S.A. Camil Fabra El Masnou 08320 Barcelona Spain

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Novartis Pharma N.V. T l/Tel: +32 2 246 16 Lietuva SIA Novartis Baltics Lietuvos filialas Tel: +370 5 269 16
Novartis Bulgaria EOOD .: +359 2 489 98 Luxembourg/Luxemburg Novartis Pharma N.V. T l/Tel: +32 2 246 16 esk republika Novartis s.r.o. Tel: +420 225 775 Magyarorsz g Novartis Hung ria Kft. Tel.: +36 1 457 65 Danmark Novartis Healthcare A/S Tlf: +45 39 16 84 Malta Novartis Pharma Services Inc. Tel: +356 2122 2Deutschland Novartis Pharma GmbH Tel: +49 911 273 0 Nederland Novartis Pharma B.V. Tel: +31 88 04 52 Eesti SIA Novartis Baltics Eesti filiaal Tel: +372 66 30 Norge Novartis Norge AS Tlf: +47 23 05 20
Novartis (Hellas) A.E.B.E. : +30 210 281 17 sterreich Novartis Pharma GmbH Tel: +43 1 86 6Espa a Novartis Farmac utica, S.A. Tel: +34 93 306 42 Polska Novartis Poland Sp. z o.o. Tel.: +48 22 375 4France Novartis Pharma S.A.S. T l: +33 1 55 47 66 Portugal Novartis Farma - Produtos Farmac uticos, S.A. Tel: +351 21 000 8Hrvatska Novartis Hrvatska d.o.o. Tel. +385 1 6274 Rom nia Novartis Pharma Services Romania SRL Tel: +40 21 31299 Ireland Novartis Ireland Limited Tel: +353 1 260 12 Slovenija Novartis Pharma Services Inc. Tel: +386 1 300 75 sland Vistor hf. S mi: +354 535 7Slovensk republika Novartis Slovakia s.r.o. Tel: + 421 2 5542 5Italia Novartis Farma S.p.A. Tel: +39 02 96 54 1

Suomi/Finland Novartis Finland Oy Puh/Tel: +358 (0)10 6133
Novartis Pharma Services Inc. : +357 22 690 Sverige Novartis Sverige AB Tel: +46 8 732 32 Latvija SIA Novartis Baltics Tel: +371 67 887 United Kingdom (Northern Ireland) Novartis Ireland Limited Tel: +44 1276 698This leaflet was last revised in

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