Dozhostill

Package Leaflet: Information for the Patient

Dorzostill, 20 mg/ml, Eye Drops, Solution

Dorzolamide

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

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

Package Leaflet Contents:

• 1. What is Dorzostill and what is it used for
• 2. Important information 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 IS DORZOSTILL AND WHAT IS IT USED FOR

Dorzostill is an eye drop solution containing dorzolamide, which belongs to a group of carbonic anhydrase inhibitors.
The eye drops are used to lower high pressure in the eye and to treat glaucoma. The drops can be used alone or with other eye drops that lower the pressure in the eye (so-called beta-adrenergic blocking agents).

• 2.

IMPORTANT INFORMATION BEFORE USING DORZOSTILL

When not to use Dorzostill

• if you are allergic (hypersensitive) to dorzolamide or any of the other 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, tell your doctor (or pharmacist) if:

• you have or have had liver problems
• you have or have had kidney stones
• you have corneal defects
• you are allergic to any medicines
• you have had eye surgery or are planning to have it
• you have eye injuries or eye infections
• you wear contact lenses (see "Important information about the ingredients of Dorzostill" below)

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

Children

Dorzolamide has been studied in infants and children under 6 years of age with elevated intraocular pressure or glaucoma. If additional information is required, you should contact your doctor.

Elderly patients

It has been shown that dorzolamide has the same effect in elderly patients as in younger patients.

Dorzostill and other medicines

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

Pregnancy and breastfeeding

Before using any medicine, consult your doctor.
Do not use Dorzostill during pregnancy or if you are planning to become pregnant.
The medicine should not be used during breastfeeding.

Driving and using machines

No studies have been conducted on the potential effects of the medicine on driving ability or using machines. Possible side effects of Dorzostill, such as dizziness and vision disturbances, may affect your ability to drive or use machines. If you experience these side effects, do not drive or use machines.

Important information about some 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 change the color of the lens. If you wear soft contact lenses, you should consult your doctor before using Dorzostill. It is essential to remove the lenses before using the medicine and wait at least 15 minutes before putting them back in.

• 3.

HOW TO USE DORZOSTILL

Always use Dorzostill exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Dosage and administration frequency
When using Dorzostill alone, the usual dose is one drop into the affected eye (or eyes) three times a day, for example, in the morning, at noon, and in the evening.
If your doctor has prescribed Dorzostill with a beta-adrenergic blocking agent to lower intraocular pressure, the usual dose is one drop of Dorzostill into the affected eye (or eyes) twice a day, for example, in the morning and evening.
When using Dorzostill and other eye drops, each medicine should be administered separately, with at least a 10-minute interval between them. If you are switching from another eye drop medicine that lowers intraocular pressure to Dorzostill, you should stop using the other medicine after a full day's dose and start using Dorzostill the next day.
Do not change the dosage of the medicine without consulting your doctor. If you are unsure, consult your doctor or pharmacist. If you need to stop treatment, you should contact your doctor immediately.
Administration instructions
Dorzostill is intended for use in the eye.
Do not touch the eye or the area around the eye with the dropper tip, as the medicine may become contaminated with bacteria, which can cause eye infections leading to serious eye damage or even vision loss. To avoid contaminating the container, avoid touching the dropper tip to any surface.
Always wash your hands before using the eye drops.

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

The dropper measures the correct dose of the medicine, so do not enlarge the dropper hole. After using all the doses, a small amount of medicine will remain in the bottom of the bottle. Do not be concerned, as the bottle contains a small amount of extra medicine to ensure that you receive the full dose prescribed by your doctor. Do not attempt to remove the remaining medicine from the bottle.

Using more than the recommended dose of Dorzostill

If you have used more drops than recommended or swallowed the medicine, contact your doctor immediately. If you swallow the medicine, you may experience symptoms such as drowsiness, and if you use too many drops, you may experience nausea, dizziness, headache, fatigue, tiredness, abnormal dreams, and difficulty swallowing.

Missing a dose of Dorzostill

It is essential to use Dorzostill as instructed 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, without taking a double dose to make up for the missed one.

Stopping treatment with Dorzostill

If you need to stop treatment, contact your doctor immediately.
If you have any further questions about using this product, 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 sensations

Common (may affect up to 1 in 10 people)

Eye disorders:sensitivity to light and eye pain due to inflammation of the front part of the eye (keratitis), conjunctivitis, eye surface disorders, tearing or itching of the eye (or eyes), inflammation or irritation of the eyelid (or eyelids) and/or skin around the eye (or eyes), blurred vision.
Other disorders:headache, nausea, fatigue, bitter taste in the mouth after using the drops.

Uncommon (may affect up to 1 in 100 people)

Eye disorders:uveitis.

Rare (may affect up to 1 in 1,000 people)

Eye disorders:eye irritation and redness, eye pain, swelling of the eye surface, eyelid crusts, transient myopia (reversible upon discontinuation of therapy), choroidal detachment, which may be accompanied by visual disturbances/changes (after eye surgery).
Other disorders:dizziness, numbness/tingling, nosebleeds, dry mouth, sore throat, allergic reactions including rash, urticaria, itching, swelling of the lips, eyes, and mouth, shortness of breath, and kidney stones.

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

Eye disorders:foreign body sensation in the eye.
Other disorders:shortness of breath (dyspnea)
Inform your doctor (or pharmacist) immediately if you experience any of these or other unusual symptoms, especially if you have any changes/visual disturbances while using Dorzostill after eye surgery.
If any of the side effects gets serious, or if you notice any side effects not listed in this package leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly to the:
Department for Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje Jerozolimskie 181C
PL-02 222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
email: ndl@urpl.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.

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 that month.
Do not use Dorzostill for more than 30 days after first opening the package. After 30 days, open a new bottle, even if there is still some medicine left in the old one.
The unopened package can be stored at a temperature below 30°C. After first opening, the package should be stored at a temperature below 25°C. The bottle should be kept in the outer carton to protect it from light.
Medicines should not be disposed of 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 PACK 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 of 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 colorless, isotonic, buffered, slightly viscous aqueous solution for use in the eye, without visible particles. It is available in sterile bottles with a dropper and screw cap made of plastic. Each bottle contains 5 ml of solution.
The bottles are packaged in cartons: 1 x 5 ml, 3 x 5 ml (pack containing 3 bottles), or 6 x 5 ml (pack containing 6 bottles). Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Bruschettini srl
Via Isonzo, 6
16147 Genoa, Italy
Phone:

For more information, contact your local representative of the Marketing Authorization Holder:

Poland

Pharm Supply Sp. z o.o.

Ul. Marconich 2, lok.9

PL 02-954 Warsaw

Phone/fax: +48 22 6423331 email: biuro@pharmsupply.com.pl

The medicinal product is authorized in the countries of 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 krople do oczu, roztwór
Romania / Dorzostill 20 mg/ml, picaturi oftalmice, solutie
Italy / Dorzostill 2% collirio, soluzione
Date of revision of the package leaflet: April 2017