TRUSOPT ® 2 % is a sterile eyedrop. TRUSOPT ® 2 % contains 2 % dorzolamide hydrochloride, a sulphonamide related compound as the active ingredient. The other ingredients are: Hydroxyethyl cellulose, mannitol, sodium citrate (dihydrate), sodium hydroxide and water for injection. Benzalkonium chloride is added as a preservative.
1. WHAT TRUSOPT ® 2 % CONTAINS
2. WHAT TRUSOPT ® 2 % IS USED FOR
TRUSOPT ® 2 % is prescribed to lower raised pressure in the eye in the treatment of glaucoma.
3. BEFORE YOU USE TRUSOPT ® 2 %
Do not use TRUSOPT ® 2 % if you are hypersensitive (allergic) to dorzolamide or any of the other ingredients of TRUSOPT ® 2 %.
Take special care with TRUSOPT ® 2 %
Tell your doctor about any medical problems you currently have or have had in the past, and about any allergies to any medications. If you suspect that TRUSOPT ® 2 % is causing an allergic reaction (e.g. skin rash or itching), stop its use and contact your doctor at once. If you develop any eye irritation or any new eye problems such as redness of the eye or swelling of the eyelids, contact your doctor immediately. If you wear contact lenses, you should consult your doctor before using TRUSOPT ® 2 %.
Use in children
TRUSOPT ® 2 % has been studied in infants and children less than 6 years of age who have raised pressure in the eye(s) or have been diagnosed with glaucoma. For more information, talk to your doctor.
Use in the elderly
In studies with TRUSOPT ® 2 %, the effects of TRUSOPT ® 2 % were similar in both elderly and younger patients.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding your baby please consult your doctor, pharmacist or other healthcare professional for advice before taking this medicine. Your doctor will decide if you should use TRUSOPT ® 2 %.
Driving and using machinery
There are side effects associated with this product that may affect your ability to drive or operate machinery (see “POSSIBLE SIDE EFFECTS”).
Important information about some of the ingredients of TRUSOPT ® 2 %
TRUSOPT ® 2 % contains the preservative benzalkonium chloride. This preservative may be deposited in soft contact lenses. If you wear contact lenses consult your doctor before using TRUSOPT ® 2 %.
What should I tell my doctor before using TRUSOPT ® 2 %
Tell your doctor about all medicines, (including eye drops) that you are using or plan to use, including those obtained without a prescription, particularly large doses of aspirin or sulpha drugs. Tell your doctor if you now have or have had any past kidney or liver problems.
4. HOW TO USE TRUSOPT ® 2 %
Your doctor will establish the appropriate dose and duration of treatment. When TRUSOPT ® 2 % is used alone, the dose is one drop in the affected eye(s) in the morning, in the afternoon and in the evening. Do not share medicines prescribed for you with any other person. If your doctor has recommended you use TRUSOPT ® 2 % with a beta-blocker eye drop to lower eye pressure, then the dose is one drop of TRUSOPT ® 2 % in the affected eye(s) in the morning and in the evening.
If you are using TRUSOPT ® 2 % with another eye drop, the drops should be instilled at least 10 minutes apart. Do not allow the tip of the container to touch the eye or areas around the eye. To avoid possible contamination, keep the tip of the container away from contact with any surface. Do not change the dosage of the drug without consulting your doctor. If you must stop treatment, contact your doctor immediately. If you have the impression that the effect of TRUSOPT ® 2 % is too strong or too weak, talk to your doctor or pharmacist.
Instructions for use
1. Before using the medication for the first time, be sure the Safety Strip on the front of the bottle is unbroken. A gap between the bottle and the cap is normal for an unopened bottle.
2. Tear off the Safety Strip to break the seal.
3. To open the bottle, unscrew the cap by turning as indicated by the arrows on the top of the cap. Do not pull the cap back directly up and away from the bottle. Pulling the cap directly up will prevent your dispenser from operating properly.
4. Tilt your head back and pull your lower eyelid down slightly to form a pocket between your eyelid and your eye.
5. Invert the bottle and press lightly with the thumb or index finger over the “Finger Push Area” (as shown) until a single drop is dispensed into the eye as directed by your doctor. DO NOT TOUCH YOUR EYE OR EYELID WITH THE DROPPER TIP. Ophthalmic medications, if handled improperly, can become contaminated by common bacteria known to cause eye infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated ophthalmic medications. If you think your medication may be contaminated, or if you develop an eye infection, contact your doctor immediately concerning continued use of this bottle.
6. If drop dispensing is difficult after opening for the first time, replace the cap on the bottle and tighten (DO NOT OVERTIGHTEN) and then remove by turning the cap in the opposite direction as indicated by the arrows on top of the cap.
7. Repeat steps 4 and 5 with the other eye if instructed to do so by your doctor.
8. Replace the cap by turning until it is firmly touching the bottle. The arrow on the left side of the cap must be aligned with the arrow on the left side of the bottle label for proper closure. Do not over-tighten or you may damage the bottle and cap.
9. The dispenser tip is designed to provide a single drop; therefore, do NOT enlarge the hole of the dispenser tip.
10. After you have used all doses, there will be some TRUSOPT ® 2 % left in the bottle. You should not be concerned since an extra amount of TRUSOPT ® 2 % has been added and you will get the full amount of TRUSOPT ® 2 % that your doctor prescribed. Do not attempt to remove excess medicine from the bottle.
5. POSSIBLE SIDE EFFECTS
TRUSOPT ® can have side effects. Not all side effects reported for TRUSOPT ® are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking this medicine, please consult your doctor, pharmacist or other healthcare professional. Although not all these side effects may occur, if they do occur, you may need medical attention. Patients may experience eye symptoms such as burning and stinging, blurred vision, itching, tearing, redness of the eye(s), eye pain or swelling or crusting of the eyelids. You may sense a bitter taste after putting in your eye drops. Other side effects include headache, nose bleed, dry mouth, nausea, tiredness, dizziness, tingling sensation, kidney stones and rarely allergic-type reactions including rash, hives, itching and shortness of breath. Side effects, other than those listed above, may also occur, and some of these may be serious, such as severe skin reactions. Ask your doctor or pharmacist for more information about side effects. Both have a more complete list of side effects. Please tell your doctor/pharmacist promptly about any of these or any other unusual symptoms. If you noticed any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
6. STORING AND DISPOSING OF TRUSOPT ® 2 %
Store all medicines out of reach of children. Store TRUSOPT ® 2 % at or below 25 °C. Protect from light. Do not use this medicine after the month and year following EXP.: on the container. DO NOT USE MORE THAN 30 DAYS AFTER OPENING. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).