10 mg / ml + 5 mg / ml eye drops , suspension 
Brinzolamide / Timolol

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In 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 packaging and other information 

1. What Azarga is and what it is used for

Azarga contains two ingredients, brinzolamide and timolol, which together lower the pressure in the eye.

Azarga is used to treat high pressure in the eyes, also called glaucoma or ocular hypertension, in adult patients over the age of 18 and in whom it is not possible to effectively control the high pressure in the eyes with just one drug.

2. What you need to know before using Azarga

Do not use Azarga

  • if you are allergic to brinzolamide, medicines called sulfonamides (for example medicines used to treat diabetes, infections, and also diuretics ), timolol, beta-blockers (medicines used to lower blood pressure or to treat heart disease), or any other ingredient of this medicinal product (listed in section 6).
  • if you currently have or have ever had lung diseases such as asthma, severe long-term obstructive bronchitis (severe lung disease that may cause wheezing, difficulty breathing, and/or persistent cough), or other types of breathing problems.
  • if you have severe hay fever.
  • if you have a low heart rate, heart failure, or diseases that affect the heart rhythm (irregular heartbeat).
  • if you have too acidic blood (a condition called hyperchloraemic acidosis )
  • if you have severe kidney problems.

Warnings and cautions

Use Azarga only as eye drops.

If there are any signs of a bad reaction or hypersensitivity reaction, stop using the medicine and talk to your doctor.

Tell your doctor before using Azarga if you have or have had

  • coronary heart disease (symptoms may include pain or tightness in the chest, shortness of breath, or suffocation), heart failure , low blood pressure
  • heart rate disorders such as slow heartbeat
  • respiratory problems, asthma, or chronic obstructive pulmonary disease
  • disease with impaired blood circulation (eg Raynaud’s disease or Raynaud’s syndrome)
  • diabetes because timolol can mask the signs and symptoms of low blood sugar
  • overactive thyroid gland because timolol can obscure signs and symptoms of thyroid disease
  • muscle weakness ( myasthenia gravis )
  • Tell your doctor before surgery that you are using Azarga as timolol may alter the effects of certain medicines during anesthesia.
  • If you have had atopy (a tendency to have an allergic reaction ) and severe allergic reactions, you may be more susceptible to having an allergic reaction while using Azarga, and treatment with adrenaline may not be as effective in treating an allergic reaction. . Therefore, tell your doctor or nurse that you are using Azarga when you receive any other treatment.
  • if you have liver problems.
  • if you have dry eyes or corneal problems.
  • if you have kidney problems.

Children and young people

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 take any other medicines.

AZARGA can affect or be affected by other medicines you are using, including other eye drops for the treatment of glaucoma ( glaucoma ). Tell your doctor if you are taking or plan to take medicines to lower your blood pressure, such as parasympathomimetics and guanethidine, or other heart medicines that contain quinidine (used to treat heart conditions and certain types of malaria ), amiodarone, or other medicines to treat heart rhythm disorders and glycosides to treat heart failure. Also tell your doctor if you are taking or plan to use medicines to treat diabetes or stomach ulcers, antifungals, antivirals or antibiotics or antidepressants such as fluoxetine and paroxetine.

If you are taking another carbohydrate inhibitor (acetazolamide or dorzolamide), talk to your doctor. Increases in pupil size during concomitant use of Azarga and adrenaline ( epinephrine ) have been reported sporadically.

Pregnancy and breastfeeding

You should not use Azarga if you are pregnant or might become pregnant unless your doctor considers it necessary. Talk to your doctor before using Azarga.

Do not use Azarga if you are breast-feeding, timolol may pass into breast milk.

Consult a doctor before taking any medicine while breast-feeding.

Driving and using machines

Do not drive or use any tools or machines until the vision is clear. You may find that your vision becomes foggy for a while just after using Azarga.

One of the active substances may affect the ability of elderly patients to perform tasks that require mental alertness and/or physical coordination. If you are affected, you should be careful when driving or using machines.

Azarga contains benzalkonium chloride

There is a preservative in Azarga (benzalkonium chloride), which can discolor soft contact lenses and cause eye irritation. Therefore, do not wear contact lenses when using Azarga. Wait 15 minutes after using Azarga before reinserting the lenses.

How to use Azarga

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

If you switch from other eye drops used to treat glaucoma and switch to Azarga, stop taking the other medicine and start using Azarga the next day. If you are not sure, ask your doctor or pharmacist.

To prevent the tip and suspension of the dropper from contaminating, make sure that you do not touch the eyelids, surrounding areas, or other surfaces with the tip of the dropper. Keep the bottle tightly closed when not in use.

The following measures are helpful in limiting the amount of drug that enters the bloodstream after the application of eye drops:

  • Close your eyes while gently pressing the inner corner of your eye with your finger for at least 2 minutes.

The recommended dose is

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

Only use Azarga in both eyes if your doctor prescribes it. Use Azarga for as long as your doctor prescribes it.

To use the eye drops:

Administration
  • Get the bottle and a mirror.
  • Wash your hands.
  • Shake the bottle carefully before use.
  • Unscrew the cap on the bottle. If the safety collar is loose after removing the hat, remove the collar before using the product.
  • Hold the bottle upside down between your thumb and fingers.
  • Tilt your head back. Pull the eyelid down with a clean finger, so that a pocket is formed between the eyelid and the eye. The drop should end up in the pocket (figure 1).
  • Move the tip of the bottle close to the eye. Use the mirror if it facilitates.
  • Do not touch the eye or eyelid, surrounding areas, or other surfaces with the bottle tip. This can contaminate the drops.
  • Gently press the bottom of the bottle with your index finger to release one drop of Azarga at a time.
  • Do not squeeze the bottle; it is designed so that a light pressure at the bottom is sufficient (figure 2).
  • After using Azarga, you should press lightly with a finger in the corner of your eye at the nose for 2 minutes (see Figure 3). This prevents Azarga from entering the rest of the body.
  • If you use drops in both eyes, repeat the procedure in the other eye.
  • Screw the cap onto the bottle firmly immediately after use.
  • Use one bottle before opening the next.

If the drop misses the eye, try again.

If you use other eye drops or ointments, wait at least 5 minutes between each medicine. Eye ointments should be used last.

If you use more Azarga than you should, rinse your eyes with lukewarm water. Do not drip in more drops until it is time for your next dose.

You may have a slower heart rate, lower blood pressure, heart failure, difficulty breathing, and the nervous system may be affected.

If you forget to use Azarga , continue with the next dose as usual. Do not take a double dose to make up for a forgotten dose. Do not use more than one drop in the affected eye (s) twice daily.

If you stop using Azarga without talking to your doctor, the pressure in your eye will not be checked, which could lead to vision loss.

If you have any further questions on the use of this product, 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 this medicine and contact your doctor immediately if you get a rash, a severe skin reaction, or severe redness and itching in the eye. This may be a sign of an allergic reaction (frequency is unknown).

You can usually continue to use the drops unless the side effects are severe. If you are worried, talk to your doctor or pharmacist. Do not stop using Azarga without talking to your doctor first.

Common side effects are

(may affect up to 1 in 10 users)

  • Effects in the eye: Inflammation of the surface of the eye, blurred vision, signs, and symptoms of eye irritation (eg burning sensation, tingling, itching, tearing, redness ), eye pain.
  • General side effects: Slower heart rate, taste changes.

Uncommon side effects are

(may affect up to 1 in 100 people)

  • Effects in the eye: Erosion of the cornea (damage to the anterior layer of the eyeball), inflammation of the surface of the eye with surface damage, inflammation inside the eye, staining of the cornea, abnormal sensation in the eyes, discharge from the eye, dry eyes, tired eyes, itchy eyes, red eyes, eyelid redness. 
  • General side effects: Decreased white blood cell count, decreased blood pressure, cough, blood in the urine, weakness in the body.

Rare side effects are may affect up to 1 in 1000 users)

  • Effects in the eye: corneal problems, photosensitivity, increased tear production, crusting on the eyelid
  • Common side effects:  difficulty sleeping, sore throat, runny nose

Has been reported ( occurs in the unknown number of users ) : 

  • Effects in the eye: Eye allergy, visual disturbance, damage to the optic nerve, increased pressure in the eye, deposits on the surface of the eye, decreased sensitivity in the eye, inflammation or infection in the conjunctiva (whites of the eyes), abnormal, double or impaired vision, increased pigmentation in the eye, growth on the surface of the eye, swollen eyes, photosensitivity, decreased growth of eyelashes or decreased number of eyelashes , drooping upper eyelids (keeps the eye half-closed), inflammation of the eyelids and eyelid glands, inflammation the cornea and loosening of the layer under the retina that contains blood vessels after filtration surgery, which can cause visual disturbances, decreased sensitivity of the cornea.
  • Heart and blood circulation: Altered rhythm or rate of the heartbeat, slow heart rate, palpitations, a type of heart rhythm, abnormal increase of pulse a, chest pain, cardiac dysfunction, myocardial infarction, increased blood pressure, decreased blood supply to the brain, stroke, edema (fluid retention), chronic heart failure (heart disease with shortness of breath and swelling of the feet and legs due to fluid retention), swollen extremities, low blood pressure, discoloration of fingers, toes and sometimes other parts of the body (Raynaud’s phenomenon), cold hands and feet.
  • Lungs / Respiratory tract: Contraction of the airways in the lungs (especially in patients with pre-existing disease), shortness of breath or shortness of breath, cold symptoms, chest tightness, sinusitis, sneezing, nasal congestion, dry nose, nosebleeds, asthma, irritation of the throat.
  • Nervous system and general disorders: Hallucinations, depression, nightmares, memory loss, headache, nervousness, irritation, fatigue, tremors, abnormal sensation, fainting, dizziness, drowsiness, general or severe weakness, unusual sensations such as. tingling in the skin.
  • Gastrointestinal disorders: Nausea, vomiting, diarrhea, flatulence, or uncomfortable feeling in the abdomen, sore throat, dry or abnormal sensation in the mouth, stomach upset, stomach pain.
  • Blood: Abnormal liver function values, increased levels of chlorine in the blood, or decreased number of red blood cells during blood tests.
  • Allergy: Increased allergic symptoms, generalized allergic reactions, including swelling under the skin that may occur in places such as. face arms and legs and may obstruct the airways which may cause difficulty in swallowing or breathing, hives, limited and generalized rash, itching, severe, sudden life-threatening allergic reaction.
  • Ears: Ringing in the ears, feeling of rotation or dizziness
  • Skin: Rash, redness or inflammation, abnormal or diminished sensation in the skin, hair loss, rash with white silvery appearance (psoriasis-like rash), or worsening of psoriasis.
  • Muscles: General back, joint, or muscle pain not caused by exercise, muscle cramps, pain in the extremities, muscle weakness/muscle fatigue, increased signs and symptoms of myasthenia gravis (muscle disorder).
  • Kidneys: Kidney pain such as back pain, frequent urination.
  • Reproduction: Sexual dysfunction, decreased libido, sexual difficulties in men.
  • Metabolism: Low blood sugar levels.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

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 bottle and carton after EXP. The expiration date is the last day of the specified month.

No special storage instructions.

You must discard the bottle 4 weeks after opening it, to prevent infection, and use a new bottle. Write down the date when you opened it on the intended space on the bottle and carton.

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

6. Contents of the packaging and other information

Content declaration

  • The active substances are brinzolamide and timolol. One milliliter suspension contains 10 mg brinzolamide and 5 mg 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 keep the acidity ( pH ) normal.

What the medicine looks like and the contents of the pack

Azarga is a liquid (white to off-white even suspension ), which is 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 Authorization Holder and Manufacturer

Marketing Authorisation Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer

SA Alcon-Couvreur NV

Rijksweg 14

2870 Puurs

Belgium

or

Alcon Cusí SA

Camil Fabra 58

08320 El Masnou,

Barcelona

Spain

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgium / Belgique / BelgienNovartis Pharma NVTel: +32 2 246 16 11 LithuaniaSIA Novartis Baltics Lithuanian branchesTel: +370 5 269 16 50
BulgariaNovartis Bulgaria EOODTel .: +359 2 489 98 28 Luxembourg / LuxemburgNovartis Pharma NVTel: +32 2 246 16 11
Czech RepublicNovartis sroTel: +420 225 775 111 HungaryNovartis Hungary Kft.Tel .: +36 1 457 65 00
DenmarkNovartis Healthcare A / STel: +45 39 16 84 00 MaltaNovartis Pharma Services Inc.Tel: +356 2122 2872
GermanyNovartis Pharma GmbHTel: +49 911 273 0 The NetherlandsNovartis Pharma BVTel: +31 88 04 52 111
EestiSIA Novartis Baltics Eesti subsidiaryTel: +372 66 30 810 NorwayNovartis Norge ASTel: +47 23 05 20 00
GreeceNovartis (Hellas) AEBE:Ηλ: +30 210 281 17 12 AustriaNovartis Pharma GmbHTel: +43 1 86 6570
SpainNovartis Pharmacéutica, SATel: +34 93 306 42 00 PolandNovartis Poland Sp. z ooTel .: +48 22 375 4888
FranceNovartis Pharma SASTel: +33 1 55 47 66 00 PortugalNovartis Farma – Pharmaceutical Products, SATel: +351 21 000 8600
CroatiaNovartis Hrvatska dooTel. +385 1 6274 220 RomaniaNovartis Pharma Services Romania SRLTel: +40 21 31299 01
IrelandNovartis Ireland LimitedTel: +353 1 260 12 55 SloveniaNovartis Pharma Services Inc.Tel: +386 1 300 75 50
IcelandVistor hf.Phone: +354 535 7000 Slovak RepublicNovartis Slovakia sroTel: + 421 2 5542 5439
ItalyNovartis Farma SpATel: +39 02 96 54 1 Finland / FinlandNovartis Finland OyPuh / Tel: +358 (0) 10 6133 200
ΚύπροςNovartis Pharma Services Inc.:Ηλ: +357 22 690 690
LatviaSIA Novartis BalticsTel: +371 67 887 070 United KingdomNovartis Pharmaceuticals UK Ltd.Tel: +44 1276 698370

Muhammad Nadeem

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