DORZOSTILL 2% Eye drops, solution

Зміст інструкції

1. WHAT DORZOSTILL IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU USE DORZOSTILL
3. HOW TO USE DORZOSTILL
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE DORZOSTILL
6. PACKAGE CONTENTS AND OTHER INFORMATION

Dorzostill 2% eye drops, solution

Dorzolamide

Generic medicine
contains important information for you.

• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT DORZOSTILL IS AND WHAT IT IS USED FOR

Dorzostill is an ophthalmic product (eye drops) containing dorzolamide, belonging to the category of
drugs called carbonic anhydrase inhibitors.
The eye drops are used for the reduction of elevated intraocular pressure and for the therapy of glaucoma. The eye drops
can be used alone or with another eye drop that reduces pressure in the eye (so-called beta-blockers).

2. WHAT YOU NEED TO KNOW BEFORE YOU USE DORZOSTILL

Do not take Dorzostill:

• if you are allergic to dorzolamide or to any of the other ingredients of this medicine (listed in section 6).
• if you have severe kidney problems
• if you have alterations of the pH (acid/base balance) of the blood

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

• you have or have had liver problems
• you have or have had kidney stones
• you have been told you have a corneal defect
• you have experienced allergies to other medicines
• you have recently, or are about to undergo eye surgery
• you have been injured in the eyes or have an eye infection
• you wear contact lenses (see “Important information regarding some excipients of Dorzostill”).

Consult your doctor immediately if you should experience eye irritation or any other new
problem such as eye redness or swelling of the superficial layer of the eye or eyelid.
Stop using Dorzostill and contact your doctor immediately if you think Dorzostill is
causing an allergic reaction (for example, skin rash, severe skin reactions or itching).

Children
Dorzolamide has been studied in infants and children under six years of age who presented
with elevated intraocular pressure/s, or who had been diagnosed with glaucoma. For more information, please
consult your doctor.

Elderly
Dorzolamide has been shown to have the same effects in elderly and young patients.

Other medicines and Dorzostill
Tell your doctor if you are taking, have recently taken or will take any other medicines, including other eye drops
or products that do not require a prescription, especially if you are taking high doses of
pain relievers containing salicylic acid (e.g. aspirin). Although there is no clinical evidence that
Dorzostill interacts with medicines containing salicylic acid, it is known that some other
drugs related to Dorzostill and taken orally interact with pain relievers containing
salicylic acid.
You should also inform your doctor if you are taking other carbonic anhydrase inhibitors such as
acetazolamide or a sulfa drug.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Dorzostill should not be used if you are or suspect you may be pregnant.
This eye drop should not be used during breastfeeding.

Driving and using machines
No studies have been conducted on the effects of Dorzostill on the ability to drive and operate machinery.
Possible undesirable effects of Dorzostill such as dizziness and visual disturbances may interfere with the
ability to drive or operate machinery. If these undesirable effects occur, you should avoid
driving or operating machinery.

Dorzostill contains the preservative benzalkonium chloride.
Benzalkonium chloride can cause eye irritation. This preservative can deposit in soft contact
lenses and can discolor them. If you wear soft contact lenses, you should ask your doctor before using Dorzostill. It is important that the lenses are removed before using the eye drops and not
reinserted before 15 minutes after using the eye drops.

3. HOW TO USE DORZOSTILL

Always use this medicine exactly as your doctor has told you. If you have any doubts, contact your
doctor or pharmacist.

Dosage and frequency of administration
When Dorzostill is used alone, the usual dose is one drop in the affected eye(s) three times a day, for
example in the morning, afternoon and evening.
If your doctor has prescribed you to use Dorzostill together with an eye drop containing a beta-blocker to
reduce eye pressure, the usual dose will be one drop of Dorzostill in the affected eye(s) twice a day, for
example in the morning and evening.
If you are using Dorzostill in combination with another eye drop, the second should be applied at least 10
minutes after the first. Otherwise, if Dorzostill is used instead of another eye drop used to reduce eye
pressure, you should stop taking the first after applying the correct daily dose, and start using Dorzostill from
the next day.
Do not change the dosage of the medicine without consulting your doctor and ask your doctor or pharmacist to
explain anything that is not clear to you. If you need to stop the treatment, consult your doctor immediately.

Instructions for use
Dorzostill is for external use in the eyes only.
Do not touch the eye or the area around the eye with the tip of the dropper. This may become contaminated with
bacteria which can cause eye infections potentially responsible for serious eye damage, up to loss of vision. To
avoid possible contamination of the container, avoid contact of the dropper tip with any surface.
Always wash your hands before instilling the eye drops.

• 1. To open the bottle, unscrew the cap.
• 2. Tilt your head back and lower the lower eyelid slightly to form a pouch between the eyelid and the eye.
• 3. Gently press the inverted bottle to dispense a single drop into the eye. Do not touch the eye, eyelid or anything else with the tip of the dropper. Keeping the affected eye closed, press with your finger against the corner of the closed eye (near the nose) for one minute.
• 4. Repeat steps 2 & 3 with the other eye if your doctor has prescribed it.

Immediately close the bottle after use by screwing the cap on firmly until it adheres to the
container. Do not overtighten.
The dropper tip delivers a drop of predefined volume; therefore, you should not widen the hole of the
dropper. After instilling all doses, some Dorzostill will remain in the bottle. You do not need to worry about
this, as the bottle contains an excess of Dorzostill in addition to the amount prescribed by your doctor. Do not
attempt to remove the excess Dorzostill from the bottle.

If you use more Dorzostill than you should
If you instill too many drops into the eye or ingest the product, contact your doctor immediately. The
symptoms include drowsiness, in case of ingestion; nausea, dizziness, headache, fatigue, tiredness,
nightmares and difficulty swallowing after instilling too many drops into the eye.

If you forget to use Dorzostill
It is important to use Dorzostill as prescribed by your doctor. If you forget a dose, take it as soon as
possible. However, if the next dose is due soon, skip the forgotten dose and continue with the next dose
according to the usual schedule.

If you stop using Dorzostill
If you need to stop the treatment, consult your doctor immediately.
If you have any doubts about the use of 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.
The potential side effects of Dorzostill may include:

Very common: (may affect more than 1 in 10 people)

Effects on the eye/eyes:burning and stinging pain

Common: (may affect up to 1 in 10 people)

Effects on the eye/eyes:sensitivity to light and eye pain resulting from inflammation of the front part of the eye (keratitis), conjunctivitis, effects on the eye surface,
tearing or itching of the eye/eyes, inflammation or irritation of the eyelid/eyelids and/or
the skin around the eye/eyes, blurred vision.

Effects on other parts of the body: headache, nausea, fatigue, bitter taste sensation after instillation
of the eye drops.

Uncommon: (may affect up to 1 in 100 people)

Effects on the eye/eyes:inflammation of the colored part of the eye

Rare: (may affect up to 1 in 1000 people)

Effects on the eye/eyes:irritation and redness of the eye/eyes, eye pain, swelling of the
superficial layer of the eye/eyes, crusting of the eyelids, temporary myopia (which disappears
upon discontinuation of treatment), choroidal detachment which may be accompanied by
changes/visual disturbances (following eye surgery).

Effects on other parts of the body: dizziness, sensation of numbness/tingling, nosebleed, dry mouth,
sore throat, severe skin reactions, allergic reactions including rash, hives, itching, possible
swelling of the lips, eyes and mouth, bronchospasm and kidney stones.

Frequency not known (the frequency cannot be estimated from the available data):

Effects on the eye/eyes:foreign body sensation in the eye (feeling that something is in the
eye)

Effects on other parts of the body: shortness of breath.
Report these or any other unusual symptoms to your doctor (or pharmacist) immediately, especially if you
experience changes or visual disturbances while using Dorzostill after eye surgery.
If any of the side effects gets worse, or if you notice any side effect

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/it/responsabili . By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE DORZOSTILL

Keep this medicine out of the sight and reach of children.
Do not use Dorzostill after the expiry date indicated on the bottle and the packaging after SCAD. The expiry
date refers to the last day of the month.
Once opened, Dorzostill can be stored for a maximum of 30 days. Open a new bottle
after 30 days even if the old bottle contains some residual product.
Store the unopened bottle at a temperature below 30°C. Once opened, store the
bottle at a temperature below 25°C. Always keep the bottle in the packaging to protect from light.
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. PACKAGE CONTENTS AND OTHER INFORMATION

What Dorzostill contains

• The active ingredient is dorzolamide. Each ml contains 20.0 mg of dorzolamide (equivalent to 22.3 mg of dorzolamide hydrochloride).
• The excipients are: hydroxyethylcellulose, mannitol, sodium citrate, sodium hydroxide/hydrochloric acid (for pH adjustment), benzalkonium chloride (preservative) and purified water.

What Dorzostill looks like and contents of the pack
Dorzostill is an eye drop in a colorless, isotonic, buffered, slightly viscous aqueous solution, free of
visible particles. It is available in sterile bottles with droppers and plastic caps. Each bottle contains 5
ml of solution.
The bottles are packaged in cartons of 1 x 5 ml (single bottle), 3 x 5 ml (carton containing 3 bottles) or
6 x 5 ml (carton containing 6 bottles). Not all pack sizes may be marketed.

Marketing Authorisation Holder and manufacturer
BRUSCHETTINI SRL - VIA ISONZO, 6 - 16147 GENOVA ITALY

This medicinal product has been authorised in the Member States of the EEA with the following names:
Austria /Dorzo-Vision 20 mg/ml eye drops

Denmark /Dorzostill 20 mg/ml eye drops, solution

France /Dorzostill 20 mg/ml, eye drops solution

Italy /Dorzostill 2% eye drops, solution

Germany /Dorzo-Vision 20 mg/ml eye drops

Netherlands /Dorzostill 2 % eye drops, solution

Poland /Dorzostill 20 mg/ml eye drops, solution

Romania /Dorzostill 20 mg/ml, ophthalmic solution