10 mg / ml eye drops , suspension
brinzolamide
1. What Brinzolamide Stada is and what it is used for
Brinzolamide Stada contains brinzolamide, which belongs to a group of medicines called carbohydrase inhibitors. It lowers the pressure in the eye.
Brinzolamide Stada 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 Stada may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions and always follow their instructions.
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 any of the other ingredients of this medicine (listed in section 6)
- if you are allergic to medicines belonging to the sulphonamides. Examples can be drugs used to treat diabetes and infection and also diuretics ( diuretic tablets) Brinzolamide Stada 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 Stada:
- if you have kidney or liver problems
- if you have dry eyes or conjunctival problems
- if you are taking other sulfonamide medicines.
Children and young people
Brinzolamide Stada should not be used by infants, children, or adolescents under 18 years of age, unless recommended by your doctor.
Other medicines and Brinzolamide Stada
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you use other carbonic anhydrase inhibitors (acetazolamide or dorzolamide, see section 1 “What Brinzolamide STADA is and what it is used for”), tell your doctor.
Pregnancy, breastfeeding, and fertility
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 Stada. The use of Brinzolamide Stada is not recommended during pregnancy or breast-feeding. Do not use Brinzolamide Stada unless your doctor clearly prescribes it.
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 experience blurred vision for a while after using Brinzolamide Stada.
Brinzolamide Stada may impair the ability to perform tasks that require mental alertness and / or physical coordination. Do not drive or use 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 Stada contains benzalkonium chloride
This medicine contains about 0.1 mg of benzalkonium chloride (a preservative ) 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 Stada
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Brinzolamide Stada 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 Stada in both eyes only if your doctor tells you to. Use the medicine for as long as your doctor prescribes it.
- Get the Brinzolamide Stada bottle and a mirror.
- Wash your hands.
- Shake the bottle and unscrew the hat. If the safety collar is loose after removing the hat, remove the collar 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 Stada 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 Stada, you should press lightly with a finger in the corner of your eye (see figure 3) for at least 1 minute. This prevents Brinzolamide Stada 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 drops, wait at least 5 minutes between the use of Brinzolamide Stada and the other eye drops. Eye ointments should be used last.
If you use more Brinzolamide Stada than you should
If you get too much in your eyes, rinse everything out with lukewarm water. Do not drip in more drops until it is time for your next regular dose.
If you forget to use Brinzolamide Stada
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 Stada
If you stop using Brinzolamide Stada without talking to your doctor, the pressure in your eye will not be checked, which could lead to vision loss.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
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.
Common side effects (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 side effects (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, fatigue, memory difficulties, depression, nervousness, general weakness, fatigue, abnormal feeling, pain, tremors, decreased sexual desire, sexual difficulties in men, cold symptoms, feeling of pressure in the chest, sinus infection, throat irritation, sore throat, abnormal or decreased feeling in the mouth, inflammation the esophagus, 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 side effects (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, itching, abnormal results in liver function 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. Genom att rapportera biverkningar kan du bidra till att öka informationen om läkemedels säkerhet.
5. Hur Brinzolamid Stada ska förvaras
Förvara detta läkemedel utom syn- och räckhåll för barn.
Används före utgångsdatum som anges på kartongen och flaskan efter EXP. Utgångsdatumet är den sista dagen i angiven månad.
Inga särskilda förvaringsanvisningar.
Du måste kasta flaskan fyra veckor efter att du öppnat den för att undvika infektioner.
Skriv upp det datum du öppnade varje flaska i utrymmet nedan och i området på varje flaska och kartongen.
För förpackningar med bara en flaska behöver bara ett datum skrivas in här nedan.
Öppnad (1):
Öppnad (2):
Öppnad (3):
Läkemedel ska inte kastas i avloppet eller bland hushållsavfall. Fråga apotekspersonalen hur man kastar läkemedel som inte längre används. Dessa åtgärder är till för att skydda miljön.
6. Förpackningens innehåll och övriga upplysningar
Innehållsdeklaration
- Den aktiva substansen är brinzolamid 10 mg/ml.
- Övriga innehållsämnen är bensalkoniumklorid lösning 50 %, karbomer 974P, dinatriumedetat, mannitol (E421), poloxamer 407, vatten för injektionsvätskor och natriumklorid. Små mängder av natriumhydroxid används för att hålla surhetsgraden (pH) normal.
Läkemedlets utseende och förpackningsstorlekar
Brinzolamid Stada är en mjölkaktig vätska (suspension) i en förpackning som innehåller 1 eller 3 plastflaskor (droppbehållare) med skruvlock som innehåller 5 ml vit, homogen suspension.
Följande förpackningsstorlekar finns tillgängliga: Ytterkartonger innehållande 1 x 5 ml, 3 x 5 ml flaskor.
Eventuellt kommer inte alla förpackningsstorlekar att marknadsföras.
Innehavare av godkännande för försäljning och tillverkare
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Tyskland
Lokal företrädare
STADA Nordic ApS
Marielundvej 46A
2730 Herlev
Danmark