10 mg/ml eye drops, suspension
brinzolamide
1. What Brinzolamide Sandoz is and what it is used for
Brinzolamide Sandoz contains brinzolamide, which belongs to a group of medicines called carbohydrase inhibitors. It lowers the pressure in the eye.
Brinzolamide Sandoz eye drops are used to treat high pressure in the eye. Such pressure can lead to a disease called glaucoma.
If the pressure becomes too high, vision may be impaired.
Brinzolamide contained in Brinzolamide Sandoz may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
2. What you need to know before you use Brinzolamide Sandoz
Do not use Brinzolamide Sandoz
- if you have severe kidney problems
- if you are allergic to brinzolamide or any of the other ingredients of this medicine (listed in section 6)
- if you are allergic to medicines belonging to the sulphonamidesExamples can be medicines used to treat diabetes and infections, as well as diuretics ( diuretic tablets). Brinzolamide Sandoz can cause the same type of allergy.
- if you have too much acid in your blood (a condition called hyperchloraemic acidosis ).
If you have any further questions, ask your doctor.
Warnings and cautions
Talk to your doctor or pharmacist before using Brinzolamide Sandoz:
- if you have kidney or liver problems
- if you have dry eyes or corneal problems
- if you are taking other sulfonamide medicines
Children and young people
Brinzolamide Sandoz should not be used by infants, children, or adolescents under 18 years of age unless recommended by your doctor.
Other medicines and Brinzolamide Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
If you use other carbonic anhydrase inhibitors (acetazolamide or dorzolamide, see section 1. “What Brinzolamide Sandoz is and what it is used for”), so tell your doctor.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Women who may become pregnant should use effective contraception while being treated with Brinzolamide Sandoz. The use of Brinzolamide Sandoz is not recommended during pregnancy or breast-feeding. Do not use Brinzolamide Sandoz unless your doctor clearly tells you to.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Do not drive or use machines until your vision is clear. You may find that your vision becomes blurred
for a while after using Brinzolamide Sandoz.
Brinzolamide Sandoz may impair the ability to perform tasks that require mental alertness and/or physical coordination. Be careful when driving or using machines if you are affected in this way.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Brinzolamide Sandoz contains benzalkonium chloride
This medicine contains 0.10 mg of benzalkonium chloride per ml. Benzalkonium chloride can be absorbed by soft contact lenses and can discolor the contact lenses. Remove contact lenses before using the medicine and wait at least 15 minutes before re-inserting the contact lenses.
Benzalkonium chloride can be irritating to the eyes, especially if you have dry eyes or problems with the cornea (the clear membrane at the front of the eye). If you experience irritation, tingling, or pain in the eye after using the medicine, consult a doctor.
3. How to use Brinzolamide Sandoz
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Brinzolamide Sandoz should only be used in the eyes. It must not be swallowed or injected.
The recommended dose is 1 drop in the affected eye or eyes twice daily – morning and evening unless your doctor prescribes otherwise. Use Brinzolamide Sandoz in both eyes only if your doctor prescribes it. Use the medicine for as long as your doctor prescribes it.
Instructions for use
1.
2.
3.
Get the Brinzolamide Sandoz bottle and a mirror
- Wash your hands.
- Shake the bottle and unscrew the hat. If the safety closure (ring) is loose after removing the hat, remove it before using the product.
- Hold the bottle upside down between your thumb and forefinger.
- Tilt your head back. Pull the eyelid down with a clean finger, so that a pocket is formed between the eyelid and the eye. The drop should end up in the pocket (figure 1).
- Move the tip of the bottle close to the eye. Use the mirror if it facilitates.
- Do not touch the eye or eyelid, surrounding areas, or other surfaces with the bottle tip. This can contaminate the drops.
- Gently press the bottom of the bottle with your index finger to release one drop of Brinzolamide Sandoz at a time.
- Do not squeeze the bottle; it is designed so that a light pressure at the bottom is sufficient (figure 2).
- After using Brinzolamide Sandoz, you should press lightly with a finger in the corner of your eye (see Figure 3) for at least 1 minute. This prevents Brinzolamide Sandoz from entering the rest of the body.
- If you drip in both eyes, repeat the procedure in the other eye.
- Screw the cap onto the bottle firmly immediately after use.
- Use one bottle before opening the next.
If the drop misses the eye, try again.
If you use other eye products, wait at least 5 minutes between using Brinzolamide Sandoz and the other eye products.
Eye ointments should be used last.
If you use more Brinzolamide Sandoz than you should
If you get too much in your eyes, rinse everything out with lukewarm water. Do not drip in more drops
If you forget to use Brinzolamide Sandoz
Then use a drop of the drug as soon as possible and then return to your normal routine. Do not take a double dose to make up for a forgotten dose.
If you stop using Brinzolamide Sandoz
If you stop using Brinzolamide Sandoz without talking to your doctor, the pressure in your eye will not be checked, which could lead to vision loss.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been seen with Brinzolamide Sandoz.
Common (may affect up to 1 in 10 people):
Side effects in the eye: blurred vision, eye irritation, eye pain, discharge from the eye, itchy eyes, dry eyes, abnormal feeling in the eye, red eyes.
The side effect is in other parts of the body: bad taste in the mouth.
Uncommon (may affect up to 1 in 100 people):
Side effects in the eye: photosensitivity, inflammation or infection of the conjunctiva, eye swelling, itching , redness or swelling of the eyelids, growth on the surface of the eye, increased pigmentation in the eye, tired eyes, crusts on the eyelids, increased tear production.
Side effects in other parts of the body: decreased or impaired heart function, palpitations, decreased heart rate, difficulty breathing, shortness of breath, cough, decreased red blood cell count, the increased chlorine content in the blood, dizziness, drowsiness, memory difficulties, depression, nervousness, general weakness, fatigue, abnormal sensation, pain, tremor, decreased libido, male sexual difficulty, cold symptoms, a sensation of pressure in the chest, sinus, throat irritation, sore throat, abnormal or decreased sensation in the mouth, inflammation of the esophagus mucosa, Abdominal pain, nausea, vomiting, stomach discomfort, frequent bowel movements, diarrhea, intestinal gas, digestive problems, kidney pain, muscle pain, muscle spasms, back pain, nose bleeds, runny nose, nasal congestion, sneezing, rash, abnormal skin sensation, itching, headache, dry mouth.
Rare(may affect up to 1 in 1,000 people):
Side effects in the eye: corneal swelling, double vision or impaired vision, abnormal vision, decreased sensitivity in the eye, swelling around the eye, increased pressure in the eye, damage to the optic nerve.
Side effects are in other parts of the body: impaired memory, drowsiness, chest pain, upper airway obstruction, congested sinuses, nasal congestion, dry nose, ringing in the ears, hair loss, general itching, feeling nervous, irritable, irregular heartbeat, weakness in the body, difficulty sleeping.
Has been reported (occurs in an unknown number of users):
Side effects in the eye: abnormal eyelids, visual disturbance, disease of the cornea, eye allergy, eyelashes grow worse or decrease in number.
Side effects are in other parts of the body: increased allergic symptoms, decreased sensation, tremors, loss of or decreased taste, decreased blood pressure, high blood pressure, increased heart rate, joint pain, asthma, pain in arm or leg, redness, inflammation or itching of the skin, abnormal liver function values in blood tests, swelling in the arm or leg, frequent urination, decreased appetite.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Brinzolamide Sandoz
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP. or EXP. The expiration date is the last day of the specified month.
No special storage instructions
You must discard the bottle four weeks after opening it for the first time to prevent infection. Write down the date you opened each bottle in the space below and in the spaces on the bottle label and carton. For packages with only one bottle, only one date needs to be entered below.
Opened (1):
Opened (2):
Opened (3):
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
The active substance is brinzolamide 0.33 mg per drop, equivalent to 10 mg/ml.
The other excipients are benzalkonium chloride, disodium edetate, mannitol (E421), carbomer 974P, tyloxapol, sodium chloride, sodium hydroxide and/or hydrochloric acid (for pH adjustment), and purified water.
What the medicine looks like and contents of the pack
Brinzolamide Sandoz is a white to off-white suspension contained in a pack containing a 5 ml or 10 ml plastic bottle (5 and 10 ml LDPE bottles with LDPE drip insert with a tamper-proof polypropylene screw cap [droptainer]).
The following pack sizes are available: packs containing 1 x 5 ml, 3 x 5 ml and 1 x 10 ml bottles.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer
SA Alcon-Couvreur NV, Rijksweg 14, 2870 Puurs, Belgium
or
Alcon Cusi SA, Camil Fabra 58, 08320 El Masnou, Barcelona, Spain
or
Lek Pharmaceuticals dd, Verovskova 57, 1526 Ljubljana, Slovenia
or
Aeropharm GmbH, Francois Mitterrand Allee 1, 07407 Rudolstadt, Germany
or
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany