Nodofree

Patient Information Leaflet: User Information

Nodofree, 20 mg/ml, Eye Drops, Solution

Dorzolamide

Please read carefully the contents of this leaflet before using the medicine, as it contains important information for the patient.

• -You should keep this leaflet, so you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Nodofree and what is it used for

Nodofree is an ophthalmic medicine in the form of sterile eye drops without preservatives, containing dorzolamide as the active substance. Dorzolamide belongs to a group of medicines called carbonic anhydrase inhibitors.
Nodofree is used to reduce increased pressure in the eye (eyes) and to treat glaucoma.
Nodofree can be used as the only eye medicine or together with other eye pressure-lowering medicines (called beta-adrenergic blocking agents).

2. Important information before using Nodofree

When not to use Nodofree:

• if the patient is allergic to dorzolamide or any of the other ingredients of this medicine (listed in section 6).
• if the patient has severe kidney function disorders or blood pH disorders.

Warnings and precautions

Before starting to use Nodofree, you should discuss it with your doctor:

• if the patient has had kidney stones in the past;
• if the patient has or has had liver function disorders;
• if the patient has corneal defects;
• if the patient has had an allergy to any medicine in the past;
• if the patient has had eye surgery or is planning such a procedure;
• if the patient has an eye infection or eye damage.

You should immediately consult a doctor if, while using this medicine, eye irritation occurs or any eye symptoms appear, such as eye redness, itching around the eye and/or eyelids.
You should stop using the medicine and immediately consult a doctor if you suspect an allergic reaction (symptoms: skin rash, itching, swelling around the mouth, eyes, and mouth, shortness of breath, wheezing).
If you wear contact lenses, you should consult a doctor before starting to use Nodofree. Before instilling the medicine, you should remove your contact lenses and put them back on at least 15 minutes after instillation.

Children and adolescents

The effect of dorzolamide has been studied in infants and children under 6 years of age with glaucoma or increased eye pressure. For further information, you should talk to your doctor, who will decide whether to use the medicine.

Use in elderly patients

Studies have shown similar effects of dorzolamide in elderly and younger patients.

Nodofree and other medicines

You should inform your doctor or pharmacist about all medicines you are using or plan to use.
You should inform your doctor about all medicines (including eye drops) you are using or plan to use, even those bought without a prescription, especially other carbonic anhydrase inhibitors, such as acetazolamide, or sulphonamides.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
Pregnancy
You should not use this medicine during pregnancy.
Breastfeeding
If treatment with this medicine is necessary, you should stop breastfeeding.
Fertility
Data from animal studies do not indicate that treatment with dorzolamide affects fertility in males and females. There are no data in humans.

Driving and using machines

During treatment with this medicine, dizziness and vision disturbances may occur, which may make it difficult to drive and use machines. You should not drive or use machines until these symptoms have resolved.

3. How to use Nodofree

This medicine should always be used exactly as your doctor has told you. If you are not sure, you should ask your doctor or pharmacist.
The correct dose and duration of treatment will be decided by your doctor.
If Nodofree is used as the only eye medicine, the recommended dose is one drop into the affected eye (eyes) three times a day, i.e., morning, noon, and evening.
If your doctor has prescribed Nodofree with another eye pressure-lowering medicine, the dose is one drop of Nodofree into the affected eye (eyes) twice a day, i.e., morning and evening.
If you are using other eye medicines at the same time as Nodofree, you should leave at least a 10-minute interval between instilling the different medicines. Eye ointments should be administered last.
If there is a need to replace the eye medicine you are currently using with Nodofree, you should stop using the other medicine (after administering the prescribed dose on the given day) and start using Nodofree the next day.
You should not change the dose of Nodofree without consulting your doctor.
Nodofree is a sterile solution that does not contain preservatives. See also section 6.

• 6. ( What Nodofree looks like and contents of the pack).

Before instilling the eye drops:

• In case of first use, before administering the eye drops, you should try using the bottle with the dropper by slowly squeezing it until one drop is released from the bottle, away from the eye.
• If you are sure you can instill a single drop, you should take the most comfortable position for instillation (you can sit, lie on your back, or stand in front of a mirror).

Instructions for use:

• 1. Before instilling the medicine, you should wash your hands carefully.
• 2. If the packaging or bottle is damaged, you should not use the medicine.
• 3. Before using the eye drops for the first time, you should unscrew the cap after making sure the tamper-evident ring on the cap is intact. While unscrewing, you will feel slight resistance until the ring breaks ( see figure 1.)
• 4. If the tamper-evident ring is loose, you should remove it before using the medicine, as it may fall into the eye and cause injury.
• 5. You should tilt your head back and then gently pull the lower eyelid down with your finger to form a "pocket" ( see figure 2.). You should avoid touching the tip of the dropper with the eye, eyelids, or fingers.
• 6. Instill one drop by slowly squeezing the bottle. The bottle should be gently squeezed in the middle so that the drop gets into the eye. Remember that there may be a few seconds' delay between squeezing the bottle and the drop being released ( see figure 3.). You should not squeeze the bottle too hard. If you have any doubts about using the medicine, you should consult your doctor, pharmacist, or nurse.
• 7. You should close your eye and press the inner corner of your eye with your finger for about two minutes. This helps prevent the medicine from entering the entire body.
• 8. You should avoid touching the tip of the dropper with the eye, eyelids, or fingers.
• 9. If your doctor has prescribed drops for the other eye, you should repeat the actions from points 5, 6, and 7.
• 10. After use and before closing the bottle, you should shake the bottle downwards without touching the tip of the dropper to remove any remaining liquid from the tip of the dropper. This is necessary to ensure that the next drops can be instilled. Immediately after use, you should tightly close the bottle ( see figure 4.). If a drop does not get into the eye, you should repeat the attempt.

Figure 1.
Figure 2.
Figure 3.
Figure 4.

Using more than the recommended dose of Nodofree

In case of instilling too many drops into the eye or accidental ingestion of the contents of the bottle, you should immediately contact a doctor.

Missing a dose of Nodofree

It is important to use this medicine as your doctor has told you. If you miss a dose, you should instill the medicine as soon as possible.
However, if it is almost time for the next dose, you should skip the missed dose and go back to your normal dosing schedule.
You should not use a double dose to make up for a missed dose.

Stopping the use of Nodofree

If you intend to stop using the medicine, you should immediately contact your doctor.
In case of any further doubts about using the medicine, you should consult 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, including hives, face, lip, tongue, and/or throat swelling, which may cause difficulty breathing or swallowing, or severe skin reactions with blistering or peeling of the skin, you should immediately stop using this medicine and contact a doctor.
During clinical trials with dorzolamide and after the medicine was marketed, the following side effects were reported:
Very common side effects (more than 1 in 10 patients)
Burning and stinging of the eyes.
Common side effects (between 1 in 10 and 1 in 100 patients)
Corneal disorders with eye pain and blurred vision (superficial punctate keratitis), tearing, discharge with itching of the eyes (conjunctivitis), eyelid inflammation/blepharitis, blurred vision, headache, nausea, bitter taste in the mouth, fatigue.
Uncommon side effects (between 1 in 100 and 1 in 1,000 patients)
Uveitis (inflammation of the uvea).
Rare side effects (between 1 in 1,000 and 1 in 10,000 patients)
Numbness and/or tingling of hands and/or feet, transient myopia (reversible upon discontinuation of treatment), fluid accumulation under the retina (after filtration surgery), eye pain, formation of crusts on the eyelids, low eye pressure, eye irritation with redness, kidney stones, dizziness, nosebleeds, throat irritation, dry mouth, local rash (contact dermatitis), severe skin reactions with blistering or peeling of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis), allergic reactions, such as hives, rash, itching. In rare cases, possible swelling of the lips, eyes, and mouth, shortness of breath, and wheezing.
Frequency not known (frequency cannot be estimated from the available data)
Shortness of breath.
Feeling of a foreign body in the eye (feeling that something is in the eye).
Palpitations, which may be rapid or irregular (heart pounding).
Increased heart rate.
Increased blood pressure.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. You can report side effects directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
You can also report side effects to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nodofree

Store in a temperature below 30°C.
After opening the bottle - store for 90 days in a temperature below 25°C.
The medicine should be discarded after 90 days from opening the bottle.
The medicine should be kept out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle.
The expiry date stated on the packaging is the last day of the given month.
The inscription on the packaging after the abbreviation "EXP" means the expiry date, and after the abbreviation "Lot" means the batch number.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Nodofree contains

• The active substance of Nodofree is dorzolamide. Each ml contains 20 mg of dorzolamide (as dorzolamide hydrochloride 22.26 mg). Each drop (about 35 µl) contains 0.70 mg of dorzolamide.
• The other ingredients are: hydroxyethylcellulose 6400-11900 mPa·s, mannitol, sodium citrate, sodium hydroxide (to adjust pH), water for injections.

What Nodofree looks like and contents of the pack

Nodofree is a sterile, colorless, clear, slightly viscous solution.
The medicine is available in white 5 ml (LDPE) bottles with a multi-dose dropper (HDPE) that prevents contamination of the solution with bacteria thanks to a system consisting of a silicone membrane and air filtration entering the bottle, with an HDPE cap with a tamper-evident seal, in a cardboard box.
Pack sizes:
1 bottle of 5 ml
3 bottles of 5 ml
Not all pack sizes may be marketed.

Marketing Authorization Holder

Zakłady Farmaceutyczne POLPHARMA S.A.
Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01

Manufacturer

Rafarm S.A.
Thesi Pousi Xatzi Agiou Louka
Paiania, 190 02
Greece
Date of last revision of the leaflet:April 2024