Dorzolamide 20mg/Ml Eye Drops Solution
PACKAGE LEAFLET: INFORMATION FOR THE USER Dorzolamide 20mg/ml Eye drops, solution
dorzolamide
Read all of this leaflet carefully before you start
using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Dorzolamide eye drops are and what they are used for
2. Before you use Dorzolamide eye drops
3. How to use Dorzolamide eye drops
4. Possible side effects
5. How to store Dorzolamide eye drops
6. Further information
1. WHAT DORZOLAMIDE EYE DROPS ARE AND WHAT THEY ARE USED FOR
The full name of your medicine is ‘Dorzolamide 20mg/ml Eye drops, solution’ (referred to as Dorzolamide eye drops in the rest of this leaflet).
Dorzolamide eye drops are a sterile eye drop solution. Dorzolamide eye drops contain dorzolamide, a sulphonamide-related compound, as the active ingredient.
Dorzolamide is an ophthalmic carbonic anhydrase inhibitor which reduces high pressure in the eye.
It is prescribed to lower raised pressure in the eye in conditions such as ocular hypertension and glaucoma (open-angle glaucoma, pseudo-exfoliative glaucoma). Dorzolamide eye drops can be used alone or in addition to other medicines which lower the pressure in the eye (so-called beta-blockers).
2. BEFORE YOU USE DORZOLAMIDE EYE DROPS
Do not use Dorzolamide eye drops
- if you are allergic (hypersensitive) to dorzolamide or any of the other ingredients of this solution.
- if you have severe kidney problems.
Take special care with Dorzolamide eye drops
Before treatment with Dorzolamide eye drops, tell your doctor
- if you have or have had liver problems in the past
- if you have been told you have a problem in the surface layer of the eye
- if you have had any allergies to any medicines
- if you have had, or are about to have eye surgery
- if you have suffered an eye injury or have an eye infection
- if you have a prior history of kidney stones
- if you are taking orally another carbonic anhydrase inhibitor such as acetazolamide
- if you wear contact lenses (see the section ‘Important information about some of the ingredients of Dorzolamide eye drops).
You should contact your doctor immediately if you develop any eye irritation or any new eye problems such as redness of the eye or swelling of the surface layer of the eye or eyelids.
Stop using Dorzolamide eye drops and contact your doctor immediately if you suspect that Dorzolamide eye drops are causing an allergic reaction (for example, skin rash or itching, inflammation of the eye).
Use in children
Dorzolamide eye drops have 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.
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
In particular you should tell your doctor if you are taking another carbonic anhydrase inhibitor such as acetazolamide. You may be taking this type of medicine by mouth, as eye drops, or by some other method.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine. Tell your doctor if you are pregnant or planning to become pregnant. Dorzolamide eye drops should not be used during pregnancy unless your doctor still recommends it. Dorzolamide eye drops should not be used while breast-feeding.
Driving and using machines
Dorzolamide eye drops may cause dizziness and visual disturbances in some patients. Do not drive or use any tools or machines until the symptoms have cleared.
Important information about some of the ingredients of Dorzolamide eye drops
Dorzolamide eye drops contain the preservative benzalkonium chloride.
• Benzalkonium chloride may cause eye irritation.
• Benzalkonium chloride is known to discolour soft contact lenses.
• Avoid contact with soft contact lenses.
• Remove contact lenses prior to application and wait until 15 minutes before reinsertion.
3. HOW TO USE DORZOLAMIDE EYE DROPS
Always use Dorzolamide eye drops exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The appropriate dosage and duration of treatment will be established by your doctor.
When Dorzolamide eye drops are used alone, the usual dose is one drop in the affected eye(s) three times a day, for example in the morning, in the afternoon and in the evening.
If your doctor has recommended you use Dorzolamide eye drops with a beta-blocker eye drop (medicines which lower the pressure of the eye), then the usual dose is one drop of Dorzolamide eye drops in the affected eye(s) two times a day, for example in the morning and in the evening.
If you use Dorzolamide eye drops with another eye drop, leave at least 10 minutes between putting in Dorzolamide eye drops and the other medicine. Alternatively if you are going to use Dorzolamide eye drops to replace another eye drop medicine, used to lower eye pressure, you should stop using the other medicine after taking the proper dosing on one day, and start Dorzolamide eye drops on the next day.
Do not change the dosage of the drug without consulting your doctor. If you must stop treatment, contact your doctor immediately.
Do not allow the tip of the container to touch your eye or areas around your 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 of the container, keep the tip of the container away from contact with any surface.
Instructions for proper use:
It is recommended that you wash your hands before putting in your eye drops.
It may be easier to apply your eye drops in front of a mirror.
1. Before using the medication for the first time, be sure that the tamper-proof seal on the bottle neck is unbroken. A gap between the bottle and the cap is normal for an unopened bottle.
2. Take off the cap of the bottle.
3. Tilt your head back and gently pull your lower eyelid down to form a small pocket between your eyelid and your eye.
4. Turn the bottle upside down, and squeeze it until a single drop is dispensed into the eye as directed by your doctor. DO NOT TOUCH YOUR EYE OR EYELID WITH THE DROPPERTIP
5. Repeat steps 3 & 4 with the other eye if instructed to do so by your doctor.
6. Put the cap back on and close the bottle straight after you have used it.
If you use more Dorzolamide eye drops than you should
If you put too many drops in your eye or swallow any of the contents, you should contact your doctor immediately.
If you forget to use Dorzolamide eye drops
It is important to use Dorzolamide eye drops as prescribed by your doctor.
If you miss a dose, use it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and go back to your regular dosing schedule.
Do not use a double dose to make up for forgotten individual doses.
If you stop using Dorzolamide eye drops
Dorzolamide eye drops should be used every day to work properly If you must stop treatment, contact your doctor immediately.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Dorzolamide eye drops can cause side effects, although not everybody gets them.
If you develop allergic reactions including hives, swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing, you should stop using this medicine and seek immediate medical advice.
The following side effects may be seen with Dorzolamide eye drops:
Very common (affects more than 1 in 10 people)
• burning and stinging of the eyes
Common (affects in between 1 and 10 out of every 100 people)
• disease of the surface layer of the eye with sore eye and blurred vision, inflammation or swelling of the surface layer of the eye(s) and possible inflammation of the eyelid(s) and/or skin around the eye(s), watering or itching of the eye(s), blurred vision, effects on the surface of the eye
• nausea, bitter taste
• weakness/fatigue
• headache
Uncommon (affects in between 1 and 10 out of every
1.000 people)
• 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
• Hypersensitivity: signs and symptoms of local reaction (affecting the eye lids) and general allergic reactions such as rash, hives, itching, in rare cases possible swelling of the lips, eyes and mouth, shortness of breath and more rarely wheezing
• dizziness, numbness/tingling sensation
• formation of kidney stones in the urinary system
• bleeding from the nose
• skin inflammation
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE DORZOLAMIDE EYE DROPS
Keep out of the reach and sight of children.
Do not use Dorzolamide eye drops after the expiry date which is stated on the bottle label and the carton after EXP: The expiry date refers to the last day of that month.
Keep the bottle in the outer carton in order to protect from light. Store below 30°C.
Dorzolamide eye drops should be used within 28 days after the bottle is first opened. Therefore, you must throw away the bottle 4 weeks after you first opened it, even if some solution is left. To help you remember, write down the date that you opened it in the space on the carton.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Dorzolamide eye drops contain
- The active substance is dorzolamide. Each ml contains 20mg dorzolamide (as dorzolamide hydrochloride).
- The other ingredients are Mannitol, Hydroxyethyl Cellulose, Benzalkonium Chloride (as a preservative), Sodium Citrate, Sodium Hydroxide for pH adjustment and Water for injections.
What Dorzolamide eye drops look like and contents of the pack
Dorzolamide eye drops are a sterile, isotonic, buffered, colourless, clear, slightly viscous solution in a white opaque medium density polyethylene bottle with a sealed dropper tip and a two-piece cap assembly Each bottle contains 5mL of the eye drop solution.
Dorzolamide eye drops are available in packs containing 1 bottle, 3 bottles or 6 bottles.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Pharmathen S.A.
6 Dervenakion str,
153 51 Pallini Attiki,
Greece
Manufacturer
Pharmathen S.A.
6 Dervenakion str.,
153 51 Pallini Attiki,
Greece
or
FamarS.A.
63 Agiou Dimitriou Street,
174 56Alimos Greece
This leaflet was last approved in
12/2010
1010122/P1