Aicisi

Patient Information Leaflet

Aicisi 10 mg/ml eye drops, suspension

brinzolamide
Please read this leaflet carefully before using this medicine because 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 give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact 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 using 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 Aicisi is and what it is 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 to treat elevated intraocular pressure. This pressure can lead to a condition called glaucoma.
If the pressure in the eye is too high, it may damage vision.

2. What you need to know before using Aicisi

Do not use Aicisi

• if you have severe kidney problems,
• if you are allergic to brinzolamide or to any of the other ingredients of this medicine (listed in section 6),
• if you are allergic to medicines called sulfonamides. Examples include drugs used to treat diabetes and infections, as well as diuretics (tablets that increase urine production). Aicisi may cause the same allergic reaction,
• if you have too much acid in your 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 corneal problems,
• if you are taking other sulfonamide medicines,
• if you have a specific type of glaucoma in which pressure inside the eye increases due to deposits blocking fluid drainage (pseudoexfoliative glaucoma or pigmentary glaucoma), or a specific type of glaucoma in which pressure inside the eye increases
  (sometimes rapidly) because the eye bulges forward and blocks fluid drainage (narrow-angle glaucoma),
• if you have ever developed a severe skin rash or skin peeling, blisters and/or mouth ulcers 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 with brinzolamide treatment. 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 must not be used in newborns, children or adolescents under 18 years of age, unless advised by a doctor.
Other medicines and Aicisi
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those without a prescription.
If you are taking another carbonic anhydrase inhibitor (acetazolamide or dorzolamide, see section 1 What Aicisi is and what it is used for), consult your doctor.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or 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 operate machinery until your vision is clear. Your vision may be blurred for a short time immediately after using Aicisi.
Aicisi may impair your ability to perform tasks requiring mental alertness and/or physical coordination. If you experience such symptoms, be cautious when driving or using machinery.

3. How to use Aicisi

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Use Aicisi only in your eyes. Do not swallow it or inject it.
The recommended dose is
1 drop in the affected eye(s), twice daily – morning and evening.
Use this dose unless your doctor tells you otherwise. Use Aicisi in both eyes only if your doctor has instructed you to do so. Use the medicine for the length of time prescribed by your doctor.
How to use it
Do not allow the tip of the multidose container to touch the eye, eyelid, surrounding areas, or any other surfaces. This could contaminate the drops. To prevent contamination of the dropper tip and suspension, wash your hands before using this medicine and replace the cap securely immediately after use. Shake the bottle before each use.

1. Before the first use, write the date of opening in the designated 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 pump mechanism until the first drop appears. Afterwards, discard the first two drops as well. When doing so, hold the bottle upside down as shown in the figure. This applies only for the first use and is not required for subsequent applications. Please avoid any contact between the dropper tip, fingers, and the eye.

3. Hold the bottle as shown in the image. Ensure that your thumb rests on the wide, non-slip finger pad.

4. Tilt your head slightly backward (neck position) and use your free hand to gently pull down the 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 the 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 the body.
6. Repeat steps 3 to 5 to administer one drop into the other eye, if your doctor has instructed you to do so.

Once opened, the bottle may 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 many drops, rinse the eye immediately with lukewarm water. Do not use further 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 dosing schedule. 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 intraocular pressure will not be controlled, which could lead to vision loss.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been observed with Aicisi.
Stop treatment with Aicisi and contact your doctor immediately if you notice any of the following symptoms:

• Flat, red spots, target-shaped or circular, on the trunk, often with central blisters, skin peeling, mouth ulcers, ulcers in the throat, nose, genitals or eyes. These serious 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 )

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

Uncommon ( may affect up to 1 in 100 people )

• Eye effects: light sensitivity, inflammation or infection of the conjunctiva, eye swelling, 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 which may be fast or irregular, reduced heart rate, breathing difficulty, shortness of breath, cough, decreased red blood cell count, increased blood chloride levels, dizziness, memory problems, depression, nervousness, reduced emotions, nightmares, generalized weakness, fatigue, feeling of abnormality, pain, movement difficulties, decreased sexual desire, male sexual dysfunction, cold-like symptoms, chest congestion, sinus infection, sore throat, throat pain, abnormal or reduced sensation in the mouth, inflammation of the oesophageal mucosa, abdominal pain, nausea, vomiting, stomach discomfort, frequent bowel movements, diarrhoea, intestinal gas, indigestion, kidney pain, muscle pain, muscle spasms, back pain, nosebleeds, runny nose, nasal congestion, sneezing, rash, abnormal skin sensation, itching, smooth rash or redness with raised bumps, skin tightness, headache, dry mouth, eye debris.

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

• Eye effects: 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: memory impairment, drowsiness, chest pain, upper respiratory tract congestion, sinus congestion, nasal congestion, dry nose, ringing in the ears, hair loss, generalized itching, feeling nervous, irritability, irregular heartbeat, body weakness, difficulty sleeping, wheezing, itchy rash

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

• Eye effects: eyelid abnormalities, vision disorders, corneal disorders, eye allergy, reduced growth or number of eyelashes, eyelid redness
• General side effects: worsening of allergic symptoms, decreased sensation, tremor, loss or reduction of taste, decreased blood pressure, increased blood pressure, increased heart rate, joint pain, asthma, pain in the extremities, skin redness, inflammation or itching, abnormalities in liver function blood tests, swelling of the extremities, frequent urination, decreased appetite, feeling unwell, flat, red, target-shaped or circular spots on the trunk, often with central blisters, skin peeling, mouth ulcers, ulcers in the throat, nose, genitals or eyes, which may be preceded by fever and flu-like symptoms. These serious skin rashes may be potentially life-threatening (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 stated on the carton and on the bottle after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
After first opening the bottle, the suspension can be used for 2 months. Keep the bottle tightly closed.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Aicisi contains

• The active substance is brinzolamide. Each millilitre contains 10 mg of brinzolamide.
• The other components are mannitol, carbomer 974P, tyloxapol, edetate disodium, 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 a dropper (PP, HDPE, LDPE) and cap (HDPE), as well as an ergonomic aid for application (PP).
Packs containing 1 or 2 bottles in a cardboard carton.
Pack sizes:
1 x 5 mL bottle
1 x 9 mL bottle
2 x 9 mL bottle
Not all pack sizes may be marketed.

Marketing Authorization Holder
OmniVision Italia S.r.l.
Via Montefeltro, 6
20156 Milano, Italy

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

This medicinal product is authorized in the European Economic Area countries under the following names:
Germany Aicisi 10 mg/ml Augentropfensuspension
Austria Aicisi 10 mg/ml Augentropfensuspension
France Aicisi 10 mg/ml Collyre en suspension
Italy Aicisi
Greece Aicisi 10 mg/ml οφθαλμικές σταγόνες, εναιώρημα
Portugal Aicisi 10 mg/ml colírio, suspensão
Spain Aicisi 10 mg/ml, Colirio en suspensión