Dorzolamide 20 Mg/Ml Eye Drops Solution
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before
you start taking 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 is and what it is used for
2. Before you use Dorzolamide 20 mg/ml Eye drops solution
3. How to use Dorzolamide 20 mg/ml Eye drops
4. Possible side effects
5. How to store Dorzolamide 20 mg/ml Eye drops
6. Further information
OWHAT DORZOLAMIDE IS AND WHAT IT IS USED FOR
Dorzolamide 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).
©BEFORE YOU USE DORZOLAMIDE 20 MG/ML EYE DROPS SOLUTION
Do NOT use Dorzolamide 20 mg/ml Eye drops solution
• If you are allergic (hypersensitive) to dorzolamide hydrochloride or to any of the other ingredients of this medicine
• If you have severe kidney impairment or problems, or a prior history of kidney stones.
Take special care with Dorzolamide 20 mg/ml Eye drops solution
Tell your doctor about any medical problems you have now or have had in the past, including eye problems and eye surgeries, and about any allergies to any medications.
If you develop any eye irritation or any new eye problems such as redness of the eye or swelling of the eyelids, contact your doctor immediately.
If you suspect that this medicine is causing an allergic reaction (for example, skin rash, severe skin reaction or itching) stop its use and contact your doctor immediately.
If you wear contact lenses, you should consult your doctor before using this medicine.
Use in children
Dorzolamide has been studied in infants and children less than six years of age who have raised pressure in the eye(s) or have been diagnosed with glaucoma. For more information, talk to your doctor.
Use in the elderly
In studies with dorzolamide, the effects of dorzolamide were similar in both elderly and younger patients.
Use in patients with liver impairment
Tell your doctor about any liver problems you now have or have suffered from in the past.
Using other medicines
Tell your doctor about all drugs (including eye drops) that you are using or plan to use, including those obtained without a prescription, particularly another carbonic anhydrase inhibitor such as acetazolamide, or a sulfa drug.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Use in pregnancy
You should not use this medicine during pregnancy. Tell your doctor if you are pregnant or intend to become pregnant.
Use in breast-feeding
If treatment with this medicine is required, breast-feeding is not recommended. Tell your doctor if you are breast-feeding or intend to breast-feed.
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 this medicine, such as dizziness and blurred vision, which may affect your ability to drive and/or operate machinery. Do not drive or operate machinery until you feel well or your vision is clear.
Important information about some of the ingredients of Dorzolamide
This medicinal product contains the preservative benzalkonium chloride. This preservative may be deposited in soft contact lenses and may possibly discolour the lenses. If you wear soft contact lenses, you should consult your doctor before using this medicine. It is important that your lenses are removed before using your eye drops and not put back into your eyes for at least 15 minutes after using your eye drops.
Your doctor can explain this to you.
HOW TO USE DORZOLAMIDE 20 MG/ML EYE DROPS SOLUTION
Always use this medicine 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 this medicine is used alone, the usual dose is one drop in the affected eye(s) in the morning, in the afternoon and in the evening.
If your doctor has recommended you use this medicine with a beta-blocker eye drop to lower eye pressure, then the dose is one drop of Dorzolamide 20 mg/ml Eye drops solution in the affected eye(s) in the morning and in the evening.
If you are using this medicine with another eye drop, the drops should be instilled at least 10 minutes apart.
Do not change the dose of your medicine without consulting your doctor.
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.
Pharma code 296
Instructions for use
It is recommended that you wash your hands before putting in your eye drops.
1. Before using the medication for the first time, be sure the tamper seal is unbroken.
2. To open the bottle, unscrew the cap.
3. Tilt your head back and pull your lower eyelid down slightly to form a pocket between your eyelid and your eye.
4. Invert the bottle, and press lightly on the sides of the bottle until a single drop is dispensed into the eye as directed by your doctor. DO NOT TOUCH YOUR EYE OR EYELID WITH THE DROPPER TIP
5. Repeat steps 3 and 4 with the other eye if instructed to do so by your doctor.
6. Replace the cap by turning until it is firmly touching the bottle.
7. The dispenser tip is designed to provide a pre-measured drop; therefore, do not enlarge the hole of the dispenser tip.
If you use more Dorzolamide than you should
If you put too many drops in your eye or swallow any of the contents of the container, you should contact your doctor immediately.
If you forget to use Dorzolamide
It is important to use your medicine 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 go back to your regular dosing schedule. Do not take a double dose to make up for the forgotten dose.
If you stop using Dorzolamide
If you want to stop using this medicine talk to your doctor first.
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 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 have been reported with dorzolamide either during clinical trials or during post-marketing experience:
Very common side effects (more than 1 user in 10)
• Burning and stinging of the eyes.
Common side effects (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
• Fatigue.
Uncommon side effects (1 to 10 users in 1,000)
• Inflammation of the iris.
Rare side effects (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
• Localised 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.
If any of the side effects get serious, or
if you notice any side effects not listed
in this leaflet, please tell your doctor.
©HOW TO STORE DORZOLAMIDE 20 MG/ML EYE DROPS SOLUTION
• Keep out of the reach and sight of children
• Do not use this medicine after the expiry date which is stated on the bottle and carton. The expiry date refers to the last day of that month • Dorzolamide 20 mg/ml Eye drops solution should be used within 28 days after the bottle is first opened • Store below 30°C • Do not refrigerate or freeze • Do not transfer Dorzolamide 20 mg/ml Eye drops solution into another container, it might get mixed up or contaminated
• 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.
FURTHER INFORMATION
What Dorzolamide contains
• The active substance is dorzolamide. Each ml contains 22.6 mg dorzolamide hydrochloride, corresponding to 20 mg of dorzolomide
• The other ingredients are hydroxyethylcellulose, mannitol e421, sodium citrate E331, sodium hydroxide E524, and water for injection. Benzalkonium chloride (0.075 mg/ml) is added as a preservative.
What Dorzolamide looks like and contents of the pack
• Clear, viscous solution, free from visible particles in white bottles with white droppers and white, HDPE tamper proof cap
• Each bottle contains 5 ml of solution. It is available in pack sizes of 1 x 5 ml, 3 x 5 ml and 6 x 5 ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder is TEVA UK Limited, Eastbourne, BN22 9AG. Manufacturer is TEVA Pharmaceutical Works Private Limited Company, Tancsics Mihaly ut 82, H-2100, Godollo, Hungary.
This leaflet was last revised in June 2011
PL 00289/1116
TEVA UK LIMITED
3-29119610/A
87166-U