Oftidorix

Package Leaflet: Information for the Patient

Oftidorix, 20 mg/ml + 5 mg/ml, Eye Drops, Solution

Dorzolamid + 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.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, 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 inform their doctor. See section 4.

Table of Contents of the Leaflet:

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

1. What is Oftidorix and what is it used for

Oftidorix 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 blocking agents". These medicines lower intraocular pressure in different ways.

Oftidorix is prescribed to lower high intraocular pressure in the treatment of glaucoma, when treatment with eye drops containing only a beta-adrenergic blocking agent is not sufficient.

2. Important information before using Oftidorix

When not to use Oftidorix:

• if the patient is allergic to dorzolamide, timolol, or any of the other ingredients of this medicine (listed in section 6),
• if the patient currently has or has a history of respiratory problems such as asthma, severe chronic obstructive pulmonary disease (severe lung disease that causes wheezing, breathing difficulties and/or persistent cough),
• if the patient has a slow heart rate, heart failure or irregular heart rhythm (irregular heartbeat),
• if the patient has severe kidney problems or has had kidney stones in the past,
• if the patient has excessive acidification of the blood due to an accumulation of chlorides in the blood (hyperchloremic acidosis).

In case of doubts about whether to use this medicine, consult a doctor or pharmacist.

Warnings and precautions

Before using Oftidorix, consult a doctor.
Inform the doctor about any eye diseases or disorders that are currently present or have occurred in the past:

• ischemic heart disease (symptoms may include chest pain or tightness, shortness of breath or feeling of suffocation), heart failure, low blood pressure,
• heart rhythm disorders, e.g. slow heartbeat,
• breathing problems, asthma or chronic obstructive pulmonary disease,
• diseases related to poor circulation (e.g. Raynaud's disease, Raynaud's syndrome),
• diabetes, as timolol may mask the symptoms of low blood sugar,
• hyperthyroidism, as timolol may mask its symptoms. You should also tell your doctor
• before surgery about using Oftidorix, as timolol may affect the action of certain anesthetics.
• about any allergies or allergic reactions, including hives, facial, lip, tongue and/or throat swelling, which may cause difficulty breathing or swallowing.
• if the patient has muscle weakness or has been diagnosed with myasthenia gravis (myasthenia gravis).
• if the patient has an eye infection, eye injury, eye surgery or reaction involving new or worsening symptoms. If the patient experiences eye irritation or other eye symptoms such as redness or swelling of the eyelids, they should contact their doctor immediately.

In case of suspected allergic reaction or hypersensitivity (e.g. rash, severe skin reaction or eye redness or burning), discontinue using the medicine and contact a doctor immediately.
The administration of Oftidorix to the eye may affect the entire body.

Children and adolescents

Experience with Oftidorix in infants and children is limited.

Elderly patients

Studies with eye drops containing dorzolamide and timolol have shown similar efficacy in older and younger patients.

Patients with liver function disorders

Inform the doctor about any current or past liver diseases.

Oftidorix and other medicines

Oftidorix may affect other medicines or other medicines may affect the use of Oftidorix, including other eye drops used in glaucoma.
Inform the doctor about the use of or intention to use blood pressure-lowering medicines, heart medicines or diabetes medicines. Tell the doctor or pharmacist about all medicines currently being taken or recently taken, as well as any medicines the patient plans to take.
This is especially important if the patient:

• takes blood pressure-lowering medicines or heart medicines (calcium channel blockers, beta-adrenergic blocking agents or digoxin)
• takes medicines for heart rhythm disorders or irregular heartbeat, such as calcium channel blockers, beta-adrenergic blocking agents or digoxin

is taking other eye drops containing a beta-adrenergic blocking agent

• is taking other carbonic anhydrase inhibitors, such as acetazolamide
• is taking monoamine oxidase inhibitors (MAOIs)
• is taking a parasympathomimetic agent prescribed to help urinate. Parasympathomimetics are also a type of medicine sometimes used to restore normal bowel movements.
• takes opioid medicines, such as morphine, used to treat moderate or severe pain
• takes diabetes medicines
• takes antidepressant medicines such as fluoxetine and paroxetine
• takes sulfonamide medicines
• takes quinidine (used to treat heart diseases and some forms of malaria)

Pregnancy and breastfeeding

In pregnancy and during breastfeeding, or if pregnancy is suspected or planned, consult a doctor or pharmacist before using this medicine.
Pregnancy
Do not use Oftidorix during pregnancy.
Breastfeeding
Do not use Oftidorix during breastfeeding. Dorzolamide and timolol may pass into breast milk. Before using the medicine during breastfeeding, consult a doctor.

Driving and using machines

No studies have been conducted on the effect of the medicine on driving or using machines. Some side effects associated with the use of Oftidorix, such as blurred vision, may affect the ability to drive or use machines.
Patients who feel unwell or have blurred vision should not drive or use machines.
Oftidorix contains the preservative benzalkonium chloride.
Oftidorix contains 0.075 mg of benzalkonium chloride per 1 ml, which corresponds to 0.375 mg/5 ml of eye drop solution.
Benzalkonium chloride may be absorbed by soft contact lenses and may change the color of contact lenses. Before using this medicine, remove contact lenses and put them back 15 minutes later.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or corneal disorders (the transparent layer on the front of the eye). If you experience any abnormal sensation, stinging or eye pain after using this medicine, consult a doctor.

3. How to use Oftidorix

This medicine should always be used as directed by the doctor. In case of doubts, consult a doctor or pharmacist.
The correct dosage and duration of treatment are determined by the doctor.
The usual dose is one drop into the affected eye(s) in the morning and evening.
If other eye drops are used in addition to Oftidorix, wait at least 15 minutes before administering the next medicine. Eye ointments should be used last.
Do not change the dose of the medicine without consulting a doctor.
Do not touch the eye or its surroundings with the dropper tip. The dropper may become contaminated with bacteria, which can cause eye infection, leading to serious eye damage or even vision loss. To avoid contaminating the dropper, wash your hands before using the medicine and avoid touching the dropper tip to any surface. If the patient believes that the medicine may have become contaminated or an eye infection has occurred, they should contact their doctor immediately regarding further use of the current package of the medicine.
To ensure proper dosing, do not enlarge the dropper tip.

Instructions for use:

• 1. Before using the medicine for the first time, make sure that the seal on the bottle neck is intact. The space between the bottle and the cap is normal for an unopened bottle.
• 2. First, wash your hands and sit or stand comfortably.
• 3. Remove the cap from the bottle.
• 4. Tilt your head back and gently pull down the lower eyelid to create a pocket between the eyelid and the eye.
• 5. Turn the bottle upside down and press until one drop of medicine is released into the eye, as directed by the doctor (Fig. 1).

DO NOT TOUCH THE EYE OR EYELID WITH THE DROPPER TIP.
Fig. 1

• 6. Gently close your eyes.
• 7. Close your eye and press the inner corner of your eye for about two minutes. This helps prevent the medicine from entering the entire body.

Fig. 2

• 8. The actions from points 5-7 should be repeated for the second eye, if directed by the doctor.
• 9. After using the medicine, immediately replace the cap and close the bottle.

Having someone else help with instillation or using a mirror can make it easier to administer the medicine.

Using more Oftidorix than recommended

In case of administering too many drops or swallowing the contents of the bottle, among other symptoms, dizziness, breathing difficulties or a feeling of slowed heart rate may occur. Consult a doctor immediately.

Missing a dose of Oftidorix

It is important to use Oftidorix as directed by the doctor.
In case of missing a dose, take it as soon as possible. If it is almost time for the next dose, skip the missed dose and return to the regular dosing schedule.
Do not take a double dose to make up for the missed dose.

Stopping the use of Oftidorix

Before stopping the use of Oftidorix, consult a doctor.
In case of any further doubts about the use of this medicine, consult a doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Usually, you should continue using the medicine unless they are serious side effects.
Then consult a doctor or pharmacist. Do not stop using Oftidorix without consulting a doctor.
Generalized allergic reactions, including swelling under the skin occurring in the face and limbs, which may block the airways and cause difficulty swallowing or breathing, hives or itchy rash, local and generalized rash, itching, severe, sudden allergic reaction that can be life-threatening.
If the patient experiences allergic reactions, including hives, facial, lip, tongue and/or throat swelling, which may cause difficulty breathing or swallowing, discontinue using Oftidorix and contact a doctor immediately.
During clinical trials or after marketing authorization, the following side effects have been reported:
Very common (may affect more than 1 in 10 people):
Burning and stinging of the eyes, unusual taste sensation.
Common (may affect up to 1 in 10 people):
Redness around the eye (eyes), tearing or feeling of itching in the eye (eyes), corneal erosion (damage to the front layer of the eyeball), swelling and/or irritation around the eye (eyes), feeling of a foreign body in the eye (feeling that something is in the eye) , decreased sensitivity of the cornea (lack of feeling, if something enters the eye and lack of pain sensation), eye pain, dry eye syndrome, blurred vision, headache, sinusitis (feeling of tension or fullness in the nose), nausea,
weakness/fatigue and tiredness.
Uncommon (may affect up to 1 in 100 people):
Dizziness, depression, uveitis, vision disturbances, including refractive disturbances (sometimes due to the withdrawal of miotics) slow heart rate, fainting, breathing difficulties, shortness of breath ,
indigestion, kidney stones (often characterized by sudden onset of severe, incapacitating pain in the lower back and/or side, groin or abdomen).
Rare (may affect up to 1 in 1,000 people)
Systemic lupus erythematosus (a disease of the immune system that can cause inflammation of internal organs), tingling or numbness of hands and feet, sleep problems, nightmares, memory loss, worsening of objective and subjective symptoms of myasthenia gravis (muscle disorders), decreased libido, stroke, transient myopia, which resolves after treatment is stopped, separation of the layer of the eye under the retina and containing blood vessels after filtration procedures, which may cause vision disturbances, drooping eyelids (causing the eye to be half-closed), double vision,
formation of crusts on the eyelids, corneal edema (with symptoms of vision disturbances), low eye pressure, ringing in the ears, low blood pressure, congestive heart failure (heart disease characterized by shortness of breath and swelling of the feet and legs due to fluid accumulation in the body), swelling, cerebral ischemia, chest pain, palpitations (faster and/or irregular heartbeat), myocardial infarction, Raynaud's disease, swelling or feeling of cold hands or feet and decreased circulation in the hands and legs, leg cramps and/or leg pain when walking (claudication), respiratory failure, runny nose or feeling of nasal congestion, nasal bleeding, bronchospasm, cough, throat irritation, dry mouth, contact dermatitis, hair loss, white-silver rash (psoriasis-like rash), Peyronie's disease, which can cause curvature of the penis), allergic reactions such as: rash, hives, itching, in rare cases possible swelling of the lips, eyes and/or mouth, wheezing, severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis).
Unknown frequency (cannot be estimated from the available data):
Palpitations, which can be fast or irregular (palpitations), accelerated heart rate, increased blood pressure.
Similar to other eye medicines, timolol may be absorbed into the bloodstream. This may cause side effects similar to those observed after oral administration of beta-adrenergic blocking agents. The occurrence of side effects after local administration to the eye is less common than, for example, after oral or intravenous administration. Additional side effects include reactions encountered during the use of beta-adrenergic blocking agents used in the treatment of eye diseases.
Unknown frequency (frequency cannot be estimated from the available data):
low blood sugar, heart failure, heart rhythm disorders, abdominal pain, vomiting, muscle pain not caused by physical exertion, sexual disorders, hallucinations.

Reporting side effects

If side effects occur, including those not listed in this leaflet, inform a doctor, pharmacist or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Jerozolimskie Avenue 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, more information can be collected on the safety of the medicine.

5. How to store Oftidorix

Store out of sight and reach of children.
Do not use Oftidorix after the expiry date stated on the label of the bottle and on the carton after: EXP. The expiry date refers to the last day of that month. The abbreviation "Lot" means batch number.
There are no special precautions for storing the medicine at a certain temperature.
Oftidorix can be used for 28 days after the first opening of the bottle. Therefore, the bottle should be discarded 4 weeks after it is first opened, even if some solution remains. To remember this, write the opening date in the space provided on the carton.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Contents of the pack and other information

What Oftidorix contains

• The active substances of Oftidorix are dorzolamide and timolol. Each milliliter contains 20 mg of dorzolamide (as 22.26 mg of dorzolamide hydrochloride) and 5 mg of timolol (as 6.83 mg of timolol maleate).
• The other ingredients are: mannitol (E 421), hydroxyethylcellulose, benzalkonium chloride (as a preservative), sodium citrate (E 331), sodium hydroxide (E 524) to adjust the pH and water for injections.

What Oftidorix looks like and what the pack contains

Oftidorix is a sterile, clear, slightly viscous, colorless, aqueous solution of eye drops.
Oftidorix is contained in a white, opaque polyethylene bottle with a medium density polyethylene dropper tip and a high-density polyethylene cap, secured with a tamper-evident ring. The bottle contains 5 ml of eye drop solution.
Oftidorix is available in the following pack sizes: 1, 3 or 6 bottles with a dropper containing 5 ml of eye drop solution. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

BAUSCH + LOMB IRELAND LIMITED
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer

Pharmathen S.A.
6 Dervenakion str.
15351 Pallini, Attiki
Greece
Famar S.A.
Plant A, 63 Agiou Dimitriou Street
174 56 Alimos
Greece
Bausch Health Poland sp. z o.o.
Przemysłowa 2
35-959 Rzeszów
Poland
Bausch Health Poland sp. z o.o.
Kosztowska 21
41-409 Mysłowice
Poland

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Bulgaria
Офтидорикс 20 mg/ml + 5mg/ml капки за очи, разтвор
Lithuania
Oftidorix 20 mg/5mg/ml akių lašai, tirpalas
Latvia
Oftidorix 20 mg + 5 mg/ml acu pilieni, šķīdums
Poland
Oftidorix

Date of last revision of the leaflet: