Trusopt
Italy
Table of Contents
Patient Information Leaflet: Information for the User
TRUSOPT 20 mg/ml eye drops, solution
dorzolamide
Please read this leaflet carefully before using this medicine because it contains important information for you.
- Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
- If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What TRUSOPT is and what it is used for
- What you need to know before using TRUSOPT
- How to use TRUSOPT
- Possible side effects
- How to store TRUSOPT
- Contents of the pack and other information
1. What TRUSOPT is and what it is used for
TRUSOPT contains dorzolamide, which belongs to a group of medicines known as "carbonic anhydrase inhibitors".
This medicine is prescribed to lower elevated intraocular pressure and for the treatment of glaucoma. This medicine may be used alone or in combination with other medicines that lower intraocular pressure (called beta-blockers).
2. What you need to know before using TRUSOPT
Do not use TRUSOPT
- if you are allergic to dorzolamide hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
- if you have severe kidney impairment or kidney problems, or a history of kidney stones.
Warnings and precautions
Talk to your doctor or pharmacist before using TRUSOPT.
Inform your doctor or pharmacist about any medical conditions you currently have or have had in the
past, including eye problems and eye surgery, and any allergies to other medicines.
If you develop eye irritation or any new eye problems, such as eye redness or eyelid swelling, contact your
doctor immediately.
If you suspect that TRUSOPT is causing an allergic reaction (e.g., rash, severe skin reaction, or itching),
stop using this medicine and contact your doctor immediately.
Children
TRUSOPT has been studied in infants and children under 6 years of age with increased eye pressure or
who have been diagnosed with glaucoma. For further information, consult your doctor.
Elderly
In clinical studies with TRUSOPT, the effects of this medicine observed in elderly patients were similar to
those in younger patients.
Use in patients with hepatic impairment
Inform your doctor about any liver problems you currently have or have had in the past.
Other medicines and TRUSOPT
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines (including eye drops). This is particularly important if you are taking another carbonic
anhydrase inhibitor such as acetazolamide or a sulfonamide medicine.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, ask
your doctor or pharmacist for advice before taking this medicine.
Pregnancy
This medicine should not be used during pregnancy. Inform your doctor if you are pregnant or plan to
become pregnant.
Breastfeeding
Breastfeeding is not recommended if treatment with this medicine is necessary. Inform your doctor if you
are breastfeeding or intend to breastfeed.
Driving and using machines
The effects of TRUSOPT on the ability to drive vehicles or operate machinery have not been studied.
There are side effects associated with the use of TRUSOPT, such as dizziness and blurred vision, which
may affect your ability to drive or operate machinery. You should avoid driving or operating machinery
until you feel well or your vision is clear.
TRUSOPT contains benzalkonium chloride
This medicine contains approximately 0.002 mg of benzalkonium chloride per drop, equivalent to 0.075
mg/ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may cause a change in their color.
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 eye or corneal disorders
(the transparent outermost layer of the eye). If you experience an unusual sensation in the eye, such as
burning or pain after using this medicine, speak with your doctor.
3. How to use TRUSOPT
Use this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist. The appropriate dose and duration of treatment will be determined by your physician.
When this medicine is used alone, the recommended dose is one drop instilled into the affected eye(s) in the morning, one in the afternoon, and one in the evening.
If your doctor has recommended using this medicine together with a beta-blocker eye drop to lower eye pressure, the recommended dose is one drop of TRUSOPT instilled into the affected eye(s) in the morning and one in the evening.
If TRUSOPT is used together with other eye drops, the drops should be administered at least 10 minutes apart.
The dropper tip must not come into contact with the eye or surrounding areas. It may become bacterially contaminated, which could lead to eye infections causing serious eye damage, including loss of vision.
To avoid possible contamination, wash your hands before using this medicine and do not let the dropper tip touch any surface. If you suspect the medicine may be contaminated or if an eye infection develops, contact your doctor immediately before continuing to use the medicine.
Instructions for use:
Do not use the container if the plastic safety seal around the neck of the container is missing or broken. When opening the container for the first time, tear off the plastic safety seal.
Each time you use TRUSOPT:
- Wash your hands.
- Open the container. Be especially careful that the tip of the dropper container does not touch the eye, the skin around the eye, or your fingers.
- Tilt your head back and hold the
container upside down over the eye.
- Pull the lower eyelid down and
look upwards. Hold the container and gently squeeze the flattened sides to release one drop into the space between the lower eyelid and the eye.
- Close the eye and press with a finger
on the inner corner of the eye for about two minutes. This helps prevent the medicine from passing into the rest of the body.
- Repeat steps 3 to 5 for the other eye if prescribed by your doctor.
- Replace the cap and close the container firmly.
If you use more TRUSOPT than you should
If you instill too many drops into the eye or if you swallow any of the contents of the container, contact your doctor immediately.
If you forget to use TRUSOPT
It is important that this medicine is administered as prescribed by your doctor. If you miss a dose, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and continue with your regular dosing schedule.
Do not take a double dose to make up for a forgotten dose.
If you stop using TRUSOPT
If you wish to stop treatment, discuss this with your doctor first. If you have any questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Should allergic reactions occur, including hives, swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing, you must stop treatment with this medicine and contact your doctor immediately.
The following side effects have been reported with TRUSOPT in clinical studies or after marketing:
Very common side effects: (affect more than 1 in 10 people)
Burning and stinging pain in the eyes.
Common side effects: (affect 1 to 10 in 100 people)
Corneal disease with eye pain and blurred vision (superficial punctate keratitis), eye discharge with itching (conjunctivitis), eyelid irritation/inflammation, blurred vision, headache, nausea, bitter taste sensation, and fatigue.
Uncommon side effects: (affect 1 to 10 in 1,000 people)
Inflammation of the iris.
Rare side effects: (affect 1 to 10 in 10,000 people)
Tingling or numbness in the hands or feet, temporary myopia which may resolve upon discontinuation of treatment, fluid accumulation under the retina (choroidal detachment after filtering surgery), eye pain, crusting of the eyelids, ocular hypotension, corneal edema (with symptoms of visual disturbances), eye irritations including redness, kidney stones, dizziness, nosebleeds, throat irritation, dry mouth, localized skin rash (contact dermatitis), severe skin reactions, allergic-type reactions including skin rashes, hives, itching, and in rare cases possible swelling of lips, eyes and mouth, shortness of breath, and more rarely laboured breathing.
Not known: (frequency cannot be estimated from the available data)
Laboured breathing, sensation of a foreign body in the eye (feeling that something is in the eye), strong heartbeat which may be rapid or irregular (palpitations), increased heart rate, increased blood pressure, and abnormal sensitivity of the eyes to light.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at: www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store TRUSOPT
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 container label and on the
carton after “Exp.” The expiry date refers to the last day of that month.
Once the container has been opened, TRUSOPT must be used within 28 days.
This medicine does not require any special storage temperature.
Store the container in the outer packaging to protect the medicine from light.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.
6. Package contents and other information
What TRUSOPT contains
- The active substance is dorzolamide.
- Each ml contains 22.26 mg of dorzolamide hydrochloride, equivalent to 20 mg of dorzolamide.
- The other components are hydroxyethylcellulose, mannitol, sodium citrate, sodium hydroxide, and water for injections. Benzalkonium chloride is added as a preservative.
Description of the appearance of TRUSOPT and package contents
TRUSOPT is a clear, colourless or almost colourless, slightly viscous solution.
TRUSOPT is supplied in a translucent white plastic container containing 5 ml of solution. The plastic container is closed with a white screw cap.
The protective seal consists of a security band located on the container label.
Pack sizes:
1 x 5 ml (single 5 ml container)
3 x 5 ml (three 5 ml containers)
6 x 5 ml (six 5 ml containers)
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Santen Italy S.r.l.
Via Roberto Lepetit, 8/10
20124 Milano, Italy
Manufacturer
Santen Oy, Kelloportinkatu 1, 33100 Tampere, Finland
This medicinal product is authorised in the European Economic Area countries under the following names:
Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Netherlands, Portugal, Spain, Sweden:
TRUSOPT