AZARGA 10 mg/ml + 5 mg/ml eye drops, suspension
What is it and how is it used?

AZARGA is used to treat high pressure in the eye. This pressure can lead to an illness called glaucoma.

AZARGA is a combination of treatments for glaucoma.
It contains two active substances which work together to reduce pressure within the eye.

What do you have to consider before using it?

Do not use AZARGA

◾if you are allergic to any of the ingredients of AZARGA. For a full list of ingredients please see section 6.
◾if you have respiratory problems such as asthma, bronchitis or other types of breathing problems.
◾if you have a slow heart beat, heart failure or disorders of heart rhythm.
◾if you have too much acidity in your blood (a condition called hyperchloraemic acidosis).
◾if you have severe kidney problems.

Take special care with AZARGA

◾if you have angina (chest pains), circulation problems or low blood pressure. AZARGA may make any of these worse. If you are concerned about any changes in these symptoms, tell your doctor as soon as possible.
◾if you get any severe allergic reaction while you are using AZARGA , whatever the cause, adrenaline treatment may not be as effective. So, when receiving any other treatment please tell the health professional that you are taking AZARGA.
◾if you have diabetes. AZARGA can mask the symptoms of low blood sugar (hypoglycaemia) such as shakiness and dizziness, so you need to use it with care.
◾if you have liver problems. Talk to your doctor.
◾if you have dry eyes or cornea problems. Talk to your doctor.
◾AZARGA is not recommended for children under 18 years.

Using 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 intend to take medicines to lower blood pressure, heart medicines, medicines to treat diabetes, medicines to treat gastric ulcers, or antifungal, antiviral or antibiotic medicines.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

You should not use AZARGA if you are pregnant or might get pregnant. Talk to your doctor before you use AZARGA.

If you are breast-feeding, you can use AZARGA.
Ask your doctor 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 AZARGA.

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

Important information about some of the ingredients of AZARGA

There is a preservative in AZARGA (benzalkonium chloride) that can discolour soft lenses and may cause eye irritation. Therefore, do not wear contact lenses whilst using AZARGA. Wait 15 minutes after using AZARGA before putting your lenses back in.

How is it used?

Always use AZARGA exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual dose is

Adults: One drop in the affected eye or eyes, twice a day-morning and night.
Only use AZARGA in both eyes if your doctor told you to. Take it for as long as your doctor told you to.

1 2 3
◾Get the AZARGA bottle and a mirror.
◾Wash your hands.
◾Shake well before use.
◾Twist off the bottle cap.
◾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 (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 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.

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 are using other eye drops, wait at least 5 minutes between using AZARGA and the other drops.

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

What are possible side effects?

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

You can usually carry on taking the drops, unless the effects are serious. If you are worried, talk to your doctor or pharmacist.

The following side effects have been seen with AZARGA:

Common side effects

(affects 1 to 10 users in 100)

Effects in the eye: blurred vision, eye irritation, eye pain, abnormal sensation in eyes

General side effects: bad taste

Uncommon side effects

(affects 1 to 10 users in 1,000)

Effects in the eye: eye surface inflammation with surface damage-inflammation inside the eye-red eye-itchy eye-eyelid itching-redness-swelling, or crusting-eye discharge-eye allergy-dry eye-tired eyes

General side effects: chronic lung disease-decreased blood pressure-throat irritation-cough-difficulty sleeping-skin inflammation-redness or itching-runny nose-hair disorder

Additionally:

AZARGA is a combination of 2 currently marketed medicines.Side effects that have been observed with the individual medicines which may occur with AZARGA are as follows:

Effects in the eye: damage to the optic nerve-increased pressure in eye-deposits on the eye surface-corneal disorder-decreased eye sensation-inflammation or infection of the conjunctiva-abnormal, double or reduced vision-increased pigmentation of the eye-growth on surface of eye-increased tear production-eye swelling-sensitivity to light-decreased growth or number of eyelashes-drooping of the eyelids-inflammation of the eyelid glands

General side effects:

Heart and circulation: changes in heart rate or rhythm-chest pain-reduced heart function-stopping of the heart-increased blood pressure-decreased blood flow to the brain-stroke-swelling of the extremities

Respiratory: shortness of breath or difficulty breathing-cold symptoms-chest congestion-sinus infection-sneezing-stuffy nose-dry nose-nose bleeds-asthma

Nervous system and general disorders: depression-difficulty with memory-headache-nervousness-irritability-tiredness-shaking-feeling abnormal-fainting-dizziness-drowsiness-generalised or severe weakness

Gastric: nausea-vomiting-diarrhoea-intestinal gas or abdominal pain-inflammation of the throat-dry or abnormal sensation in mouth-decreased taste sensation-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

Ear: ringing in the ears-sensation of spinning or dizziness

Skin: itching- rash-abnormal or decreased skin sensation-loss of hair

Muscular: generalised back, joint, or muscle pain-muscle spasms-pain in extremities-muscle weakness

Kidney: kidney pain such as lower back pain-frequent urination

Reproduction: decreased sex drive-male sexual difficulty

Metabolism: low blood sugar

If any of these side effects gets serious or if you notice any side effects not listed, please tell your doctor or pharmacist.

How should it be stored?

Keep outof the reach and sight of children.

Do not use AZARGA 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.

Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer require. These measures will help protect the environment.

Further information

What AZARGA contains

The active substances are brinzolamide and timolol. One ml of suspension contains 10 mg of brinzolamide and 5 mg of timolol.

The other ingredients are benzalkonium chloride, 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 the 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
Alcon Laboratories (UK) Ltd.
Pentagon Park
Boundary Way
Hemel Hempstead
Herts HP2 7UD
United Kingdom

Manufacturer

S.A. Alcon-Couvreur N.V.

Rijksweg 14

B-2870 Puurs

Belgium

or

Alcon Cusí, S.A.,
Camil Fabra 58,

08320 El Masnou,

Barcelona,

Spain

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

Lietuva Alcon Pharmaceuticals Ltd. atstovyb 370 5 2 314 756 BelgiëBelgiqueBelgien LuxembourgLuxemburg SA Alcon-Couvreur NV 32 03 890 27 11 BelgiëBelgiqueBelgien

Magyarország Alcon Hungária Gyógyszerkereskedelmi Kft. 36-1-463-9080 359 2 950 15 65

eská republika Alcon Pharmaceuticals Czech Republic s.r.o. 420 225 377 333 Nederland Alcon Nederland BV 31 0 183 654321

Danmark Alcon Danmark AS 45 3636 3434 Norge Alcon Norge AS 47 23 25 25 50

Deutschland Alcon Pharma GmbH 49 0761 1304-0 Österreich Alcon Ophthalmika GmbH 43 01 596 69 70

Polska Alcon Polska Sp. z o.o. 48 22 820 3450 30 210 68 78 300

Eesti Alcon Eesti 372 6 313 214 Portugal Alcon Portugal Produtos e Equipamentos Oftalmológicos, Lda. 351 214 400 300

España Alcon Cusí, S.A. 34 93 497 7000 România S.C. Alcon Romania S.R.L. 40 21 203 93 24

France Laboratoires Alcon 33 01 47 10 47 10 Slovenija Alcon d.o.o. 386 1 422 5280

Slovenská republika Alcon Pharmaceuticals Ltd oz 421 2 5441 0378 Ireland Malta United Kingdom Alcon Laboratories UK Ltd. 44 0 1442 34 1234 United Kingdom

Ísland Alcon Danmark AS 45 3636 3434 SuomiFinland Alcon Finland Oy 358 207 871 600

ItaliaAlcon Italia S.p.A. 39 02 81803.1Sverige Alcon Sverige AB 46 08 634 40 00 E-post receptionenalconlabs.com

Latvija

Alcon Pharmaceuticals Ltd
+ 371 7 321 121