Patient Information Leaflet: Read this leaflet carefully before using this medicine as it contains important information for you.

Dorzoclar 20 mg/ml eye drops, solution

Dorzolamide

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 others, even if they have the same symptoms as you, because it could 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:

What Dorzoclar is and what it is used for
What you need to know before using Dorzoclar
How to use Dorzoclar
Possible side effects
How to store Dorzoclar
Contents of the pack and other information

1. What Dorzoclar is and what it is used for

Dorzoclar contains dorzolamide, which belongs to a group of medicines called "carbonic anhydrase inhibitors".
This medicine is prescribed to lower elevated intraocular pressure and for the treatment of glaucoma. This medicine may be used alone or in combination with other medicines that lower intraocular pressure (called beta-blockers).

2. What you need to know before using Dorzoclar

Do not use Dorzoclar

if you are allergic 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 Dorzoclar.
Inform your doctor or pharmacist about any medical conditions you currently have or have had in the past, including eye problems or eye surgery, and any allergies to any medicines.
If you develop eye irritation or any new eye problems, such as eye redness or swelling of the eyelids, contact your doctor immediately.
If you think Dorzoclar is causing you an allergic reaction (for example rash, serious skin reactions, or itching), stop using this medicine and contact your doctor immediately.

Children
Dorzoclar has been studied in infants and children under 6 years of age with increased eye pressure or who have been diagnosed with glaucoma. Consult your doctor for further information.

Use in the elderly
In studies with Dorzoclar, the effects of this medicine were found to be similar in elderly patients and younger patients.

Use in patients with hepatic impairment
Inform your doctor if you have any liver problems or have had them in the past.

Other medicines and Dorzoclar
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines (including eye drops). This is particularly important if you are taking other carbonic anhydrase inhibitors such as acetazolamide or sulfonamides.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
You must not use this medicine during pregnancy. Inform your doctor if you are pregnant or planning to become pregnant.

Breastfeeding
Breastfeeding is not recommended if treatment with this medicine is required. Inform your doctor if you are breastfeeding or intend to breastfeed.

Driving or operating machinery
The effects of this medicine on the ability to drive or operate machinery have not been studied. However, there are side effects associated with this medicine, such as dizziness and blurred vision, which may affect your ability to drive and/or operate machinery. If this occurs, do not drive or operate machinery until you feel well or your vision is clear.

Dorzoclar contains benzalkonium chloride
This medicine contains 2.32 micrograms of benzalkonium chloride per drop, equivalent to 0.075 mg/ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may cause a change in their colour. 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 eye or corneal disorders (the outermost transparent layer of the eye). If you experience an unusual sensation in the eye, burning, or pain after using this medicine, speak with your doctor.

3. How to use Dorzoclar

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The appropriate dose and duration of treatment will be determined by your doctor.
When this medicine is used alone, the recommended dose is one drop into the affected eye(s) in the morning, afternoon, and evening.
If your doctor has advised you to use this medicine together with a beta-blocking eye drop to reduce intraocular pressure, the recommended dose is one drop of Dorzoclar into the affected eye(s) in the morning and evening.
If you are using Dorzoclar with other eye drops, administer the drops at least 10 minutes apart.
Avoid letting the dropper tip touch the eye or surrounding areas. It could become contaminated with bacteria that may cause serious eye infections, including potential loss of vision.
To avoid possible contamination, wash your hands before using this medicine and always keep the dropper tip away from contact with any surface.
If you think your medicine may have become contaminated, or if you develop an eye infection, contact your doctor immediately before continuing to use this bottle.

Instructions for use:
Always wash your hands before instilling the eye drops.
Apply the eye drops as follows:

Unscrew the protective cap.
Tilt your head backward and look up at the ceiling.
Gently pull down the lower eyelid to form a small pocket.
Squeeze the inverted bottle to release one drop into the eye.
While keeping the treated eye closed, press a finger against the inner corner of the closed eye (where the eye meets the nose) and wait for about 2 minutes. This helps prevent the medicine from passing into the rest of the body. Avoid touching the dropper tip to the eye or anything else. Replace and tighten the cap immediately after use.

If you use more Dorzoclar than you should
If you instill too many drops into the eye or if you swallow the contents of the bottle, contact your doctor immediately.

If you forget to use Dorzoclar
It is important to use this medicine as prescribed by your doctor. If you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and return to your regular dosing schedule.
Do not use a double dose to make up for a forgotten dose.

If you stop using Dorzoclar
If you wish to stop using this medicine, discuss it with your doctor first. 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 everybody gets them.
If you experience allergic reactions including hives, swelling of the face, lips, tongue and/or throat which may cause difficulty breathing or swallowing, you must stop using this medicine and contact your doctor immediately.

The following side effects have been reported with Dorzoclar, both during clinical studies and from post-marketing experience:

Very common side effects: (affects more than 1 in 10 people)
Burning and stinging in the eyes.

Common side effects: (affects 1 to 10 in 100 people)
Corneal changes with eye pain and blurred vision (superficial punctate keratitis), eye discharge with itching (conjunctivitis), eyelid irritation/inflammation, blurred vision, headache, nausea, bitter taste, and fatigue.

Uncommon side effects: (affects 1 to 10 in 1,000 people)
Inflammation of the iris.

Rare side effects: (affects 1 to 10 in 10,000 people)
Tingling or numbness in the hands and feet, temporary myopia which may resolve upon discontinuation of treatment, development of fluid under the retina (choroidal detachment following filtering surgery), eye pain, eyelid crusting, reduction in eye pressure, corneal oedema (with symptoms of visual disturbances), ocular irritation including redness, kidney stones, dizziness, nosebleeds, throat irritation, dry mouth, localized skin rash (contact dermatitis), severe skin reactions, allergic-type reactions such as skin rash, urticaria, itching, and in rare cases possible swelling of the lips, eyes and mouth, shortness of breath, and more rarely wheezing.

Not known (frequency cannot be estimated from the available data):
Shortness of breath, sensation of a foreign body in the eye (feeling that something is in the eye), strong heartbeat which may be fast or irregular (palpitations), increased heart rate, increased blood pressure.

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 http://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 Dorzoclar

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and carton after "Exp.".
The expiry date refers to the last day of that month.
Dorzoclar must be used within 28 days of first opening the bottle.
Do not store above 25°C. Keep the bottle in the original packaging to protect it from light.
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 Dorzoclar contains

The active substance is dorzolamide.
1 ml contains 20 mg of dorzolamide (equivalent to 22.3 mg of dorzolamide hydrochloride).
The other ingredients are: hydroxyethylcellulose, mannitol, sodium citrate dihydrate and purified water. Benzalkonium chloride is added as a preservative.

Description of the appearance of Dorzoclar and contents of the pack
Dorzoclar is a slightly viscous, clear, colourless or almost colourless solution.
Pack sizes:
1 x 5.0 ml
3 x 5.0 ml
6 x 5.0 ml
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 authorised in the European Economic Area countries under the following names:
UK
Dorzolamide 20 mg/ml eye drops solution
ITALY
Dorzoclar 20 mg/ml eye drops, solution