Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - azarga

Document Subject

Generated Narrative: MedicinalProductDefinition mp244f0d5975a83ec03b917d6f24b1b649

identifier: http://ema.europa.eu/identifier/EU/1/08/482/001-002

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: AZARGA 10 mg/ml + 5 mg/ml eye drops, suspension

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-244f0d5975a83ec03b917d6f24b1b649

identifier: http://ema.europa.eu/identifier/EU/1/08/482/001-002

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - azarga

Attesters

What is in this leaflet

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

AZARGA contains two active substances, brinzolamide and timolol, which work together to reduce pressure within the eye.

AZARGA is used to treat high pressure in the eyes, also called glaucoma or ocular hypertension, in adult patients that are more than 18 years of age and in whom high pressure in the eyes cannot be controlled effectively by one medicine alone.

Do not use AZARGA

• If you are allergic to brinzolamide, medicines called sulphonamides (examples include medicines used to treat diabetes, infections and also diuretics (water tablets)), timolol, beta- blockers (medicines used to lower blood pressure or to treat heart disease) or any of the other ingredients of this medicine (listed in section 6).
• If you have now or have had in the past respiratory problems such as asthma, severe long lasting obstructive bronchitis (severe lung condition which may cause wheezing, difficulty in breathing and/or long standing cough) or other types of breathing problems.
• If you have severe hay fever
• If you have a slow heart beat, heart failure or disorders of heart rhythm (irregular heartbeats).
• If you have too much acidity in your blood (a condition called hyperchloraemic acidosis).
• If you have severe kidney problems.

Warnings and precautions Only use AZARGA for dropping in your eye(s).

If signs of serious reactions or hypersensitivity occur, discontinue the use of this product and talk to your doctor.

Talk to your doctor or pharmacist before using AZARGA if you have or have had in the past:

• coronary heart disease (symptoms can include chest pain or tightness, breathlessness or choking), heart failure, low blood pressure
• disturbances of heart rate such as slow heart beat
• breathing problems, asthma or chronic obstructive pulmonary disease
• poor blood circulation disease (such as Raynaud s disease or Raynaud s syndrome)
• diabetes as timolol may mask signs and symptoms of low blood sugar
• overactivity of the thyroid gland as timolol may mask signs and symptoms of thyroid disease
• muscular weakness (myasthenia gravis)
• tell your doctor before you have an operation that you are using AZARGA as timolol may change effects of some medicines used during anaesthesia.
• if you have a history of atopy (a tendency to develop an allergic reaction) and severe allergic reactions you may be more sensitive to developing an allergic reaction whilst using AZARGA and adrenaline may not be as effective to treat an allergic reaction. When receiving any other treatment please tell the doctor or nurse that you are taking AZARGA.
• if you have liver problems.
• if you have dry eyes or cornea problems.
• if you have problems with your kidneys.
• if you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after using AZARGA or other related medicines.

Take special care with AZARGA: Serious skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in association with brinzolamide treatment. Stop using AZARGA 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 AZARGA is not recommended for children and adolescents under 18 years.

Other medicines and AZARGA Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

AZARGA can affect, or be affected by, other medicines you are taking, including other eye drops for the treatment of glaucoma. Tell your doctor if you are taking or intent to take medicines to lower blood pressure like parasympathomimetics and guanetidine, or other heart medicines including quinidine (used to treat heart conditions and some types of malaria), amiodarone or other medicines to treat heart rhythm disorders and glycosides to treat heart insufficiency. Also tell your doctor if you are taking or intend to take medicines to treat diabetes, or to treat gastric ulcers, antifungal, antiviral or antibiotic medicines, or antidepressants such as fluoxetine and paroxetine.

If you are taking another carbonic anhydrase inhibitor (acetazolamide or dorzolamide), talk to your doctor. Increase in pupil size when taking Azarga and adrenaline (epinephrine) together has been reported occasionally.

Pregnancy and breast-feeding You should not use AZARGA if you are pregnant or might get pregnant, unless your doctor considers it necessary. Talk to your doctor before you use AZARGA.

Do not use AZARGA if you are breast feeding, timolol may get into your milk. Ask your doctor for advice before taking any medicine during breastfeeding.

Driving and using machines Do not drive or use machines until your vision is clear. You may find that your vision is blurred for some time just after using AZARGA.

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

AZARGA contains benzalkonium chloride

This medicine contains 3.34 g benzalkonium chloride per drop (= 1 dose) which is equivalent to 0.01% or 0.1 mg/ml.

AZARGA 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. If you are changing from another eye drop medicine used to treat glaucoma to AZARGA, you should stop using the other medicine and start using AZARGA the following day. Check with your doctor or pharmacist if you are not sure

To prevent contamination of the dropper tip and the suspension, care must be taken not to touch the eyelids, surrounding areas or other surfaces with the dropper tip. Keep the bottle tightly closed when not in use.

The following measure is useful to limit the amount of medicine that will come into the blood after application of eye drops:

• Keep the eyelid closed, while simultaneously applying gentle pressure to the corner of the eye next to the nose with a finger for at least 2 minutes.

The recommended dose is One drop in the affected eye or eyes, twice a day. Only use AZARGA 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 AZARGA bottle and a mirror.
• Wash your hands.
• Shake well before use.
• Twist off the bottle 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 fingers.
• 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 AZARGA 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 AZARGA, press a finger into the corner of your eye, by the nose for 2 minutes (picture 3). This helps to stop AZARGA getting into the rest of the body.
• If you use drops in both eyes, repeat the steps for your other eye.
• Close the bottle cap 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 drop or eye ointment medicines leave at least 5 minutes between each medicine. Eye ointments should be administered last.

If you use more AZARGA than you should, rinse your eye with warm water. Do not put in any more drops until it is time for your next regular dose.

You may experience a decreased heart rate, decreased blood pressure, heart failure, difficulty breathing and your nervous system may be affected

If you forget to use AZARGA, continue with the next dose as planned. Do not use a double dose to make up for the forgotten dose. Do not use more than one drop in the affected eye(s) twice daily.

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects although not everybody gets them.

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

• severe redness and itching of the eye, 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).

You can usually carry on taking the drops, unless the effects are serious. If you are worried, talk to your doctor or pharmacist. Do not stop using Azarga without speaking to your doctor first.

Common (may affect up to 1 in 10 people)

• Effects in the eye: eye surface inflammation, blurred vision, signs and symptoms of eye irritation (e.g. burning, stinging, itching, tearing, redness), eye pain.
• General side effects: heart rate decreased, taste disturbances.

Uncommon (may affect up to 1 in 100 people)

• Effects in the eye: corneal erosion (damage to the front layer of the eyeball), Eye surface inflammation with surface damage, inflammation inside the eye, corneal staining, abnormal sensation in the eyes, eye discharge, dry eye, tired eyes, itchy eye, eye redness, eyelid redness.
• General side effects: decrease in white blood cell count, decreased blood pressure, cough, blood in urine, body weakness.

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

• Effects in the eye: corneal disorder, sensitivity to light, increased tear production, eyelid crusting
• General side effects: difficulty sleeping (insomnia), throat pain, running nose

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

• Effects in the eye: eye allergy, disturbance of vision, damage to the optic nerve, increased pressure in eye, deposits on the eye surface, decreased eye sensation, inflammation or infection of the conjunctiva (white of the eye), abnormal, double or reduced vision, increased pigmentation of the eye, growth on surface of eye, eye swelling, sensitivity to light, decreased growth or number of eyelashes, drooping of the upper eyelids (making the eye stay half closed), inflammation of the eyelid and eye lid glands, inflammation in the cornea and detachment of the layer below the retina that contains blood vessels following filtration surgery which may cause visual disturbances, decreased corneal sensitivity.
• General side effects: 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).
• Heart and circulation: changes in rhythm or rate of the heartbeat, slow heart rate, palpitations, a type of heart rhythm disorder, abnormal increase in heart rate, chest pain, reduced heart function, heart attack, increased blood pressure, reduced blood supply to the brain, stroke, oedema (fluid build up), congestive heart failure (heart disease with shortness of breath and swelling of the feet and legs due to fluid build up), swelling of the extremities, low blood pressure, discoloration of the fingers, toes, and occasionally other areas of the body (Raynaud s phenomenon), cold hands and feet.
• Respiratory: Constriction of the airways in the lungs (predominantly in patients with pre- existing disease) shortness of breath or difficulty breathing, cold symptoms, chest congestion, sinus infection, sneezing, stuffy nose, dry nose, nose bleeds, asthma, throat irritation.
• Nervous system and general disorders: hallucinations, depression, nightmares, memory loss, headache, nervousness, irritability, tiredness, shaking, feeling abnormal, fainting, dizziness, drowsiness, generalised or severe weakness, unusual sensations like pins and needles.
• Gastric: nausea, vomiting, diarrhoea, intestinal gas or abdominal discomfort, inflammation of the throat, dry or abnormal sensation in mouth, indigestion, stomach ache.
• Blood: abnormal liver function values, increased blood chlorine levels, or decreased red blood cell count as seen in a blood test.
• Allergy: increased allergic symptoms, generalised allergic reactions including swelling beneath the skin that can occur in areas such as the face and limbs and can obstruct the airway which may cause difficulty swallowing or breathing, hives, localised and generalised rash, itchiness, severe sudden life-threatening allergic reaction.
• Ear: ringing in the ears, sensation of spinning or dizziness.
• Skin: rash, skin redness or inflammation, abnormal or decreased skin sensation, hair loss, rash with white silvery coloured appearance (psoriasiform rash) or worsening of psoriasis.
• Muscular: generalised back, joint, or muscle pain not caused by exercise, muscle spasms, pain in extremities, muscle weakness/tiredness, increases in the signs and symptoms of myasthenia gravis (muscle disorder).
• Kidney: kidney pain such as lower back pain, frequent urination.
• Reproduction: sexual dysfunction, decreased libido, male sexual difficulty.
• Metabolism: low blood sugar levels.

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 the carton after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Throw away the bottle 4 weeks after first opening to prevent infections, and use a new bottle. Write down the date of opening on the bottle label and carton label in the space provided.

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 AZARGA contains

• The active substances are brinzolamide and timolol. One ml of suspension contains 10 mg of brinzolamide and 5 mg of timolol (as maleate).
• The other ingredients are benzalkonium chloride (see section 2 AZARGA contains benzalkonium ), carbopol 974P, disodium edetate, mannitol (E421), purified water, sodium chloride, tyloxapol, hydrochloric acid and/or sodium hydroxide. Tiny amounts of hydrochloric acid and/or sodium hydroxide are added to keep acidity levels (pH levels) normal.

What AZARGA looks like and contents of the pack AZARGA is a liquid (white to off-white uniform suspension) supplied in a pack containing one 5 ml plastic bottle with a screw cap or in a pack containing three 5 ml bottles. 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 web site: