20 mg/ml eye drops, solution
dorzolamide
What Trusopt is and what it is used for
Trusopt contains dorzolamide which belongs to a group of medicines called carbonic anhydrase inhibitors.
This medicine is used to lower elevated pressure in the eye and the treatment of glaucoma. This medicine can be used alone or together with other medicines that lower the pressure in the eye (so-called beta-receptor blockers ).
What you need to know before using Trusopt
Do not use Trusopt
- if you are allergic to dorzolamide hydrochloride or any of the other ingredients of this medicine (listed in section 6).
- if you have severely reduced kidney function or kidney problems, or previously had kidney stones.
Warnings and precautions
Talk to your doctor or pharmacist before using Trusopt
Tell your doctor or pharmacist about any medical problems you have or have had in the past, including eye problems and eye operations, as well as allergies to any medicine or medicines.
If you feel irritation of any kind in the eye or get other eye problems, such as red eyes or swollen eyelids, you should contact a doctor as soon as possible.
If you suspect that Trusopt is causing an allergic reaction (e.g. skin rash, severe skin reaction, or itching ), stop treatment with this medicine and contact a doctor as soon as possible.
Children
Trusopt has been used in studies in infants and children under 6 years of age with increased pressure in the eye(s) or with a diagnosis of glaucoma. For further information, talk to your doctor.
Older
In studies with Trusopt, the effect was comparable in older and younger patients.
Use in patients with impaired liver function
Tell your doctor if you have or have ever had any kind of liver problem.
Other medicines and Trusopt
Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines (including eye drops ). This is especially important if you are using another carbonic anhydrase inhibitor such as acetazolamide or drugs containing sulfonamides.
Pregnancy, breastfeeding, and fertility
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Trust should not be used during pregnancy. Therefore, tell your doctor if you are or plan to become pregnant.
Breast-feeding
If treatment with Trusopt is necessary, breastfeeding is not recommended. Tell your doctor if you are breastfeeding or plan to breastfeed.
Driving ability and use of machinery
No studies regarding effects on the ability to drive and use machines have been performed. Trusopt can cause side effects such as dizziness and blurred vision, which can affect your ability to drive or use machinery. Wait to drive or use machines until you feel well or your vision is clear.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased 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. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Trusopt contains excipients
Trusopt contains benzalkonium chloride
This medicine contains approximately 0.002 mg benzalkonium chloride per drop corresponding to 0.075 mg/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 putting them back in.
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 feel irritation, tingling, or pain in the eye after using the medicine, consult a doctor.
How to use Trusopt
Always use this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure. The appropriate dose and duration of treatment are determined by the doctor.
When this medicine is used alone, the recommended dose is 1 drop in the affected eye(s) in the morning, afternoon, and evening.
If your doctor recommends using this medicine in combination with other eye drops called beta blockers to lower the pressure in the eye, the recommended dose is 1 drop of Trusopt in the affected eye(s) in the morning and the evening.
If Trusopt is used together with other eye drops, the eye drops should be taken at least 10 minutes apart.
Make sure the tip of the bottle does not touch the eye or the area around the eye. This can lead to the drops being contaminated with bacteria, which can cause an eye infection. Such an infection can lead to serious eye damage, even loss of vision.
Wash your hands before using this medicine to avoid contamination and make sure the tip of the bottle does not touch other surfaces. If you think your medication may have been contaminated, or if you develop an eye infection, contact your doctor immediately regarding the continued use of this bottle.
Instructions for use:
Do not use the bottle if the plastic sealing strip around the neck of the bottle is missing or broken. Remove the sealing strip when opening the bottle for the first time.
Each time you use Trusopt:
[OCUMETER PLUS bottle only]
1. Make sure the sealing strip on the front of the bottle is unbroken before using the bottle for the first time. A gap between the bottle and cap is normal for an unopened bottle.
2. First wash your hands, then remove the sealing strip.
3. Open the bottle by unscrewing the cap, and turning in the direction of the arrows. Do not pull the cap straight up from the bottle, as this may impair the function of the bottle tip.
4. Tilt your head back and pull down the lower eyelid slightly so that a pocket is formed between the eyelid and the eye.
5. Turn the bottle upside down. Press lightly with your thumb or index finger on the area to be pressed until a drop has been instilled into the eye, as directed by your doctor.
DO NOT TOUCH YOUR EYE OR EYELID WITH THE TIP OF THE BOTTLE.
6. If it is difficult to get drops out after opening the bottle for the first time, put the cap back on the bottle (do not tighten it too tightly). Remove the hat as usual by turning it according to the arrows.
7. If your doctor prescribed treatment for your other eye, repeat steps 4 and 5.
8. Screw the cap so that it is fixed on the bottle. The arrow on the left side of the cap must line up with the arrow on the left side of the bottle to be properly closed. Be careful not to screw the cap on too tightly as this may damage the bottle and cap.
9. The hole in the tip is designed to get a single drop out, so DO NOT enlarge the hole in the bottle tip yourself.
10. When you have finished using the bottle, there will be a certain amount of medicine left. This is normal because an extra amount of medicine has been added. You will be given the amount prescribed by your doctor. Do not try to get the excess medicine out of the bottle.
If you have used too much Trusopt
If you put too many drops in the eye, have swallowed some of the contents of the container, or if, for example, a child accidentally swallowed the drops, immediately contact a doctor or hospital for an assessment of the risk and advice.
If you forget to use Trusopt
It is important to take Trusopt as prescribed by your doctor. If you forget to take a dose, take it as soon as possible. If, on the other hand, it is time to take the next dose, then skip the forgotten dose and then regularly follow the dosing schedule.
Do not take a double dose to make up for a missed dose.
If you stop using Trusopt
If you want to stop treatment with Trusopt, consult your doctor first. If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience an allergic reaction with symptoms such as hives, and swelling of the face, lips, tongue, and/or throat which may cause breathing and swallowing difficulties, stop using Trusopt and seek medical attention immediately.
The following side effects have been reported with Trusopt, either in clinical studies or after approval:
Very common side effects ( affects more than 1 in 10 users):
Burning and stinging sensation in the eye.
Common side effects ( affects 1 to 10 users in 100):
Affects the cornea with sore eyes and blurred vision (superficial punctate keratitis ), increased tearing or itching of the eyes ( conjunctivitis ), irritation/inflammation of the eyelids, blurred vision, headache, nausea, bitter taste in the mouth, and fatigue.
Uncommon side effects ( affects 1 to 10 users in 1,000):
Inflammation of the iris of the eye.
Rare side effects ( affects 1 to 10 users in 10,000):
Tingling or numbness in the hands or feet, temporary nearsightedness that may disappear when treatment is stopped, fluid under the retina of the eye (detachment of the choroid of the eye after filtration surgery), pain in the eyes, deposits on the eyelids, low pressure in the eye, swelling of the cornea (with symptoms such as vision changes), eye irritation including redness, kidney stones, dizziness, nosebleed throat irritation, dry mouth, limited area of skin rash ( contact dermatitis ), severe skin reactions, allergy-like reactions such as skin rash, hives, itching and in rare cases swelling of the lips, eyes and mouth, shortness of breath as well as more rare wheezing.
Frequency not known: (cannot be estimated from the available data)
Shortness of breath, feeling of debris in the eye, strong heartbeats that may be fast or irregular (palpitations).
How to store Trusopt
Keep this medicine out of sight and reach of children.
Use before the expiry date which is stated on the label and carton after EXP. The expiration date is the last day of the specified month.
Trusopt should be used within 28 days of opening the bottle.
No special temperature instructions.
Store the bottle in the outer carton. Light sensitive.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is dorzolamide.
- 1 ml contains 22.26 mg dorzolamide hydrochloride corresponding to 20 mg dorzolamide.
- Other ingredients are hydroxyethyl cellulose, mannitol, sodium citrate, sodium hydroxide, and water for injection. Benzalkonium chloride is added as a preservative.
Appearance and package sizes of the medicine
Trusopt is a clear, colorless to almost colorless, slightly viscous solution.
Trusopt is packaged in a white, transparent plastic bottle containing 5 ml of solution. The plastic bottle is closed with a white screw cap.
The OCUMETER Plus bottle consists of a transparent, high-density polyethylene bottle containing 5 ml of solution. There is a sealing strip to show that the bottle is unbroken.
Package sizes:
1 x 5 ml (1 bottle of 5 ml)
3 x 5 ml (3 bottles of 5 ml)
6 x 5 ml (6 bottles of 5 ml)
Not all packages may be marketed.
Marketing authorization holder:
Santen Oy
Niittyhaankatu 20
33720 Tampere
Finland
Manufacturer:
Fareva Mirabel
Route de Marsat, Riom;
63963 Clermont-Ferrand, Cedex 9
France
Santen Oy
Kelloportinkatu 1
33100 Tampere
Finland
This medicine is approved in the European Economic Area under the names:
Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Netherlands, Portugal, Spain, Sweden:
Panty opt