AICISI 10 mg /Ml Глазные Капли, Суспензия

Содержание инструкции

1. Aicisi 10 mg/ml eye drops, suspension
   1. What is Aicisi and what is it used for
   2. What you need to know before you use Aicisi
   3. How to use Aicisi
   4. Possible side effects
   5. How to store Aicisi
   6. Contents of the pack and other information

Aicisi 10 mg/ml eye drops, suspension

brinzolamide

Read this leaflet carefully before you start to use 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 they have the same symptoms as you, 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 Aicisi is and what it is used for
• 2. What you need to know before you use Aicisi
• 3. How to use Aicisi
• 4. Possible side effects
• 5. How to store Aicisi
• 6. Contents of the pack and other information

1. What is Aicisi and what is it used for

Aicisi contains brinzolamide which belongs to a group of medicines called carbonic anhydrase inhibitors.
It reduces pressure in the eye.
Aicisi eye drops are used for the treatment of high pressure in the eye. This pressure can
lead to a condition called glaucoma.
If the pressure in the eye is too high, it can damage your vision.

2. What you need to know before you use Aicisi

Do not use Aicisi

• if you have severe kidney problems,
• if you are allergic to brinzolamide or any of the other ingredients of this medicine (listed in section 6),
• if you are allergic to medicines called sulfonamides. Examples include medicines used for the treatment of diabetes and infections and also diuretics (tablets that promote diuresis). Aicisi may cause the same allergic reaction,
• if you have too much acidity in the blood (a condition called hyperchloremic acidosis).

If you have further questions, consult your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before using Aicisi:

• if you have kidney or liver problems,
• if you have dry eyes or problems with the cornea,
• if you are taking other sulfonamide medicines,
• if you have a specific form of glaucoma in which the pressure inside the eye increases due to deposits that block the outflow of fluid (pseudoexfoliative glaucoma or pigmentary glaucoma) or a specific form of glaucoma in which the pressure inside the eye increases

(sometimes rapidly) because the eye protrudes forward and blocks the outflow of fluids (angle-closure
glaucoma),

• if you have ever developed a severe skin rash or skin peeling, blisters and/or ulcers in the mouth after using Aicisi or other related medicines.

Take special care with Aicisi:
Severe 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
severe skin reactions described in section 4, stop treatment with Aicisi and contact your
doctor immediately.

Children and adolescents
Aicisi should not be used by newborns, children or adolescents under the age of 18 years unless
advised by your doctor.

Other medicines and Aicisi
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those available without a prescription.
If you are taking another carbonic anhydrase inhibitor (acetazolamide or dorzolamide, see
section 1 What is Aicisi and what is it used for), consult your doctor.

Pregnancy and breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Women of childbearing potential are advised to use effective contraceptive methods during treatment with
Aicisi. The use of Aicisi is not recommended during pregnancy or breastfeeding.
Do not use Aicisi unless clearly indicated by your doctor.
Ask your doctor or pharmacist for advice before using any medicine.

Driving and using machines
Do not drive or use machines until your vision is clear. Your vision may be blurred
for a while immediately after using Aicisi.
Aicisi may impair the ability to perform operations that require mental attention and/or
physical coordination. If you experience such symptoms, be careful when driving vehicles or using
machines.

3. How to use Aicisi

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.
Use Aicisi only for your eyes. Do not swallow it and do not inject it.

The recommended dose is
1 drop in the affected eye(s), twice a day - morning and evening.
Use this dose unless your doctor tells you to do otherwise. Use Aicisi in both
eyes only if your doctor has told you to do so. Use the medicine for the period of time that your
doctor has prescribed.

How to use it
Do not allow the tip of the multi-dose container to touch the eye or eyelid, the surrounding
areas or other surfaces. It could infect the drops. To prevent contamination of the dropper tip and the
suspension, wash your hands before using this medicine and firmly replace
the cap immediately after use. Shake the bottle before each use.

• 1. Before the first application, write the date of opening in the appropriate space on the bottle label. Remove the cap before each application.

• 2. Before the first application of the Aicisi bottle, press several times to activate the pumping mechanism until the first drop appears. Subsequently, also discard the first two drops. When doing so, hold the bottle upside down as shown in the figure. This only applies to the first application and is not necessary for all other applications. Please avoid any contact between the dropper tip, fingers and the eye.

• 3. Hold the bottle as shown in the image. Make sure your thumb rests on the large, circular, non-slip thumb rest.

• 4. Tilt your head slightly backwards (neck position) and use your free hand to gently pull down your lower eyelid. Apply one drop of Aicisi into the conjunctival sac of the affected eye by pressing the pump mechanism once. Make sure the bottle is held vertically.

• 5. Close your eye and press on the inner corner of the eye with your finger for at least one minute. This helps prevent the medicine from entering the rest of your body.
• 6. Repeat as described in point 3 - 5 to administer one drop into the other eye, if your doctor has told you to do so.

Once opened, the bottle can be used for 2 months. After this time, the bottle must be
discarded even if some suspension remains.
If a drop misses the eye, try again.
If you are using other eye drops, wait at least 5 minutes between applying Aicisi and the other eye drops.
Ophthalmic ointments should be administered last.

If you use more Aicisi than you should
If you have instilled too much eye drops, immediately wash your eye with lukewarm water. Do not use other drops until the
time of your next regular dose.

If you forget to use Aicisi
Use a single drop as soon as you remember, then return to your normal instillation routine.
Do not use a double dose to make up for a missed dose.

If you stop using Aicisi
If you stop using Aicisi without consulting your doctor, your eye pressure will not be controlled and
this could lead to loss of vision.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The following side effects have been observed with Aicisi.
Stop treatment with Aicisi and immediately contact your doctor if you notice any of the following
symptoms:

• flat, reddish patches, target-shaped or circular on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital and eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis)

Common( may affect up to 1 in 10 people)

• Effects on the eye:blurred vision, eye irritation, eye pain, eye discharge, itchy eyes, dry eyes, abnormal eye sensation, redness of the eye
• General side effects:unpleasant taste

Uncommon( may affect up to 1 in 100 people)

• Effects on the eye: sensitivity to light, inflammation or infection of the conjunctiva, swollen eyes, itchy eyelids, redness or swelling, deposits in the eye, glare, burning sensation, growth on the surface of the eye, increased pigmentation of the eye, tired eyes, crusting of the eyelids or increased tear production
• General side effects: reduced heart function, strong heartbeat that may be accelerated or irregular, decreased heart rate, difficulty breathing, shortness of breath, cough, decreased red blood cell count, increased chlorine levels in the blood, dizziness, memory problems, depression, nervousness, decreased emotions, nightmares, general weakness, fatigue, feeling abnormal, pain, difficulty moving, decreased sexual desire, male sexual dysfunction, cold symptoms, chest congestion, sinus infection, throat irritation, sore throat, abnormal or decreased sensation in the mouth, inflammation of the esophagus, abdominal pain, nausea, vomiting, stomach upset, frequent bowel movements, diarrhea, intestinal gas, indigestion, kidney pain, muscle pain, muscle spasms, back pain, nosebleeds, runny nose, stuffy nose, sneezing, rash, abnormal skin sensation, itching, smooth or reddish rash with raised bumps, skin tightness, headache, dry mouth, debris in the eyes.

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

• Effects on the eye: corneal swelling, double or reduced vision, abnormal vision, flashes of light in the visual field, decreased eye sensitivity, swelling around the eye, increased pressure in the eye, optic nerve damage
• General side effects: impaired memory, drowsiness, chest pain, upper respiratory tract congestion, sinus congestion, nasal congestion, dry nose, ringing in the ears, hair loss, general itching, feeling nervous, irritability, irregular heartbeat, body weakness, difficulty sleeping, wheezing, itchy rash

Not known( frequency cannot be estimated from available data)

• Effects on the eye: eyelid abnormalities, visual disturbances, corneal disorders, eye allergy, decreased eyelash growth or number, redness of the eyelid
• General side effects: increased allergic symptoms, decreased sensitivity, tremor, loss or decrease of taste, decreased blood pressure, increased blood pressure, increased heart rate, joint pain, asthma, limb pain, skin redness, inflammation or itching, abnormalities in liver function blood tests, swelling of the extremities, frequent urination, decreased appetite, feeling unwell, flat, reddish patches, target-shaped or circular on the trunk, often with blisters, skin peeling, mouth, throat, nose, genital and eye ulcers, which may be preceded by fever and flu-like symptoms. These severe skin rashes can be potentially life-threatening (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at: www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Aicisi

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 package and the bottle after
“Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
After the first opening of the bottle, the suspension can be used for 2 months. Keep the bottle
tightly closed.
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 Aicisi contains

• The active substance is brinzolamide. Each millilitre contains 10 mg of brinzolamide.
• The other ingredients are mannitol, carbomer 974P, tyloxapol, disodium edetate, sodium chloride, sodium hydroxide and water for injections.

Description of the appearance of Aicisi and contents of the pack
Aicisi is a milky liquid (a suspension) supplied in a white multidose container (HDPE) with
droppers (PP, HDPE, LDPE) and cap (HDPE), as well as an ergonomic applicator aid (PP).
Packs of 1 or 2 vials in a cardboard box.
Packs:
1 x 5 mL vial
1 x 9 mL vial
2 x 9 mL vial
Not all pack sizes may be marketed.

Marketing Authorisation Holder
OmniVision Italia S.r.l.
Via Montefeltro, 6
20156 Milan, Italy

Manufacturer
Tubilux Pharma S.p.A.
Via Costarica 20/22
00071 Pomezia (RM), Italy

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Germany Aicisi 10 mg/ml eye drop suspension
Austria Aicisi 10 mg/ml eye drop suspension
France Aicisi 10 mg/ml eye drop suspension
Italy Aicisi
Greece Aicisi 10 mg/ml ophthalmic drops, suspension
Portugal Aicisi 10 mg/ml eye drops, suspension
Spain Aicisi 10 mg/ml, eye drop suspension