Dorzostill

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Dorzostill 2% eye drops, solution

Dorzolamide
Generic medicine
Please read this leaflet carefully before you start using this medicine because
it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, inform 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 using 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 drop) containing dorzolamide, belonging to a class of
medicines called carbonic anhydrase inhibitors.
The eye drop is used to reduce elevated intraocular pressure and for the treatment of glaucoma. The eye drop can
be used alone or in combination with another eye drop that reduces intraocular pressure (so-called beta-blockers).

2. WHAT YOU SHOULD KNOW BEFORE USING 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 blood pH imbalances (acid-base disturbances).

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

• you have or have previously had liver problems;
• you have or have previously had kidney stones;
• you have been told you have a corneal defect;
• you have had allergic reactions to other medicines;
• you have recently undergone or are about to undergo eye surgery;
• you have suffered an eye injury or have an eye infection;
• you wear contact lenses (see the section “Important information about certain excipients in Dorzostill”).

Contact your doctor immediately if you develop eye irritation or any new symptoms such as eye redness or swelling of the outer layer of the eye or eyelid.
Stop using Dorzostill and contact your doctor immediately if you suspect that 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 had elevated intraocular pressure or who had been diagnosed with glaucoma. For further information, consult your doctor.

Elderly
Dorzolamide has been shown to have similar effects in elderly and younger patients.

Other medicines and Dorzostill
Inform your doctor if you have recently used, are currently using, or plan to use any other medicines, including other eye drops or over-the-counter products, especially if you are taking high doses of painkillers containing salicylic acid (e.g. aspirin). Although there is no clinical evidence showing that Dorzostill interacts with medicines containing salicylic acid, it is known that other oral medications related to Dorzostill can interact with salicylic acid-containing painkillers.
You should also inform your doctor if you are taking other carbonic anhydrase inhibitors such as acetazolamide or sulfa medicines.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Dorzostill must not be used during confirmed or suspected pregnancy.
This eye drop must not be used during breastfeeding.

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

Dorzostill contains the preservative benzalkonium chloride.
Benzalkonium chloride may cause eye irritation. This preservative may be deposited in soft contact lenses and may cause discoloration. If you wear soft contact lenses, you should consult your doctor before using Dorzostill. It is important to remove your contact lenses before using the eye drops and not to reinsert them for at least 15 minutes after using the eye drops.

3. HOW TO USE DORZOSTILL

Use this medicine exactly as directed by your doctor. 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 or eyes three times a day, for example in the morning, afternoon, and evening.
If your doctor has prescribed Dorzostill to be used together with a beta-blocker eye drop to reduce intraocular pressure, the usual dose will be one drop of Dorzostill in the affected eye or eyes twice daily, for example in the morning and evening.
If Dorzostill is used in combination with another eye drop, the second should be administered at least 10 minutes after the first. Otherwise, if Dorzostill is used to replace another eye drop previously used to reduce intraocular pressure, discontinue the first medication after administering the correct daily dose, and start using Dorzostill from the following day.
Do not change the dosage of the medicine without consulting your doctor, and ask your doctor or pharmacist to explain anything you do not understand. If you need to stop treatment, consult your doctor immediately.
Instructions for use

Dorzostill is for ophthalmic use only.

Do not touch the eye or the area around the eye with the dropper tip. This could become contaminated with
bacteria that may cause eye infections potentially leading to serious eye damage, up to and including loss of vision. To avoid possible contamination of the container, avoid contact between the dropper tip and any surface.
Always wash your hands before instilling the eye drops.

1. To open the bottle, unscrew the cap.
2. Tilt your head backward and gently pull down the lower eyelid to form a pouch between the eyelid and the eye.
3. Gently squeeze the inverted bottle until a single drop is dispensed into the eye. Do not touch the eye, eyelid, or any other surface with the dropper tip. With the affected eye closed, press with your finger against the inner corner of the closed eye (near the nose) for one minute.
4. Repeat steps 2 & 3 for the other eye if prescribed by your doctor.

Immediately close the bottle after use by screwing the cap back on until it fits securely on the container. Do not over-tighten.
The dropper tip delivers a drop of predetermined volume; therefore, do not enlarge the dropper opening. After administering all prescribed doses, some Dorzostill will remain in the bottle. This is normal, as the bottle contains an excess amount of Dorzostill beyond the quantity 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. Symptoms may 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 miss a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule.
If you stop using Dorzostill
If you need to stop treatment, consult your doctor immediately.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicinal product can cause adverse reactions, although not everyone experiences them.
Potential adverse reactions of Dorzostill may include:
Very common: (may affect more than 1 in 10 people)
Eye-related effects: burning and stinging pain
Common: (may affect up to 1 in 10 people)
Eye-related effects: light sensitivity and eye pain due to inflammation of the front part of the eye (keratitis), conjunctival inflammation, effects on the surface of the eye, tearing or eye itching, inflammation or irritation of the eyelid(s) and/or skin around the eye(s), blurred vision.
Effects on other parts of the body: migraine, nausea, fatigue, bitter taste sensation after eye drop instillation.
Uncommon: (may affect up to 1 in 100 people)
Eye-related effects: inflammation of the colored part of the eye
Rare: (may affect up to 1 in 1,000 people)
Eye-related effects: eye irritation and redness, eye pain, swelling of the outer layer of the eye, eyelid crusting, temporary myopia (which resolves 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, epistaxis, dry mouth, throat irritation, severe skin reactions, allergic reactions including rash, urticaria, itching, possible swelling of the lips, eyes and mouth, bronchospasm and kidney stones.
Frequency not known (frequency cannot be estimated from the available data):
Eye-related effects: sensation of foreign body in the eye (feeling that something is in the eye)
Effects on other parts of the body: shortness of breath.
Immediately report to your doctor (or pharmacist) these or any other unusual symptoms, particularly if visual changes or disturbances occur while using Dorzostill following eye surgery.
If any of the adverse reactions worsen, or if you notice any adverse reaction not listed in this leaflet, inform your doctor or pharmacist.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting adverse reactions, 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 stated on the bottle and carton after EXP. 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 previous bottle still contains residual product.
Store the unopened bottle at a temperature below 30°C. After opening, store the bottle at a temperature below 25°C. Always keep the bottle in the carton to protect it from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Dorzostill contains

• The active substance 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 isotonic, buffered, slightly viscous, colourless aqueous eye drop solution free from visible particles. It is supplied in sterile dropper bottles with plastic caps. Each bottle contains 5 ml of solution.
The bottles are packed 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 EEA Member States under the following names:
Austria / Dorzo-Vision 20 mg/ml eye drops, solution
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, solution
Netherlands / Dorzostill 2% eye drops, solution
Poland / Dorzostill 20 mg/ml eye drops, solution
Romania / Dorzostill 20 mg/ml, ophthalmic drops, solution

This leaflet was last approved in [MM/YYYY]