DIMAZ 20 mg /Ml Eye Drops, Solution

Зміст інструкції

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

Dimaz20 mg/ml eye drops, solution
dorzolamide
Generic Equivalent

Read 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those 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 you use 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 is Dimaz and what is it used for

Dimaz contains dorzolamide which belongs to a group of medicines called "carbonic anhydrase inhibitors". Dimaz is available as an eye drop without preservatives.
Dimaz is used to lower increased intraocular pressure and for the therapy of glaucoma.
Dimaz can be used alone or with other medicines that lower intraocular pressure
(called beta-blockers).

2. What you need to know before you use 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 kidney impairment or kidney problems, or a history of kidney stones. If you have any doubts about using this medicine, ask your doctor or pharmacist.

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

Children
Dorzolamide (with preservatives) has been studied in infants and children under 6 years of age with
increased pressure in the eye(s) or who have been diagnosed with glaucoma. For more
information, ask your doctor.

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

Use in patients with hepatic impairment
Tell your doctor about any liver problems you currently have or have suffered from in the past.

Other medicines and Dimaz
Tell 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 a
other carbonic anhydrase inhibitor such as acetazolamide (used to treat glaucoma) or other
medicines to reduce edema (excess fluid retention) or medicines containing sulfonamide
(used e.g. for the treatment of infections).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
This medicine should not be used during pregnancy. Tell your doctor if you are pregnant or
are planning a pregnancy.
Breastfeeding
This medicine should not be used during breastfeeding. Tell your doctor if you are breastfeeding or
intend to breastfeed.
Fertility
There are no data to suggest an effect of treatment with dorzolamide on human fertility.

Driving and operating machinery
Studies on the effects on the ability to drive and operate machinery have not been conducted.
Dimaz may cause undesirable effects such as dizziness and blurred vision that may impair
your ability to drive and 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 able to drive
a vehicle or perform work that requires greater attention. One of the factors that can
influence your abilities regarding these aspects is the use of medicines due to their effects and/or
side effects.
The description of these effects and side effects can be found in other sections. Therefore read
all the information contained in this leaflet as a guide. If you are not sure, ask your doctor or
pharmacist.

3. How to use Dimaz

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your
doctor or pharmacist.
The doctor will determine the appropriate dosage and duration of treatment.
When this medicine is used alone, the recommended dose is equivalent to one drop in the affected eye(s)
in the morning, afternoon and evening.
If the doctor has recommended the use of this medicine to lower eye pressure
together with an eye drop containing a beta-blocker, the recommended dose is one drop of Dimaz to
be instilled in the affected eye(s) in the morning and one in the evening.
If you are using Dimaz with another eye drop, the drops must be instilled at least 10 minutes apart.
Eye ointments should be administered last.
Do not change the dosage without first consulting your doctor.
Avoid contact between the tip of the bottle and the eye or the surrounding area. Contamination with bacteria may occur, which can cause eye infections resulting in serious eye damage up to loss of vision. To prevent any type of contamination of
the bottle, wash your hands before using this medicine and make sure that the tip of the single-dose container does not come into contact with any surface.

Before instilling the eye drops:

• When using the medicine for the first time, before dispensing the drop into the eye, you must first practice using the dropper by slowly pressing the bottle to dispense a drop into the air, away from the eye.
• When you are confident that you can dispense one drop at a time, choose the most comfortable position for instilling the drops (you can 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. If the packaging or the bottle is damaged, the medicine should not be used.
• 3. When using the medicine for the first time, the cap must be unscrewed after making sure that the safety seal is intact. You should feel slight resistance until this tamper-evident seal breaks ( see figure 1).

Figure 1

• 4. If the tamper-evident seal is loose, it should be discarded as it could fall into the eye and cause injury.
• 5. Tilt your head back and gently pull down the lower eyelid, forming a pocket between the eyelid and the eye ( see figure 2). Avoid contact between the tip of the bottle and the eye, eyelid or fingers to prevent contamination of the solution.

Figure 2

• 6. One drop should be instilled into the pocket by slowly pressing the bottle. Gently press the bottle in the center and let a drop fall into the eye. There may be a few seconds delay between when you press the bottle and the drop comes out ( see figure 3).

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

Figure 3
7 Close your eye and press with your finger on the inner corner of the eye for about two minutes ( see

figure 4). This helps to 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 told you to do so.
• 9. After use and before re-capping the bottle, it must be turned upside down once without touching the tip of the dropper, to remove any residual liquid on the tip. This is necessary to ensure the dispensing of subsequent drops. After instillation, the cap of the bottle must be screwed on ( see figure 5).

Figure 5
If a drop does not reach the eye, you should try again.

If you use more Dimaz than you should
If you instill too many drops into the eye, if you have ingested 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 instructions.

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

If you stop using Dimaz
If it is necessary to stop treatment with this medicine, contact your doctor immediately.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience allergic reactions such as hives, swelling of the face, lips, tongue, and/or
throat causing difficulty in breathing and swallowing, or severe skin reactions with
blistering and peeling, stop treatment with this medicine and
contact your doctor immediately 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 irritation of the eyes.

Common (may affect up to 1 in 10 people)

• Corneal disease with eye pain and blurred vision (superficial punctate keratitis), tearing, itchy eye discharge (conjunctivitis), eyelid irritation/inflammation, 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 of the hands and feet.
• Temporary myopia (which resolves with discontinuation of treatment), fluid formation under the retina (choroidal detachment after filtering surgery), eye pain, crusting on the eyelids, decreased intraocular pressure, 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 more rarely wheezing.

Frequency not known (the 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 that may be fast or irregular (palpitations).
• Increased heart rate.
• Increased blood pressure.

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 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 pack 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 particular storage conditions.
Once opened, store at a temperature below 30°C.
Vial of 5 ml
Dispose of 60 days after first opening of the vial, even if some solution remains.
Vial of 10 ml
Dispose of 90 days after first opening of the vial, even if some solution remains.
To help you remember the date of first opening, write the date on the pack.
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. Contents of the pack and other information

What Dimaz contains

• The active ingredient 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 ingredients 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, colorless, viscous solution.
This medicine is available in white LDPE bottles with a multi-dose dropper applicator in
HDPE with a silicone valve and a tamper-evident HDPE screw cap, and 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 Member States of the European Economic Area with the
following denominations:
Member StateMedicinal Product Name
Austria Itoco 20 mg/ml - Eye drops, solution
Czech Republic Dorzolamide Polpharma
Denmark Itoco
Finland Itoco
France Ofriri 20 mg/mL, solution for eye drops
Ireland Itoco 20 mg/ml eye drops, solution
Italy Dimaz
Norway Dimaz
Portugal Dimaz
Sweden Dimaz