BLIZOMIT 10 mg/mL + 5 mg/mL EYE DROPS, SUSPENSION

Introduction

Package Leaflet: Information for the User

Blizomit 10mg/ml + 5mg/ml eye drops, suspension

brinzolamida/timolol

Read the package leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this package 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What is Blizomit and what is it used for
2. What you need to know before you use Blizomit
3. How to use Blizomit
4. Possible side effects
5. Storing Blizomit
6. Contents of the pack and other information

1. What is Blizomit and what is it used for

Blizomit contains two active substances, brinzolamida and timolol, which work together to reduce the pressure inside the eye.

This medicine is used to treat high pressure in the eyes, also called glaucoma or ocular hypertension, in adult patients over 18 years of age and in those who cannot be effectively controlled with a single medication.

2. What you need to know before you use Blizomit

Do not use Blizomit

• If you are allergic to brinzolamida, medicines called sulfonamides (including, for example, medicines used to treat diabetes and infections, also diuretics (pills to urinate)), timolol, beta-blockers (medicines used to lower blood pressure or to treat heart disease) or to any of the other components of this medicine (listed in section 6).
• If you currently have or have had in the past respiratory problems such as asthma, severe chronic obstructive bronchitis (a serious lung condition that can cause wheezing, difficulty breathing and/or persistent cough) or other types of respiratory problems.
• If you have severe hay fever.
• If you have a slow heart rate, heart failure, or heart rhythm disorders (irregular heartbeats).
• If you have too much acid in the blood (a disease called hyperchloremic acidosis).
• If you have severe kidney problems.

Warnings and precautions

Use this medicine only in your eye(s).

If you have signs of hypersensitivity or severe reactions, stop using this medicine and consult your doctor.

Consult your doctor or pharmacist before starting to use this medicine if you have or have had in the past:

• coronary heart disease (symptoms may include chest pain or discomfort, shortness of breath or choking), heart failure, low blood pressure,
• heart rhythm disorders such as slow heartbeat,
• respiratory problems, asthma, or chronic obstructive pulmonary disease,
• disease due to poor blood circulation (such as Raynaud's disease or Raynaud's syndrome),
• diabetes, as timolol may mask the signs and symptoms of low blood sugar,
• hyperactivity of the thyroid gland, as timolol may mask the signs and symptoms of thyroid disease,
• muscle weakness (myasthenia gravis),
• if you are about to undergo surgery, inform your doctor that you are using this medicine, as timolol may change the effects of some medicines used during anesthesia,
• if you have a history of atopy (tendency to develop an allergic reaction) and severe allergic reactions, you may be more sensitive to having an allergic reaction while using this medicine, and adrenaline may not be as effective in treating an allergic reaction. When receiving any other treatment, inform the doctor or nurse that you are using this medicine,
• if you have liver problems,
• if you have dry eyes or corneal problems,
• if you have kidney problems,
• if you have ever developed a severe skin rash or skin peeling, blisters, and/or sores in the mouth after using this medicine or other related medicines.

Be careful with this medicine:

Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with brinzolamida treatment. Stop using this medicine and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Children and adolescents

This medicine is not recommended for children and adolescents under 18 years of age.

Other medicines and Blizomit

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

This medicine may affect, or be affected by, other medicines you are using, including other eye drops for the treatment of glaucoma. Consult your doctor if you are using or think you might use medicines to lower blood pressure, such as parasimpaticomimetics and guanethidine, or other heart medicines, including quinidine (used to treat heart conditions and some types of malaria), amiodarone, or other medicines to treat heart rhythm disorders, and glycosides to treat heart failure. Also, consult your doctor if you are using or think you might use medicines to treat diabetes or to treat stomach ulcers, antifungal, antiviral, or antibiotic medicines, or antidepressants such as fluoxetine and paroxetine.

Consult your doctor if you are using another carbonic anhydrase inhibitor (acetazolamide or dorzolamide).

It has been occasionally reported an increase in pupil size when using this medicine with adrenaline (epinephrine).

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan to become pregnant, do not use this medicine unless your doctor considers it necessary. Consult your doctor before using this medicine.

Do not use this medicine during breastfeeding, as timolol may pass into breast milk. Consult your doctor before using any medicine during breastfeeding.

Driving and using machines

Do not drive or use machines until your vision is clear. Immediately after applying this medicine, you may notice that your vision becomes blurry for a while.

One of the active ingredients may worsen the ability to perform tasks that require mental alertness and/or physical coordination. If you notice these effects, be careful when driving or using machines.

Blizomit contains benzalkonium chloride

This medicine contains 1.7 µg of benzalkonium chloride per drop (= 1 dose), equivalent to 0.1 mg/ml.

Benzalkonium chloride can be absorbed by soft contact lenses and may alter the color of the contact lenses. Remove contact lensesbefore using this medicine and wait 15 minutes before putting them back. Benzalkonium chloride may cause eye irritation, especially if you have dry eyes or other corneal diseases (the transparent layer of the front of the eye). Consult your doctor if you feel any unusual sensation, itching, or pain in the eye after using this medicine.

3. How to use Blizomit

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

In the event that this medicine replaces a previous eye drop used for the treatment of glaucoma, discontinue the use of the previous medicine and start using this medicine the next day. In case of doubt, consult your doctor or pharmacist.

To avoid possible contamination of the dropper tip and the suspension, you should be careful not to touch the eyelids, the area around them, or other surfaces with the dropper. You should keep the bottle well closed when not in use.

The following instruction is useful to reduce the amount of medicine that passes into the bloodstream after applying the eye drops:

• Keep the eyelid closed while pressing with your finger the edge of the eye, next to the nose, for at least 2 minutes.

The recommended dose is

One drop in the affected eye(s), twice a day.

This medicine should only be applied to both eyes if your doctor has recommended it. Follow the treatment for the entire period of time indicated by your doctor.

How to use

1 2 3

• Take the Blizomit bottle and stand in front of a mirror.
• Wash your hands.
• Shake well before use.
• Remove the cap. After removing the cap, you should remove the security seal ring if it is loose before using this medicine.
• Hold the bottle, upside down, between your thumb and index finger.
• Tilt your head back. Gently pull down the lower eyelid to form a pocket, where the drop should fall (Figure 1).
• Bring the tip of the bottle close to the eye. You can use a mirror to help you.
• Do not touch the eye, eyelid, surrounding areas, or other surfaces with the dropperbecause the drops could become contaminated.
• Gently press the base of the bottle to release one drop of Blizomit at a time.
• Do not squeeze the bottle:it is designed so that a gentle pressure on the base is enough (Figure 2).
• After using Blizomit, press with your finger the edge of the eye, next to the nose, for 2 minutes (Figure 3). This helps prevent Blizomit from passing into the rest of the body.
• If you are applying drops in both eyes, repeat all the previous steps with the other eye.
• Close the bottle tightly immediately after using the product.
• Use one bottle before opening the next one.

If a drop falls outside the eye, try again.

If you are using another eye drop or ointment, wait at least 5 minutes between applying each medicine. Eye ointments should be administered last.

If you use more Blizomit than you should, you can rinse your eyes with warm water. Do not apply more drops until it is time for the next dose.

You may experience a decrease in heart rate, decrease in blood pressure, heart failure, difficulty breathing, and effects on the nervous system.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount used.

If you forget to use Blizomit, continue with the next dose that was scheduled. Do not apply a double dose to make up for the forgotten doses. Do not apply more than one drop twice a day in the affected eye(s).

If you stop using Blizomitwithout consulting your doctor, the pressure in your eye will not be controlled, which could lead to loss of vision.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Stop using Blizomit and seek immediate medical attentionif you notice any of the following symptoms:

• severe redness and itching in the eye, reddish spots not raised, target-like or circular on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin eruptions can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Unless the effects are severe, continue with the treatment as usual. If these effects concern you, consult your doctor or pharmacist. Do not stop using this medicine without consulting your doctor first.

Frequent adverse effects (may affect up to 1 in 10 people)

• Eye effects:inflammation of the eye surface, blurred vision, signs and symptoms of eye irritation (e.g., burning, stinging, itching, tearing, redness), eye pain.
• Other adverse effects:decreased heart rate, taste disturbances.

Infrequent adverse effects (may affect up to 1 in 100 people)

• Eye effects:corneal erosion (damage to the outer layer of the eyeball), inflammation of the eye surface with damaged surface, inflammation inside the eye, corneal spots, abnormal sensation in the eyes, eye discharge, dry eye, tired vision, eye itching, red eye, eyelid redness.
• Other adverse effects:decreased white blood cell count, decreased blood pressure, cough, blood in urine present, body weakness.

Rare adverse effects (may affect up to 1 in 1,000 people)

• Eye effects:corneal disorder, sensitivity to light, increased tear production, eyelid crusts.
• Other adverse effects:difficulty sleeping (insomnia), sore throat, runny nose.

Frequency not known (cannot be estimated from available data)

• Eye effects:eye allergy, vision changes, optic nerve damage, increased eye pressure, deposits on the eye surface, decreased stimulation perception in the eye, conjunctivitis (infection of the white part of the eye), abnormal vision, double or reduced vision, increased eye pigmentation, lump on the eye surface, eye swelling, sensitivity to light, decreased eyelash growth or number, drooping eyelids (causing the eye to remain half-closed), eyelid and eyelid gland inflammation, corneal inflammation and detachment of the layer under the retina that contains blood vessels, which can cause vision changes after filtration surgery, decreased corneal sensitivity, corneal erosion.
• Other adverse effects:reddish spots not raised, target-like or circular on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes that can be preceded by fever and flu-like symptoms. These severe skin eruptions can be potentially life-threatening (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Heart and circulation:changes in heart rhythm or frequency, slow heart rate, palpitations, type of heart rhythm disorder, abnormal increase in heart rate, chest pain, reduced heart function, heart attack, increased blood pressure, reduced blood flow to the brain, stroke, edema (fluid accumulation), congestive heart failure (heart disease with difficulty breathing and swelling of the feet and legs due to fluid accumulation), swelling of the limbs, decreased blood pressure, discoloration of the fingers and toes and occasionally other parts of the body (Raynaud's phenomenon), coldness in feet and hands.
• Respiratory:constriction of the airways in the lungs (mainly in patients with pre-existing disease), shortness of breath or difficulty breathing, cold symptoms, chest congestion, sinus infection (sinusitis), sneezing, stuffy nose, nasal dryness, nosebleeds, asthma, throat irritation.
• Nervous system and general disorders:hallucinations, depression, nightmares, memory loss, headache, nervousness, irritability, fatigue, tremors, abnormal sensation, fainting, dizziness, somnolence, generalized or severe weakness, unusual sensations such as tingling.
• Gastrointestinal:nausea, vomiting, diarrhea, intestinal gas or abdominal discomfort, throat inflammation, dry or abnormal mouth sensation, indigestion, stomach pain.
• Blood:abnormal liver function test values, increased blood chloride levels, or decreased red blood cell count in blood tests.
• Allergy:increased allergy symptoms, generalized allergic reactions including swelling under the skin that can occur in areas such as the face and limbs and can obstruct the airways, causing difficulty swallowing or breathing, hives, localized and generalized rash, itching, sudden and severe allergic reaction that can be life-threatening.
• Ear:ringing in the ears, sensation of dizziness or vertigo.
• Skin:rash, redness, or inflammation of the skin, abnormal or decreased sensation in the skin, hair loss, rash with a white silvery appearance (psoriasiform rash) or worsening of psoriasis.
• Muscular:muscle pain not caused by exercise, in joints, back, or generalized, muscle spasms, pain in the limbs, muscle weakness/fatigue, increased signs and symptoms of myasthenia gravis (muscle disorder).
• Kidney:kidney pain presented as lower back pain, frequent urination.
• Reproduction:sexual dysfunction, decreased sexual desire, male sexual problems.
• Metabolism:low blood sugar levels.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Blizomit

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the bottle and carton after "EXP". The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

To avoid infections, discard the bottle 4 weeks after the first opening. Write the opening date on the space provided on the bottle label and carton.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE point. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Blizomit

• The active ingredients are brinzolamide and timolol. One ml of suspension contains 10 mg of brinzolamide and 5 mg of timolol (as maleate).
• The other ingredients are benzalkonium chloride (50% solution) (see section 2 "Blizomit contains benzalkonium chloride"), carbomer, disodium edetate, mannitol (E421), water for injectable preparations, sodium chloride, poloxamer, hydrochloric acid, and/or sodium hydroxide.

Very small amounts of hydrochloric acid and/or sodium hydroxide are added to maintain normal acidity levels (pH levels).

Appearance of the Product and Package Contents

10 ml plastic bottle with a sealed LDPE white dropper tip and an HDPE/LDPE white cap with a tamper-evident seal, containing 5 ml of homogeneous white suspension.

The following package sizes are available: cartons containing 1 x 5 ml, 3 x 5 ml.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Pharmathen S.A.

Dervenakion 6

15351 Pallini, Attiki

Greece

Manufacturer

Pharmathen S.A.

Dervenakion 6

15351 Pallini, Attiki

Greece

Or

Balkanpharma-Razgrad AD

68 Aprilsko vastanie Blvd.,

Razgrad, 7200,

Bulgaria

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

Date of the last revision of this leaflet:September 2023

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es.