Brinzolamide and timolol Accord

Package leaflet: Information for the user

Brinzolamide and Timolol Accord 10 mg/mL + 5 mg/mL eye drops, suspension

brinzolamide/timolol
Please read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Brinzolamide and Timolol Accord is and what it is used for

Brinzolamide and Timololo Accord contains two active substances, brinzolamide and timolol, which work together to reduce the pressure inside the eye.
Brinzolamide and Timololo Accord is used to treat high eye pressure, also called glaucoma or ocular hypertension, in patients over 18 years of age in whom high eye pressure cannot be effectively controlled by a single medicine.

2. What you need to know before using Brinzolamide and Timololo Accord

Do not use Brinzolamide and Timololo Accord

• If you are allergic to brinzolamide, to medicines known as sulfonamides (for example, medicines used to treat diabetes, infections, or diuretics (tablets to increase urine production)), to timololo, beta-blockers (medicines used to lower blood pressure or treat heart conditions), or to any of the other ingredients of this medicine (listed in section 6).
• If you have or have previously had respiratory problems such as asthma, severe chronic obstructive bronchitis (a serious lung disease that may cause wheezing, difficulty breathing, and/or long-lasting cough), or other types of breathing problems.
• In case of severe hay fever.
• If you have a slow heart rate, heart failure, or heart rhythm disorders (irregular heartbeat).
• If you have too much acid in your blood (a condition called hyperchloremic acidosis).
• If you have severe kidney problems.

For athletes: Using this medicine without therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.

Warnings and precautions
Apply Brinzolamide and Timololo Accord drops only into the eyes.
If you experience signs of severe reactions or hypersensitivity, stop using this medicine and inform your doctor.
Talk to your doctor or pharmacist before using Brinzolamide and Timololo Accord if you have or have previously had:

• Coronary heart disease (symptoms may include chest pain or tightness, shortness of breath, or suffocation), heart failure, or low blood pressure.
• Changes in heart rate such as slow heartbeat.
• Breathing problems, asthma, or chronic obstructive pulmonary disease.
• Circulatory disorders (such as Raynaud's disease or Raynaud's syndrome).
• Diabetes, as timololo may mask the signs and symptoms of low blood sugar.
• Overactivity of the thyroid gland, as timololo may mask signs and symptoms of thyroid disease.
• Muscle weakness (myasthenia gravis).
• Before undergoing surgery, inform your doctor that you are using Accord, as timololo may alter the effects of certain medicines used during anesthesia.
• If you have a history of atopy (a tendency to develop allergic reactions) or severe allergic reactions, you may be more likely to develop an allergic reaction while using Accord, and adrenaline treatment may not be sufficiently effective in treating such reactions. If you undergo any other treatment, inform your doctor or nurse that you are taking Brinzolamide and Timololo Accord.
• 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, skin peeling, blisters, and/or mouth ulcers after using this or related medicines.

Exercise particular caution with Brinzolamide and Timololo Accord:
Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with brinzolamide treatment. If you notice any symptoms related to these severe skin reactions described in section 4, stop treatment with brinzolamide and contact your doctor immediately.

Children and adolescents
Brinzolamide and Timololo Accord is not recommended for children and adolescents under 18 years of age.

Other medicines and Brinzolamide and Timololo Accord
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Brinzolamide and Timololo Accord may interact with other medicines you are taking, including other eye drops for glaucoma. Inform your doctor if you are taking or plan to take medicines to lower blood pressure, such as parasympathomimetics and guanethidine, or other heart medications including quinidine (used to treat heart problems and some types of malaria), amiodarone, or other medicines for heart rhythm disorders, and glycosides for heart failure.
Also inform your doctor if you are taking or plan to take medicines for diabetes, for gastric ulcers, antifungals, antiviral medicines, antibiotics, or antidepressants such as fluoxetine and paroxetine.
If you are taking another carbonic anhydrase inhibitor (acetazolamide or dorzolamide), inform your doctor.
Occasionally, increased pupil size has been reported when Brinzolamide and Timololo Accord is used concomitantly with adrenaline (epinephrine).

Pregnancy and breastfeeding
Do not use Brinzolamide and Timololo Accord during pregnancy or if you are trying to become pregnant unless your doctor considers it necessary. Consult your doctor before using Brinzolamide and Timololo Accord.
Do not use Brinzolamide and Timololo Accord while breastfeeding, as timololo may be excreted in breast milk.
Ask your doctor for advice before taking any medicine while breastfeeding.

Driving and using machines
Do not drive or operate machinery until your vision is clear. Your vision may be blurred for a certain period of time immediately after using Brinzolamide and Timololo Accord.
One of the active substances may reduce your ability to perform tasks requiring mental alertness and/or physical coordination. If you experience such symptoms, exercise caution when driving or using machinery.

Brinzolamide and Timololo Accord contains benzalkonium chloride
This medicine contains 0.0033 mg of benzalkonium chloride per drop, equivalent to 0.01% or 0.1 mg/mL.
Benzalkonium chloride is a preservative in Brinzolamide and Timololo Accord that may be absorbed by soft contact lenses, potentially altering their color. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or corneal disorders (the eye's outermost transparent layer). If you experience an unusual sensation, burning, or pain in the eye after using this medicine, speak with your doctor.

3. How to use Brinzolamide and Timololo Accord

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
If you are switching from a previously used eye drop for glaucoma treatment to Brinzolamide
and Timololo Accord, you must stop using the other medicine and start using Brinzolamide and
Timololo Accord the following day. If you have any doubts, consult your doctor or pharmacist.
To prevent contamination of the dropper and suspension, take care not to touch the
eyelids, surrounding areas, or other surfaces with the dropper tip. Keep the bottle tightly closed when
not in use.
The following procedure helps reduce the amount of medicine entering the bloodstream after
eye drop application:

• Keep the eyelid closed and simultaneously apply gentle pressure with one finger to the inner corner of the eye near the nose for at least 2 minutes.

Recommended dose: One drop in the affected eye(s), twice daily.
Use Brinzolamide and Timololo Accord in both eyes only if specifically instructed by your doctor. Use the
medicine for the duration recommended by your doctor.
How to use

• Take the bottle and a mirror.
• Wash your hands.
• Shake well before use.
• Unscrew the bottle cap. After removing the cap, if the safety ring has loosened, remove it before using the product.
• Hold the bottle upside down between your thumb and index finger.
• Tilt your head backward. Pull down the lower eyelid with a clean finger to form a "pocket" between the eyelid and the eye. The drop should be instilled here (Figure 1).
• Hold the tip of the bottle close to the eye. Use the mirror if it helps.
• Do not touch the eye, eyelid, surrounding areas, or other surfaces with the tip of the bottle. This could contaminate the eye drop.
• Instill one drop into the pocket (Figure 2).
• After using Brinzolamide and Timololo Accord, press with a finger on the corner of the eye near the nose for at least 1 minute (Figure 3). This helps prevent Brinzolamide and Timololo Accord from spreading throughout the body.
• If you need to apply the eye drop to both eyes, repeat the steps for the other eye.
• Immediately recap the bottle tightly after use.
• Use up the entire contents of the bottle before opening a new one.

If a drop does not enter the eye, try again.
If you are using other eye drops or eye ointments, wait at least 5 minutes between the instillation of
each medicine. Ophthalmic ointments should be administered last.
If you use more Brinzolamide and Timololo Accord than you should, immediately rinse the eye with warm
water. Do not use the eye drop again until the next scheduled dose.
You may experience a decreased heart rate, low blood pressure, heart failure, breathing difficulties, and effects on the nervous system.
If you forget to use Brinzolamide and Timololo Accord, continue treatment with the next dose as scheduled. Do not use a double dose to make up for a missed dose.
Do not use more than one drop in the affected eye(s), twice daily.
If you stop treatment with Brinzolamide and Timololo Accord without consulting your
doctor, intraocular pressure will not be controlled, possibly leading to vision loss.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using this medicine and contact your doctor immediately if you develop any of the
following symptoms:

• severe redness and itching of the eye, flat reddish spots on the trunk, target-like or circular in appearance, often with central blisters, skin peeling, mouth, throat, nose, genital and eye ulcers. These serious skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

You can generally continue using the eye drops unless the side effects you experience are severe. If
you are concerned, consult your doctor or pharmacist. Do not stop using Brinzolamide and Timololo
Accord without first discussing it with your doctor.
Common side 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 sensation, tearing, redness), eye pain.
• General side effects: decreased heart rate, taste disturbance.

Uncommon side effects (may affect up to 1 in 100 people):

• Eye effects: corneal erosion (damage to the front surface of the eyeball), inflammation of the eye surface with surface damage, intraocular inflammation, corneal staining, abnormal eye sensitivity, eye discharge, dry eyes, tired eyes, itchy eyes, red eyes, eyelid redness.
• General side effects: reduction in the number of white blood cells, decreased blood pressure, cough, blood in the urine, generalized fatigue.

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

• Eye effects: corneal disorders, light sensitivity, increased tearing, crusting of the eyelid.
• General side effects: difficulty sleeping (insomnia), sore throat, runny nose.

Not known (frequency cannot be estimated from the available data):

• Eye effects: eye allergy, visual disturbance, optic nerve damage, increased intraocular pressure, deposits on the eye surface, reduced eye sensitivity, inflammation or infection of the conjunctiva (white of the eye), abnormal, double or reduced vision, increased ocular pigmentation, new growth on the eye surface, eye swelling, light sensitivity, reduced growth or number of eyelashes, drooping of the upper eyelids (eye half-closed), inflammation of the eyelids and eyelid glands, corneal inflammation, and detachment of the layer beneath the retina containing blood vessels following filtering surgery, which may cause visual disturbances, reduced corneal sensitivity.
• Heart and circulation: changes in heart rhythm or rate, slowed heart rate, palpitations, a type of heart rhythm disorder, abnormally increased heart rate, chest pain, reduced heart function, heart attack, increased blood pressure, reduced blood supply to the brain, stroke, edema (fluid accumulation), congestive heart failure (heart disease with shortness of breath and swelling of the feet and legs due to fluid buildup), swelling of the extremities, low blood pressure, change in color of fingers and toes and occasionally other body areas (Raynaud's phenomenon), cold hands and feet.
• Respiratory: narrowing of the airways in the lungs (mainly in patients with pre-existing disease), shortness of breath or difficulty breathing, cold-like symptoms, chest congestion, nasal infection, sneezing, nasal congestion, dry nose, nosebleeds, asthma, throat irritation.
• Nervous system and systemic disorders: depression, nightmares, memory loss, headache, nervousness, irritability, fatigue, tremor, abnormal sensation, fainting, dizziness, drowsiness, generalized or severe weakness, unusual sensations such as pins and needles, hallucinations.
• Gastrointestinal: nausea, vomiting, diarrhea, intestinal gas or abdominal discomfort, sore throat, dry or abnormal mouth sensation, indigestion, stomach ache.
• Blood: blood tests showing abnormal liver function values, increased blood chloride levels, decreased red blood cell count detectable in blood tests.
• Allergy: worsening of allergy symptoms, generalized allergic reactions including swelling under the skin which may occur in areas such as the face and limbs and which may obstruct the airways causing difficulty in swallowing or breathing, hives, localized and generalized skin rash, itching, severe sudden allergic reactions that may be life-threatening.
• Ear: ringing in the ears, sensation of dizziness or vertigo.
• Skin: skin rash, redness or inflammation of the skin, reduced or abnormal skin sensitivity, hair loss, white-silver appearing skin rash (psoriasiform eruption) or worsening of psoriasis.
• Musculoskeletal: generalized back, joint or muscle pain not caused by exercise, muscle spasms, pain in the extremities, muscle weakness/fatigue, increased signs and symptoms of myasthenia gravis (a muscle disorder).
• Kidneys: kidney pain similar to lower back pain, frequent urination.
• Reproduction: sexual dysfunction, decreased libido, male sexual difficulties.
• Metabolism: low blood sugar levels.
• General side effects: flat reddish spots on the trunk, target-like or circular in appearance, often with central blisters, skin peeling, mouth, throat, nose, genital and eye ulcers, which may be preceded by fever and flu-like symptoms. These serious skin reactions may be potentially life-threatening (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
Website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side
effects, you can help provide more information on the safety of this medicine.

5. How to store Brinzolamide and Timololo Accord

Keep this 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 that month.
This medicine requires no special storage conditions.
To prevent infections, discard the bottle 4 weeks after first opening and use a new bottle.
Write the date of opening in the space provided on the label of the bottle and carton.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Brinzolamide and Timolol Accord contains

• The active substances are brinzolamide and timolol. One mL of suspension contains 10 mg of brinzolamide and 5 mg of timolol (as maleate).
• The other components are benzalkonium chloride (see section 2 “Brinzolamide and Timolol Accord contains benzalkonium chloride”), carbomer, disodium edetate, mannitol (E421), purified water, sodium chloride, hydrochloric acid and/or sodium hydroxide.

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

Description of the appearance of Brinzolamide and Timolol Accord and contents of the pack
Brinzolamide and Timolol Accord is a liquid (a uniform suspension ranging from white to almost white) supplied in a pack containing a low-density polyethylene (LDPE) bottle of 10 mL with a dropper inserted in LDPE and a high-density polyethylene (HDPE) cap, containing 5 mL of suspension.
Cartons containing 1, 3 or 6 bottles.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer
Lusomedicamenta Sociedade Técnica Farmacêutica S.A.
Rua Norberto De Oliveira 1-5
Povoa De Santo Adriao, Lisbon
2620-111
Portugal