Package Insert: Information for the Patient

Brinzolamida Stada 10 mg/ml Eye Drops Suspension

Read this entire package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1.What is Brinzolamida Stada and what is it used for

2.What you need to know before starting to use Brinzolamida Stada

3.How to use Brinzolamida Stada

4.Possible adverse effects

5.Storage of Brinzolamida Stada

6.Contents of the package and additional information

Brinzolamida Stadacontains brinzolamida which belongs to a group of medicines called carbonic anhydrase inhibitors and reduces the pressure inside the eye.

Brinzolamidaeye drops are used to treat high eye pressure. This pressure can lead to a disease called glaucoma.

If the pressure in the eye is too high, it can damage your vision.

Do not use Brinzolamida Stada

• if you have severe kidney problems.
• if you are allergic to brinzolamida or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to certain medicines called sulfonamides. For example, medicines used to treat diabetes and infections, and also diuretics (tablets to make you urinate). Brinzolamida may cause the same allergy.
• if you have too much acid in your blood (a condition called hyperchloremic acidosis).

If you are unsure, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Brinzolamida Stada:

• if you have kidney or liver problems.
• if you have dry eye or corneal problems.
• if you are using other medicines that contain sulfonamides
• if you have ever developed a severe skin rash or skin peeling, blisters, and/or mouth sores after using brinzolamida or other related medicines.

Be especially careful with brinzolamida

Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with brinzolamida treatment. Stop using brinzolamida 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

Brinzolamida should not be used in infants, children, and adolescents under 18 years, unless your doctor recommends it.

Use of Brinzolamida Stada with other medicines

Inform your doctor or pharmacist if you are using, have used recently, or might have to use any other medicine.

Consult your doctor if you are using another carbonic anhydrase inhibitor (acetazolamide or dorzolamide, see section 1 “What is Brinzolamida Stada and what it is used for”).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you might be pregnant, consult your doctor or pharmacist before using this medicine.

Women who may become pregnant are advised to use effective contraceptive methods during treatment with brinzolamida. Brinzolamida is not recommended during pregnancy or breastfeeding. Do not use brinzolamida unless clearly indicated by your doctor.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machines

Do not drive or use machines until your vision is clear. Immediately after applying brinzolamida, you may notice that your vision becomes blurry.

Brinzolamida may impair your ability to perform tasks that require mental acuity and/or physical coordination. If you notice these effects, be careful when driving or using machines.

Brinzolamida Stada contains benzalkonium chloride

This medicine contains approximately 0.1 mg of benzalkonium chloride (a preservative) in each ml. Benzalkonium chloride may be absorbed by soft contact lenses and may change the color of the lenses. Remove your contact lenses before using this medicine and reinsert them 15 minutes later.

Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or corneal problems. If you feel an unusual sensation in your eyes, burning, or eye pain after using this medicine, talk to your doctor.

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

Only usebrinzolamidain your eye(s). Do not swallow or inject.

The recommended dose is1 drop in the affected eye(s) two times a day - in the morning and at night.

This is the dosage you should follow unless your doctor has indicated otherwise. You should only applybrinzolamidain both eyes if your doctor has recommended it. Follow the treatment for the entire period of time indicated by your doctor.

How to use

Image 1Image 2Image 3

• Take the brinzolamida bottle and stand in front of a mirror.
• Wash your hands.
• Shake the bottle and remove the cap. After removing the cap, you must remove the safety ring before using this medication.
• Hold the bottle, upside down, between your thumb and index finger.
• Incline your head back. Gently separate your eyelid from your eye with a finger, until a pouch forms, in which the drop should fall (image 1).
• Bring the tip of the bottle close to your eye. You can help yourself with the mirror.
• Do not touch your eye, eyelid, nearby areas or other surfaces with the dropper, because the drops could become contaminated.
• Press gently on the base of the bottle so that a drop of brinzolamidafalls each time.
• Do not squeeze the bottle: it is designed so that a gentle pressure on the base is enough (image 2).
• After using brinzolamida, press with your finger the edge of your eye, next to your nose (image 3) for at least 1 minute. This helps to prevent brinzolamidafrom passing to the rest of your body.
• If you apply drops in both eyes, repeat all the previous steps with the other eye.
• Tighten the cap well on the bottle immediately after using the product.
• Finish the bottle you are using before opening the next one.

If a drop falls outside the eye, try again.

If you are using another eye drop, wait at least 5 minutes between the application of brinzolamidaand the other drops. Eye ointments should be administered last.

If you use more Brinzolamida Stada than you should

If too much has been applied, you can remove it by washing your eyes with warm water. Do not apply more drops until it is time for the next dose.

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

If you forgot to use Brinzolamida Stada

Apply a drop as soon as you realize and then continue with your regular treatment regimen. Do not apply a double dose to compensate for the missed one.

If you interrupt the treatment with Brinzolamida Stada

If you stop using brinzolamidawithout consulting your doctor, the pressure in your eye will not be controlled, which could cause you to lose vision.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Stop using brinzolamide and seek medical attention immediately if you notice any of the following symptoms:

• Flat red spots, often with blisters in the center, that may peel and form ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin eruptions may be accompanied by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

The following side effects have been observed with brinzolamide.

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

• Eye effects:blurred vision, eye irritation, eye pain, eye discharge, eye itching, dry eyes, abnormal sensation in the eye, eye redness.

• Other effects:bad taste.

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

• Eye effects:light sensitivity, conjunctival inflammation or infection, eye swelling, eye itching, eyelid redness or swelling, corneal bulge, increased eye pigmentation, tired eyes, eyelid crusts, increased tear production.

• Other effects:reduced heart function or decreased heart rate, palpitations, decreased heart rate, shortness of breath, lack of breath, cough, decreased red blood cell count, increased blood chlorine levels, dizziness, somnolence, memory problems, depression, nervousness, generalized weakness, fatigue, abnormal sensation, pain, tremors, decreased sexual behavior, male sexual problems, cold symptoms, chest congestion, nasal sinus infection, throat irritation, sore throat, abnormal perception of stimuli in the mouth, esophageal mucosa inflammation, abdominal pain, nausea, vomiting, stomach pain, frequent bowel movements, diarrhea, intestinal gas, digestive disorders, kidney pain, muscle pain, muscle spasms, back pain, nasal bleeding, nasal discharge (runny nose), nasal congestion, sneezing, rash, abnormal skin sensation, itching, headache, dry mouth.

Very rare side effects(may affect up to 1 in 1,000 people)

• Eye effects:corneal edema, double vision or reduced vision, abnormal vision, decreased eye sensitivity, eye swelling around the eye, increased eye pressure, optic nerve damage.

• Other effects:memory loss, somnolence, chest pain, upper respiratory tract congestion, sinus congestion, nasal congestion, dry nose, tinnitus in the ears, hair loss, generalized itching, restlessness, irritability, irregular heart rate, generalized weakness, difficulty sleeping.

Unknown frequency(cannot be estimated from available data)

• Eye effects:eyelid abnormalities, vision abnormalities, corneal abnormalities, eye allergy, decreased eyelash growth or number.

• Other effects:flat red spots, often with blisters in the center, that may peel and form ulcers in the mouth, throat, nose, genitals, and eyes that may be accompanied by fever and flu-like symptoms. These severe skin eruptions may be potentially fatal (Stevens-Johnson syndrome, toxic epidermal necrolysis), increased allergy symptoms, decreased perception of stimuli, tremors, decreased or lost taste, decreased blood pressure, increased blood pressure, increased heart rate, joint pain, asthma, pain in extremities, itching, skin inflammation or redness, abnormal liver function test results, extremity swelling, frequent urination, decreased appetite.

Reporting of side effects

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

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

Do not use this medication after the expiration date that appears on the bottle and on the box after “CAD”. The expiration date corresponds to the last day of the month indicated.

This medication does not require special conditions for conservation.

To avoid infections,you must discard each bottle four weeks after having opened it for the first time.Note the opening date of each bottle in the space below and on the space of the bottle label and box label.

On the packaging that only contains one bottle, note only one date.

Opening date (1):

Opening date (2):

Opening date (3):

Medicines should not be thrown down the drains or in the trash. Deposit the packaging and the medicines that you do not need in the SIGRE collection pointof your pharmacy. Ask your pharmacist how to dispose of the packaging and the medicines that you no longer need. In this way, you will help to protect the environment.

Composition of Brinzolamida Stada

• The active ingredient is brinzolamida 10 mg/ml.
• The other components are benzalkonium chloride solution 50 %, carbomer 974P, disodium edetate, mannitol (E421), poloxamer 407, water for injection, and sodium chloride. Small amounts of sodium hydroxide are added to maintain normal acidity levels (pH levels).

Appearance of the product and contents of the package

Brinzolamida Stada is a milky liquid (a suspension) that is presented in a box containing 1 or 3 plastic bottles (dropper bottles) with a screw cap that contain 5 ml of a white homogeneous suspension.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

Famar S.A.

Plant A

63 Agiou Dimitriou Street

174 56 Alimos

Athens (Greece)

or

Balkanpharma-Razgrad AD

68 Aprilsko vastanie Blvd.

Razgrad 7200 (Bulgaria)

or

Pharmathen S.A.

Dervenakion 6

Pallini 15351

Athens (Greece)

or

Centrafarm Services B.V.

Van de Reijtstraat 31-E,

4814 NE Breda (Netherlands)

or

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel (Germany)

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

Republic of CzechiaBrinzolamide STADA 10mg/ml ocní kapky, suspenze

GermanyBrinzolamid AL 10 mg/ml Augentropfensuspension

DenmarkBrinzolamid Stada

SpainBrinzolamida STADA 10 mg/ml colirio en suspensión

FranceBRINZOLAMIDE EG 10 mg/ml, collyreen suspensión

ItalyBrinzolamide EG

NetherlandsBrinzolamide CF 10 mg/ml, oogdruppels, suspensie

SwedenBrinzolamid Stada 10 mg/ml ögondroppar, suspension

Last review date of this leaflet:September 2022

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