Azarga 10 mg/ml + 5 mg/ml eye drops in suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

brinzolamide/timolol

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as 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 you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What AZARGA is and what it is used for

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

AZARGA is used to treat elevated eye pressure, also called glaucoma or ocular hypertension, in adult patients over 18 years of age and in those in whom elevated eye pressure cannot be effectively controlled with a single medication.

2. What you need to know before using AZARGA

Do not use AZARGA

• • If you are allergic to brinzolamide, sulfonamide medicines (including, for example, medicines used to treat diabetes and infections, as well as diuretics (water tablets), timolol, beta-blockers (medicines used to lower blood pressure or to treat heart conditions), or to any of the other ingredients of this medicine (listed in section 6).
• If you currently have or have previously had breathing problems such as asthma, severe chronic obstructive bronchitis (a serious lung condition that may cause wheezing, difficulty breathing and/or persistent cough) or other types of respiratory disorders.
• If you have severe hay fever.
• If you have a slow heart rate, heart failure, or heart rhythm disorders (irregular heartbeats).
• If you have too much acid in your blood (a condition called hyperchloremic acidosis).
• If you have severe kidney problems.

Warnings and precautions

Use AZARGA only in your eye(s).

If you experience signs of hypersensitivity or serious reactions, stop using this medicine and consult your doctor.

Talk to your doctor or pharmacist before using AZARGA if you have or have previously had:

• coronary heart disease (symptoms may include chest tightness or pain, shortness of breath or suffocation), heart failure, low blood pressure,
• heart rhythm disorders such as slow heartbeat.
• respiratory problems, asthma or chronic obstructive pulmonary disease (COPD)
• disease 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
• overactive thyroid gland (hyperthyroidism), as timolol may mask 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 alter the effects of certain medicines used during anesthesia.
• if you have a history of atopy (a tendency to develop allergic reactions) or severe allergic reactions, you may be more sensitive to allergic reactions while using AZARGA, and adrenaline may be less effective in treating an allergic reaction. When receiving any other treatment, inform the doctor or nurse that you are using AZARGA.
• if you have liver problems.
• if you have dry eyes or corneal problems.
• if you have kidney problems.
• if you have ever developed a severe skin rash, skin peeling, blisters and/or mouth sores after using AZARGA or other related medicines.

Take special care 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 immediate medical attention if you notice any 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 of age.

Other medicines and AZARGA

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

AZARGA may affect, or may be affected by, other medicines you are taking, including other eye drops used to treat glaucoma. Consult your doctor if you are taking or planning to take medicines to lower blood pressure such as parasympathomimetics and guanethidine, 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 used to treat heart failure. Also consult your doctor if you are taking or planning to take medicines for diabetes or stomach ulcers, antifungal, antiviral or antibiotic medicines, or antidepressants such as fluoxetine and paroxetine.

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

Occasionally, an increase in pupil size has been reported when Azarga is used together with adrenaline (epinephrine).

Pregnancy and breastfeeding

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

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

Consult your doctor before using any medicine during breastfeeding.

Driving and using machines

Do not drive or operate machinery until your vision is clear. Immediately after applying AZARGA, you may notice blurred vision for a period of time.

One of the active ingredients 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.

AZARGA contains benzalkonium chloride

This medicine 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 can be absorbed by soft contact lenses and may change their color. 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 (the transparent layer at the front of the eye). Consult your doctor if you experience a foreign body sensation, stinging, or eye pain after using this medicine.

3. How to use AZARGA

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

If AZARGA is replacing a previously used eye drop for the treatment of glaucoma, stop using the previous medicine and start using AZARGA the following day. If in doubt, consult your doctor or pharmacist.

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

The following instruction is useful for reducing the amount of medicine that passes into the bloodstream after applying the eye drops:

• Keep the eyelid closed while pressing with a finger on the inner corner of the eye near the nose for at least 2 minutes.

Recommended dose

One drop in the affected eye(s) twice daily.

Apply AZARGA to both eyes only if your doctor has specifically instructed you to do so. Continue treatment for the entire duration prescribed by your doctor.

How to use

• Take the AZARGA bottle and position yourself in front of a mirror.

• Wash your hands.

• Shake well before use.

• Unscrew the cap. After removing the cap, remove the safety seal ring if it is loose before using this medicine.

• Hold the bottle upside down between your thumb and little finger.

• Tilt your head backward. Gently pull down the eyelid to form a pouch, into which the drop should fall (Figure 1).

• Bring the tip of the bottle close to the eye. You may use the mirror to assist.

• Do not touch the eye, eyelid, surrounding areas, or any other surfaces with the dropper, as the drops could become contaminated.

• Gently press the base of the bottle so that one drop of AZARGA 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 AZARGA, press with your finger on the corner of the eye near the nose for 2 minutes (Figure 3). This helps prevent AZARGA from passing into the rest of the body.

• If drops are being applied to both eyes, repeat all the previous steps for the other eye.

• Close the bottle tightly immediately after using the product.

• Use one bottle completely before opening the next.

If a drop misses the eye, try again.

If you are using another eye drop or ointment, wait at least 5 minutes between applying each medication. Ophthalmic ointments should be administered last.

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

You may experience a slow heart rate, low blood pressure, heart failure, difficulty breathing, and effects on the nervous system.

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

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

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

4. Possible adverse effects

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

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

• severe redness and itching in the eye, flat red spots on the trunk, often with central blisters, target-shaped or circular rashes, 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).

Unless the effects are serious, continue treatment as usual. If you are concerned about these effects, consult your doctor or pharmacist. Do not stop using Azarga without first consulting your doctor.

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• Eye effects: corneal erosion (damage to the front layer of the eyeball), inflammation of the surface of the eye with surface damage, intraocular inflammation, corneal spots, abnormal sensation in the eyes, eye discharge, dry eye, eye fatigue, eye itching, red eye, eyelid redness.
• Other adverse effects: decreased white blood cell count, low blood pressure, cough, presence of blood in urine, body weakness.

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

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

Frequency not known (cannot be estimated from available data)

• Eye effects: ocular allergy, vision disturbances, optic nerve damage, increased intraocular pressure, deposits on the eye surface, decreased perception of stimuli in the eye, inflammation or infection of the conjunctiva (white part of the eye), abnormal vision including double or reduced vision, increased pigmentation of the eye, lump on the eye surface, eye swelling, light sensitivity, decreased growth or number of eyelashes, drooping of the upper eyelids (causing the eye to be partially closed), eyelid inflammation and inflammation of eyelid glands, corneal inflammation, and detachment of the layer beneath the retina containing blood vessels, which may cause vision disturbances after filtration surgery; decreased corneal sensitivity, corneal erosion.
• Heart and circulation: changes in heart rhythm or heartbeat frequency, slow heart rate, palpitations, type of cardiac arrhythmia, abnormally increased heart rate, chest pain, reduced cardiac function, heart attack, increased blood pressure, reduced blood flow to the brain, stroke, edema (fluid accumulation), congestive heart failure (heart disease causing breathing difficulties and swelling of feet and legs due to fluid accumulation), swelling of extremities, low blood pressure, discoloration of fingers and toes, and occasionally other body parts (Raynaud's phenomenon), coldness in hands and feet.
• Respiratory: narrowing 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 (sinusitis), sneezing, nasal congestion, dry nose, nosebleeds, asthma, throat irritation.
• Nervous system and general disorders: hallucinations, depression, nightmares, memory loss, headache, nervousness, irritability, fatigue, tremor, abnormal sensation, syncope, dizziness, somnolence, 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 chloride levels, or decreased red blood cell count in blood tests.
• Allergy: worsening of allergy symptoms, generalized allergic reactions including swelling under the skin that may occur in areas such as the face and extremities and may obstruct airways, causing difficulty swallowing or breathing, urticaria, localized or generalized rash, itching, sudden and severe life-threatening allergic reaction.
• Ear: tinnitus, sensation of dizziness or vertigo.
• Skin: rash, redness or inflammation of the skin, abnormal or decreased skin sensation, hair loss, silvery-white rash (psoriasiform rash) or worsening of psoriasis.
• Musculoskeletal: muscle pain not caused by exercise, joint, back or generalized pain, muscle spasms, limb pain, muscle weakness/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 adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of AZARGA

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 the 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 contamination, discard the bottle 4 weeks after first opening. Write the date of opening in the space provided on the label of the bottle and on the carton.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of AZARGA

• 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 components are benzalkonium 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.

Very small amounts of hydrochloric acid and/or sodium hydroxide are added to maintain normal acidity levels (pH levels).

Nature of the product and pack contents

AZARGA is a liquid (a uniform suspension ranging from white to off-white) supplied in a carton containing one 5 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 Authorization 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

For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Other sources of information

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