AZARGA 10 mg /Ml + 5 Mg/Ml Eye Drops, Suspension

Зміст інструкції

1. AZARGA 10 mg/ml + 5 mg/ml eye drops, suspension
   1. What is AZARGA 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 10 mg/ml + 5 mg/ml eye drops, suspension

brinzolamide/timolol

Read this leaflet carefully before you start using this medicine as it contains important
information for you.

• Keep this leaflet. 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. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of 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

1. What is AZARGA and what it is used for

AZARGA contains two active ingredients, brinzolamide and timolol, which work together to reduce the
pressure inside the eye.
AZARGA is used for the treatment of high pressure in the eyes, also called glaucoma or
ocular hypertension, in patients over the age of 18 years and in whom high pressure in the eyes
cannot be effectively controlled by one medicine alone.

2. What you need to know before you use AZARGA

Do not use AZARGA

• If you are allergic to brinzolamide, to medicines called sulfonamides (for example medicines used for the treatment of diabetes, infections and also diuretics (tablets to promote diuresis), to timolol, beta-blockers (medicines used to lower blood pressure or to treat heart disease) or to any of the other ingredients of this medicine (listed in section 6).
• If you have or have had in the past problems with your airways such as asthma, severe long-lasting obstructive bronchitis (a serious lung disease that can cause wheezing, difficulty breathing and/or long-lasting cough) or other types of breathing problems.
• In case of severe hay fever
• If you have a slowed heartbeat, heart failure or heart rhythm disorders (irregular heartbeat).
• If you have too much acidity in the blood (a condition called hyperchloremic acidosis).
• If you have serious kidney problems.

Warnings and precautions
Put the drops of AZARGA only in your eyes.
If you experience signs of serious or hypersensitivity reactions, stop using this medicine and
inform your doctor.
Talk to your doctor or pharmacist before using AZARGA if you suffer from, or have suffered in the past from

• coronary heart disease (symptoms may include chest pain or tightness, shortness of breath or suffocation), heart failure, low blood pressure.
• changes in heart rate such as slow heartbeat.
• breathing problems, asthma or chronic obstructive lung disease.
• disease with poor circulation (such as Raynaud's disease or Raynaud's syndrome)
• diabetes, as timolol can mask the signs and symptoms of low blood sugar
• hyperactivity of the thyroid gland, as timolol can mask signs and symptoms of a thyroid disease
• muscle weakness (myasthenia gravis)
• before an operation inform your doctor that you are using AZARGA, as timolol can change the effects of some medicines used during anesthesia.
• if you have a history of atopy (a tendency to develop an allergic reaction) and severe allergic reactions, you may be more likely to develop an allergic reaction with the use of AZARGA and adrenaline treatment may not be sufficiently effective for treating the allergic reaction. If you are undergoing any other treatment, inform your doctor or nurse that you are taking 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 or peeling of the skin, blisters and/or ulcers in the mouth 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 treatment with brinzolamide. If you notice any symptoms related to
these serious skin reactions described in section 4, stop treatment with AZARGA and
seek immediate medical attention.

Children and adolescents
AZARGA is not recommended in 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 take any other
medicines.
AZARGA can interact with other medicines that 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 reduce blood pressure, such as parasympathomimetics and guanethidine or other medicines for the
heart including quinidine (used to treat heart problems and some types of malaria), amiodarone or
other medicines to treat heart rhythm disturbances and glycosides for heart failure.
Tell your doctor also if you are taking or intend to take medicines for the treatment of
diabetes, or for the treatment of stomach ulcers or antimycotics, antiviral or antibiotics or
antidepressants such as fluoxetine and paroxetine.
If you are taking another carbonic anhydrase inhibitor (acetazolamide or dorzolamide), tell your
doctor.
An increase in pupil size has been occasionally reported during concomitant use of Azarga and epinephrine (adrenaline).

Pregnancy and breastfeeding
You should not use AZARGA if you are pregnant or possibly becoming pregnant unless your doctor
considers it necessary .Ask your doctor before using AZARGA.
Do not use AZARGA during breastfeeding, timolol can be excreted in breast milk.
Ask your doctor for advice before using any medicine during breastfeeding.

Driving and using machines
Do not drive or use machines until your vision is clear. Your vision may be blurred
for a certain period of time immediately after using AZARGA.
One of the active ingredients can decrease the ability to perform operations that require mental
attention and/or physical coordination. If you experience such a symptom, be careful when driving vehicles or
using machines.

AZARGA contains benzalkonium chloride
This medicine contains 3.34 µg of benzalkonium chloride per drop (= 1 dose) which is equivalent to
0.01% or 0.1 mg/ml.
AZARGA contains a preservative (benzalkonium chloride) that can be absorbed by
soft contact lenses and can lead to a change in their color. Remove your contact lenses before using
this medicine and wait 15 minutes before re-applying them. Benzalconium chloride can also cause
irritation to the eyes especially if you have dry eyes or corneal disorders (the most superficial transparent layer of the eye). If you feel any abnormal sensation in your eye, burning or pain after
using this medicine, talk to your doctor.

3. How to use AZARGA

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
If you are changing the eye drops previously used for the treatment of glaucoma with AZARGA,
you must stop using the other medicine and start using AZARGA the next day. If you have
doubts, consult your doctor or pharmacist.
To prevent contamination of the dropper and the suspension, be careful not to touch the
eyelids, the surrounding area or other surfaces with the dropper. Keep the bottle tightly closed when
not in use.
The following operation is useful to limit the amount of medicine that goes into the blood after
application of the eye drops:

• Keep the eyelid closed and at the same time apply gentle pressure with a finger on the inner corner of the eye near the nose for at least 2 minutes.

The recommended dose is
One drop in the affected eye(s), twice a day.
Use AZARGA in both eyes only if instructed by your doctor. Use the medicine for the
period of time recommended by your doctor.

How to use it

1 2 3

• Take the AZARGA bottle and a mirror.
• Wash your hands.
• Shake well before use.
• Unscrew the cap of the bottle. After removing the cap, if the safety ring has come loose, remove it before using the product.
• Take the bottle, turn it upside down and hold it between your thumb and index finger.
• Tilt your head back. Lower the lower eyelid with a clean finger, so as to form a “pocket” between the eyelid and the eye. The drop should be inserted there (figure 1).
• Hold the tip of the bottle close to the eye. Use the mirror if it can help you.
• Do not touch the eye or eyelid, the surrounding areas or other surfaces with the tip of the bottle. This could infect the eye drops.
• Gently press the base of the bottle to release one drop of AZARGA at a time.
• Do not press the bottle forcefully: it is designed to work with light pressure on the bottom (figure 2).
• After using AZARGA, press your finger on the corner of the eye, near the nose for 2 minutes (figure 3). This helps to prevent AZARGA from spreading throughout the body.
• If you need to put the eye drops in both eyes, repeat the steps for the other eye.
• Screw the cap back on tightly immediately after use.
• Finish the bottle before opening the next one.

If a drop does not enter the eye, try again.
If you are using other eye drops or ointments, allow at least 5 minutes to pass between instillation of
each medicine. Ophthalmic ointments should be administered last.

If you take more AZARGA than you should,immediately wash the eye with lukewarm water. Do not use the eye drops
until the time of the next dose.
You may experience decreased heart rate, decreased blood pressure,
heart failure, difficulty breathing and your nervous system may be affected.

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

If you stop taking AZARGAwithout talking to your doctor, the intraocular
pressure will not be controlled with possible loss of vision.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using AZARGA and contact your doctor immediately if you notice any of the
following symptoms:

• severe redness and itching of the eye, reddish patches that are not raised on the trunk, resembling a target or circular, often with central blisters, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Generally you can continue to use the eye drops, unless the effects experienced are severe. If
you are worried, contact your doctor or pharmacist. Do not stop using AZARGA without first
talking to your doctor.

Common(may affect up to 1 in 10 people)

• Effects on the eye:inflammation of the surface of the eyes, blurred vision, signs and symptoms of eye irritation (for example burning, irritation, itchy sensation, tearing, redness), eye pain.
• General side effects: decreased heart rate, altered taste

Uncommon(may affect up to 1 in 100 people)

• Effects on the eye:erosion of the cornea (damage to the front surface of the eyeball), inflammation of the surface of the eyes with damage to the surface, intraocular inflammation, corneal discoloration, abnormal eye sensitivity, eye discharge, dry eyes, tired eyes, itchy eyes, red eyes, redness of the eyelids.
• General side effects:reduction in the number of white blood cells, decreased blood pressure, cough, blood in the urine, general fatigue.

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

• Effects on the eye:corneal disorders, light sensitivity, increased tearing, crusting on the eyelid
• General side effects: difficulty sleeping (insomnia), sore throat, runny nose

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

• Effects on the eye: eye allergy, visual impairment, optic nerve damage, increased eye pressure, deposits on the eye surface, reduced eye sensitivity, inflammation or infection of the conjunctiva (white of the eye), abnormal vision, double or reduced vision, increased eye pigmentation, new formation on the eye surface, eye swelling, light sensitivity, reduced growth or number of eyelashes, drooping of the upper eyelids (eye remains half-closed), inflammation of the eyelids and eyelid glands, corneal inflammation and detachment of the layer under the retina containing blood vessels following filtering surgery which may cause visual disturbances, reduced corneal sensitivity.
• General side effects: reddish patches that are not raised on the trunk, resembling a target or circular, often with central blisters, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes which may be preceded by fever and flu-like symptoms. These severe skin reactions can be potentially life-threatening (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Heart and circulation: changes in heart rate or rhythm, slowed heart rate, palpitations, a type of heart rhythm disorder, abnormally increased heart rate, chest pain, reduced heart function, heart attack, increased blood pressure, reduced blood supply to the brain, stroke, edema (fluid retention), congestive heart failure (heart disease with shortness of breath and swelling of the feet and legs due to fluid accumulation), swelling of the extremities, low blood pressure, change in the color of the fingers of the hands and feet and occasionally other areas of the body (Raynaud's phenomenon), cold hands and feet.
• Respiratory: constriction of the airways in the lungs (mainly in patients with pre-existing disease), shortness of breath or difficulty breathing, cold symptoms, chest congestion, nasal cavity infection, sneezing, stuffy nose, dry nose, nosebleeds, asthma, throat irritation.
• Nervous system and systemic disorders: hallucinations, depression, nightmares, memory loss, headache, nervousness, irritability, fatigue, tremor, abnormal sensation, fainting, dizziness, drowsiness, general weakness or severe weakness, unusual sensations such as pins and needles.
• Gastric: nausea, vomiting, diarrhea, intestinal gas or abdominal discomfort, throat inflammation, dry or abnormal mouth sensation, indigestion, stomach pain
• Blood: blood tests showing abnormal liver function values, increased levels of chlorine in the blood, decreased red blood cell count
• Allergy: increased allergy symptoms, widespread allergic reactions including swelling under the skin that can occur in areas such as the face and limbs and that can obstruct the airways causing difficulty swallowing or breathing, hives, localized and widespread rash, itching, severe, life-threatening allergic reactions.
• Ear: ringing in the ears, sensation of dizziness or vertigo
• Skin: rash, redness or inflammation of the skin, reduced or abnormal skin sensitivity, hair loss, white-silver appearance rash (psoriasiform rash) or worsening of psoriasis.
• Muscular: generalized back, joint or muscle pain not caused by exercise, muscle spasms, pain in the extremities, muscle weakness/lassitude, increased signs and symptoms of myasthenia gravis (muscle disease).
• Kidneys: kidney pain similar to back pain in the lumbar region, 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, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system detailed in Annex V. By reporting side effects you can help to
provide more information on the safety of this medicine.

5. How to store AZARGA

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 vial and the packaging after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
To prevent infections, discard the vial 4 weeks after first opening and use a new vial.
Write the date of opening in the appropriate space on the label of the vial and the packaging.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What AZARGA contains

• The active ingredients 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 chloride”), carbopol 974P, disodium edetate, mannitol (E421), purified water, sodium chloride, tyloxapol, hydrochloric acid and/or sodium hydroxide. Small amounts of hydrochloric acid and/or sodium hydroxide are added to maintain normal acidity levels (pH levels).

Description of AZARGA and contents of the pack
AZARGA is a liquid (uniform suspension from white to off-white) supplied in a pack
containing a 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
Roonstraße 25
D-90429 Nuremberg
Germany
S.A. Alcon -Couvreur N.V
Rijksweg 14

• B -2870 Puurs Belgium

Siegfried El Masnou, S.A.
Camil Fabra 58
El Masnou
08320 Barcelona
Spain
For further information on this medicinal product, contact the local representative of the
Marketing Authorisation Holder.

België/Belgique/Belgien
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11

Lietuva
SIA Novartis Baltics Lietuvos filialas
Tel: +370 5 269 16 50

България
Novartis Bulgaria EOOD
Тел.: +359 2 489 98 28

Luxembourg/Luxemburg
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11

Česká republika
Novartis s.r.o.
Tel: +420 225 775 111

Magyarország
Novartis Hungária Kft.
Tel.: +36 1 457 65 00

Danmark
Novartis Healthcare A/S
Tlf: +45 39 16 84 00

Malta
Novartis Pharma Services Inc.
Tel: +356 2122 2872

Deutschland
Novartis Pharma GmbH
Tel: +49 911 273 0

Nederland
Novartis Pharma B.V.
Tel: +31 88 04 52 111

Eesti
SIA Novartis Baltics Eesti filiaal
Tel: +372 66 30 810

Norge
Novartis Norge AS
Tlf: +47 23 05 20 00

Ελλάδα
Novartis (Hellas) A.E.B.E.
Τηλ: +30 210 281 17 12

Österreich
Novartis Pharma GmbH
Tel: +43 1 86 6570

España
Novartis Farmacéutica, S.A.
Tel: +34 93 306 42 00

Polska
Novartis Poland Sp. z o.o.
Tel.: +48 22 375 4888

France
Novartis Pharma S.A.S.
Tél: +33 1 55 47 66 00

Portugal
Novartis Farma - Produtos Farmacêuticos, S.A.
Tel: +351 21 000 8600

Hrvatska
Novartis Hrvatska d.o.o.
Tel. +385 1 6274 220

România
Novartis Pharma Services Romania SRL
Tel: +40 21 31299 01

Ireland
Novartis Ireland Limited
Tel: +353 1 260 12 55

Slovenija
Novartis Pharma Services Inc.
Tel: +386 1 300 75 50

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Novartis Slovakia s.r.o.
Tel: + 421 2 5542 5439

Italia
Novartis Farma S.p.A.
Tel: +39 02 96 54 1

Suomi/Finland
Novartis Finland Oy
Puh/Tel: +358 (0)10 6133 200

Κύπρος
Novartis Pharma Services Inc.
Τηλ: +357 22 690 690

Sverige
Novartis Sverige AB
Tel: +46 8 732 32 00

United Kingdom (Northern Ireland)
Novartis Ireland Limited
Tel: +44 1276 698370

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, http://www.ema.europa.eu

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070