Azarga
brinzolamide, timolol
brinzolamide/timolol
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them even if their signs of illnesses are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What AZARGA is and what it is used for
What you need to know before you use AZARGA
How to use AZARGA
Possible side effects
How to store AZARGA
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.
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.
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.
AZARGA is not recommended for children and adolescents under 18 years.
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.
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.
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.
This medicine contains 3.34 µg 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.
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.
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.
You may experience a decreased heart rate, decreased blood pressure, heart failure, difficulty breathing and your nervous system may be affected
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.
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.
sensation in the eyes, eye discharge, dry eye, tired eyes, itchy eye, eye redness, eyelid redness.
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.
sinus infection, sneezing, stuffy nose, dry nose, nose bleeds, asthma, throat irritation.
drowsiness, generalised or severe weakness, unusual sensations like pins and needles.
may cause difficulty swallowing or breathing, hives, localised and generalised rash, itchiness,
severe sudden life-threatening allergic reaction.
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.
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.
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.
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road Dublin 4
Ireland
D-90429 Nuremberg Germany
S.A. Alcon-Couvreur N.V. Rijksweg 14
B-2870 Puurs Belgium
Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764 08013 Barcelona
Spain
Siegfried El Masnou, S.A. Camil Fabra 58
El Masnou 08320 Barcelona Spain
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
SIA Novartis Baltics Lietuvos filialas Tel: +370 5 269 16 50
Novartis Bulgaria EOOD Тел.: +359 2 489 98 28
Novartis s.r.o.
Tel: +420 225 775 111
Novartis Healthcare A/S Tlf: +45 39 16 84 00
Novartis Pharma Services Inc. Tel: +356 2122 2872
Novartis Pharma GmbH Tel: +49 911 273 0
Novartis Pharma B.V. Tel: +31 88 04 52 111
SIA Novartis Baltics Eesti filiaal Tel: +372 66 30 810
Novartis Norge AS Tlf: +47 23 05 20 00
Novartis (Hellas) A.E.B.E. Τηλ: +30 210 281 17 12
Novartis Pharma GmbH Tel: +43 1 86 6570
Novartis Farmacéutica, S.A. Tel: +34 93 306 42 00
Novartis Poland Sp. z o.o. Tel.: +48 22 375 4888
Novartis Pharma S.A.S.
Tél: +33 1 55 47 66 00
Novartis Farma - Produtos Farmacêuticos, S.A.
Tel: +351 21 000 8600
Novartis Hrvatska d.o.o. Tel. +385 1 6274 220
Novartis Pharma Services Romania SRL Tel: +40 21 31299 01
Novartis Ireland Limited
Tel: +353 1 260 12 55
Novartis Pharma Services Inc.
Tel: +386 1 300 75 50
Vistor hf.
Sími: +354 535 7000
Novartis Farma S.p.A. Tel: +39 02 96 54 1
Novartis Finland Oy
Puh/Tel: +358 (0)10 6133 200
Novartis Pharma Services Inc. Τηλ: +357 22 690 690
Novartis Sverige AB Tel: +46 8 732 32 00
SIA Novartis Baltics Tel: +371 67 887 070
Novartis Ireland Limited Tel: +44 1276 698370