Vizidor duo
Poland
Table of Contents
Patient Information Leaflet
Vizidor Duo, (20 mg + 5 mg)/ml, eye drops, solution
Dorzolamide + Timolol
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.
- 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 personally. 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of the leaflet
- What Vizidor Duo is and what it is used for
- What you need to know before you use Vizidor Duo
- How to use Vizidor Duo
- Possible side effects
- How to store Vizidor Duo
- Contents of the pack and other information
1. What Vizidor Duo is and what it is used for
Vizidor Duo 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-blockers".
Both active substances reduce intraocular pressure, but they work in different ways.
Vizidor Duo is indicated for the treatment of glaucoma to reduce elevated intraocular pressure,
when eye drops containing only a beta-blocker are not sufficient.
Vizidor Duo eye drops is a sterile solution that does not contain preservatives.
2. Important information before using Vizidor Duo
When not to use Vizidor Duo
- 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 previously had respiratory disorders such as asthma or severe chronic obstructive pulmonary disease (a serious lung condition that may cause wheezing, difficulty breathing, and/or persistent cough);
- if the patient has bradycardia (slow heart rate), heart failure, or cardiac arrhythmias (irregular heartbeat);
- if the patient has severe kidney disease or kidney problems, or has previously had kidney stones;
- if the patient has excessive blood acidity caused by accumulation of chloride ions in the blood (hyperchloremic acidosis).
If the patient is unsure whether they can use this medicine, they should contact their doctor or pharmacist.
Warnings and precautions
Before starting treatment with Vizidor Duo, discuss this with your doctor.
Inform your doctor about all current or past medical conditions, especially eye problems, including:
- coronary heart disease (symptoms may include chest pain or tightness, shortness of breath, or angina), heart failure, low blood pressure;
- heart rhythm disorders, such as slow heart rate;
- breathing problems, asthma, or chronic obstructive pulmonary disease;
- circulatory disorders (such as Raynaud's disease or Raynaud's syndrome);
- diabetes, because timolol may mask the subjective and objective symptoms of low blood sugar;
- hyperthyroidism, because timolol may mask its subjective and objective symptoms.
Do not use this medicine if the patient has previously experienced contact hypersensitivity to silver.
Before undergoing surgery, inform the doctor that you are using Vizidor Duo, as timolol may alter the effects of certain drugs used during anesthesia.
Also inform your doctor about any allergies or anaphylactic reactions, including hives, facial swelling, swelling of the lips, tongue, and/or throat, which may cause difficulty breathing or swallowing.
Tell your doctor if the patient has muscle weakness or diagnosed myasthenia gravis (Myasthenia gravis).
Contact your doctor immediately if eye irritation occurs or any new eye problems develop, such as redness of the eye or eyelid swelling.
If the patient suspects that Vizidor Duo is causing an allergic reaction or hypersensitivity (e.g., skin rash, severe skin reaction, or redness and itching of the eye), stop using this medicine immediately and contact a doctor.
Inform your doctor if an eye infection or eye injury occurs, if eye surgery is planned, or if a reaction occurs accompanied by new symptoms or worsening of existing ones.
After administration into the eye, Vizidor Duo may affect the entire body.
Vizidor Duo has not been studied in patients wearing contact lenses. Contact your doctor before using Vizidor Duo if the patient wears soft contact lenses.
Children
Experience with the use of Vizidor Duo (solution with preservative) in infants and children is limited.
Elderly patients
Studies with Vizidor Duo have shown that the effect of this medicine (solution with preservative) in elderly patients is similar to that in younger patients.
Use in patients with liver function impairment
Inform your doctor about any liver problems the patient currently has or has had in the past.
Vizidor Duo and other medicines
Vizidor Duo may affect the action of other medicines, or other medicines the patient is taking may affect the action of this medicine, including other eye drops used to treat glaucoma.
Tell your doctor if the patient is using or plans to take medicines for lowering blood pressure, heart conditions, or diabetes. Inform your doctor or pharmacist about all medicines the patient is taking, has recently taken, or plans to take.
This is particularly important if the patient:
- is taking medicines that lower blood pressure or treat heart conditions (such as calcium channel blockers, beta-blockers, or digoxin);
- is taking medicines used for heart rhythm disorders or to restore normal heart rhythm, such as calcium channel blockers, beta-blockers, or digoxin;
- is using other eye drops containing beta-blockers;
- is taking other carbonic anhydrase inhibitors, such as acetazolamide;
- is taking monoamine oxidase inhibitors (MAOIs);
- is taking parasympathomimetic drugs, which may be prescribed to facilitate urination; parasympathomimetic drugs are also sometimes used to restore normal intestinal motility;
- is taking opioid medicines, such as morphine, used to treat moderate to severe pain;
- is taking antidiabetic medicines;
- is taking antidepressants, such as fluoxetine or paroxetine;
- is taking sulfonamides;
- is taking quinidine (used to treat heart conditions and certain types of malaria).
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Use during pregnancy
Vizidor Duo should not be used during pregnancy unless the doctor considers it necessary.
Use during breastfeeding
Do not use Vizidor Duo while breastfeeding. Timolol may pass into human milk.
Driving and operating machinery
No studies have been conducted on the effects of this medicine on the ability to drive or operate machinery. Some adverse effects associated with the use of Vizidor Duo, such as blurred vision, may affect the ability to drive and/or operate machinery. Do not drive or operate machinery until well-being improves or normal vision is restored.
3. How to use Vizidor Duo
This medicine should always be used exactly as directed by the doctor. If in doubt, consult a doctor or pharmacist. The appropriate dosage and duration of treatment will be determined by the doctor.
Recommended dose: One drop of the medicine instilled into the affected eye(s) in the morning and evening.
If Vizidor Duo is used together with other eye drops, an interval of at least ten minutes should be maintained between instillation of each medicine.
Do not change the dose without consulting your doctor.
If a patient has difficulty administering eye drops, they should ask a family member or caregiver for help.
Avoid contact between the tip of the dropper and the eye or surrounding area. This may cause eye injury. The eye drop solution may become contaminated with bacteria, which could lead to eye infection, potentially causing serious eye damage or even loss of vision.
To avoid contamination of the multidose container, protect the dropper tip from contact with any surface.
Instructions for use
Before instilling eye drops:
- Wash hands before opening the bottle.
- Do not use this medicine if the tamper-evident seal on the bottle neck is damaged prior to first use.
- At first use, before administering the eye drop, the patient should test the dropper bottle by slowly squeezing it until one drop is dispensed. This should be done away from the eye.
- If the patient is confident they can instill one drop at a time, they should assume the most comfortable position for administering the drops (sitting, lying on the back, or standing in front of a mirror).
Instillation:
- Hold the bottle just below the cap and unscrew the cap to open the bottle. Do not touch the dropper tip to prevent contamination of the solution.
- Tilt the head backward and hold the bottle above the eye.
- Gently pull down the lower eyelid and look upward. Gently squeeze the middle part of the bottle until a drop freely enters the patient's eye. Note that there may be a delay of several seconds between squeezing the bottle and the drop being released. Do not squeeze the bottle too hard.
If there are any doubts regarding administration of the medicine, the patient should consult a doctor, pharmacist, or nurse.
- To spread the drop over the eye surface, blink several times.
- Close the eye and press gently on the inner corner of the eye with a finger for about two minutes. This helps prevent the medicine from entering the rest of the body.
- If the doctor has instructed to treat the other eye as well, repeat steps 2 to 5. Sometimes only one eye requires treatment, and the doctor will inform the patient which eye is affected.
- After use and before recapping, shake the bottle downward without touching the dropper tip to remove any residual liquid from the tip. This is necessary to ensure that subsequent drops can be dispensed properly.
- After completing all doses, some amount of Vizidor Duo will remain in the bottle. The patient should not be concerned, as the bottle contains an additional amount of Vizidor Duo to ensure the patient receives the full dose prescribed by the doctor. After completion of the prescribed treatment, do not use any excess medicine remaining in the bottle.
Do not use the eye drops for longer than 28 days after first opening the bottle.
Overdose of Vizidor Duo
If a patient uses more eye drops than recommended, or if any of the contents are swallowed, symptoms may include dizziness, breathing difficulties, or a sensation of slowed heartbeat. Seek immediate medical advice from a doctor.
Missed dose of Vizidor Duo
It is important to use Vizidor Duo as directed by the doctor.
If a patient misses a dose, it should be administered as soon as possible. However, if it is almost time for the next dose, the missed dose should be skipped and the regular dosing schedule should be resumed.
Do not use a double dose to make up for a missed dose.
Stopping Vizidor Duo
If a patient intends to discontinue treatment, they should first consult their doctor.
If there are any further doubts about the use of this medicine, consult a doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everybody gets them.
You can usually continue using the drops unless symptoms are severe. You should inform your
doctor or pharmacist if you are concerned about any of these symptoms. Do not stop using Vizidor
Duo without consulting your doctor.
If the patient experiences allergic reactions, including hives, swelling of the face, lips, tongue and (or)
throat, possibly causing difficulty in breathing or swallowing, or severe skin reactions with blistering
or peeling of the skin, you must stop using the medicine and seek immediate medical help or go to
the nearest emergency department.
The following adverse effects have been reported during clinical trials or after the medicine has been
placed on the market, related to Vizidor Duo or one of its components:
Very common (occur in more than 1 in 10 people)
- Burning and stinging sensation in the eyes
- Unusual taste.
Common (occur in no more than 1 in 10 people)
- Redness of the eye(s) or around the eye(s)
- Watery eyes or itching sensation in the eye(s)
- Corneal abrasions (damage to the front layer of the eyeball), swelling and (or) irritation of the eye(s) or around the eye(s)
- Foreign body sensation in the eye
- Reduced corneal sensitivity (inability to feel a foreign body in the eye and lack of pain sensation)
- Eye pain
- Dry eye sensation
- Blurred vision
- Headache
- Sinusitis (feeling of pressure and fullness in the nose)
- Nausea
- Weakness and fatigue.
Uncommon (occur in no more than 1 in 100 people)
- Dizziness
- Depression
- Iritis
- Vision disorders, including refractive changes (in some cases due to discontinuation of miotic drugs)
- Slowing of the heart rate
- Fainting
- Breathing difficulties (dyspnoea)
- Indigestion
- Kidney stones.
Rare (occur in no more than 1 in 1,000 people)
- Systemic lupus erythematosus (an immune system disorder that may cause inflammation of internal organs)
- Tingling or numbness of hands and feet
- Insomnia
- Nightmares
- Memory loss
- Worsening of objective and subjective symptoms of myasthenia (a muscle disease)
- Decreased libido
- Stroke
- Transient myopia, which may resolve after discontinuation of the medicine
- Choroidal detachment after filtration procedures, a layer of the eye located beneath the retina containing blood vessels, which may cause visual disturbances
- Drooping of the upper eyelid (causing the eye to be partially closed)
- Double vision
- Eyelid sticking
- Corneal edema (with symptoms of visual disturbances)
- Low intraocular pressure
- Ringing in the ears
- Low blood pressure
- Changes in heart rhythm or heart rate
- Congestive heart failure (a heart condition characterized by breathlessness and swelling of feet and legs due to fluid retention)
- Edema (related to fluid retention)
- Cerebral ischemia (reduced blood flow to the brain)
- Chest pain
- Palpitations (faster and (or) irregular heartbeat)
- Heart attack
- Raynaud's phenomenon, swelling or cooling of hands and feet and poor circulation in hands and feet
- Leg muscle cramps and (or) leg pain when walking (claudication)
- Dyspnoea
- Impaired lung function
- Catarrh or blocked nose
- Nosebleeds
- Constriction of airways in the lungs
- Cough
- Throat irritation
- Dryness of the mouth
- Diarrhea
- Contact dermatitis
- Hair loss
- Skin rash with white-silvery appearance (psoriasis-like rash)
- Peyronie's disease (which may cause penile curvature)
- Allergic reactions such as rash, urticaria, itching, and in rare cases possible swelling of lips, eyes and mouth, wheezing or severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis).
Frequency not known (frequency cannot be estimated from the available data)
- Strong heartbeat, which may be fast or irregular (palpitations)
- Increased heart rate
- Increased blood pressure
Like other medicines administered to the eye, timolol is absorbed into the bloodstream. This may
cause similar adverse effects as those observed after oral administration of beta-blockers. The
frequency of adverse effects after local ocular administration is lower than, for example, after oral or
intravenous administration. The listed adverse effects include those observed with beta-blocker
medicines for ophthalmic use:
Frequency not known (frequency cannot be estimated from the available data)
- Low blood glucose levels
- Heart failure
- A certain type of heart rhythm disorder
- Abdominal pain
- Vomiting
- Muscle pain unrelated to physical exertion
- Sexual dysfunction
- Hallucinations
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, you should inform your doctor or
pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps provide more information on the safety of the medicine.
5. How to store Vizidor Duo
Keep this medicine out of the sight and reach of children.
Store below 30°C.
After first opening the bottle, this medicine can be stored for a maximum of 28 days.
Do not use this medicine after the expiry date stated on the carton and bottle following the word EXP. The expiry date refers to the last day of the stated month. Ensure that the bottle is tightly closed.
Do not use this medicine if you notice that the seal on the bottle neck is damaged before first use.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
6. Package contents and other information
What Vizidor Duo contains
- The active substances are dorzolamide and timolol. Each millilitre contains 20 mg of dorzolamide (as dorzolamide hydrochloride) and 5 mg of timolol (as timolol maleate – 6.83 mg).
- The other ingredients are: hydroxyethylcellulose, mannitol (E421), sodium citrate (E331), sodium hydroxide (E524), and water for injections.
What Vizidor Duo looks like and contents of the pack
Vizidor Duo eye drops solution is available as a 5 ml clear, colourless, slightly viscous aqueous solution in an LDPE bottle with a dropper (made of HDPE and silicone) and a cap made of HDPE.
Pack sizes: 1, 3 or 4 bottles in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Bausch+Lomb Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Manufacturer
EXCELVISION
27 rue de la Lombardière, ZI La Lombardière,
07100 ANNONAY
France
PHARMATHEN S.A.
Dervenakion 6,
15351 Pallini (Attikis)
Greece
This medicinal product is authorised in the European Economic Area countries under the following names:
Austria Vizidor Duo 20 mg/ml + 5 mg/ml Augentropfen
Bulgaria Oftidorix PF 20 mg/ml + 5 mg/ml капки за очи, разтвор
Croatia Oftidorix PF 20 mg/ml + 5 mg/ml kapi za oko, otopina
Denmark Vizidorduo
Ireland Dorzolamide+Timolol PharmaSwiss 20mg/ml + 5mg/ml Eye Drops, Solution
Germany Vizidor Duo 20 mg/ml + 5 mg/ml Augentropfen, Lösung
Poland Vizidor Duo
Hungary Dozopticum Duo 20 mg/ml + 5 mg/ml oldatos szemcsepp
United Kingdom Vizidor Duo
Latvia: Vizidorix 20 mg/ 5 mg/ ml acu pilieni, šķīdums
Lithuania: Dorzolamide/Timolol Bausch 20 mg/5 mg/ml akių lašai (tirpalas)
Estonia: Vizidor Duo
Slovakia: Vizidor Duo 20 mg/ml + 5 mg/ml
Greece: Vizidor Duo
Czech Republic: Vizidor Duo
Finland: Vizidorduo
Norway: Vizidorduo
Sweden: Vizidorduo
Cyprus: Vizidor Duo