Label: information for the user

AZARGA 10mg/ml+5mg/ml eye drop suspension

brinzolamida/timolol

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 do not appear in this label. See section 4.

1.What is AZARGA and for what it is used

2.What you need to knowbefore starting to use AZARGA

3.How to use AZARGA

4.Possible adverse effects

5.Storage of AZARGA

6.Contents of the package andadditional information

AZARGA contains two active ingredients, brinzolamida and timolol, which work together to reduce pressure inside the eye.

AZARGA is used to treat high eye pressure, also known as glaucoma or ocular hypertension, in adult patients aged 18 years and older, and in those whose high eye pressure cannot be effectively controlled with a single medication.

Do not use AZARGA

• If you are allergic to brinzolamide, medications called sulfonamides (including examples of medications used to treat diabetes and infections, also diuretics (tablets to urinate), timolol, beta-blockers (medications used to lower blood pressure or to treat heart diseases), or to any of the other components of this medication (included in section 6).
• If you currently suffer or have suffered in the past from respiratory problems such as asthma, chronic obstructive pulmonary disease (a serious lung condition that can cause wheezing, difficulty breathing, and/or persistent cough), or other types of respiratory problems.
• If you suffer from severe hay fever.
• If you suffer from a slow heart rate, heart failure, or heart rhythm disorders (irregular heartbeats).
• If you have excessive acid in your blood (a disease called hyperchloremic acidosis).
• If you suffer from severe kidney problems.
  

Warnings and precautions

Only use AZARGA in your eye(s).

If you have signs of hypersensitivity or severe reactions, stop using this medication and consult your doctor.

Consult your doctor or pharmacist before starting to use AZARGA if you suffer or have suffered in the past from:

• coronary heart disease (symptoms may include chest tightness or pain, shortness of breath, or feeling of choking), heart failure, low blood pressure,

• heart rhythm disorders such as slow heart rate.
• respiratory problems, asthma, or chronic obstructive pulmonary disease
• diseases due to poor blood circulation (such as Raynaud's disease or Raynaud's syndrome)
• diabetes as timolol may mask the signs and symptoms of low blood sugar
• hyperthyroidism as timolol may mask the signs and symptoms of thyroid disease
• muscle weakness (myasthenia gravis)
• if you are about to undergo surgery, inform your doctor that you are using AZARGA as timolol may change the effects of some medications used during anesthesia.

• If you have a history of atopy (tendency to develop an allergic reaction) and severe allergic reactions, you may be more sensitive to experiencing an allergic reaction while using AZARGA, and adrenaline may not be as effective in treating an allergic reaction. When receiving any other treatment, inform your doctor or nurse that you are using AZARGA.
• If you have liver problems.
• If you have dry eyes or corneal problems.
• If you have severe kidney problems.
• If you have ever developed a severe skin rash or skin peeling, blisters, and/or mouth sores after using AZARGA or other related medications.

Be especially careful with AZARGA:

Severe 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 severe skin reactions described in section 4.

Children and adolescents

AZARGA is not recommended for children and adolescents under 18 years old.

Other medications and AZARGA

Inform your doctor or pharmacist if you are using, have used, recently used, or may need to use any other medication.

AZARGA may affect, or may be affected by, other medications you are using, including other eye drops for glaucoma treatment. Consult your doctor if you are using or think you will use medications to lower blood pressure such as cholinergic agonists and guanethidine, or other heart medications including quinidine (used to treat heart conditions and some types of malaria), amiodarone, or other medications to treat heart rhythm disorders and cardiac glycosides to treat heart failure. Consult your doctor also if you are using or think you will use medications to treat diabetes or to treat stomach ulcers, antifungal, antiviral, or antibacterial medications, or antidepressants such as fluoxetine and paroxetine.

Consult your doctor if you are using another carbonic anhydrase inhibitor (acetazolamide or dorzolamide).

There have been occasional reports of increased pupil size when using Azarga with adrenaline (epinephrine).

Pregnancy and lactation

If you are pregnant, think you may be pregnant, or intend to become pregnant, do not use AZARGA unless your doctor considers it necessary. Consult your doctor before using AZARGA.

Do not use AZARGA during lactation, timolol may pass into breast milk.

Consult your doctor before using any medication during lactation.

Driving and operating machinery

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

One of the active components may worsen the ability to perform tasks that require mental sharpness and/or physical coordination. If you notice these effects, be careful when driving or operating machinery.

AZARGA contains benzalkonium chloride

This medication contains 3.34 µg of benzalkonium chloride per drop (= 1 dose), equivalent to 0.01% or 0.1 mg/ml.

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

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

If AZARGA replaces a previously used eye drop for glaucoma treatment, stop using the previous medication and start using AZARGA the next day. In case of doubt, consult your doctor or pharmacist.

To avoid possible contamination of the dropper tip and the suspension, be careful not to touch the eyelids, around them, or other surfaces with the dropper. Keep the bottle tightly closed when not in use.

The following instruction is useful to reduce the amount of medication that passes into the bloodstream after applying the eye drop:

-Keep the eyelid closed while pressing with your finger the edge of the eye near the nose for at least 2 minutes.

The recommended dose is

Onedrop in the affected eye(s), twice a day.

AZARGA should only be applied in both eyes if your doctor recommends it. Follow the treatment for the entire period of time indicated by your doctor.

How to use

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• Take the AZARGA bottle and stand in front of a mirror.
• Wash your hands.

• Shake well before use.
• Remove the cap.After removing the cap, remove the safety 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 the eyelid from the eye with a finger, until a pouch forms, where the drop should fall (Figure1).
• Bring the dropper tip close to the eye. You can help yourself with the mirror.
• Do not touch the eye, eyelid, nearby areas, or other surfaces with the dropper, as the drops may become contaminated.
• Press gently on the bottle base to allow one drop of AZARGA to fall each time.
• Do not squeeze the bottle: it is designed to allow a gentle pressure on the base to be sufficient (Figure2).
• After using AZARGA, press with your finger the edge of the eye, near the nose for 2minutes (Figure3). This helps to prevent AZARGA from passing into the rest of the body.
• If drops are applied in both eyes, repeat all the previous steps for the other eye.
• Close the bottle tightly immediately after use.
• Use only one bottle before opening the next one.

If a drop falls outside the eye, try again.

If you are using another eye drop or ointment, wait at least 5minutes between the application of each medication. Eye ointments should be applied last.

If you use more AZARGA than you should, you can remove it by washing your eyes with warm water. Do not apply more drops until it is time for the next dose.

You may experience a decrease in heart rate, decrease in blood pressure, heart failure, difficulty breathing, and nervous system effects.

If you forgot to use AZARGA,continue with the next scheduled dose. Do not apply a double dose to compensate for the missed doses. Do not apply more than onedrop twice a day in the affected eye(s).

If you interrupt treatment with AZARGAwithout consulting your doctor, your eye pressure will not be controlled, which may cause vision loss.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

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

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

•severe redness and itching in the eye, non-elevated reddish spots in the shape of a target or circles on the trunk, often with central blisters, skin peeling, mouth, 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).

Unless the effects are severe, continue with the treatment as usual. If these effects concern you, consult your doctor or pharmacist. Do not stop applying Azarga without consulting your doctor first.

Frequent(may affect up to 1in every 10people)

• Eye effects:inflammation of the eye surface, blurred vision, signs and symptoms of eye irritation (e.g., burning, stinging, itching, tearing, redness), eye pain.
• Other adverse effects:decreased heart rate, taste alterations.

Poorly frequent(may affect up to 1 in every 100 people)

• Eye effects:corneal erosion (damage to the anterior layer of the eyeball), inflammation of the eye surface with damaged surface, inflammation within the eye, corneal spots, abnormal sensation in the eyes, eye discharge, dry eye, tired eyes, eye itching, red eye, eyelid redness.
• Other adverse effects:decreased white blood cell count, decreased blood pressure, cough, blood in urine present, general weakness.

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

• Eye effects:corneal disorder, light sensitivity, increased tear production, eyelid crusts.
• Other adverse effects:difficulty sleeping (insomnia), sore throat, runny nose.

Frequency not known (cannot be estimated from available data)

• Eye effects:eye allergy, vision alterations, optic nerve damage, increased eye pressure, deposits on the eye surface, decreased perception of stimuli in the eye, conjunctival inflammation or infection (white part of the eye), abnormal vision, double vision, reduced vision, increased eye pigmentation, bump on the eye surface, eye swelling, light sensitivity, decreased hair growth or number of eyelashes, eyelid drooping (causing the eye to be half-closed), eyelid and eyelid gland inflammation, corneal inflammation and retinal detachment with underlying blood vessels that may cause vision alterations after surgery, decreased corneal sensitivity, corneal erosion.
• Heart and circulation:changes in heart rhythm or rate, slow heart rate, palpitations, type of heart rhythm disorder, abnormal increase in heart rate, chest pain, reduced heart function, heart attack, increased blood pressure, reduced blood flow to the brain, stroke, edema (fluid accumulation), congestive heart failure (heart disease with difficulty breathing and swelling of the feet and legs due to fluid accumulation), limb swelling, decreased blood pressure, discoloration of the fingers and toes and, occasionally, other body parts (Raynaud's phenomenon), cold feet and hands.
• Respiratory:constriction of airways in the lungs (predominantly in patients with pre-existing disease), shortness of breath or difficulty breathing, cold symptoms, chest congestion, sinusitis (nasal sinus infection), sneezing, nasal congestion, dry nose, nasal bleeding, asthma, throat irritation.
• Nervous system and general disorders:hallucinations, depression, nightmares, memory loss, headache, nervousness, irritability, fatigue, tremor, abnormal sensation, fainting, dizziness, drowsiness, generalized or severe weakness, unusual sensations such as tingling.
• Gastrointestinal:nausea, vomiting, diarrhea, gas or abdominal discomfort, throat inflammation, dry or abnormal mouth sensation, indigestion, stomach pain.
• Blood:abnormal liver function test results, increased blood levels of chloride, or decreased red blood cell count in blood tests.
• Allergy:increased allergy symptoms, generalized allergic reactions including skin swelling that may occur in areas such as the face and extremities and may obstruct airways causing difficulty breathing or swallowing, urticaria, localized and generalized rash, itching, sudden and severe life-threatening allergic reaction.
• Ear:tinnitus in the ears, sensation of dizziness or vertigo.
• Skin:eruption, redness, or inflammation of the skin, abnormal or decreased sensation in the skin, hair loss, white plate-like rash (psoriasiform rash) or worsening of psoriasis.
• Muscle:non-exercise-related muscle pain, in joints, back, or generalized, muscle spasms, limb pain, muscle weakness or fatigue, increased signs and symptoms of myasthenia gravis (muscle disorder).
• Kidney:kidney pain presenting as lower back pain, frequent urination.
• Reproduction:sexual dysfunction,decreased libido, male sexual problems.
• Metabolism:low blood sugar levels.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the national notification system included in theAppendix V. By reporting adverse 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, discard the bottle 4weeks after the first opening. Write the opening date in the space provided on the label of the bottle and on the box.

Medicines should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the containers and of the medications that you no longer need. In this way, you will help to protect the environment.

Composition of AZARGA

• The active principlesare brinzolamide and timolol.Aml of suspension contains 10mg of brinzolamide and 5mg of timolol (as maleate).

• The other components arebenzalkonium chloride (see section 2 “AZARGA contains benzalkonium chloride”), carbomer 974P, disodium edetate, mannitol (E421), purified water, sodium chloride, tiloxapol, hydrochloric acid and/or sodium hydroxide.

Small quantities of hydrochloric acid and/or sodium hydroxide are added to maintain normal acidity levels (pH levels).

Appearance of the product and contents of the pack

AZARGA is a liquid (a uniform white to off-white suspension) that is presented in a box containing aplastic bottle of 5ml with a screw cap, or in a box containing threeplastic bottles of 5ml with screw caps.

Only some pack sizes may be marketed.

Marketing authorization holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Responsible person 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,

08320 El Masnou,

Barcelona,

Spain

Novartis Pharma GmbH

Sophie-Germain-Strasse 10

90443 Nürnberg

Germany

Further information on this medicinal product can be obtained by contacting the local representative of the marketing authorization holder:

Last update of the summary of product characteristics:

Other sources of information

The detailed informationon this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu