Brinzolamide Stada 10 mg/ml eye drops in suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Brinzolamide Stada 10 mg/ml eye drops, suspension

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

• Keep this leaflet as 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, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

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

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

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

2. What you need to know before using Brinzolamide Stada

Do not use Brinzolamide Stada

• if you have severe kidney problems.
• if you are allergic to brinzolamide or to any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to a group of medicines called sulfonamides. For example, medicines used to treat diabetes and infections, as well as diuretics (tablets for increasing urine production). Brinzolamide may cause the same allergic reaction.
• if you have too much acid in your blood (a condition called hyperchloremic acidosis).

If you have any doubts, consult your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Brinzolamide Stada:

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

Take special care with brinzolamide

Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with brinzolamide treatment. Stop using brinzolamide and seek immediate medical attention if you notice any symptoms related to these serious 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 specifically recommended by your doctor.

Using Brinzolamide Stada with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

Pregnancy and breastfeeding

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

Women of childbearing potential are advised to use effective contraception during treatment with brinzolamide. Brinzolamide is not recommended during pregnancy or while breastfeeding. Do not use brinzolamide unless clearly indicated by your doctor.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Do not drive or operate machinery until your vision is clear. Immediately after applying brinzolamide, you may notice blurred vision.

Brinzolamide may impair your ability to perform tasks requiring mental alertness and/or physical coordination. If you experience these effects, be cautious when driving or using machines.

Brinzolamide Stada contains benzalkonium chloride

This medicine 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 contact lenses. You should remove your 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 transparent layer at the front of the eye). If you experience any unusual sensation, stinging, or eye pain after using this medicine, speak with your doctor.

3. How to use Brinzolamide Stada

Follow exactly the instructions for administering this medicine as given 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 is 1 drop in the affected eye(s) twice daily – in the morning and at night.

This is the dosage you should follow unless your doctor has instructed you otherwise. Brinzolamide should be applied to both eyes only if your doctor has specifically recommended it. Continue treatment for the full duration prescribed by your doctor.

How to use

Image 1 Image 2 Image 3

• Take the brinzolamide bottle and position yourself in front of a mirror.
• Wash your hands.
• Shake the bottle and unscrew the cap. After removing the cap, remove the security seal ring before using this medicine.
• Hold the bottle upside down between your thumb and middle finger.
• Tilt your head backward. Gently pull down the eyelid of the eye with one finger to form a pouch, into which the drop should fall (image 1).
• Bring the tip of the bottle close to the eye. You may use the mirror to assist.
• Do not touch the eye, eyelid, surrounding areas, or any other surfaces with the dropper, as the drops could 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 sufficient (image 2).
• After using brinzolamide, press with your finger on the edge of the eye next to the nose (image 3) for at least 1 minute. This helps prevent brinzolamide from passing into the rest of the body.
• If applying drops to both eyes, repeat all the previous steps for the other eye.
• Immediately after use, tightly screw the cap back onto the bottle.
• Finish using the bottle you are currently using before opening a new 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 Brinzolamide Stada than you should

If you have applied too much, you can remove the excess by rinsing your eyes with lukewarm water. Do not apply further drops until it is time for your next dose.

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

If you forget to use Brinzolamide Stada

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

If you stop using Brinzolamide Stada

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

If you have any further 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 everyone will experience them.

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

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

The following adverse effects have been observed with brinzolamide.

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

• Eye effects: light sensitivity, conjunctival inflammation or infection, eye swelling, itching, eyelid redness or swelling, lump on the surface of the eye, increased ocular pigmentation, eye fatigue, eyelid crusting, increased tear production.

• Other effects: reduced or decreased cardiac function, palpitations, decreased heart rate, difficulty breathing, shortness of breath, cough, decreased number of red blood cells in blood, increased blood chloride levels, dizziness, somnolence, memory problems, depression, nervousness, generalized weakness, fatigue, abnormal sensation, pain, tremor, decreased sexual drive, male sexual problems, cold-like symptoms, chest congestion, sinus infection, throat irritation, sore throat, abnormal or decreased perception of stimuli in the mouth, inflammation of the esophageal mucosa, abdominal pain, nausea, vomiting, stomach pain, frequent bowel movements, diarrhea, flatulence, digestive disturbances, kidney pain, muscle pain, muscle spasms, back pain, nosebleeds, nasal discharge (runny nose), nasal congestion, sneezing, rash, abnormal skin sensation, itching, headache, dry mouth.

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

• Eye effects: corneal swelling, double or reduced vision, abnormal vision, decreased eye sensitivity, 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, ringing in the ears, hair loss, generalized itching, restlessness, irritability, irregular heart rate, generalized weakness, difficulty sleeping.

Frequency not known (cannot be estimated from available data)

• Eye effects: eyelid abnormalities, vision disturbances, corneal disorders, eye allergy, decreased growth or number of eyelashes.

• Other effects: flat, red, target-shaped or circular rashes on the trunk, often with central blisters, skin peeling, mouth ulcers, and sores in the throat, nose, genitals, and eyes, which may be preceded by fever and flu-like symptoms. These severe skin rashes may be potentially life-threatening (Stevens-Johnson syndrome, toxic epidermal necrolysis), worsening of allergy symptoms, decreased perception of stimuli, tremor, decreased or loss of taste, decreased blood pressure, increased blood pressure, increased heart rate, joint pain, asthma, limb pain, itching, skin swelling or redness, abnormal liver blood test results, swelling of limbs, frequent need to urinate, decreased appetite.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Brinzolamide Stada

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 the month indicated.

This medicine does not require any special storage conditions.

To prevent infection, each bottle must be discarded four weeks after first opening. Record the opening date of each bottle in the space below and in the space provided on the label of the bottle and carton.

In the package containing only one bottle, record only one date.

Date of opening (1):

Date of opening (2):

Date of opening (3):

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point in your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Brinzolamide Stada

• The active substance is brinzolamide 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. Very small amounts of sodium hydroxide are added to maintain normal acidity levels (pH levels).

Nature of the medicinal product and contents of the pack

Brinzolamide Stada is a milky-looking liquid (a suspension) supplied in a box containing 1, 3 or 6 plastic bottles (dropper bottles) with screw caps, each containing 5 ml of white, homogeneous suspension.

Only certain pack sizes may be marketed.

Marketing Authorisation 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 (The Netherlands)

or

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel (Germany)

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Czech Republic Brinzolamide STADA 10mg/ml ocní 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

The Netherlands Brinzolamide CF 10 mg/ml, oogdruppels, suspensie

Sweden Brinzolamid Stada 10 mg/ml ögondroppar, suspension

Date of the most recent revision of this leaflet: September 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/