Dimaz

Package leaflet: Information for the user

Dimaz 20 mg/ml eye drops, solution

dorzolamide
Generic Medicine
Please read all of this leaflet carefully before you start using this medicine, as it contains important information for you.

• 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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Dimaz is and what it is used for

Dimaz contains dorzolamide, which belongs to a group of medicines called "carbonic anhydrase inhibitors". Dimaz is available as a preservative-free eye drop solution.
Dimaz is used to reduce elevated intraocular pressure and for the treatment of glaucoma.
Dimaz may be used alone or in combination with other medicines that reduce intraocular pressure (called beta-blockers).

2. What you need to know before using Dimaz

Do not use Dimaz

• if you are allergic to dorzolamide or to any of the other ingredients of this medicine (listed in section 6).
• If you have abnormal blood pH (hyperchloremic acidosis), severe renal impairment or kidney problems, or a history of kidney stones. If you have any doubts about using this medicine, consult your doctor or pharmacist.

Warnings and precautions
Talk to your doctor or pharmacist before using Dimaz.
Inform your doctor or pharmacist about any current or past medical conditions, including eye problems and eye surgeries, as well as any allergies to other medicines.
If you develop eye irritation or any new eye problems such as redness or swelling of the eyelids, contact your doctor immediately.
If you suspect that Dimaz is causing an allergic reaction (e.g. rash, severe skin reaction, or itching), stop using the medicine and contact your doctor immediately.
If you wear contact lenses, you must consult your doctor before using Dimaz.

Children
Dorzolamide (with preservatives) has been studied in infants and children under 6 years of age with increased intraocular pressure or who have been diagnosed with glaucoma. For further information, consult your doctor.

Elderly
In studies with dorzolamide, effects were similar in elderly and younger patients.

Use in patients with hepatic impairment
Inform your doctor if you currently have or have previously had any liver problems.

Other medicines and Dimaz
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 another carbonic anhydrase inhibitor such as acetazolamide (used to treat glaucoma) or other medicines to reduce edema (excessive fluid retention), or medicines containing sulfonamides (used, for example, to treat infections).

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
This medicine should not be used during pregnancy. Inform your doctor if you are pregnant or intend to become pregnant.

Breastfeeding
This medicine should not be used during breastfeeding. Inform your doctor if you are breastfeeding or intend to breastfeed.

Fertility
There are no data suggesting that treatment with dorzolamide affects human fertility.

Driving and using machines
No studies have been conducted on the effects on the ability to drive vehicles or operate machinery.
Dimaz may cause side effects such as dizziness and blurred vision, which could impair your ability to drive or operate machinery. Wait until you feel well or your vision is clear before driving or operating machinery. It is your responsibility to assess whether you are fit to drive a vehicle or perform work requiring heightened attention. One of the factors that may affect your ability in this regard is the use of medicines due to their effects and/or side effects.
A description of these effects and side effects can be found in other sections. Therefore, read all the information contained in this leaflet carefully. If you are unsure, consult your doctor or pharmacist.

3. How to use Dimaz

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Your doctor will determine the appropriate dosage and duration of treatment.

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 recommended using this medicine to lower eye pressure in combination with a beta-blocker eye drop, the recommended dose is one drop of Dimaz instilled into the affected eye(s) in the morning and one drop in the evening.

If you are using Dimaz together with another eye drop, the drops should be administered at least 10 minutes apart. Ocular ointments should be administered last.

Do not change the dosage without first consulting your doctor.

Avoid letting the tip of the bottle come into contact with the eye or surrounding area. Contamination with bacteria may occur, which could lead to eye infections and potentially cause serious eye damage, including loss of vision. To prevent any contamination of the bottle, wash your hands before using this medicine and ensure that the tip of the single-dose container does not touch any surface.

Before instilling the eye drops:

• When using the medicine for the first time, before administering the drop into the eye, practice using the dropper by slowly squeezing the bottle to release one drop into the air, away from the eye.
• Once you feel confident about administering one drop at a time, choose the most comfortable position for instilling the drops (you may sit, lie on your back, or stand in front of a mirror).

Instructions for use:

1. Wash your hands thoroughly before using this medicine.
2. Do not use the medicine if the package or bottle is damaged.
3. When using the medicine for the first time, unscrew the cap only after ensuring that the tamper-evident band is intact. You should feel slight resistance until this tamper-evident band breaks ( see figure 1 ).

Figure 1

4. If the tamper-evident band is loose, discard the bottle, as it could fall into the eye and cause injury.
5. Tilt your head backward and gently pull down the lower eyelid to form a pouch between the eyelid and the eye ( see figure 2 ). Avoid contact between the dropper tip and the eye, eyelid, or fingers to prevent contamination of the solution.

Figure 2

6. Instill one drop into the pouch by slowly squeezing the bottle. Gently press the center of the bottle to release one drop into the eye. There may be a short delay between squeezing the bottle and the drop coming out ( see figure 3 ).

Do not squeeze too hard. If you are unsure how to administer the medicine, ask your doctor, pharmacist, or nurse.

Figure 3
7. Close the eye and press with a finger on the inner corner of the eye for about two minutes ( see
figure 4 ). This helps prevent the medicine from passing into the rest of the body.

Figure 4

8. Repeat steps 5, 6, and 7 in the other eye if your doctor has instructed you to do so.
9. After use and before recapping the bottle, invert it downward once without touching the dropper tip to remove any residual liquid from the tip. This is necessary to ensure proper delivery of subsequent drops. After instillation, screw the cap back onto the bottle ( see figure 5 ).

Figure 5
If a drop misses the eye, try again.

If you use more Dimaz than you should
If you instill too many drops into the eye, if you have swallowed some of the contents of the bottle, or if, for example, a child has accidentally ingested the drops, contact your doctor or hospital for risk assessment and advice.

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

If you stop using Dimaz
If it becomes necessary to stop treatment with this medicine, contact your doctor immediately.

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 everyone gets them.
If allergic reactions occur, such as hives, swelling of the face, lips, tongue, and/or throat causing
difficulty in breathing or swallowing, or severe skin reactions with blistering and peeling, stop using
this medicine immediately and contact your doctor or go to the nearest emergency room.

The following side effects have been reported with dorzolamide:

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

• Burning and eye irritation.

Common (may affect up to 1 in 10 people)

• Corneal disease with eye pain and blurred vision (superficial punctate keratitis), tearing, eye discharge with itching (conjunctivitis), irritation/inflammation of the eyelid, blurred vision.
• Headache.
• Nausea.
• Bitter taste sensation.
• Fatigue.

Uncommon (may affect up to 1 in 100 people)

• Inflammation of the iris and ciliary body of the eye (iridocyclitis).

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

• Tingling and numbness in the hands and feet.
• Temporary myopia (which resolves upon discontinuation of treatment), fluid accumulation under the retina (choroidal detachment after filtering surgery), eye pain, crusting of the eyelids, ocular hypotension, corneal edema (with symptoms of visual disturbances), eye irritation with redness.
• Kidney stones.
• Dizziness.
• Nosebleeds, throat irritation.
• Dry mouth.
• Localized skin rashes (contact dermatitis), severe skin reactions with blistering or peeling (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Allergic-type reactions including skin rashes, hives, itching. In rare cases, possible swelling of lips, eyes and mouth, shortness of breath, and even more rarely, wheezing.

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

• Shortness of breath.
• Foreign body sensation 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, please inform your doctor or pharmacist. You can also report side effects directly via the Italian Medicines Agency website: https://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 Dimaz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and on the label of the
vial after Exp.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
After opening, store below 30°C.
5 ml vial
Discard 60 days after first opening the vial, even if some solution remains.
10 ml vial
Discard 90 days after first opening the vial, even if some solution remains.
To help you remember the date of first opening, write the date on the carton.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Dimaz contains

• The active substance is dorzolamide. Each ml contains dorzolamide hydrochloride equivalent to 20 mg of dorzolamide. Each drop (approximately 35 µl) contains 0.70 mg of dorzolamide.
• The other components are: hydroxyethylcellulose, mannitol (E421), sodium citrate (E331), sodium hydroxide (E524) (for pH adjustment), and purified water.

Description of the appearance of Dimaz and contents of the pack
Dimaz is a clear, colourless, viscous solution.
This medicinal product is available in white LDPE bottles with a multidose dropper applicator in HDPE, equipped with a silicone valve and a tamper-evident screw cap in HDPE, and presented in a cardboard box.
Pack sizes:
1 bottle x 5 ml
3 bottles x 5 ml
1 bottle x 10 ml
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Alfa Intes Industria Terapeutica Splendore S.r.l.
Via Fratelli Bandiera 26 - 80026 Casoria (NA)
Italy

Manufacturer
Warszawskie Zakłady Farmaceutyczne Polfa S.A.
ul. Karolkowa 22/24, 01-207 Warszawa
Poland

This medicinal product is authorised in the European Economic Area countries with the following names:

| Member State | Medicinal Product Name | |------------------------|-----------------------------------------------| | Austria | Itoco 20 mg/ml - Augentropfen, Lösung | | Czech Republic | Dorzolamide Polpharma | | Denmark | Itoco | | Finland | Itoco | | France | Ofriri 20 mg/mL, collyre en solution | | Ireland | Itoco 20 mg/ml eye drops, solution | | Italy | Dimaz | | Norway | Dimaz | | Portugal | Dimaz | | Sweden | Dimaz |