BRINZOLAMIDE STADA 10 mg/ml EYE DROPS, SUSPENSION

Introduction

Patient Information: Summary of Product Characteristics

Brinzolamida Stada 10 mg/ml eye drops, suspension

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

• Keep this summary, 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 only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this summary. See section 4.

Contents of the Summary

1. What is Brinzolamida Stada and what is it used for
2. What you need to know before using Brinzolamida Stada
3. How to use Brinzolamida Stada
4. Possible side effects
5. Storage of Brinzolamida Stada
6. Package contents and additional information

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

Brinzolamida Stada contains brinzolamide, which belongs to a group of medications called carbonic anhydrase inhibitors, and reduces the pressure inside the eye.

Brinzolamide eye drops are used to treat high pressure in the eyes. This pressure can lead to a disease called glaucoma.

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

2. What you need to know before using Brinzolamida Stada

Do not use Brinzolamida Stada

• if you have severe kidney problems.
• if you are allergic to brinzolamide or any of the other components of this medication (listed in section 6).
• if you are allergic to a group of medications called sulfonamides. For example, medications used to treat diabetes and infections, as well as diuretics (pills to urinate). Brinzolamide could cause you the same allergy.
• if you have too much acid in the blood (a disease called hyperchloremic acidosis).

If you have any doubts, 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 medications that contain sulfonamides.
• if you have ever developed a severe skin rash or skin peeling, blisters, and/or sores in the mouth after using brinzolamide or other related medications.

Be careful with brinzolamide

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

Children and adolescents

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

Using Brinzolamida Stada with other medications

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

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

Consult your doctor or pharmacist before using any medication.

Driving and using machines

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

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

Brinzolamida Stada contains benzalkonium chloride

This medication contains approximately 0.1 mg of benzalkonium chloride (a preservative) per ml. Benzalkonium chloride may be absorbed by soft contact lenses and may change the color of the contact lenses. You should remove your contact lenses before using this medication and put them back on 15 minutes later.

Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or corneal disorders (the transparent layer on the front of the eye). If you feel an abnormal sensation in your eyes, itching, or eye pain after using this medication, talk to your doctor.

3. How to use Brinzolamida Stada

Follow the administration instructions for this medication exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Use brinzolamide only in your eye(s). Do not swallow or inject.

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

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

How to use

Image 1 Image 2 Image 3

• Take the brinzolamide bottle and stand in front of a mirror.
• Wash your hands.
• Shake the bottle and unscrew the cap. After removing the cap, you must remove the security seal ring before using this medication.
• Hold the bottle, upside down, between your thumb and index finger.
• Tilt your head back. Gently separate the eyelid of the eye with a finger, until a pouch forms, where the drop should fall (image 1).
• Bring the tip of the bottle close to the eye. You can use the mirror to help you.
• Do not touch the eye, eyelid, nearby areas, or other surfaces with the dropper, as the drops may become contaminated.
• Gently press the base of the bottle to release one drop of brinzolamide at a time.
• Do not squeeze the bottle: it is designed so that gentle pressure on the base is enough (image 2).
• After using brinzolamide, press the edge of the eye, next to the nose (image 3), for at least 1 minute. This helps prevent brinzolamide from entering the rest of the body.
• If you are applying drops to both eyes, repeat all the previous steps with the other eye.
• Screw the cap back 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 applying brinzolamide and the other drops. Ophthalmic ointments should be administered last.

If you use more Brinzolamida Stada than you should

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

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 medication and the amount used.

If you forget to use Brinzolamida Stada

Apply one drop as soon as you remember and then continue with your usual treatment regimen. Do not apply a double dose to make up for the forgotten one.

If you stop using Brinzolamida Stada

If you stop using brinzolamide without consulting your doctor, the pressure in your eye will not be controlled, which could lead to vision loss.

If you have any other questions about using this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

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

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

The following side effects have been observed with brinzolamide.

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

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

• Other effects:bad taste.

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

• Eye effects:sensitivity to light, conjunctival inflammation or infection, eye swelling, itching, redness or swelling of the eyelid, lump on the surface of the eye, increased eye pigmentation, tired eyes, crusts on the eyelid, increased tear production.

• Other effects:reduced or decreased heart function, palpitations, decreased heart rate, difficulty breathing, shortness of breath, cough, decreased red blood cell count, increased blood chloride levels, dizziness, drowsiness, memory problems, depression, nervousness, general weakness, fatigue, feeling of abnormality, pain, tremors, decreased sexual activity, sexual problems in men, cold symptoms, chest congestion, nasal sinus infection, sore throat, abnormal sensation in the mouth, esophageal mucosal inflammation, abdominal pain, nausea, vomiting, stomach pain, frequent bowel movements, diarrhea, gas, digestive disorders, kidney pain, muscle pain, muscle spasms, back pain, nosebleeds, nasal discharge (runny nose), stuffy nose, sneezing, rash, abnormal sensation on the skin, itching, headache, dry mouth.

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

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

• Other effects:memory loss, drowsiness, chest pain, upper respiratory tract congestion, sinus congestion, nasal congestion, nasal dryness, ringing in the ears, hair loss, generalized itching, feeling of restlessness, irritability, irregular heart rate, general weakness, difficulty sleeping.

Frequency not known(cannot be estimated from available data)

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

• Other effects:reddish patches, not raised, in a target or circular shape on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes, which can be preceded by fever and flu-like symptoms. These severe skin rashes can be potentially fatal (Stevens-Johnson syndrome, toxic epidermal necrolysis), increased allergy symptoms, decreased sensation, tremors, decreased or lost taste, decreased blood pressure, increased blood pressure, increased heart rate, joint pain, asthma, pain in limbs, itching, skin inflammation or redness, abnormal liver blood test results, swelling of the limbs, frequent urination, decreased appetite.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this summary. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Brinzolamida Stada

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

Do not use this medication after the expiration date shown on the bottle and carton after "EXP". The expiration date corresponds to the last day of the month indicated.

This medication does not require special storage conditions.

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

In the package that contains only one bottle, write only one date.

Opening date (1):

Opening date (2):

Opening date (3):

Medications should not be thrown away in drains or trash. Deposit the packaging and medications you no longer need in the SIGRE Point of your pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Brinzolamida Stada

• The active ingredient is brinzolamide 10 mg/ml.
• The other ingredients are benzalkonium chloride 50% solution, 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 and package contents

Brinzolamida Stada is a milky liquid (a suspension) that comes in a carton of 1 or 3 plastic bottles (droppers) with a screw cap that contain 5 ml of homogeneous white suspension.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

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

Czech Republic Brinzolamide STADA 10mg/ml oční kapky, suspenze

Germany Brinzolamid AL 10 mg/ml Augentropfensuspension

Denmark Brinzolamid Stada

Spain Brinzolamida STADA 10 mg/ml colirio en suspensión

France BRINZOLAMIDE EG 10 mg/ml, collyre en suspension

Italy Brinzolamide EG

Netherlands Brinzolamide CF 10 mg/ml, oogdruppels, suspensie

Sweden Brinzolamid Stada 10 mg/ml ögondroppar, suspension

Date of the last revision of this summary:September 2022

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