Nodom Combi

Package Leaflet: Information for the Patient

Nodom Combi, 20 mg/ml + 5 mg/ml, Eye Drops, Solution

Dorzolamide + Timolol

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

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

Table of Contents of the Leaflet

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

1. What is Nodom Combi and what is it used for

Nodom Combi contains two active substances: dorzolamide and timolol.

• Dorzolamide belongs to a group of medicines called “carbonic anhydrase inhibitors”.
• Timolol belongs to a group of medicines called “beta-adrenergic blockers”. These medicines together lower the pressure in the eye through two different mechanisms.

Nodom Combi is used to lower high pressure in the eye in the treatment of glaucoma when treatment with eye drops containing only a beta-adrenergic blocker is not enough.

2. Important information before using Nodom Combi

When not to use Nodom Combi:

• if you are allergic to dorzolamide hydrochloride, timolol maleate, or any of the other ingredients of this medicine (listed in section 6);
• if you have a respiratory disease such as asthma (current or in the past) or chronic obstructive pulmonary disease (severe lung disease that causes wheezing, difficulty breathing, and/or a long-lasting cough);
• if you have a slow heart rate, severe heart failure, or irregular heart rhythm (irregular heartbeat);
• if you have severe kidney disease or disorders, or have had kidney stones in the past;
• if you have excessive acidification of the blood due to accumulation of chloride ions in the blood (hyperchloremic acidosis).

In case of doubt, whether Nodom Combi can be used, consult a doctor or pharmacist.

Warnings and precautions

Before starting to use Nodom Combi, discuss it with your doctor.
Tell your doctor about all current or past eye disorders and diseases, especially if you have:

• ischemic heart disease (symptoms may include chest pain or feeling of pressure in the chest, shortness of breath, or feeling of choking), heart failure, low blood pressure;
• heart rate disorders, such as slow heart rate;
• breathing problems, asthma, or chronic obstructive pulmonary disease;
• diseases related to poor blood circulation (such as Raynaud's disease or Raynaud's syndrome);
• diabetes, as timolol may mask the subjective and objective symptoms of low blood sugar;
• hyperthyroidism, as timolol may mask the subjective and objective symptoms of hyperthyroidism.

Before surgery, tell your doctor that you are using Nodom Combi, as timolol may affect the action of certain anesthetics.
Also, inform your doctor about any allergies or allergic reactions, such as hives, facial swelling, lip swelling, tongue and/or throat swelling, which can cause difficulty breathing or swallowing.
Tell your doctor if you have muscle weakness or have been diagnosed with myasthenia.
If you experience any eye irritation or new eye problems, such as eye redness or eyelid swelling, contact your doctor immediately.
If you suspect that Nodom Combi is causing an allergic reaction or hypersensitivity (e.g., skin rash, severe skin reaction, or eye redness and itching), discontinue use of this medicine and contact your doctor immediately.
Tell your doctor about any infection or injury to the eyeball, eye surgery, other reactions, or worsening of symptoms.
When Nodom Combi is instilled into the eye, it may cause systemic effects.
If you wear soft contact lenses, consult your doctor before using this medicine.

Use in children

Experience with Nodom Combi in infants and children is limited.

Use in elderly patients

In studies where Nodom Combi was used, the effect of the medicine in elderly patients and younger patients was similar.

Use in patients with liver function disorders

Tell your doctor if you have current or past liver disorders.

Nodom Combi and other medicines

Nodom Combi may affect the action of other medicines or other medicines used by the patient may affect the action of Nodom Combi, including other eye drops used to treat glaucoma.
Tell your doctor if you are taking or plan to take blood pressure-lowering medicines, heart medicines, or diabetes medicines.
Tell your doctor or pharmacist about any other medicines you are taking or plan to take. This is especially important if you:

• are taking medicines to lower high blood pressure or medicines used to treat certain heart diseases (such as calcium channel blockers, beta-adrenergic blockers, or digoxin);
• are taking medicines to treat heart rhythm disorders or irregular heartbeat (such as calcium channel blockers, beta-adrenergic blockers, or digoxin);
• are using other eye drops containing beta-adrenergic blockers;
• are taking other carbonic anhydrase inhibitors, such as acetazolamide;
• are taking monoamine oxidase inhibitors (MAOIs) for depression;
• are taking parasympathomimetic medicines prescribed to facilitate urination; Parasympathomimetic medicines are also a type of medicine sometimes used to restore normal bowel movements.
• are taking opioid medicines (such as morphine) used to treat moderate or severe pain;
• are taking diabetes medicines;
• are taking antidepressant medicines, including fluoxetine and paroxetine;
• are taking sulfonamide medicines;
• are taking quinidine (used to treat heart diseases and certain types of malaria).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Do not use Nodom Combi during pregnancy.
Do not use Nodom Combi during breastfeeding. Nodom Combi may pass into breast milk. During breastfeeding, consult your doctor before taking any medicine.
Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines

No studies have been conducted on the effect on the ability to drive or operate machines. Some side effects associated with the use of Nodom Combi, such as blurred vision, may affect the ability to drive or operate machines. Patients who feel unwell or have blurred vision should not drive or operate machines until these symptoms have resolved.

Nodom Combi contains benzalkonium chloride

The medicine contains 0.075 mg of benzalkonium chloride per 1 ml of solution.
Benzalkonium chloride may be absorbed by soft contact lenses and change their color. Remove contact lenses before instillation and wait at least 15 minutes before reinserting. Benzalkonium chloride may also cause eye irritation, especially in people with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If you experience any abnormal sensations in the eye, stinging, or eye pain after using the medicine, contact your doctor.

3. How to use Nodom Combi

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Your doctor will determine the correct dosage and duration of treatment.
The recommended dose is one drop into the affected eye(s) twice daily, for example, in the morning and evening.
If you are using Nodom Combi with other eye drops, wait at least 10 minutes between administering Nodom Combi and the other medicine.
Do not change the dose of the medicine without consulting your doctor.
Do not touch the eye or the area around the eye with the dropper tip. It may become contaminated with bacteria, which can cause an eye infection leading to serious eye damage, even loss of vision. To avoid contaminating the dropper, do not touch the tip to any surface. If you suspect that the medicine may have become contaminated or you have developed an eye infection, contact your doctor immediately about continuing to use this bottle.
To ensure proper dosing, do not enlarge the dropper tip.

Instructions for proper use:

It is recommended to wash your hands before administering the drops.
Administering the drops may be easier if you do it in front of a mirror.

• 1. Before using the medicine for the first time, make sure that the seal on the bottle neck is intact. In a new package, the gap between the bottle and the cap is normal.
• 2. Unscrew the bottle cap.
• 3. Tilt your head back and gently pull the lower eyelid down to create a pocket between the eyelid and the eyeball.
• 4. Turn the bottle upside down and press it so that one drop falls into the eye. DO NOT TOUCH THE EYE OR EYELID WITH THE DROPPER TIP.
• 5. 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 (see the diagram below).
• 6. Repeat steps 3, 4, and 5 with the second eye, if your doctor has instructed you to do so.
• 7. Immediately after use, screw the cap back on and close the bottle.

If the drop does not get into the eye, try again.

Using more Nodom Combi than prescribed

If too many drops are administered to the eye or the contents of the bottle are swallowed, dizziness, breathing difficulties, or a feeling of slow heart rate may occur.
Contact your doctor immediately.

Missing a dose of Nodom Combi

It is important to use Nodom Combi as directed by your doctor.
If you miss a dose, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and return to your normal dosing schedule.
Do not take a double dose to make up for a missed dose.

Stopping the use of Nodom Combi

If you want to stop using the medicine, discuss it with your doctor first.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Nodom Combi can cause side effects, although not everybody gets them.
Continue using the drops unless severe side effects occur. If you are unsure, contact your doctor or pharmacist. Do not stop using Nodom Combi without consulting your doctor.
Generalized allergic reactions include swelling under the skin, which can occur in areas such as the face and limbs, and can narrow the airways, causing difficulty swallowing or breathing, hives, or itchy rash, local and generalized rash, itching, severe, sudden, life-threatening allergic reaction.
The following side effects have been reported with Nodom Combi or one of its ingredients during clinical trials or after marketing:

Very common(may affect more than 1 in 10 people):
Burning and stinging in the eye/eyes, change in taste sensation.
Common(may affect up to 1 in 10 people):
Eye redness or around the eye, tearing or feeling of itching in the eye/eyes, corneal erosion (damage to the front layer of the eyeball), swelling or irritation of the eye/eyes or around the eye/eyes, feeling of a foreign body in the eye, decreased corneal sensitivity (lack of feeling that something has entered the eye and lack of feeling pain), eye pain, feeling of dryness of the eyeball, blurred vision, headache, sinusitis (feeling of tension and fullness in the nose), nausea (nausea), weakness and fatigue.
Uncommon(may affect up to 1 in 100 people):
Dizziness, depression, uveitis, vision disorders, including changes in refraction (in some cases due to withdrawal of pupil-constricting medicines), slow heart rate, loss of consciousness, breathing difficulties (apnea), indigestion, kidney stones (often with sudden onset of severe, crampy pain in the lower back or side, groin, or abdomen).
Rare(may affect up to 1 in 1,000 people):
Systemic lupus erythematosus (an immune system disease that can cause inflammation of internal organs), tingling and numbness of hands or feet, sleep problems, nightmares, memory loss, worsening of myasthenia symptoms (muscle disorder), decreased libido, separation of the layer of the eye under the retina and containing blood vessels after filtration surgery (may cause vision disorders), drooping eyelids (causing the eye to be half-closed), double vision, eyelid sticking together, corneal edema (causing vision disorders), low eye pressure, ringing in the ears, low blood pressure, changes in heart rhythm or rate, chest pain, congestive heart failure (heart disease characterized by shortness of breath and swelling of the feet and ankles due to fluid retention), swelling (fluid accumulation), cerebral ischemia (reduced blood flow to the brain), chest pain, palpitations (rapid and/or irregular heartbeat), myocardial infarction, Raynaud's phenomenon, swelling of hands or cold hands and feet, decreased blood flow to the hands and feet, muscle cramps in the legs or leg pain when walking (intermittent claudication), shortness of breath, feeling of lack of air, runny nose or feeling of nasal congestion, nosebleeds, bronchospasm (narrowing of the airways in the lungs causing difficulty breathing), cough, throat irritation, dry mouth, diarrhea, contact dermatitis, hair loss, white-silver skin rash (psoriasis-like rash), Peyronie's disease (may cause penis curvature), allergic reactions such as rash, hives, itching, in rare cases possible swelling of lips, eyes, and mouth, wheezing, or severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis).
As with other eye medicines, timolol is absorbed into the bloodstream, which can cause side effects similar to those observed after oral administration of beta-adrenergic blockers. Side effects occur less frequently after topical administration of eye drops than after oral administration or injections.
Among the additional side effects listed, reactions typical of the therapeutic group of beta-adrenergic blockers used in ophthalmic diseases are included.
Frequency not known(cannot be estimated from the available data):
Low blood sugar, heart failure, heart rhythm disorders, abdominal pain, vomiting, muscle pain unrelated to physical exertion, sexual function disorders, shortness of breath, feeling of a foreign body in the eye (feeling that something is in the eye), hallucination, strong heartbeat that may be rapid or irregular (palpitations), rapid heartbeat, increased blood pressure.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported 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 Nodom Combi

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and carton after: EXP. The expiry date refers to the last day of the month stated.
The inscription on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot indicates the batch number.
There are no special precautions for storage temperature of the medicinal product.
The shelf life after opening the bottle is 28 days. Therefore, after 4 weeks from opening the bottle, it should be discarded, even if some solution remains. To make it easier to remember the opening date of the bottle, write it on the carton.
Medicines should not be disposed of via wastewater or household waste. 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 Nodom Combi contains

• The active substances of the medicine are dorzolamide and timolol. Each milliliter contains 20 mg of dorzolamide (as dorzolamide hydrochloride 22.26 mg) and 5 mg of timolol (as timolol maleate 6.83 mg).
• The other ingredients are: mannitol, hydroxyethylcellulose, benzalkonium chloride 50% solution, sodium citrate, sodium hydroxide 1N (to adjust pH), water for injections.

What Nodom Combi looks like and what the pack contains

Nodom Combi is a sterile, clear, slightly viscous, colorless aqueous solution.
It is available in MDPE bottles with an LDPE dropper and an HDPE cap with a tamper-evident seal, containing 5 ml of eye drop solution.
Pack sizes: 1, 3, or 6 bottles of 5 ml each.
Not all pack sizes may be marketed.

Marketing authorization holder

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
Phone: +48 22 364 61 01

Manufacturer

Famar S.A., Plant A
63 Agiou Dimitriou Street, 174 56 Alimos
Greece
Pharmathen S.A.
6 Dervenakion str., 15351 Pallini, Attiki
Greece
Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
Date of last revision of the leaflet:April 2023