Trusopt

Dorzolamide hydrochloride.

Each ml contains 22.26 mg of dorzolamide hydrochloride equivalent to 20 mg of dorzolamide.
Excipients/Inactive Ingredients: The other ingredients are hydroxyethylcellulose, mannitol, sodium citrate, sodium hydroxide, and water for injections. Benzalkonium chloride is added as a preservative.

TRUSOPT contains dorzolamide which belongs to a group of medicines called "carbonic anhydrase inhibitors".

This medicine is prescribed to lower raised pressure in the eye and to treat glaucoma. This medicine can be used alone or in addition to other medicines which lower the pressure in the eye (so-called beta-blockers).

Always use this medicine exactly as advised by the doctor. Check with the doctor or pharmacist if unsure. The appropriate dosage and duration of treatment will be established by the doctor.
When this medicine is used alone, the recommended dose is one drop in the affected eye(s) in the morning, in the afternoon and in the evening.
If the doctor has recommended to use this medicine with a beta-blocker eye drop to lower eye pressure, then the recommended dose is one drop of TRUSOPT in the affected eye(s) in the morning and in the evening.
If using TRUSOPT 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. It may become contaminated with bacteria that can cause eye infections leading to serious damage of the eye, even loss of vision. To avoid possible contamination, wash hands before using this medicine and keep the tip of the container away from contact with any surface. If it is possible that the medication may be contaminated, or if an eye infection develops, contact the doctor immediately concerning continued use of this container.
Forgotten use of TRUSOPT: It is important to take this medicine as prescribed by the doctor. If a dose is missed, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule.
Do not take a double dose to make up for the forgotten dose.
Stopping use of TRUSOPT: If the use of this medicine wants to be stopped, talk to the doctor first. If there are any further questions on the use of this product, ask the doctor or pharmacist.

If the patient puts too many drops in the eye or swallows any of the contents of the container, the patient should contact the doctor immediately.

Do not use TRUSOPT: if allergic to dorzolamide hydrochloride or any of the other ingredients of this medicine (listed in Description); if with severe kidney impairment or problems, or a prior history of kidney stones.

Talk to the doctor or pharmacist before using TRUSOPT.
Tell the doctor or pharmacist about any current or past medical problems, including eye problems and eye surgeries, and about any allergies to any medications.
If any eye irritation or any new eye problems such as redness of the eye or swelling of the eyelids develop, contact the doctor immediately.
If TRUSOPT is suspected to cause an allergic reaction (for example, skin rash, severe skin reaction or itching), stop using this medicine and contact the doctor immediately.
Use in patients with liver impairment: Tell the doctor about any current or past liver problems.
TRUSOPT contains benzalkonium chloride: This medicine contains approximately 0.002 mg benzalkonium chloride in each drop which is equivalent to 0.075 mg/ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. The patient should remove contact lenses before using this medicine and put them back 15 minutes afterwards.
Benzalkonium chloride may also cause eye irritation, especially if having dry eyes or disorders of the cornea (the clear layer at the front of the eye). If feeling abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to the doctor.
Driving and using machines: No studies on the effects on the ability to drive or use machines have been performed. There are side effects associated with TRUSOPT, such as dizziness and blurred vision, which may affect the ability to drive and/or operate machinery. Do not drive or operate machinery until feeling well or vision is clear.
Use in Children: TRUSOPT 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 the doctor.
Use in the Elderly: In studies with TRUSOPT, the effects of this medicine were similar in both elderly and younger patients.

If pregnant or breast-feeding, possibly pregnant or planning to have a baby, ask the doctor or pharmacist for advice before taking this medicine.
Pregnancy: Do not use this medicine during pregnancy. Tell the doctor if pregnant or intending to become pregnant.
Breast-feeding: If treatment with this medicine is required, breast-feeding is not recommended. Tell the doctor if breast-feeding or intending to breast-feed.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If allergic reactions develop, including hives, swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing, stop using this medicine and seek immediate medical advice.
The following side effects have been reported with TRUSOPT either during clinical trials or during post-marketing experience.
Very common side effects (affects more than 1 user in 10): Burning and stinging of the eyes.
Common side effects (affects 1 to 10 users in 100): Disease of the cornea with sore eye and blurred vision (superficial punctuate keratitis), discharge with itching of the eyes (conjunctivitis), irritation/inflammation of the eyelid, blurred vision, headache, nausea, bitter taste, and fatigue.
Uncommon side effects (affects 1 to 10 users in 1,000): Inflammation of the iris.
Rare side effects (affects 1 to 10 users in 10,000): Tingling or numbness of the hands or feet, temporary shortsightedness which may resolve when treatment is stopped, development of fluid under the retina (choroidal detachment, following filtration surgery), eye pain, eyelid crusting, low pressure in the eye, swelling of the cornea (with symptoms of visual disturbances), eye irritation including redness, kidney stones, dizziness, nose bleed, throat irritation, dry mouth, localized skin rash (contact dermatitis), severe skin reactions, allergic type reactions such as rash, hives, itching, in rare cases possible swelling of the lips, eyes and mouth, shortness of breath, and more rarely wheezing.
Not known (frequency cannot be estimated from the available data): Shortness of breath, foreign body sensation in eye (feeling that there is something in the eye), forceful heartbeat that may be rapid or irregular (palpitations).
Reporting of side effects: If any side effects occur, talk to the doctor, pharmacist or nurse. This includes any possible side effects not previously listed.

Tell the doctor or pharmacist if using, have recently used or might use any other medicines (including eye drops). This is particularly important if taking another carbonic anhydrase inhibitor such as acetazolamide, or a sulpha drug.

Instructions for use: Do not use the container if the plastic safety strip around the neck is missing or broken. When opening the container for the first time, tear off the plastic safety strip.
Every time TRUSOPT is used: 1. Wash hands.
2. Open the container. Take special care that the tip of the dropper container does not touch the eye, the skin around the eye or the fingers.
3. Tilt the head backwards and hold the container upside down over the eye.
4. Pull the lower eyelid downwards and look up. Hold and gently squeeze the container on the flattened sides of the container and let one drop fall into the space between the lower eyelid and the eye.
5. Press a finger into the corner of the eye, by the nose, or close the eyelids for 2 minutes. This helps to stop the medicine from getting into the rest of the body.
6. Repeat steps 3 to 5 with the other eye if instructed to do so by the doctor.
7. Put the cap back on and close the container tightly.

TRUSOPT should be used within 1 month after the container is opened.
Do not store over 30°C.
Store container in outer carton in order to protect from light.

Antiglaucoma Preparations

S01EC03 - dorzolamide ; Belongs to the class of carbonic anhydrase inhibitors. Used in the treatment of glaucoma.

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