Download Alcon Azopt 1% Ophthalmic drops, suspension Composition: 1 ml

This leaflet's format was set and its contents inspected and approved by
the Ministry of Health
Patient leaflet in accordance with the Pharmacists’ Regulation (Preparations) – 1986
The preparation shall be sold only with a doctor's prescription
Alcon Azopt 1%
Ophthalmic drops, suspension
Composition: 1 ml contains: 10 mg Brinzolamide
Excipients appear at the end of the leaflet.
Read this leaflet in its entirety before using the medication. This leaflet contains concise information on the
medication. If you have additional questions, ask the physician or pharmacist.
This medication was prescribed for you. Do not share it with others. It may harm them, even if you think their
medical condition is similar.
The medicine’s safety and efficacy in infants, children and adolescents below 18 years of age has not been
established.
1. What is the medication’s indication?
Alcon Azopt 1% ophthalmic drops are used for reducing intraocular pressure in patients with increased
intraocular blood pressure or in open angle glaucoma patients who are unresponsive to beta-blockers or in
patients in whom beta-blockers are contra-indicated or as adjunctive therapy to beta-blockers.
Therapeutic group: Carbonic anhydrase inhibitors – intraocular pressure reducing medications.
2. Before using the medication
Do not use the medication if:
 Do not use if you know of sensitivity to one of the medication’s components.
 You know of an allergy to medications of the sulfonamide family. This family of medications also
includes medications for treating diabetes, infectious diseases and diuretics.
 You suffer from severe renal function problems.
 You suffer from elevated acidosis caused by an increased level of chlorine (hyperchloraemic
acidosis).
Special warning concerning use of the medication
Before treatment with Alcon Azopt 1%, inform the physician if:
 You are taking other medications from the sulfonamide family.
 You have liver or kidney problems.
 You suffer from dry eye or problems in the cornea.
If you are taking, or if you have recently taking other medications including over-the-counter
medications and nutritional supplements, inform the physician or pharmacist. In particular, if you are
taking or intend to take:
 Other medications from the carbonic anhydrase family (such as Acetazolamide or Dorzolamide)
Pregnancy and breastfeeding:
If you are pregnant, planning pregnancy, think you may be pregnant or breastfeeding, consult the physician or
pharmacist before using the medication.
Women who intend to become pregnant should use effective contraceptives during treatment with Alcon
Azopt 1%.
Use of Alcon Azopt 1% is not recommended for pregnant or breastfeeding women.
Do not use Alcon Azopt 1% unless as instructed by the physician only.
Driving and operating machinery
Do not drive or operate dangerous machinery while using the medication since the medication might cause
blurred vision for some time immediately after using Alcon Azopt 1%. You may resume driving and operating
machinery once your vision returns to normal.
Using Alcon Azopt 1% might cause reduced ability to perform tasks requiring alertness and/or physical
coordination. If you are affected, exercise caution when driving and operating machinery.
Important information on some of the medication’s components:
The preparation contains the preservative Benzalkonium chloride that might be absorbed by soft contact lenses
(change their color) and cause eye irritation.
Do not use the preparation when wearing soft contact lenses. Remove the lenses before using the preparation,
and they can be worn again no less than 15 minutes after instilling the medication into the eye.
3. How will you use the medication?
Always use as instructed by the physician. You should check with the physician or pharmacist if you are
unsure.
The dosage and manner of treatment will be determined only by the physician. The usual dosage is normally
one drop, twice or three time a day in each treated eye.
Do not exceed the recommended dose.
Do not swallow. This medication is for external use only. Shake the bottle well before use.
Medication instructions for use:
To avoid contamination, do not allow the tip of the bottle touch any surface (including the eye). Keep the
bottle closed tightly.
The drop bottle may not be full; this is to allow better control of instilment.
How to use the drops: First, wash your hands. Tilt your head back. With your index finger, pull the lower
eyelid down, to create a type of “pocket” (illustration 1). Instill the medication into the “pocket”. Close your
eyes gently. Do not blink. Keep your eyes closed for 1 to 2 minutes.
Do not squeeze the bottle, a gentle press of the bottle’s base is enough to release the drop (illustration 2).
In addition to the above instructions – immediately after instilling the drops into the eye, press the inner corner
of the eye with your middle finger. Continue applying pressure for 1 to 2 minutes after instilling into the eye.
This action helps preventing the medication from being absorbed into the body, thereby help prevent side
effects (illustration 3).
Repeat the above actions in the other eye, if the doctor instructed treatment in both eyes.
After using the medication, wash your hands to cleanse them from leftover medication.
To avoid spreading infection, do not use the same medication container for more than one person.
If a drop missed the eye, try again.
If you accidentally took a higher dose, wash the eye with warm water. Do not apply another dose until the time
of the next dose.
If you accidentally took an overdose or if a child accidentally swallowed from the medication, see a physician
or go the hospital emergency room immediately and bring the medication package with you.
If you forgot to take the medication at the scheduled time, do not take a double dose. Take a dose immediately
when you remember, but if you remembered at a time close to the next dose, skip the missed dose and
continue to the next dose
If you are using other eye drops, wait at least 5 minutes between the administration of this medication and the
administration of other eye drops. Use eye ointments last.
Follow the treatment plan as recommended by the physician.
Even if your condition improves, do not stop treatment with the medication without consulting the physician.
If you stop taking the medication, intraocular pressure will not be controlled and this might result in loss of
vision.
Do not take medications in the dark! Check the label and dose each time you take a medication. Wear glasses
if you need them.
If you have additional questions on using the medication, consult the physician or the pharmacist.
4. Side effects
As with any medication, use of Alcon Azopt 1% might cause side effects in some users. Do not be alarmed to
read the list of side effects. You may experience none of them.
Common side effects (effects appearing in one out of 10 users):
Eye effects:
Blurred vision, eye irritation, pain in the eye, discharge from the eye, itching in the eye, dryness in the eye,
irregular sensation in the eye, redness in the eye.
General effects:
Bad taste
Uncommon side effects (effects appearing in one out of 100 users):
Eye effects:
Sensitivity to light, conjunctiva inflammation of infection, eye swelling, itching in eyelids, redness or
swelling, lesion on the surface of the eye, increased eye pigmentation, eye fatigue, formation of film on the
eyelid or excessive tearing.
General effects:
Reduced heart function, palpitations, slower heart rate, difficulty breathing, cough, reduced number of red
blood cells in blood counts, increased chloride level in the blood, dizziness, drowsiness, memory difficulties,
depression, agitation, weakness, fatigue, malaise, pain, tremors, reduced libido, sexual dysfunction in men,
symptoms of cold, chest pressure, sinusitis, throat irritation, sore throat, reduced or abnormal sensation in
mouth, esophagitis, abdominal pains, nausea, vomiting, upset stomach, frequent stools, diarrhea, flatulence,
indigestion, kidney pains, muscle pains, muscle cramps, back aches, nose bleeds, rhinitis, nasal congestion,
sneezing, rash, different skin sensation, headaches, dryness in mouth.
Rare side effects (effects appearing in one out of 1,000 users):
Eye effects:
Cornea swelling, reduced or double vision, vision disorder, reduced eye sensitivity, swelling around the eye,
increased intraocular pressure, damage to the optic nerve.
General effects:
Memory impairment, drowsiness, chest pains, upper respiratory tract congestion, snus congestion, nasal
congestion, nasal dryness, tinnitus, hair loss, general itch, agitation, irritation, irregular heart rate, body
weakness, difficulty falling asleep.
Side effects of unknown frequency:
Eye effects:
Eyelid disorder, vision disturbances, cornea disorder, eye allergy, reduced number of eyelashes or reduced
growth.
General effects:
Increased allergic symptoms, reduced sensation, tremor, loss or impairment of the sense of taste, drop in blood
pressure, elevated blood pressure, increased heart rate, joint aches, asthma, pain in limbs, skin redness,
inflammation or itching, abnormal results in liver function tests, swelling of limbs, frequent urination, reduced
appetite.
If a side effect appeared, if one of the side effects aggravates or when you experience a side effect not
mentioned in the leaflet, consult the physician.
Reporting of suspected adverse reactions
Suspected adverse events should be reported to the Ministry of Health according to the National
Regulation by clicking on the link “Adverse Drug Reactions Report” on the Ministry of Health’s
website (www.health.gov.il) which directs to the online form for reporting adverse events,
or by entering the following link:
https://forms.gov.il/globaldata/getsequence/[email protected].
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5. How to store the medication?
 Prevent poisoning! This medication and any other medication should be kept in a closed place out of the
reach of children and/or infants, preventing poisoning. Do not induce vomiting without explicit instruction
from the physician.
 Do not use the medication after the expiry date (exp. date) imprinted on the carton/label. The expiry date
refers to the last day of that month.
 Store at a temperature between 4 – 30°C
 Do not use this medication after 1 month from first opening.
Do not dispose of this medication in the garbage bin after the end of treatment, but bring this package to the
pharmacy near you.
6. Additional information
In addition to the active substance, the medication also contains:
Benzalkonium chloride, disodium edetate, sodium chloride, tyloxapol, mannitol, carbomer 974P, sodium
hydroxide, hydrochloric acid, purified water.
Medication’s appearance and package contents:
Alcon Azopt 1 % is a milky fluid (suspension) in a plastic bottle containing 5 ml of eye drops.
Registration owner and its address: Lapidot Medical Import and Marketing Ltd., 8 Hashita St., Caesarea
Industrial Area, 3088900
Manufacturer’s name and address: Alcon Couvrer, Puurs, Belgium
Medication’s registration no. in the National Medication Register at the Ministry of Health: 136 60
29640 00
This leaflet was reviewed and approved by the Ministry of Health on:
For simplicity and to facilitate reading, this leaflet is written in masculine address. Despite this, the medication
is intended for both genders.