PACKAGE LEAFLET: INFORMATION FOR THE USER

Dorzolamide Warren 20 mg/ml eye drops, solution

(dorzolamide)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-    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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.    What Dorzolamide Warren is and what it is used for

2.    What you need to know before you take Dorzolamide Warren

3.    How to use Dorzolamide Warren

4.    Possible side effects

5.    How to store Dorzolamide Warren

6.    Contents of the pack and other information

1. What Dorzolamide Warren is and what it is used for

Dorzolamide Warren 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).

2. What you need to know before you take Dorzolamide Warren

Do not take Dorzolamide Warren if

•    you are allergic (hypersensitive) to dorzolamide hydrochloride or any of the other ingredients of this medicine (listed in Section 6).

•    you have severe kidney impairment or problems, or a prior history of kidney stones.

Warnings and precautions

Talk to your doctor or pharmacist before taking your medicine if:

•    you have now or have had in the past, including eye problems and eye surgeries, and about any allergies to any medications.

•    you develop any eye irritation or any new eye problems such as redness of the eye or swelling of the eyelids.

•    you suspect that this medicine is causing an allergic reaction (for example, skin rash, severe skin reaction or itching) and stop its use.

•    any liver problems you now have or have suffered from in the past.

•    if you wear contact lenses (see the section Dorzolamide Warren contains the preservative benzalkonium chloride).

Children

Dorzolamide Warren 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 your doctor.

Other medicines and Dorzolamide Warren

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including those obtained without a prescription, particularly another carbonic anhydrase inhibitor such as acetazolamide, or a sulfa drug.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice befor taking this medicine.

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.

Dorzolamide Warren contains Benzalkonium Chloride

Dorzolamide Warren contains the preservative benzalkonium chloride. May cause eye irritation. Avoid contact with soft contact lenses. Remove contact lenses prior to application and wait at least 15 minutes before reinsertion. Known to discolour soft contact lenses.

3. How to use Dorzolamide Warren

Always use Dorzolamide Warren 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 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 Warren 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 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 your hands before using this medicine and keep the tip of the container away from contact with any surface. If you think your medication may be contaminated, or if you develop an eye infection, contact your doctor immediately concerning continued use of this bottle.

Instructions for 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. Then break the seal.

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.    Invert the bottle, 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 DROPPER TIP.

5.    Repeat steps 3 and 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 Warren than you should

If you put too many drops in your eye or the contents of the container are swallowed, you should contact your doctor immediately.

If you forget to use Dorzolamide Warren

It is important to take this 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 a forgotten dose.

If you stop using Dorzolamide Warren

If you want to stop using this medicine talk to your doctor first. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Dorzolamide Warren 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 Warren 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, and fatigue.

Uncommon side effects: (1 to 10 users in 1,000)

Inflammation of the iris.

Rare side effects: (1 to 10 user 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.

If any of the side effects get serious, or if you notice any side effects not listed in the leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Dorzolamide Warren

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 carton and label after ‘EXP’. The expiry date refers to the last day of that month.

Shelf-life after first opening: 28 days.

This medicinal product does not require any special storage conditions. Keep the bottle in the outer carton in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Dorzolamide Warren contains

-    The active substance is dorzolamide.

Each ml contains 22.3 mg of dorzolamide hydrochloride corresponding to 20 mg of dorzolamide

-    The other ingredients are hydroxyethylcellulose, mannitol, sodium citrate, sodium hydroxide and water for injections. Benzalkonium chloride is added as a preservative

What Dorzolamide Warren looks like and contents of the pack

Dorzolamide Warren 20 mg/ml eye drops, solution is a slightly opalescent, colourless to nearly colourless, slightly viscous solution filled in gamma sterilized low density polyethylene (LDPE) bottle with translucent LDPE nozzle and white high density polyethylene (HDPE) cap with a tamper evident ring, that has to be broken upon first time use.

Pack sizes:

1 x 5.0 ml (single 5 ml container)

3 x 5.0 ml (three 5 ml containers)

6 x 5.0 ml (six 5 ml containers)

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

WARREN GENERICS s.r.o.

U Stare tvrze 285/21,

196 00 Praha 9,

Czech Republic

Manufacturer:

IMUNA PHARM, a.s.

Jarkova 269/17 Sarisske Michal’any 082 22 Slovak Republic

Wessling Hungary Kft.

1047 Budapest, Foti ut 56.

Hungary

This medicinal product is authorised in the Member States of the EEA under the following names:

Cyprus    UNIDROPS® 20 mg/ml o^Oakpmer; oxayove^, Siakupa

Germany    Dorzolamid Warren 20 mg/ml Augentropfen, Losung

Greece    UNIDROPS® 20 mg/ml o^Oakpmer; oxayove^, Siakupa

Hungary    Dorzolamide Warren 20 mg/ml oldatos szemcsepp

The Netherland    Dorzolamide Warren 20 mg/ml oogdruppels, oplossing

The United Kingdom    Dorzolamide Warren 20 mg/ml eye drops, solution

This leaflet was last revised in April 2016.

February 2016 5/5 5