Zoliop

Patient Information Leaflet

ZOLIOP 20 mg/ml EYE DROPS, SOLUTION

Dorzolamide
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 you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Zoliop is and what it is used for
2. What you need to know before using Zoliop
3. How to use Zoliop
4. Possible side effects
5. How to store Zoliop
6. Contents of the pack and other information

1. What Zoliop is and what it is used for

Zoliop is an eye drop solution and each bottle contains 5 ml of medicine.
The active substance in Zoliop is dorzolamide hydrochloride, which belongs to a group of
medicines known as 'carbonic anhydrase inhibitors'. This medicine is used to reduce intraocular
pressure in cases of glaucoma or ocular hypertension (increased eye pressure), and can be used
either alone or in combination with other medicines called 'beta-blockers'.

2. What you need to know before using Zoliop:

Do not use Zoliop:

• If you are allergic (hypersensitive) to dorzolamide hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
• If you have severe kidney impairment or kidney problems, or a history of kidney stones.

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

• If you currently have or have ever had any medical condition, including eye problems or eye surgery, or if you have allergies to other medicines.
• If you develop eye irritation or any new eye problems, such as redness of the eye or eyelid swelling, contact your doctor immediately.
• If you suspect that this medicine is causing an allergic reaction (e.g., skin rash, severe skin reaction, or itching), stop using the medicine and contact your doctor immediately.
• If you have or have previously had liver problems.
• If you wear contact lenses (see the subsection below “This medicine contains the preservative benzalkonium chloride”).

Children
This medicine has been studied in newborns and children under 6 years of age with elevated eye pressure or who have been diagnosed with glaucoma. For further information, consult your doctor.

Other medicines and Zoliop
Tell your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines, especially another carbonic anhydrase inhibitor such as acetazolamide, or a sulfonamide medicine.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine. This medicine should not be used during pregnancy or while breastfeeding.

Driving and using machines
In some patients, this medicine may cause dizziness or blurred vision. You should avoid driving or operating machinery until you feel well or no longer have blurred vision.

This medicine contains 0.075 mg of the preservative benzalkonium chloride per ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may cause discoloration. Remove your contact lenses before using this medicine and wait 15 minutes before reinserting them. Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or corneal disorders (the transparent outer layer of the eye). If you experience any unusual sensation, burning, or pain in the eye after using this medicine, speak with your doctor.

3. How to use Zoliop

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
If you wear contact lenses, remove them before applying the drops and wait at least 15 minutes before reinserting them.

Dosage
The appropriate dosage and duration of treatment will be determined by your doctor.

• If this medicine is used alone, the dose is one drop into the affected eye or eyes, in the morning, afternoon, and evening.
• If this medicine is used together with a beta-blocking eye drop, the dose is one drop into the affected eye or eyes, in the morning and evening.
• If this medicine is used together with another eye drop, the drops should be administered at least 10 minutes apart.

Instructions for use:
This medicine is for ophthalmic use only; do not swallow.
Always wash your hands before applying the eye drops. Apply one drop of the medicine into each affected eye as follows:

1. Tilt your head backward and look up toward the ceiling.
2. Gently pull down the lower eyelid to form a small pouch.
3. Squeeze the inverted dropper bottle to release one drop into the eye.
4. Close the eye and press with a finger against the inner corner of the eye for about two minutes. This helps prevent the medicine from passing into the rest of the body.
5. Immediately replace the cap tightly after use.

THE TIP OF THE DROPPER MUST NOT TOUCH THE EYE,
SURROUNDING AREAS, OR ANY SURFACE. It may become
bacterially contaminated, which could lead to eye infections causing serious eye damage, including loss of vision.
The dropper tip is designed to deliver a single drop. DO NOT enlarge the opening of the tip.

Children
This medicine has been studied in infants and children under 6 years of age who have elevated intraocular pressure or who have been diagnosed with glaucoma. For further information, please speak with your doctor.

If you use more Zoliop than you should
If you instill too many drops into the eye or if the contents of the bottle are swallowed, contact your doctor immediately, as this may cause drowsiness, nausea, dizziness, headache, fatigue, abnormal dreams, and difficulty swallowing, possibly requiring hospitalization.

If you forget to use Zoliop
If you forget to instill a dose, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and continue with your regular dosing schedule. Do not use a double dose to make up for a forgotten dose.

If you stop using Zoliop
Do not stop using this medicine without first discussing it with your doctor. If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences
them.
Serious side effects
Stop using the medicine and contact your doctor immediately if you experience any of the
following symptoms (systemic allergic reaction): skin rash; swelling of the face, lips, tongue or
throat; difficulty breathing or swallowing.
The following side effects have been reported with this medicine in clinical studies or after
marketing:
Very common side effects (may occur in more than 1 out of 10 patients):

• Burning and stinging pain in the eyes.

Common (may occur in up to 1 out of 10 patients):

• Corneal disease with eye pain and blurred vision (superficial punctate keratitis), inflammation or irritation of the eyelid, eye discharge with itching (conjunctivitis), vitreous eye, blurred vision.
• Fatigue, weakness, headache, nausea, bitter taste sensation.

Uncommon (may occur in up to 1 out of 100 patients):

• Inflammation of the iris.

Rare (may occur in up to 1 out of 1,000 patients):

• Tingling or numbness of the hands or feet.
• Corneal edema (with symptoms of visual disturbances), ocular hypotension, fluid accumulation under the retina (choroidal detachment following filtering surgery), temporary myopia that resolves upon discontinuation of treatment, eye irritation including redness, eye pain, crusting of the eyelids.
• Kidney stones, dizziness, nosebleeds, throat irritation, dry mouth.
• Severe skin reactions including blisters, localized skin rashes (contact dermatitis), and systemic allergic reactions such as skin rashes, swelling of lips, eyes and mouth, shortness of breath, and more rarely, labored breathing.

Side effects with unknown frequency (cannot be estimated from available data):

• Labored breathing.
• Foreign body sensation in the eye (feeling that something is in the eye).
• Strong heartbeat which may be rapid or irregular (palpitations).
• Increased heart rate.
• Increased blood pressure.
• Abnormal sensitivity of the eyes to light.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or
pharmacist. You may also report side effects directly via the national reporting system at
https://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 Zoliop

Keep this medicine out of the sight and reach of children.
Do not use this medicine if you notice that the seal is broken or damaged before first use.
Do not use this medicine after the expiry date stated on the label of the bottle and on the carton after SC or SCAD. The expiry date refers to the last day of that month.
The medicine must be used within 28 days of first opening, even if the bottle is not empty; any remaining product should be discarded.
Do not store the bottle at a temperature above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Zoliop contains

• The active substance is dorzolamide. Each ml of solution contains 20 mg of dorzolamide (equivalent to 22.26 mg of dorzolamide hydrochloride).
• The other ingredients are benzalkonium chloride (preservative), hydroxyethylcellulose, mannitol, sodium dihydrogen citrate dihydrate, water for injections, and sodium hydroxide or hydrochloric acid (to adjust pH).

Description of the appearance of Zoliop and contents of the pack
This medicine is a clear, colourless to almost colourless, slightly viscous solution, contained in a 5 ml bottle.
The medicine is available in packs containing 1, 2 or 3 bottles.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Farmigea S.p.A., Via G.B. Oliva 6/8, 56121 Pisa, Italy
Manufacturer
Farmigea S.p.A., Via G.B. Oliva 8, 56121 Pisa, Italy
Exclusive distributor for sale
Elleva Pharma S.r.l. - Via S. Francesco 5/7 - 80034 Marigliano, Naples, Italy
This patient information leaflet was last revised in 03/2026