Nodofree

Nodofree, 20 mg/ml, eye drops, solution
Dorzolamide
Please read the following information carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are similar.
• If you experience any adverse effects, including any not listed in this leaflet, inform your 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 preservative-free eye drops containing dorzolamide as the active substance. Dorzolamide belongs to a group of medicines called carbonic anhydrase inhibitors.
Nodofree is used to reduce elevated intraocular pressure (in the eye[s]) and to treat glaucoma.
Nodofree may be used alone as a single eye medication or in combination with other eye medicines that lower intraocular pressure (known as beta-blockers).

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 impairment or blood pH disturbances.

Warnings and precautions
Before starting treatment with Nodofree, discuss the following with your doctor:

• if the patient previously had kidney stones;
• if the patient has or has had liver function disorders;
• if the patient has corneal defects;
• if the patient previously experienced an allergic reaction to any medicine;
• if the patient has had or is scheduled for eye surgery;
• if the patient has an eye infection or eye injury.

Seek immediate medical advice if, during treatment with this medicine, eye irritation or any eye-related symptoms occur, such as eye redness, itching in or around the eye and/or eyelids.
Discontinue use of the medicine and seek immediate medical advice if an allergic reaction is suspected (symptoms: skin rash, itching, swelling of the lips, eyes or mouth, shortness of breath, wheezing).
If the patient wears contact lenses, consult a doctor before starting treatment with Nodofree. Contact lenses must be removed before instilling the drops and may be reinserted at least 15 minutes after administration.

Children and adolescents
The effect of dorzolamide has been studied in infants and children under 6 years of age with glaucoma or elevated intraocular pressure. For further information, consult a doctor, who will decide whether to use the medicine.

Use in elderly patients
Studies have shown similar effects of dorzolamide in elderly patients compared to younger individuals.

Nodofree and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or planning to take.
Inform your doctor about all medicines (including eye drops) the patient is currently using or planning to use, even those purchased without a prescription, especially other carbonic anhydrase inhibitors such as acetazolamide, or sulfonamides.

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
This medicine should not be used during pregnancy.

Breastfeeding
If treatment with this medicine is necessary, breastfeeding must be discontinued.

Effect on fertility
Animal studies do not indicate that dorzolamide treatment affects fertility in males or females. There is no data available in humans.

Driving and operating machinery
Dizziness and visual disturbances may occur during treatment with this medicine, which may impair the ability to drive or operate machinery. Do not drive or operate machinery until these symptoms have resolved.

3. How to use Nodofree

This medicine should always be used according to the doctor's instructions. If in doubt, consult your doctor or pharmacist.
The correct dosage and duration of treatment will be determined by the doctor.
If Nodofree is used as the sole medication, the recommended dose is one drop into the affected eye(s) three times daily – in the morning, at noon, and in the evening.
If the doctor has prescribed Nodofree in combination with another medicine for lowering intraocular pressure, the recommended dose is one drop of Nodofree into the affected eye(s) twice daily – in the morning and in the evening.
If the patient is using other eye medications together with Nodofree, an interval of at least 10 minutes should be maintained between the administration of each medicine. Ointments should be administered last.
If there is a need to switch from another eye drop medication to Nodofree, treatment with the previous medicine should be discontinued (after administering the recommended dose for that day), and treatment with Nodofree should begin the following day.
Do not change the dose of Nodofree without consulting your doctor.
Nodofree is a sterile solution that does not contain preservatives. See also section 6 (What Nodofree looks like and contents of the pack).

Before instilling eye drops:

• At first use, before administering the drop into the eye, the patient should practice using the dropper bottle by slowly squeezing it until one drop is dispensed away from the eye.
• If the patient feels confident about instilling a single drop, they should assume the most comfortable position for instillation (sitting, lying on the back, or standing in front of a mirror).

Instructions for use:

1. Before instilling the medicine, the patient should wash hands thoroughly.
2. Do not use the medicine if the packaging or bottle is damaged.
3. Before first use, unscrew the cap after ensuring that the tamper-evident ring on the cap is intact. During unscrewing, the patient will feel slight resistance until the ring breaks (see Figure 1).
4. If the tamper-evident ring is loose, remove it before using the medicine, as it may fall into the eye and cause injury.
5. The patient should tilt the head backward and gently pull down the lower eyelid with a finger to form a "pocket" between the eyeball and the eyelid (see Figure 2). Avoid contact between the dropper tip and the eye, eyelids, or fingers.
6. Instill one drop by slowly squeezing the bottle. Gently squeeze the middle part of the bottle so that the drop enters the patient's eye. Note that there may be a delay of several seconds between squeezing the bottle and the release of the drop (see Figure 3). The patient should not squeeze the bottle too hard. If in doubt about how to use the medicine, the patient should consult a doctor, pharmacist, or nurse.
7. The patient should close the eye and press the inner corner of the eye with a finger for about two minutes. This helps prevent the medicine from being absorbed into the rest of the body.
8. Avoid contact between the dropper tip and the eye, eyelids, or fingers.
9. If the doctor has prescribed drops for the second eye, repeat steps 5, 6, and 7.
10. After use and before closing the bottle, shake the bottle downward without touching the dropper tip to remove any residual liquid from the tip. This is necessary to ensure proper function for subsequent drops. Immediately after use, close the bottle tightly (see Figure 4).
11. If the drop misses the eye, repeat the instillation attempt.

Figure 1. Figure 2. Figure 3. Figure 4.
Use of a higher than recommended dose of Nodofree
If too many drops have been instilled into the eye or if the contents of the bottle have been accidentally ingested, contact a doctor immediately.
Missed dose of Nodofree
It is important to use this medicine as directed by the doctor. If a dose is missed, instill the drop as soon as possible.
However, if it is almost time for the next dose, skip the missed dose and return to the regular dosing schedule.
Do not use a double dose to make up for a missed dose.
Discontinuing use of Nodofree
If the patient intends to stop using the medicine, they should contact the doctor immediately.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
If the patient experiences allergic reactions, including hives, swelling of the face, lips, tongue
and (or) throat, which may cause difficulty in breathing or swallowing, or severe skin reactions
with blistering or peeling of the skin, the use of this medicine must be stopped immediately and
immediate medical advice must be sought.
During clinical trials and post-marketing use of dorzolamide, the following adverse reactions have been reported:

Very common adverse reactions (occurring in more than 1 in 10 patients)
Burning and stinging of the eyes.

Common adverse reactions (occurring in 1 to 10 in 100 patients)
Corneal disorders with eye pain and blurred vision (superficial punctate keratitis), watery eyes, eye discharge with itching (conjunctivitis), eyelid irritation/inflammation, blurred vision, headache, nausea, bitter taste in the mouth, fatigue.

Uncommon adverse reactions (occurring in 1 to 10 in 1,000 patients)
Iridocyclitis (inflammation of the iris and ciliary body).

Rare adverse reactions (occurring in 1 to 10 in 10,000 patients)
Tingling and (or) numbness of the hands and (or) feet, transient myopia (resolving after discontinuation of treatment), fluid accumulation under the retina (choroidal detachment following filtration surgery), eye pain, crusting of the eyelids, low intraocular pressure, corneal edema (with visual disturbance symptoms), eye irritation with redness, kidney stones, dizziness, nosebleeds, throat irritation, dry mouth, local skin 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, swelling of the lips, eyes and oral cavity, shortness of breath and wheezing may occur.

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, possibly rapid or irregular heartbeat (palpitations).
Increased heart rate.
Increased blood pressure.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 4921301, Fax: +48 22 4921309, Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Nodofree

Store below 30°C.
After first opening the bottle – store for 90 days at a temperature below 25°C.
The medicine should be discarded 90 days after first opening the bottle.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the bottle.
The expiry date refers to the last day of the specified month.
The marking on the packaging following the abbreviation "EXP" indicates the expiry date, and following the abbreviation "Lot" indicates the batch number.
Medicines should not be disposed of 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 pack and other information

What Nodofree contains

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

What Nodofree looks like and contents of the pack
Nodofree is a sterile, colourless, transparent, slightly viscous solution.
The medicine is available in white 5 ml bottles (LDPE), with a multidose dropper (HDPE)
preventing bacterial contamination of the solution, thanks to a system consisting of
a silicone membrane and filtration of air drawn into the bottle, with a closure cap made of HDPE
and a tamper-evident seal, packed in a cardboard box.
Pack sizes:
1 bottle of 5 ml
3 bottles of 5 ml
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. 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