Optilamid

Package leaflet: Information for the patient

Optilamid, 10 mg/ml, eye drops, suspension
Brinzolamide
Please read carefully all the information in this leaflet before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The 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 or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Optilamid is and what it is used for

Optilamid contains brinzolamide, which belongs to a group of medicines called carbonic anhydrase inhibitors. It reduces the pressure inside the eye.
Optilamid eye drops are used to treat high pressure inside the eye. This pressure may lead to the development of a disease called glaucoma.
If the pressure in your eye is too high, it may cause damage to your vision.

2. Important information before using Optilamid

When not to use Optilamid

• if the patient has severe kidney function disorders
• if the patient is allergic to brinzolamide or any of the other ingredients of this medicine (listed in section 6)
• if the patient is allergic to medicines called sulfonamides. Examples of sulfonamides include medicines used to treat diabetes, infections, and diuretics (water tablets); Optilamid may cause the same allergic reactions.
• if the patient has excessive acidification of the blood (a condition called hyperchloremic acidosis). If in doubt, consult a doctor.

Warnings and precautions
Before starting to use Optilamid, discuss with your doctor or pharmacist if:

• the patient has kidney or liver function disorders
• the patient has dry eye or corneal disorders
• the patient is taking other sulfonamide medicines
• the patient has ever experienced severe skin rash, skin peeling, blistering, and/or mouth ulcers after using brinzolamide or other related medicines.

Special caution with brinzolamide:
Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported during treatment with brinzolamide. Treatment with brinzolamide must be discontinued immediately and medical help should be sought promptly if any symptoms related to these severe skin reactions described in section 4 occur.

Children and adolescents
Optilamid should not be used in infants, children, or adolescents under 18 years of age unless specifically advised by a doctor.

Optilamid and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently using or has recently used, as well as any medicines the patient plans to use, including over-the-counter medicines.
Inform your doctor if you are taking other carbonic anhydrase inhibitors (acetazolamide or dorzolamide, see section 1. What Optilamid is and what it is used for).

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Women of childbearing potential are advised to use an effective method of contraception during treatment with Optilamid. Use of Optilamid is not recommended in women who are pregnant or breastfeeding. Optilamid must not be used unless otherwise decided by a doctor.
Always consult a doctor or pharmacist before taking any medicine.

Driving and using machines
Do not drive or operate machinery until vision returns to normal. Vision may be blurred for some time after instilling Optilamid.
Optilamid may impair the ability to perform tasks requiring increased attention and/or motor coordination. If such symptoms occur, caution should be exercised when driving or operating machinery.

Optilamid contains benzalkonium chloride
The medicine contains 0.15 mg of benzalkonium chloride per ml of suspension.
Benzalkonium chloride may also cause eye irritation, especially in individuals with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If abnormal sensations in the eye, stinging, or eye pain occur after using the medicine, contact a doctor.
Benzalkonium chloride may be absorbed by soft contact lenses and may change their colour. Contact lenses must be removed before instillation and at least 15 minutes should be waited before reinserting them.

3. How to use Optilamid

This medicine should always be used exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Optilamid should be used only for ophthalmic (eye) administration. Do not swallow or inject it.
The recommended dose is one drop into the affected eye or eyes, twice daily – in the morning and evening.
Use this dose unless your doctor has advised otherwise. Optilamid may be used in both eyes only if so directed by your doctor. Continue using the medicine for as long as your doctor recommends.

Instructions for use

Figure 1. Figure 2. Figure 3.

• Prepare the Optilamid bottle and a mirror.
• Wash your hands.
• Shake the bottle and unscrew the cap. If the tamper-evident ring is loose after removing the cap, remove it before using the medicine.
• Hold the inverted bottle between your thumb and middle finger.
• Tilt your head backward. Using a clean finger, gently pull down the lower eyelid to form a "pocket" between the eyeball and the eyelid; the drop should be instilled into this pocket (Figure 1).
• Bring the dropper tip close to the eye. A mirror may help.
• Do not let the dropper tip touch the eye, eyelid, surrounding areas, or any other surface. This may contaminate the drops.
• Squeeze one drop of Optilamid into the formed "pocket" (Figure 2).
• After instilling the drop, press with your finger on the inner corner of the eye near the nose (Figure 3) for at least 1 minute. This helps prevent the medicine from draining into the rest of the body.
• If using drops in both eyes, repeat the above steps for the second eye.
• Immediately after use, replace the cap on the bottle.
• Open a new bottle only after completely using the contents of the previous one.

If you are using other eye drops, wait at least 5 minutes between instilling Optilamid and applying other eye drops. Ointments should be used last.
Use of more than the recommended dose of Optilamid
If too many drops are used, rinse the eyes with lukewarm water. Do not instill additional drops until the next scheduled dose.
Missed dose of Optilamid
If you forget to use a dose of Optilamid, instill one drop as soon as you remember, then return to your regular dosing schedule. Do not use a double dose to make up for a missed dose.
Stopping Optilamid treatment
If you stop using Optilamid without consulting your doctor, intraocular pressure will no longer be controlled, which may lead to vision loss.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions have been observed during the use of brinzolamide.
You should stop using brinzolamide and seek immediate medical help
if you notice any of the following symptoms:

• red, flat, circular or target-like skin rashes on the trunk, often with blisters in the centre, peeling of the skin, mouth ulcers, throat, nose, genital organs and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Common adverse reactions (may affect up to 1 in 10 patients)
Eye-related symptoms:

• blurred vision, eye irritation, eye pain, eye discharge, eye itching, dry eyes, unusual sensation in the eye, eye redness.

General symptoms:

• unpleasant taste in the mouth.

Uncommon adverse reactions (may affect up to 1 in 100 patients)
Eye-related symptoms:

• light sensitivity, inflammation or infection of the conjunctiva, eye swelling, eyelid itching, eyelid redness or swelling, increased eye surface area (progressive conjunctival overgrowth onto the cornea), increased pigmentation of the eye, eye fatigue, eyelid crusts, increased tear production.

General symptoms:

• slowed or weakened heart function, palpitations, slow heart rate, breathing difficulties, shortness of breath, cough, decreased number of red blood cells in blood, increased chloride levels in blood, dizziness, drowsiness, memory disturbances, depression, nervousness, general weakness, fatigue, unusual feeling, pain, chills, decreased libido, sexual dysfunction in men, cold-like symptoms, chest congestion, sinus infection, sore throat, throat irritation, unusual or reduced sensation in the mouth, oesophagitis, abdominal pain, nausea, vomiting, upset stomach, frequent bowel movements, diarrhoea, gas accumulation in the intestines, digestive disturbances, kidney pain, muscle pain, muscle cramps, back pain, nosebleeds, runny nose, nasal congestion, sneezing, rash, unusual skin sensation, skin itching, headache, dry mouth.

Rare adverse reactions (may affect up to 1 in 1,000 patients)
Eye-related symptoms:

• corneal swelling, double or limited vision, abnormal vision, reduced sensation in the eye, swelling around the eye, increased intraocular pressure, optic nerve damage.

General symptoms:

• memory disturbances, drowsiness, chest pain, congestion in the upper respiratory tract, sinus congestion, rhinitis, dry nose, ringing in the ears, hair loss, generalized itching, tremor sensation, irritability, irregular heartbeat, general weakness, difficulty falling asleep.

Frequency not known (frequency cannot be estimated from the available data)
Eye-related symptoms:

• eyelid abnormalities, visual disturbances, corneal disease, eye allergy, reduced growth or number of eyelashes.

General symptoms:

• severe allergic reactions, reduced sensation, tremor, loss or reduced sense of taste, low blood pressure, high blood pressure, increased heart rate, joint pain, asthma, limb pain, skin redness, skin inflammation or itching, abnormal liver function test results, limb swelling, frequent urination,

decreased appetite, red, flat, circular or target-like rashes on the trunk, often with blisters in the centre, peeling of the skin, mouth ulcers, throat, nose, genital organs and eyes, which may be preceded by fever and flu-like symptoms. These severe skin rashes may be life-threatening (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. 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 responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Optilamid

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle label and carton
after: EXP. The expiry date refers to the last day of the stated month.
The marking on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot indicates the batch number.
No special storage instructions are required for this medicine.
To prevent contamination, discard the bottle 4 weeks after first opening.
The date of opening of each bottle should be recorded in the space provided below and in the designated space on the label of the bottle and carton.
For a package containing one bottle, enter only one date.
Date of opening (1):
Date of opening (2):
Date of opening (3):
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 package and other information

What Optilamid contains

• The active substance is brinzolamide. Each ml of suspension contains 10 mg of brinzolamide. Each drop contains 0.27 mg of brinzolamide.
• The other ingredients are: benzalkonium chloride, mannitol (E421), carbomer 974P, disodium edetate, sodium chloride, purified water. In addition, small amounts of hydrochloric acid or sodium hydroxide are added to maintain the acidity (pH) of the product.

What Optilamid looks like and contents of the pack
Optilamid is a white or almost white, homogeneous suspension.
The medicine is supplied in a sterile polyethylene (LDPE) bottle with a capacity of 10 ml containing 5 ml of suspension, with a polyethylene dropper (LDPE) and a screw cap made of HDPE with a tamper-evident seal.
Pack sizes: 1 or 3 bottles.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01

Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
Lusomedicamenta Sociedade Técnica Farmacêutica, S.A.
Rua Norberto de Oliveira, no 1/5, Póvoa de Santo Adrião, 2620-111,
Portugal