PACKAGE LEAFLET: INFORMATION FOR THE USER
Dorzolamide 20mg/ml Eye drops, solution dorzolamide
Read all of this leaflet carefully before you start using Using other medicines this medicine. Please tell your doctor or pharmacist if you are taking or Keep this leaflet. You may need to read it again. have recently taken any other medicines, including If you have any further questions, ask your doctor or medicines obtained without a prescription. pharmacist. In particular you should tell your doctor if you are taking This medicine has been prescribed for you. Do not another carbonic anhydrase inhibitor such as pass it on to others. It may harm them, even if their acetazolamide. You may be taking this type of medicine symptoms are the same as yours. by mouth, as eye drops, or by some other method.
If any of the side effects gets serious, or if you notice Pregnancy and breast-feeding any side effects not listed in this leaflet, please tell Ask your doctor or pharmacist for advice before taking any your doctor or pharmacist. medicine. Tell your doctor if you are pregnant or planning In this leaflet: to become pregnant. Dorzolamide eye drops should not 1. What Dorzolamide eye drops are and what they are be used during pregnancy unless your doctor still used for recommends it. 2. Before you use Dorzolamide eye drops Dorzolamide eye drops should not be used while breast- 3. How to use Dorzolamide eye drops feeding.
4. Possible side effects Driving and using machines 5. How to store Dorzolamide eye drops Dorzolamide eye drops may cause dizziness and visual 6. Further information disturbances in some patients. Do not drive or use any 1. WHAT DORZOLAMIDE EYE DROPS ARE AND tools or machines until the symptoms have cleared.
WHAT THEY ARE USED FOR Important information about some of the ingredients The full name of your medicine is “Dorzolamide 20mg/ml of Dorzolamide eye drops Eye drops, solution” (referred to as Dorzolamide eye Dorzolamide eye drops contain the preservative drops in the rest of this leaflet). benzalkonium chloride. Benzalkonium chloride may cause eye irritation. Dorzolamide eye drops are a sterile eye drop solution. Benzalkonium chloride is known to discolour soft Dorzolamide eye drops contain dorzolamide, a contact lenses. sulphonamide-related compound, as the active ingredient. Avoid contact with soft contact lenses.
Dorzolamide is an ophthalmic carbonic anhydrase inhibitor Remove contact lenses prior to application and wait which reduces high pressure in the eye. until 15 minutes before reinsertion.
It is prescribed to lower raised pressure in the eye in 3. HOW TO USE DORZOLAMIDE EYE DROPS conditions such as ocular hypertension and glaucoma Always use Dorzolamide eye drops exactly as your doctor (open-angle glaucoma, pseudo-exfoliative glaucoma). has told you. You should check with your doctor or Dorzolamide eye drops can be used alone or in addition to pharmacist if you are not sure. other medicines which lower the pressure in the eye (so- called beta-blockers). The appropriate dosage and duration of treatment will be established by your doctor. 2. BEFORE YOU USE DORZOLAMIDE EYE DROPS When Dorzolamide eye drops are used alone, the usual Do not use Dorzolamide eye drops dose is one drop in the affected eye(s) three times a day, - if you are allergic (hypersensitive) to Dorzolamide or for example in the morning, in the afternoon and in the any of the other ingredients of this solution. evening. - if you have severe kidney problems. If your doctor has recommended you use Dorzolamide Take special care with Dorzolamide eye drops eye drops with a beta-blocker eye drop (medicines which Before treatment with Dorzolamide eye drops, tell your lower the pressure of the eye), then the usual dose is one doctor drop of Dorzolamide eye drops in the affected eye(s) two if you have or have had liver problems in the past times a day, for example in the morning and in the if you have been told you have a problem in the evening. surface layer of the eye if you have had any allergies to any medicines If you use Dorzolamide eye drops with another eye drop, if you have had, or are about to have eye surgery leave at least 10 minutes between putting in Dorzolamide if you have suffered an eye injury or have an eye eye drops and the other medicine. Alternatively if you are infection going to use Dorzolamide eye drops to replace another if you have a prior history of kidney stones eye drop medicine, used to lower eye pressure, you if you are taking orally another carbonic anhydrase should stop using the other medicine after taking the inhibitor such as acetazolamide proper dosing on one day, and start Dorzolamide eye drops on the next day. if you wear contact lenses (see the section ‘Important information about some of the ingredients of Do not change the dosage of the drug without consulting Dorzolamide eye drops’). your doctor. If you must stop treatment, contact your doctor immediately. You should contact your doctor immediately if you develop any eye irritation or any new eye problems such as Do not allow the tip of the container to touch your eye or redness of the eye or swelling of the surface layer of the areas around your eye. It may become contaminated with eye or eyelids. bacteria that can cause eye infections leading to serious Stop using Dorzolamide eye drops and contact your damage of the eye, even loss of vision. To avoid possible doctor immediately if you suspect that Dorzolamide eye contamination of the container, keep the tip of the drops are causing an allergic reaction (for example, skin container away from contact with any surface. rash or itching, inflammation of the eye). Instructions for proper use: Use in children It is recommended that you wash your hands before Dorzolamide eye drops have been studied in infants and putting in your eye drops. children less than 6 years of age who have raised It may be easier to apply your eye drops in front of a pressure in the eye(s) or have been diagnosed with mirror. glaucoma. For more information, talk to your doctor.
1. Before using the medication for the first time, be sure Hypersensitivity: signs and symptoms of local that the tamper-proof seal on the bottle neck is reactions (affecting the eye lids) and general allergic unbroken. A gap between the bottle and the cap is reactions such as rash, hives, itching, in rare cases normal for an unopened bottle. possible swelling of the lips, eyes and mouth, 2. Take off the cap of the bottle. shortness of breath and more rarely wheezing, 3. Tilt your head back dizziness, numbness/tingling sensation and gently pull your formation of kidney stones in the urinary system lower eyelid down bleeding from the nose to form a small skin inflammation pocket between your eyelid and If any of the side effects gets serious, or if you notice any your eye. side effects not listed in this leaflet, please tell your doctor 4. Turn the bottle or pharmacist. upside down, and squeeze it until a single drop is 5. HOW TO STORE DORZOLAMIDE EYE DROPS dispensed into the eye as directed by your doctor. DO NOT TOUCH YOUR EYE OR EYELID WITH Keep out of the reach and sight of children. THE DROPPER TIP. Do not use Dorzolamide eye drops after the expiry date 5. Repeat steps 3 & 4 with the other eye if instructed to which is stated on the bottle label and the carton after do so by your doctor. EXP:. The expiry date refers to the last day of that month. 6. Put the cap back on and close the bottle straight after you have used it. Keep the bottle in the outer carton in order to protect from light. Store below 30°C. If you use more Dorzolamide eye drops than you should Dorzolamide eye drops should be used within 28 days If you put too many drops in your eye or swallow any of after the bottle is first opened. Therefore, you must throw the contents, you should contact your doctor immediately. away the bottle 4 weeks after you first opened it, even if some solution is left. To help you remember, write down If you forget to use Dorzolamide eye drops the date that you opened it in the space on the carton. It is important to use Dorzolamide eye drops as prescribed by your doctor. Medicines should not be disposed of via wastewater or
If you miss a dose, apply it as soon as possible. However, household waste. Ask your pharmacist how to dispose of if it is almost time for the next dose, skip the missed dose medicines no longer required. These measures will help to protect the environment. and go back to your regular dosing schedule.
Do not use a double dose to make up for forgotten 6. FURTHER INFORMATION individual doses. What Dorzolamide eye drops contain If you stop using Dorzolamide eye drops The active substance is Dorzolamide. Each ml Dorzolamide eye drops should be used every day to work contains 20 mg Dorzolamide (as Dorzolamide properly. If you must stop treatment, contact your doctor hydrochloride). immediately. The other ingredients are Mannitol, Hydroxy Ethyl Cellulose, Benzalkonium Chloride (as a If you have any further questions on the use of this preservative), Sodium Citrate, Sodium Hydroxide for product, ask your doctor or pharmacist. pH adjustment and Water for injection. 4. POSSIBLE SIDE EFFECTS What Dorzolamide eye drops look like and contents of Like all medicines, Dorzolamide eye drops can cause side the pack effects, although not everybody gets them. Dorzolamide eye drops are a sterile, isotonic, buffered, If you develop allergic reactions including hives, swelling colourless, clear, slightly viscous solution in a white of the face, lips, tongue, and/or throat which may cause opaque medium density polyethylene bottle with a sealed difficulty in breathing or swallowing, you should stop using dropper tip and a two-piece cap assembly. Each bottle this medicine and seek immediate medical advice. contains 5 mL of the eye drop solution.
The following side effects may be seen with Dorzolamide Dorzolamide eye drops are available in packs containing 1 eye drops. bottle, 3 bottles or 6 bottles. Very common (affects more than 1 in 10 people) Not all pack sizes may be marketed. burning and stinging of the eyes Marketing Authorisation Holder Common (affects in between 1 and 10 out of every 100 Pharmathen S.A., 6, Dervenakion str., 153 51 Pallini Attiki, people) Greece disease of the surface layer of the eye with sore eye and blurred vision, inflammation or swelling of the Manufacturer surface layer of the eye(s) and possible inflammation Pharmathen S.A., 6, Dervenakion str., 153 51 Pallini Attiki, of the eyelid(s) and/or skin around the eye(s), Greece watering or itching of the eye(s), blurred vision, Or effects on the surface of the eye Famar S.A., 63 Agiou Dimitriou Street, 174 56 Alimos, nausea, bitter taste Greece weakness/fatigue Distributor: headache Beacon Pharmaceuticals Ltd., 85 High Street, Tunbridge Uncommon (affects in between 1 and 10 out of every Wells, TN1 1YG, UK. 1000 people) This leaflet was last approved in 12/2010. inflammation of the middle layer of the eye
Rare (affects in between 1 and 10 out of every 10,000 people) swelling of the surface layer of the eye(s), separation of part of the lining of the eye due to a build up of fluid which may be accompanied by visual changes/disturbances (following eye surgery), low pressure in the eye, redness of the eye(s), eye pain, crusting of the eyelid(s), temporary shortsightedness (which stops when the medicine is discontinued) throat irritation, dry mouth