Oftidorix

Patient Information Leaflet

Oftidorix, 20 mg/ml + 5 mg/ml, eye drops, solution
Dorzolamide + Timolol
Please read this leaflet 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 the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor. See section 4.

Table of contents :

1. What Oftidorix is and what it is 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 Oftidorix is and what it is 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 known as "beta-blockers". These medicines reduce intraocular pressure in various ways.

Oftidorix is prescribed to reduce elevated intraocular pressure in the treatment of glaucoma, when treatment with eye drops containing a beta-blocker alone is insufficient.

2. Important information before using Oftidorix

When not to use Oftidorix:

• if the patient is allergic to dorzolamide, timolol, or any of the ingredients of this medicine (listed in section 6),
• if the patient currently has or has previously had respiratory disorders such as asthma, severe chronic obstructive pulmonary disease (severe lung disease causing wheezing, breathing difficulties and/or persistent cough),
• if the patient has slow heart function, heart failure, or cardiac arrhythmias (irregular heartbeat),
• if the patient has severe kidney function impairment or has previously had kidney stones,
• if the patient has developed excessive blood acidity due to accumulation of chlorides in the blood (hyperchloremic acidosis).

If in doubt whether this medicine should be used, consult a doctor or pharmacist.
Warnings and precautions
Before using Oftidorix, consult a doctor.
Inform the doctor about any eye diseases or disorders currently present or experienced in the past:

• ischemic heart disease (symptoms may include chest pain or tightness, shortness of breath, or a feeling of suffocation), heart failure, low blood pressure,
• disturbances in heart rate, e.g. slow heartbeat,
• breathing problems, asthma, or chronic obstructive pulmonary disease,
• conditions related to poor circulation (e.g. Raynaud's disease, Raynaud's syndrome),
• diabetes, because timolol may mask symptoms of low blood sugar,
• hyperthyroidism, because timolol may mask its symptoms. Also inform the doctor
  • before surgery about the use of Oftidorix, as timolol may alter the effects of certain anesthetic drugs.
  • about any allergies or allergic reactions, including hives, facial swelling, swelling of the lips, tongue and/or throat, which may cause difficulty in breathing or swallowing.
  • if the patient has muscle weakness or diagnosed myasthenia (myasthenia gravis).
  • if the patient develops an eye infection, eye injury, eye surgery, or a reaction involving new or worsening symptoms. If the patient experiences eye irritation or other eye-related symptoms such as redness or eyelid swelling, contact a doctor immediately.

If you suspect that Oftidorix is causing an allergic reaction or hypersensitivity (e.g. rash, severe skin reaction, or eye redness or burning), discontinue use of the medicine immediately and contact a doctor without delay.
Administration of Oftidorix into the eye may affect the entire body.
Children and adolescents
Experience with the use of Oftidorix in infants and children is limited.
Elderly patients
Studies with eye drops containing dorzolamide and timolol have shown similar drug effects in older and younger individuals.
Patients with liver function disorders
Inform the doctor about any current or past liver diseases.
Oftidorix and other medicines
Oftidorix may affect other medicines being used, or other medicines may affect the use of Oftidorix, including other eye drops used for glaucoma.
Inform the doctor about the use of, or intended use of, medicines that lower blood pressure, heart medications, or diabetes medicines. Inform the doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient plans to use.
This is particularly important if the patient:

• is taking medicines that lower blood pressure or medicines used to treat heart diseases (calcium channel blockers, beta-blockers, or digoxin)

• is taking medicines for heart rhythm disorders or irregular heartbeat, such as calcium channel blockers, beta-blockers, or digoxin

• is using other eye drops containing a beta-blocking agent

• is using other carbonic anhydrase inhibitors, such as acetazolamide

• is using monoamine oxidase inhibitors (MAOIs)

• is using a parasympathomimetic medicine prescribed to assist urination. Parasympathomimetics are also a specific type of medicine sometimes used to restore normal intestinal peristalsis.

• is taking opioid medicines, e.g. morphine, used to treat moderate or severe pain

• is taking medicines for diabetes

• is taking antidepressants such as fluoxetine and paroxetine

• is taking a sulfonamide-type medicine

• is taking quinidine (used to treat heart conditions and certain forms of malaria)

Pregnancy and breastfeeding
During pregnancy and breastfeeding, or if pregnancy is suspected, or if planning to become pregnant, consult a doctor or pharmacist before using this medicine.
Pregnancy
Do not use Oftidorix during pregnancy.
Breastfeeding
Do not use Oftidorix while breastfeeding. Dorzolamide and timolol may pass into breast milk. Consult a doctor before using this medicine during breastfeeding.
Driving and operating machinery
No studies on the effect of the medicine on the ability to drive or operate machinery have been conducted. Some adverse effects associated with the use of Oftidorix, such as blurred vision, may affect the ability to drive and/or operate machinery.
Patients who feel unwell or have blurred vision should not drive or operate machinery.
Oftidorix contains a preservative – benzalkonium chloride.
Oftidorix contains 0.075 mg of benzalkonium chloride per ml, equivalent to 0.375 mg/5 ml of eye drop solution.
Benzalkonium chloride may be absorbed by soft contact lenses and may alter the color of contact lenses. Remove contact lenses before using this medicine and reinsert them 15 minutes after administration.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or corneal disorders (the transparent layer at the front of the eye). If you experience abnormal sensations, stinging, or eye pain after using this medicine, consult a doctor.

3. How to use Oftidorix

This medicine should always be used exactly as recommended by your doctor. If in doubt, consult your 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 being used at the same time as Oftidorix, wait at least 15 minutes before applying the next medicine. Ointments should be used last.
Do not change the dose of this medicine without consulting your doctor.
Do not let the dropper tip touch the eye or surrounding areas. The dropper may become contaminated with bacteria that could cause an eye infection, potentially leading to serious eye damage or even loss of vision. To prevent contamination, wash your hands before using the medicine and avoid contact between the dropper tip and any surface. If you suspect the medicine may have become contaminated or if an eye infection occurs, contact your doctor immediately regarding continued use of the current container.
To ensure correct dosing, do not enlarge the dropper tip.

Instructions for use:

1. Before first use, check that the seal on the neck of the bottle is intact. The space between the bottle and 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 backward and gently pull down the lower eyelid to create a small pocket between the eyelid and the eye.
5. Turn the bottle upside down and gently squeeze until one drop of medicine falls into the eye, as directed by your doctor (Fig. 1).

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

6. Gently close your eyes.
7. Close the eye and press gently on the inner corner of the eye for about two minutes. This helps prevent the medicine from draining into the rest of the body.

Fig. 2

8. Repeat steps 5–7 for the second eye if instructed by your doctor.
9. Immediately replace and tighten the cap on the bottle after using the medicine.

Having another person assist with instillation or using a mirror may make administering the medicine easier.

Use of a higher than recommended dose of Oftidorix
If too many drops are administered into the eye or if the contents of the bottle are swallowed, symptoms such as dizziness, breathing difficulties, or a sensation of slowed heart rate may occur. Seek immediate medical attention.

Missed dose of Oftidorix
It is important to use Oftidorix exactly as prescribed by your doctor.
If a dose is missed, take it 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 one.

Stopping Oftidorix treatment
Do not stop using Oftidorix without first consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
Treatment should usually be continued unless the adverse reactions are serious.
In such a case, consult a doctor or pharmacist. Do not discontinue treatment with
Oftidorix without consulting your doctor.
Generalised allergic reactions, including subcutaneous swelling around the face and limbs,
which may block the airways causing difficulty in swallowing or breathing, urticaria or itchy rash,
localised and generalised rash, itching, severe sudden life-threatening allergic reaction.
If a patient experiences allergic reactions, including urticaria, swelling of the face, lips, tongue and (or)
throat, which may cause difficulty in breathing or swallowing, treatment with Oftidorix must be discontinued
immediately and medical advice must be sought without delay.
The following adverse reactions have been reported during clinical trials or after marketing authorization:

Very common (may affect more than 1 in 10 people):
Burning and stinging sensation in the eyes, unusual taste sensation.

Common (may affect up to 1 in 10 people):
Redness around the eye(s), tearing or itchy eye(s), corneal erosion (damage to the front layer of the eyeball),
swelling and/or irritation around the eye(s), foreign body sensation in the eye (feeling that something is in the eye),
decreased corneal sensitivity (lack of sensation if something enters the eye, lack of pain sensation), eye pain,
dry eye syndrome, blurred vision, headache, sinusitis (feeling of pressure or fullness in the nose), nausea,
weakness/fatigue and tiredness.

Uncommon (may affect up to 1 in 100 people):
Dizziness, depression, iritis (inflammation of the iris), visual disturbances, including refractive disorders (sometimes due to discontinuation of miotics), bradycardia (slow heart rate), fainting, breathing difficulties, dyspnoea, indigestion, kidney stones (often characterised by sudden onset of severe, debilitating pain in the lower back and/or flank, groin or abdomen).

Rare (may affect up to 1 in 1,000 people):
Systemic lupus erythematosus (an autoimmune disease that may 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 disorder), decreased libido, stroke, transient myopia resolving after discontinuation of treatment, detachment of the choroid (the vascular layer beneath the retina) following filtration procedures, which may lead to visual disturbances, ptosis (drooping eyelid causing the eye to be partially closed), double vision, formation of crusts on the eyelids, corneal oedema (with symptoms of visual disturbance), low intraocular pressure, tinnitus (ringing in the ears), hypotension (low blood pressure), congestive heart failure (heart disease characterised by breathlessness and swelling of feet and legs due to fluid accumulation in the body), oedema, cerebral ischaemia, chest pain, palpitations (faster and/or irregular heartbeat), myocardial infarction (heart attack), Raynaud's phenomenon, swelling or sensation of cold hands or feet, reduced circulation in arms and legs, leg cramps and/or leg pain while walking (claudication), respiratory failure, nasal discharge or sensation of nasal congestion, nosebleeds, narrowing of the airways in the lungs causing breathing difficulties, cough, throat irritation, dry mouth, diarrhoea, contact dermatitis, alopecia (hair loss), silvery-white scaly rash (psoriasiform rash), Peyronie's disease (which may cause penile curvature), allergic reactions such as: rash, urticaria, pruritus (itching), in rare cases possible swelling of lips, eyes and oral cavity, wheezing, severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Frequency not known (frequency cannot be estimated from available data):
Pounding heartbeat, which may be fast or irregular (palpitations), tachycardia (increased heart rate), increased blood pressure.

As with other ophthalmic medications, timolol may be absorbed systemically via the bloodstream. This may lead to adverse reactions similar to those observed with oral administration of beta-adrenergic blocking agents. Adverse reactions following topical ocular administration are less frequent than, for example, with oral or intravenous administration. Additional adverse reactions include those commonly observed with beta-adrenergic blocking agents used in the treatment of eye diseases.

Frequency not known (frequency cannot be estimated from available data):
Hypoglycaemia (low blood glucose), heart failure, cardiac arrhythmias, lower abdominal pain, vomiting, non-exertional muscle pain, sexual dysfunction, hallucinations.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration 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
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Oftidorix

Keep the medicine out of the 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 the specified month. The abbreviation "Lot" indicates the batch number.
No special precautions regarding storage temperature are required.
Oftidorix can be used for 28 days after the first opening of the bottle. The bottle should therefore be discarded 4 weeks after first opening, even if some solution remains. To help remember, write down the date of opening in the designated space on the carton.
Medicines must 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 Oftidorix contains

• The active substances are dorzolamide and timolol. Each millilitre contains 20 mg of dorzolamide (as 22.26 mg dorzolamide hydrochloride) and 5 mg of timolol (as 6.83 mg timolol maleate).
• Other components are: mannitol (E 421), hydroxyethylcellulose, benzalkonium chloride (as preservative), sodium citrate (E 331), sodium hydroxide (E 524) for pH adjustment, and water for injections.

What Oftidorix looks like and contents of the pack
Oftidorix is a sterile, clear, slightly viscous, colourless, watery solution for eye drops.
Oftidorix is supplied in a white, opaque polyethylene bottle with a low-density polyethylene dropper tip closure and a high-density polyethylene screw cap secured with a tamper-evident ring. The bottle contains 5 ml of solution for eye drops.
Oftidorix is available in pack sizes of 1, 3 or 6 bottles with dropper containing 5 ml of solution for eye drops. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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.
ul. Przemysłowa 2
35-959 Rzeszów
Poland
Bausch Health Poland sp. z o.o.
ul. Kosztowska 21
41-409 Mysłowice
Poland
This medicinal product is authorised 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