Package leaflet: Information for the patient

Dorzostill, 20 mg/ml, eye drops, solution
Dorzolamide
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for a specific person. Do not pass it on to others. It may harm other people even if their symptoms are the same.
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet:

What Dorzostill is and what it is used for
Important information before using Dorzostill
How to use Dorzostill
Possible side effects
How to store Dorzostill
Contents of the pack and other information
WHAT DORZOSTILL IS AND WHAT IT IS USED FOR

Dorzostill is an eye medicine (eye drops) containing dorzolamide, which belongs to a group of medicines called carbonic anhydrase inhibitors.
The eye drops are used to reduce elevated intraocular pressure and to treat glaucoma. The drops may be used alone or together with other eye drops that reduce intraocular pressure (so-called beta-blockers).

IMPORTANT INFORMATION BEFORE USING DORZOSTILL

When not to use Dorzostill

if you are allergic (hypersensitive) to dorzolamide or any of the ingredients of Dorzostill (see section 6)
if you have severe kidney problems
if you have blood pH (acid-base balance) disorders

Warnings and precautions
Before using Dorzostill, inform your doctor (or pharmacist) if:

you have or have previously had liver problems
you have or have previously had kidney stones
you have corneal abnormalities
you are allergic to any medicines
you have had eye surgery or it is planned
you have suffered an eye injury or have an eye infection
you wear contact lenses (see section "Important information about certain ingredients of Dorzostill" below).

If you experience eye irritation or any new eye problems, including eye redness or swelling of the eye surface or eyelids, contact your doctor immediately.
If you suspect that Dorzostill is causing an allergic reaction (e.g. rash or itching), stop using it immediately and contact your doctor.

Children
Dorzolamide has been studied in infants and children under 6 years of age who had elevated intraocular pressure or diagnosed glaucoma. If additional information is needed, please consult your doctor.

Elderly patients
Dorzolamide has been shown to have the same effect in elderly patients as in younger individuals.

Dorzostill and other medicines
Tell your doctor about all medicines you are currently taking or plan to take, including other eye drops or over-the-counter medicines, especially if you are taking high doses of painkillers containing salicylic acid (e.g. aspirin).
Although there is no evidence that dorzolamide interacts with salicylic acid-containing painkillers, interactions are known between salicylic acid-containing painkillers and other carbonic anhydrase inhibitors taken orally.
You should also inform your doctor if you are using another carbonic anhydrase inhibitor, such as acetazolamide, or medicines from the sulfonamide group.

Pregnancy and breastfeeding
Consult your doctor before taking any medicine.
Do not use Dorzostill during pregnancy, or if pregnancy is suspected.
The medicine should not be used during breastfeeding.

Driving and using machines
Studies on the possible effect of the medicine on driving and operating machinery have not been conducted. Possible side effects of Dorzostill such as dizziness and visual disturbances may affect the ability to drive and operate machinery. If these side effects occur, do not drive or operate machinery.

Important information about certain ingredients of Dorzostill
Dorzostill contains benzalkonium chloride as a preservative. Benzalkonium chloride may cause eye irritation. This preservative may deposit on soft contact lenses and may change the lens colour. If you wear soft contact lenses, consult your doctor before using Dorzostill. It is important to remove contact lenses before applying the medicine and to reinsert them only 15 minutes after administration.

HOW TO USE DORZOSTILL

Always use Dorzostill exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist again.
Dosage and frequency of administration
When Dorzostill is used alone, the usual dose is one drop administered into the affected eye(s) three times daily, for example in the morning, at midday and in the evening.
If your doctor has prescribed Dorzostill together with a beta-blocker to reduce intraocular pressure, the usual dose is one drop of Dorzostill administered into the affected eye(s) twice daily, for example in the morning and evening.
When using Dorzostill together with other eye drops, each medicine should be administered separately, with at least a 10-minute interval between them. When switching from another intraocular pressure-lowering eye drop to Dorzostill, discontinue the other medicine after administering the correct dose for one day and start using Dorzostill the next day.
Do not change the dosage without consulting your doctor. If in doubt, consult your doctor or pharmacist. If you need to stop treatment, contact your doctor immediately.

Instructions for use
Dorzostill is intended for ocular administration.
Do not touch the eye or surrounding area with the dropper tip, as the medicine may become contaminated with bacteria that can cause eye infections leading to serious eye damage or even vision loss. To avoid contamination of the container, avoid contact between the dropper tip and any surface.
Always wash your hands before using the eye drops.

To open the bottle, unscrew the cap.
Tilt your head back and gently pull down the lower eyelid to form a pocket between the eyelid and the eye.
Turn the bottle upside down and gently squeeze to administer one drop into the eye. Do not touch the eye, eyelid or any other surface with the dropper tip. After instillation, close the eye and gently press with a finger on the inner corner of the eye (near the nose) for 1 minute.
Repeat steps 2 and 3 for the second eye, if instructed by your doctor. Immediately after use, close the bottle by screwing the cap tightly. Do not overtighten the cap.

The dropper delivers the correct drop size; do not enlarge its opening. After all doses have been used, a small amount of the preparation may remain at the bottom of the bottle. This is normal, as the bottle contains an additional amount of Dorzostill to ensure you receive the full prescribed dose. Do not attempt to extract the remaining medicine from the bottle.

Use of a higher than recommended dose of Dorzostill
If more drops than recommended are administered into the eye or if the medicine is swallowed, contact your doctor immediately. Swallowing Dorzostill may cause symptoms such as drowsiness, and administering too many drops into the eye may cause nausea, dizziness, headache, fatigue, unusual dreams and difficulty swallowing.

Missed dose of Dorzostill
It is important to use Dorzostill as prescribed by your doctor. If you miss 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 double the dose to make up for a missed one.

Stopping Dorzostill treatment
If you need to stop treatment, contact your doctor immediately.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Dorzostill can cause side effects, although not everybody gets them.
Possible side effects of Dorzostill are as follows:
Very common (may affect more than 1 in 10 people)
Eye disorders: burning and stinging sensation
Common (may affect up to 1 in 10 people)
Eye disorders: light sensitivity and eye pain due to inflammation of the front part of the eye (keratitis), conjunctivitis, eye surface discomfort, tearing or itching of the eye(s), inflammation or irritation of the eyelid(s) and/or skin around the eye(s), blurred vision.
Disorders of other body parts: headache, nausea, fatigue, bitter taste in the mouth after using the drops.
Uncommon (may affect up to 1 in 100 people)
Eye disorders: iritis.
Rare (may affect up to 1 in 1000 people)
Eye disorders: eye irritation and redness, eye pain, swelling of the eye surface, eyelid crusting, transient myopia (resolving after discontinuation of therapy), choroidal detachment, which may be accompanied by visual disturbances (after eye surgery).
Disorders of other body parts: dizziness, numbness/tingling sensation, nosebleeds, dry mouth, throat irritation, allergic reactions including rash, urticaria, itching, swelling of lips, eyes and mouth, shortness of breath and kidney stones.
Frequency not known (frequency cannot be estimated from available data):
Eye disorders: foreign body sensation in the eye.
Disorders of other body parts: dyspnoea (shortness of breath)
Inform your doctor (or pharmacist) immediately if any of these or other unusual symptoms occur, especially if you experience any visual changes or disturbances while using Dorzostill after eye surgery.
If any of the side effects worsen or if you notice any side effects not listed in this leaflet, inform your doctor.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. Side effects can also be reported directly to:
Department for Monitoring of Adverse Drug Reactions
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
e-mail: [email protected]
Reporting side effects helps to provide more information on the safety of medicines.

5. HOW TO STORE DORZOSTILL
Keep out of the sight and reach of children.
Do not use Dorzostill after the expiry date stated on the bottle and carton as EXP.
The expiry date refers to the last day of the stated month.
Do not use Dorzostill for longer than 30 days after first opening the container. After 30 days, open a new bottle, even if a small amount of Dorzostill remains in the old one.
The unopened, factory-sealed pack may be stored below 30°C. After first opening, store the pack below 25°C. Keep the bottle in the outer carton to protect it from light.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

What Dorzostill contains

The active substance is dorzolamide. One ml contains 20.0 mg of dorzolamide (equivalent to 22.3 mg/ml dorzolamide hydrochloride).
The other ingredients are: hydroxyethylcellulose, mannitol, sodium citrate, sodium hydroxide / hydrochloric acid (for pH adjustment), benzalkonium chloride (preservative), purified water.

What Dorzostill looks like and contents of the pack
Dorzostill is a clear or slightly opalescent, colourless, isotonic, buffered, slightly viscous aqueous solution for ophthalmic use, free from visible solid particles. It is available in sterile plastic bottles with a dropper and screw cap. Each bottle contains 5 ml of solution.
The bottles are packed in cartons: 1 x 5 ml, 3 x 5 ml (pack containing three bottles), or 6 x 5 ml (pack containing six bottles). Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Bruschettini srl
Via Isonzo, 6
16147 Genoa, Italy
Tel.:

For further information, contact the local representative of the Marketing Authorisation Holder:

Poland
Pharm Supply Sp. z o.o.
Ul. Marconich 2, lok.9
PL 02-954 Warsaw
Tel./fax: +48 22 6423331
e-mail: [email protected]

The medicinal product is authorised in the European Economic Area under the following names:
Austria / Dorzo-Vision 20 mg/ml Augentropfen
Denmark / Dorzostill 20 mg/ml ojendraber, oplosning
France / Dorzostill 20 mg/ml, collyre en solution
Netherlands / Dorzostill 2% eye drops, solution
Germany / Dorzo-Vision 20 mg/ml Augentropfen
Poland / Dorzostill 20 mg/ml eye drops, solution
Romania / Dorzostill 20 mg/ml, picaturi oftalmice, solutie
Italy / Dorzostill 2% collirio, soluzione